http://repub.eur.nl/res/aut/21787/ List of Publications en http://repub.eur.nl/static-eur/img/logo.png http://repub.eur.nl http://repub.eur.nl/res/pub/37632/ 2012-10-01T00:00:00Z Objective: To assess the differential implications of cardiac biomarker type on peri-procedural myocardial infarction (PMI) reporting. Setting: The Resolute 'All-Comers' stent trial. Interventions: Blood samples for creatine kinase (CK), CK-myoband (CK-MB) mass or cardiac troponin (cTn) (optional) were collected before and at 6, 12 and 18 h after the assigned percutaneous coronary intervention or at discharge. PMIs were adjudicated using either the 2007 universal definition of MI (type-4a) or the extended historical definition of MI. Patients: 2121/2292 patients (92.5%) had an analysable dataset for either biomarker. 890/2121 patients (42%) presented with an acute coronary syndrome (ACS). 267/890 patients (30%) were within 24 h of an ST-segment elevation MI. Main outcome measures: Type-4a MI was diagnosed in 208/2121 patients (9.8%) when cTn was used (CKMB mass if cTn not available), and in 93/2121 of patients (4.4%) when CK-MB mass was used (cTn if CK-MB mass not available). With the extended historical CK-based definition of MI, PMI was diagnosed in 65/2121 patients (3.1%). Adjudication of type-4a MI in patients with an ACS was problematic with <10% of the potential type-4a MI being confirmed as an event, as compared with approximately 95% in stable patients undergoing elective PCI. Type-4a MI was not associated with the subsequent hazard for cardiac mortality (p=0.6). Conclusions: The percentage of adjudicated PMI events is driven by the MI-definition criteria and biomarker type. Type-4a MI may not be a reliable component of the primary composite end point in coronary stent investigations which recruit patients with ACS. Trial registration number: http://www.ClinicalTrials. gov; Unique identifier: NCT00617084. http://repub.eur.nl/res/pub/33182/ 2011-12-01T00:00:00Z Background: Vessel angulation and large changes in vessel geometry after stent implantation have been associated with an increased risk of target lesion failure (TLF) using bare-metal stents. Second-generation drug-eluting stents (DES)offer superior conformability and inhibition of neointima. The aim of the study is to investigate the relationship between pre and post-implant vessel geometry and the occurrence of TLF at 1 year after treatment with second-generation DES; and to compare the conformability of Resolute and Xience stents. Methods: The RESOLUTE All-Comers trial randomized 2292 patients (3366 lesions) to Resolute zotarolimus-DES (Medtronic CardioVascular) or Xience everolimus-DES (Abbott Vascular). At 1 year, 176 lesions (121 patients)presented with TLF; a composite of cardiac death, acute myocardial infarction (AMI) and target lesion revascularization (TLR). Lesions with TLF were matched with 176 lesions (168 patients) without TLF adjusting for clinical and procedural characteristics. The number of bends, vessel curvature and angulation were assessed with quantitative coronary angiography pre and post-implantation. The absolute difference post minus pre-implantation was used as a surrogate of stent conformability. Results: At pre-implantation, lesions without and with TLF had similar numbers of bends/lesion (1.81 vs 1.74; P =.35), vessel curvature (0.295 cm-1vs 0.363 cm-1; P =.13) and vessel angulation (46.3° vs 43.5°; P =.80), respectively. Lesions without and with TLR also had similar numbers of bends/lesion (1.39 vs 1.39; P =.83), vessel curvature (0.368 cm-1vs 0.325 cm-1; P =.33) and angulation (40.2° vs 37.2°; P =.19). Lesions without and with in-hospital AMI also presented with similar number of bends/lesion (1.69 vs 1.81; P =.48), vessel curvature (0.349 cm-1vs 0.345 cm-1; P =.91) and vessel angulation (43.53° vs 48.45°; P =.38). The absolute difference post- - pre-implantation was similar in lesions without and with TLF, TLR and In-hospital AMI. The absolute difference post- - pre-implantation was similar with both Resolute and Xience in vessel curvature (-0.046 cm-1vs -0.047 cm-1; P =.66) and was smaller in number of bends/lesion (-0.08 vs -0.16; P =.13) and in vessel angulation (-6.0° vs -10.1°; P =.03) with the Resolute. Conclusions: Bended, curved, and angulated lesions and changes in the number of bends/lesion, vessel curvature, and angulation from pre to post-implantation have no relation with TLF and TLR at 1 year and have no relation with In-hospital AMI using second-generation of DES. Resolute appears to be more conformable than Xience. http://repub.eur.nl/res/pub/33590/ 2011-12-01T00:00:00Z Aims To investigate the ability of SYNTAX score and Clinical SYNTAX score (CSS) to predict very long-term outcomes in an all-comers population receiving drug-eluting stents. Methods and resultsThe SYNTAX score was retrospectively calculated in 848 patients enrolled in the SIRolimus-eluting stent compared with pacliTAXel-Eluting Stent for coronary revascularization (SIRTAX) trial. The CSS was calculated using age, and baseline left ventricular ejection fraction and creatinine clearance. A stratified post hoc comparison was performed for all-cause mortality, cardiac death, myocardial infarction (MI), ischaemia-driven target lesion revascularization (TLR), definite stent thrombosis, and major adverse cardiac events (MACE) at 1- and 5-year follow-up. Tertiles for SYNTAX score and CSS were defined as SSLOW ≤7, 7< SSMID ≤14, SSHIGH >14 and CSSLOW ≤8.0, 8.0 <CSSMID ≤17.0 and CSSHIGH >17.0, respectively. Major adverse cardiac events rates were significantly higher in SSHIGH compared with SSLOW at 1- and 5-year follow-up, which was also seen at 5 years for all-cause mortality, cardiac death, MI, and TLR. Stratifying outcomes across CSS tertiles confirmed and augmented these results. Within CSSHIGH, 5-year MACE increased with use of paclitaxel- compared with sirolimus-eluting stents (34.7 vs. 21.3, P 0.008). SYNTAX score and CSS were independent predictors of 5-year MACE; CSS was an independent predictor for 5-year mortality. Areas-under-the-curve for SYNTAX score and CSS for 5-year MACE were 0.61 (0.560.65) and 0.62 (0.570.67), for 5-year all-cause mortality 0.58 (0.510.65) and 0.66 (0.590.73) and for 5-year cardiac death 0.63 (0.540.72) and 0.72 (0.630.81), respectively.ConclusionSYNTAX score and to a greater extent CSS were able to stratify risk for very long-term adverse clinical outcomes in an all-comers population receiving drug-eluting stents. Predictive accuracy for 5-year all-cause mortality was improved using CSS.Trial Registration Number: NCT00297661. Published on behalf of the European Society of Cardiology. http://repub.eur.nl/res/pub/33363/ 2011-07-15T00:00:00Z The purpose of this study was to assess the impact of body mass index (BMI) on clinical outcome of patients treated by percutaneous coronary intervention (PCI) using drug-eluting stents. Patients were stratified according to BMI as normal (<25 kg/m2), overweight (25 to 30 kg/m2), or obese (>30 kg/m2). At 5-year follow-up all-cause death, myocardial infarction, clinically justified target vessel revascularization (TVR), and definite stent thrombosis were assessed. A complete dataset was available in 7,427 patients, of which 45%, 22%, and 33% were classified according to BMI as overweight, obese, and normal, respectively. Mean age of patients was significantly older in those with a normal BMI (p <0.05). Incidence of diabetes mellitus, hypertension, and dyslipidemia increased as BMI increased (p <0.05). Significantly higher rates of TVR (15.3% vs 12.8%, p = 0.02) and early stent thrombosis (1.5% vs 0.9%, p = 0.04) were observed in the obese compared to the normal BMI group. No significant difference among the 3 BMI groups was observed for the composite of death/myocardial infarction/TVR or for definite stent thrombosis at 5 years, whereas the normal BMI group was at higher risk for all-cause death at 5 years (obese vs normal BMI, hazard ratio 0.74, confidence interval 0.53 to 0.99, p = 0.05; overweight vs normal BMI, hazard ratio 0.73, confidence interval 0.59 to 0.94, p = 0.01) in the multivariate Cox proportional hazard model. Age resulted in a linearly dependent covariate with BMI in the all-cause 5-year mortality multivariate model (p = 0.001). In conclusion, the "obesity paradox" observed in 5-year all-cause mortality could be explained by the higher rate of elderly patients in the normal BMI group and the existence of colinearity between BMI and age. However, obese patients had a higher rate of TVR and early stent thrombosis and a higher rate of other risk factors such as diabetes mellitus, hypertension, and hypercholesterolemia. http://repub.eur.nl/res/pub/34494/ 2011-06-01T00:00:00Z This report describes the 4-year clinical outcomes of the SPIRIT II study, which randomized 300 patients to treatment with the XIENCE V everolimus-eluting stent (EES), or the TAXUS paclitaxel-eluting stent. At 4-year clinical follow-up, which was available in 256 (85.3%) patients, treatment with EES lead to a trend for lower rates of ischemia-driven major adverse cardiovascular events, a composite of cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization (EES 7.7% vs. paclitaxel-eluting stent 16.4%, P = 0.056). Treatment with EES also resulted in a trend toward lower rates of cardiac death and numerically lower rates of myocardial infarction, ischemia-driven target lesion revascularization, and stent thrombosis. Overall, this study reports numerically fewer clinical events in patients treated with EES at 4-year follow-up, which is consistent with results from earlier follow-up. Copyright http://repub.eur.nl/res/pub/34636/ 2011-06-01T00:00:00Z Objectives: This study sought to assess the impact of the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score (SXscore) on clinical outcomes in patients undergoing percutaneous coronary intervention. Background: The SXscore has been demonstrated to have an ability to predict clinical outcomes in patients undergoing percutaneous revascularization. Current studies are limited by the relatively small number of patients in each SXscore group. Methods: Patient-level data from 7 contemporary coronary stent trials were pooled by an independent academic research organization (Cardialysis, Rotterdam, the Netherlands). Analysis was performed on a cohort of 6,508 patients treated with drug-eluting stents and who had calculated SXscores. Clinical outcomes in terms of death, myocardial infarction (MI), repeat revascularization, and major adverse cardiac events (MACE, a composite of death, MI, and repeat revascularization) were subsequently stratified according to SXscore quartiles: SXscoreQ1≤8 (n = 1,702); 8 < SXscoreQ2<15 (n = 1,528); 15 ≤ SXscoreQ3≥23 (n = 1,620); and SXscoreQ4<23 (n = 1,658). Results: One-year outcomes were available in 6,496 patients (99.8%). At 1-year follow-up, all clinical outcomes including mortality, MI, repeat revascularization, MACE, and definite and any stent thrombosis were all significantly higher in patients in the highest SXscore quartile. Similar trends were observed in a subgroup of 2,093 patients (32.2%) who presented with an ST- or nonST-segment elevation MI. The rate of MACE among patients with an SXscore >32 and ≤32 was 24.9% and 14.0%, respectively (p < 0.001). The SXscore was identified as an independent predictor of all clinical outcomes including mortality, MACE, and stent thrombosis (p < 0.001 for all). Conclusions: This study confirms the consistent ability of the SXscore to identify patients who are at highest risk of adverse events. http://repub.eur.nl/res/pub/25262/ 2011-05-19T00:00:00Z We explored the impact of patient demographics, anthropometric measurements, cardiovascular risk factors, and soluble biomarkers on necrotic core and atheroma size in patients with coronary disease. The IBIS-2 trial enrolled 330 patients. In the multivariate analysis, at baseline, creatinine had a positive, whereas baseline mean lumen diameter and myeloperoxidase had a negative, independent association with percentage of necrotic core (PNC); while age, glomerular filtration rate <60, HbA1c, previous PCI or CABG and baseline % diameter stenosis were positively, and acute coronary syndromes (ACS) were negatively associated with baseline percentage atheroma volume (PAV). The variables associated with a decrease in PNC from baseline were darapladib, ACS and a large content of NC at baseline, while variables associated with an increase in PNC were previous stroke and % diameter stenosis at baseline. Those variables associated with a decrease in PAV from baseline were waist circumference, statin use, CD40L and baseline PAV, while the only variable associated with an increase in PAV was baseline diastolic blood pressure. Treatment with darapladib was associated with a decrease in necrotic core, but was not associated with a decrease in percentage atheroma volume. On the contrary, statin use was only associated with a decrease in percentage atheroma volume. http://repub.eur.nl/res/pub/23037/ 2011-04-21T00:00:00Z http://repub.eur.nl/res/pub/33484/ 2011-04-01T00:00:00Z Aims: The aims of this study were to evaluate the SYNTAX score (SXscore) calculated at 2 stages during a primary percutaneous intervention (PPCI), that is, SXscore I (diagnostic) and SXscore II (postwiring), and assess its additional value to standard clinical risk scores in acute myocardial infarction. Methods and Results: SXscores I and II were applied to 736 consecutive acute ST-elevation myocardial infarction patients referred for PPCI between November 2006 and February 2008. SXscore changed significantly before (I: 16, interquartile range 9.5-23) and after wiring (II: 11, interquartile range 6-19), P < .001. Kaplan-Meier methods were used to compare the primary end point major adverse coronary events (MACE; composite of repeat MI, target vessel revascularization [TVR], and mortality) and secondary end point mortality at 1.5 years in tertiles of SXscore I and SXscore II. Major adverse coronary event was highest in the higher SXscore I tertile (11% vs 15% vs 23%, log-rank <0.01), driven primarily by increased rate of mortality (9% vs 11% vs 17%, log-rank 0.02). Major adverse coronary event was also highest in SXscore II tertile, by a combination of increased mortality and also TVR (TVR rate 2% vs 3% vs 9%, log-rank <0.01). Predictive Cox regression models for mortality and MACE were significantly and similarly improved by the addition of either SXscore I or SXscore II (hazard ratio 1.63, 95% CI 1.18-2.26, P < .01 for MACE) with respective c indices of 0.61 and 0.63 for MACE and 0.60 and 0.61 for mortality. Conclusions: SXscore during PPCI is a useful tool that provides additional risk stratification to known risk factors of long-term mortality and MACE in patients with ST-elevation myocardial infarction. http://repub.eur.nl/res/pub/34515/ 2011-04-01T00:00:00Z Although percent plaque components on plaque-based measurement have been used traditionally in previous studies, the impact of vessel-based measurement for percent plaque components have yet to be studied. The purpose of this study was therefore to correlate percent plaque components derived by plaque- and vessel-based measurement using intravascular ultrasound Virtual Histology (IVUS-VH). The patient cohort comprised of 206 patients with de novo coronary artery lesions who were imaged with IVUS-VH. Age ranged from 35 to 88 years old, and 124 patients were male. Whole pullback analysis was used to calculate plaque volume, vessel volume, and absolute and percent volumes of fibrous, fibrofatty, necrotic core, and dense calcium. The plaque and vessel volumes were well correlated (r = 0.893, P < 0.001). There was a strong correlation between percent plaque components volumes calculated by plaque and those calculated by vessel volumes (fibrous; r = 0.927, P < 0.001, fibrofatty; r = 0.972, P < 0.001, necrotic core; r = 0.964, P < 0.001, dense calcium; r = 0.980, P < 0.001,). Plaque and vessel volumes correlated well to the overall plaque burden. For percent plaque component volume, plaque-based measurement was also highly correlated with vessel-based measurement. Therefore, the percent plaque component volume calculated by vessel volume could be used instead of the conventional percent plaque component volume calculated by plaque volume. http://repub.eur.nl/res/pub/34681/ 2011-04-01T00:00:00Z Objectives: This study assessed the ability of the SYNTAX score (SXscore) to stratify risk in patients treated with percutaneous coronary intervention (PCI) using zotarolimus-eluting or everolimus-eluting stents. Background: The SXscore can identify patients treated with PCI who are at highest risk of adverse events. Methods: The SXscore was calculated prospectively in 2,033 of the 2,292 patients enrolled in the RESOLUTE All Comers study (RESOLUTE III All Comers Trial: A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention). Clinical outcomes in terms of a patient-oriented composite endpoint (POCE) of all-cause death, myocardial infarction (MI), and repeat revascularization; the individual components of POCE; target lesion failure (TLF) (a composite of cardiac death, target-vessel MI, and clinically driven target lesion revascularization); and stent thrombosis were subsequently stratified according to SXscore tertiles: SXscoreLOW≤9 (n = 698), 9 <SXscoreMID≤17 (n = 676); SXscoreHIGH>17 (n = 659). Results: At 12-month follow-up, rates of POCE, MI, repeat revascularization, TLF, and the composite of death/MI were all significantly higher in patients in the highest SXscore tercile. Rates of stent thrombosis were all highest in the SXscoreHIGHtertile (p > 0.05). After multivariate adjustment, the SXscore was identified as an independent predictor of POCE, MI, repeat revascularization, and TLF (p < 0.05 for all). At 12-month follow-up, the SXscore, ACEF score, and Clinical SXscore had C-statistics of 0.57, 0.78, and 0.67, respectively, for mortality and of 0.62, 0.56, 0.63, respectively, for POCE. No significant between-stent differences were observed for TLF or POCE in any of the SXscore tertiles. Conclusions: The SYNTAX score is able to stratify risk amongst an all-comers population treated with PCI with second-generation drug-eluting stents (DES); however, improvements can be made with the inclusion of clinical variables. (RESOLUTE III All Comers Trial: A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention; NCT00617084) http://repub.eur.nl/res/pub/34685/ 2011-03-01T00:00:00Z Objectives: We compared the 5-year outcomes of diabetic patients with multivessel disease treated with sirolimus-eluting stents (SES), bare-metal stents (BMS), and coronary artery bypass graft surgery (CABG) enrolled in the ARTS (Arterial Revascularization Therapy Study) I and II studies. Background: Diabetes is an established risk factor for major adverse cardiac events after revascularization. Recent trials suggest that revascularization with drug-eluting stents has equivalent safety to CABG up to 2 years. Methods: The ARTS I and II studies included 367 diabetic patients (SES: 159, CABG: 96, and BMS: 112) compared with respect to 5-year clinical outcomes. Results: The rate of major adverse cardiovascular and cerebrovascular events was significantly higher in patients treated with BMS (BMS 53.6% vs. CABG 23.4% vs. SES 40.5%; log-rank, p < 0.01 for SES vs. BMS and SES vs. CABG). There was no significant difference in mortality among all 3 groups. There was, however, a statistically significant difference in the myocardial infarction rate between BMS and CABG arms (BMS 11.0%, CABG 5.2%, SES 4.8%, p = 0.04 for SES vs. BMS and p = 0.76 for SES vs. CABG). The rate of repeat revascularization was significantly lower in patients treated with CABG compared with SES (SES 33.2% vs. CABG 10.7%, p < 0.001). Revascularization rate of patients treated with SES at 5 years approached that of patients treated with BMS although remained significantly lower. This "catch-up" phenomenon was not apparent in the nondiabetic population. Conclusions: At 5-year follow-up, CABG has comparable safety and superior efficacy compared with BMS and SES in the treatment of diabetic patients with multivessel disease. http://repub.eur.nl/res/pub/23509/ 2011-02-01T00:00:00Z Introduction: Coronary artery disease (CAD) is the leading cause of mortality in developed countries. Angina, myocardial infarction, heart failure and other clinical manifestations of coronary atherosclerosis lead to considerable patient morbidity and constitute an increasingly heavy burden on health systems worldwide. Areas covered: This article reviews the recent major developments in the treatment of CAD, which can be achieved using medical therapy either in isolation or in combination with revascularization, performed via coronary artery bypass surgery (CABG) or percutaneous coronary intervention (PCI). There is no dispute that optimal medical treatment is the cornerstone of CAD management; however, timely revascularization offers superior symptom control in patients with severe symptoms and may also offer a survival advantage in some patients with diffuse disease and diabetes. Importantly, the advances in PCI technology, especially with the introduction of drug-eluting stents has narrowed the gap between CABG and PCI for the treatment of CAD. Expert opinion: The continuous developments in diagnosis and treatment of CAD call for contemporary trials with detailed analysis to provide evidence that will help in the choice of the best and most cost-effective treatment strategy. http://repub.eur.nl/res/pub/33715/ 2011-02-01T00:00:00Z AimsThe first generation of the everolimus-eluting bioresorbable vascular scaffold (BVS 1.0) showed an angiographic late loss higher than the metallic everolimus-eluting stent Xience V due to scaffold shrinkage. The new generation (BVS 1.1) presents a different design and manufacturing process than the BVS 1.0. This study sought to evaluate the differences in late shrinkage, neointimal response, and bioresorption process between these two scaffold generations using optical coherence tomography (OCT).Methods and resultsA total of 12 lesions treated with the BVS 1.0 and 12 selected lesions treated with the revised BVS 1.1 were imaged at baseline and 6-month follow-up with OCT. Late shrinkage and neointimal area (NIA) were derived from OCT area measurements. Neointimal thickness was measured in each strut. Strut appearance has been classified as previously described. Baseline clinical, angiographic, and OCT characteristics were mainly similar in the two groups. At 6 months, absolute and relative shrinkages were significantly larger for the BVS 1.0 than for the BVS 1.1 (0.98 vs. 0.07 mm2and 13.0 vs. 1.0, respectively; P 0.01). Neointimal area was significantly higher in the BVS 1.0 than in the BVS 1.1 (in-scaffold area obstruction of 23.6 vs. 12.3; P < 0.01). Neointimal thickness was also larger in the BVS 1.0 than in the BVS 1.1 (166.0 vs. 76.4 m; P < 0.01). Consequently, OCT, intravascular ultrasound, and angiographic luminal losses were higher with the BVS 1.0 than with the BVS 1.1. At 6 months, strut appearance was preserved in only 2.9 of the BVS 1.0 struts, but remained unchanged with the BVS 1.1 indicating different state of strut microstucture and/or their reflectivity.ConclusionThe BVS 1.1 has less late shrinkage and less neointimal growth at 6-month follow-up compared with the BVS 1.0. A difference in polymer degradation leading to changes in microstructure and reflectivity is the most plausible explanation for this finding. http://repub.eur.nl/res/pub/34687/ 2011-02-01T00:00:00Z Background-The age, creatinine, and ejection fraction (ACEF) score (age/left ventricular ejection fraction+1 if creatinine >2.0 mg/dL) has been established as an effective predictor of clinical outcomes in patients undergoing elective coronary artery bypass surgery; however, its utility in "all-comer" patients undergoing percutaneous coronary intervention is yet unexplored. Methods and Results-The ACEF score was calculated for 1208 of the 1707 patients enrolled in the LEADERS trial. Post hoc analysis was performed by stratifying clinical outcomes at the 1-year follow-up according to ACEF score tertiles: ACEFlow≤1.0225, 1.0225< ACEFmid≤1.277, and ACEFhigh>1.277. At 1-year follow-up, there was a significantly lower number of patients with major adverse cardiac event-free survival in the highest tertile of the ACEF score (ACEFlow=92.1%, ACEFmid=89.5%, and ACEFhigh=86.1%; P=0.0218). Cardiac death was less frequent in ACEFlowthan in ACEFmidand ACEFhigh(0.7% vs 2.2% vs 4.5%; hazard ratio=2.22, P=0.002) patients. Rates of myocardial infarction were significantly higher in patients with a high ACEF score (6.7% for ACEFhighvs 5.2% for ACEFmidand 2.5% for ACEFlow; hazard ratio=1.6, P=0.006). Clinically driven target-vessel revascularization also tended to be higher in the ACEFhighgroup, but the difference among the 3 groups did not reach statistical significance. The rate of composite definite, possible, and probable stent thrombosis was also higher in the ACEFhighgroup (ACEFlow=1.2%, ACEFmid=3.5%, and ACEFhigh=6.2%; hazard ratio=2.04, P=0.001). Conclusions-ACEF score may be a simple way to stratify risk of events in patients treated with percutaneous coronary intervention with respect to mortality and risk of myocardial infarction. http://repub.eur.nl/res/pub/23736/ 2011-01-01T00:00:00Z Objectives This study sought to evaluate the impact of SYNTAX score (SXscore), and compare its performance in isolation and combination with the PAMI (The Primary Angioplasty in Myocardial Infarction Study) score, for the prediction of 1-year clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention. Background Patients with STEMI were excluded from the original SYNTAX score (SXscore) algorithm. Therefore, the utility of using the SXscore in this patient group remains undefined. Methods SXscore was calculated retrospectively in 807 patients with STEMI enrolled in the randomized STRATEGY (Single High-Dose Bolus Tirofiban and Sirolimus-Eluting Stent Versus Abciximab and Bare-Metal Stent in Acute Myocardial Infarction) and MULTISTRATEGY (Multicenter Evaluation of Single High-Dose Bolus Tirofiban Versus Abciximab With Sirolimus-Eluting Stent or Bare-Metal Stent in Acute Myocardial Infarction Study) clinical trials. Clinical outcomes of all-cause death, reinfarction, and clinically driven target vessel revascularization were subsequently stratified according to SXscore tertiles: SXLOW ≤9 (n = 311), 9 < SX MID ≤16 (n = 234), SXHIGH >16 (n = 262). Results At 1-year follow-up, all clinical outcomes including mortality, mortality/reinfarction, major adverse cardiac events (MACE) (a composite of all-cause death, reinfarction and target vessel revascularization), and definite, definite/probable, and any stent thrombosis were all significantly higher in patients in the highest SXscore tertile. SXscore was identified as an independent predictor of mortality, MACE, and stent thrombosis out to 1-year follow-up. The combination SYNTAX-PAMI score led to a net reclassification improvement of 15.7% and 4.6% for mortality and MACE, respectively. The C-statistics for the SXscore, PAMI score, and the combined SYNTAX-PAMI score were 0.65, 0.81, and 0.73 for 1-year mortality, and 0.68, 0.64, and 0.69 for 1-year MACE, respectively. Conclusions SXscore does have a role in the risk stratification of patients with STEMI having primary percutaneous coronary intervention; however, this ability can be improved through a combination with clinical variables. (Multicentre 2×2 Factorial Randomised Study Comparing Tirofiban Versus Abciximab and SES Versus BMS in AMI; NCT00229515) http://repub.eur.nl/res/pub/28601/ 2010-12-01T00:00:00Z The aim of this study was to describe vaso-reactivity (by Acetylcholine and Methergine tests) at 2 year follow-up in parallel with the individual changes in the echogenicity characteristics of the polymer struts of the everolimus eluting bioresorbable vascular scaffold (BVS), from post-treatment to 2 year follow-up, in patients enrolled in the ABSORB Cohort A study. Intravascular ultrasound assessment was performed with a phased array catheter (EagleEye, Volcano Corporation, Cordova, CA, USA) with automated pullback at 0.5 mm per second. The % ratio at 6 months and 2 years [(Scaffold Area post PCI- Lumen Area)/Scaffold Area post PCI] was calculated as a measure of scaffold shrinkage. The % change of hyperechogenicity was defined as: ([post-procedural hyperechogenicity] - [2 year follow up hyperechogenicity])/[post-procedural hyperechogenicity]) × 100. The vasomotion test with intracoronary acetylcholine (10-6M) or intravenous methergine (0.4 mg) was performed at 2 years. Overall nine patients received all these analyses and were enrolled in the present analysis. A 50-96% reduction in hyperechogenicity was observed between baseline and 2 years, which corresponded to a change in vasoreactivity between 2 and 22%. A vasoconstriction of the scaffolded segment was observed in the 5 patients, who underwent the methergine test, with a mean decrease in lumen diameter after methergine of 9 ± 7% (P = 0.06), while vasodilatation occurred in the 4 patients who underwent the acetylcholine test with a mean increase in lumen diameter after acetylcholine of 8 ± 5% (P = 0.125). Bioresorption of the BVS is accompanied by re-establishment of both endothelial and non-endothelial dependent vasomotion. http://repub.eur.nl/res/pub/28560/ 2010-11-16T00:00:00Z Although serial changes in necrotic core and calcium are regarded as surrogates for the bioresorption process in patients treated with the bioresorbable everolimus-eluting vascular scaffolds (BVS), these temporal changes have not yet been fully investigated. Shin's method may be offer a more suitable technique for this analysis because it includes all the contents of both the lumen and vessel wall. The purpose of this study was to assess the serial changes of necrotic core and dense calcium content in coronary lesions that were treated with a BVS implant using Virtual Histology intravascular ultrasound (VH-IVUS) analyzed using Shin's method. A total of 29 patients (92 coronary segments) were imaged to evaluate the serial changes in necrotic core and dense calcium using Shin's method. Lesions treated with a BVS implant were analyzed with serial VH-IVUS assessments, i.e., pre- and post-stenting, and at 6 months and 2 years follow-up. In Shin's method contours are drawn around the IVUS catheter (instead of delineating the lumen) and the vessel. The mean necrotic core area decreased by 6.9% from post-stenting to 6 months (1.71 ± 1.03 mm2vs. 1.36 ± 0.91 mm2, P = 0.027), and by 20.5% (1.71 ± 1.03 mm2vs. 1.20 ± 0.70 mm2, P = 0.003) from post-steting to 2 years; while the mean dense calcium areas decreased by 27.2% (1.07 ± 0.55 mm2vs. 0.78 ± 0.64 mm2, P = 0.039) from post-stenting and 2 years. At 2 years, absolute necrotic core and dense calcium content were significantly decreased as compared to post-stenting values. The present study demonstrates that the bioresorption process in patients who undergoing BVS device implantation can be assessed using VH-IVUS analysed using Shin's method. http://repub.eur.nl/res/pub/27689/ 2010-11-15T00:00:00Z The aim of this study was to compare clinical outcome at 5 years in patients with complete and incomplete revascularization treated with coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) with drug-eluting stents. Baseline and procedural angiograms and surgical case-record forms were centrally assessed for completeness of revascularization. Patients treated with PCI for incomplete revascularization were stratified according to Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) score tertiles. Complete revascularization was achieved in 360 of 588 patients (61.2%) in the PCI with sirolimus-eluting stent group and 477 of 567 patients (84.1%) in the CABG group (p <0.05). There was no significant difference in 5-year survival without major adverse cardiac and cerebrovascular events (MACCEs; death, cerebrovascular accident, myocardial infarction, and any revascularization) between patients with complete and incomplete revascularization treated with PCI or CABG. Survival free from MACCEs in patients with incomplete revascularization treated with PCI was significantly lower than those with complete revascularization treated with CABG (hazard ratio 1.66, 0.96 to 1.80, log-rank p = 0.001). The 5-year MACCE-free survival in patients with incomplete revascularization treated with PCI stratified according to SYNTAX score tertiles showed a significantly lower MACCE survival in the higher SYNTAX tertile compared to the low (hazard ratio 0.56, 0.32 to 0.96, log-rank p = 0.04) and intermediate (hazard ratio 0.50, 0.28 to 0.91, log-rank p = 0.02) tertiles, whereas survival between the low and intermediate SYNTAX tertiles was not significantly different (hazard ratio 1.13, 0.60 to 2.13, log-rank p = 0.71). In conclusion, this study suggests that patients with complex coronary disease, in whom complete revascularization cannot be achieved with PCI, should be offered surgical revascularization. However, in those patients with less complex disease, PCI is a valid alternative even if complete revascularization cannot be achieved. http://repub.eur.nl/res/pub/28567/ 2010-11-15T00:00:00Z Background: The purpose of this study was to compare the performance of both conventional quantitative coronary angiography (QCA) and the dedicated three branch QCA model for bifurcations in the prediction of a functionally significant lesion according to fractional flow reserve (FFR) in patients with bifurcation lesions. Methods: Twenty patients with bifurcation lesions underwent coronary angiography together with a functional evaluation of both the main branch and side-branch using FFR. QCA was performed off-line with both conventional QCA software (CAASII, Pie Medical Imaging, Maastricht, The Netherlands) and three branch QCA software (CAAS5, Pie Medical Imaging, Maastricht, The Netherlands). A stenosis was considered hemodynamically significant when the FFR value was ≤0.80 and anatomically significant when the diameter stenosis was >50%. The QCA and FFR data were correlated by means of the Pearson correlation. Results: Eighteen bifurcation lesions were suitable for the QCA analysis. In the main vessel, a significant inverse correlation with FFR was seen with both conventional QCA (Pearson r = 0.52 for the MV, P = 0.02), and the three branch QCA model (Pearson r = 0.67 for the MV, P = 0.002). Conversely, in the side-branch, the correlation between QCA and FFR was only significant with the three branch QCA model (Pearson r = 0.57, P = 0.02 for the SB). Conclusions: In bifurcation lesions the correlation between the anatomic severity of a coronary stenosis and its functional significance appears to be somewhat higher when QCA is performed using the three branch model. This is most notable for side-branch stenoses which can be overestimated when using conventional QCA. http://repub.eur.nl/res/pub/21827/ 2010-11-01T00:00:00Z Objectives The aim of this study was to assess the differences in terms of curvature and angulation of the treated vessel after the deployment of either a metallic stent or a polymeric scaffold device. Background Conformability of metallic platform stents (MPS) is the major determinant of geometric changes in coronary arteries caused by the stent deployment. It is not known how bioresorbable polymeric devices perform in this setting. Methods This retrospective study compares 102 patients who received an MPS (Multi-link Vision or Xience V, Abbott Vascular, Santa Clara, California) in the SPIRIT FIRST and II trials with 89 patients treated with the Revision 1.1 everolimus-eluting bioresorbable vascular scaffold (BVS) (Abbott Vascular, Santa Clara, California) from cohort B of the ABSORB (A bioabsorbable everolimus-eluting coronary stent system) trial. All patients were treated with a single 3 × 18 mm device. Curvature and angulation were measured with dedicated software by angiography. Results Both the MPS and BVS groups had significant changes in relative region curvature (MPS vs. BVS: 28.7% vs. 7.5%) and angulation (MPS vs. BVS: 25.4% vs. 13.4%) after deployment. The unadjusted comparisons between the 2 groups showed for BVS a nonsignificant trend for less change in region curvature after deployment (MPS vs. BVS: 0.085 cm-1 vs. 0.056 cm-1, p = 0.06) and a significantly lower modification of angulation (MPS vs. BVS 6.4° vs. 4.3°, p = 0.03). By multivariate regression analysis, the independent predictors of changes in curvature and angulation were the pre-treatment region curvature, the pre-treatment region angulation, and the used device. Conclusions Bioresorbable vascular scaffolds have better conformability than conventional MPS. The clinical significance of the observed differences will require further investigation. http://repub.eur.nl/res/pub/32984/ 2010-11-01T00:00:00Z http://repub.eur.nl/res/pub/28561/ 2010-10-25T00:00:00Z Cardiac enzyme release is common after percutaneous coronary intervention (PCI). At present there is no established relationship between the quantity of necrotic core and dense calcium, as assessed by Shin's method using intravascular ultrasound virtual histology (VH-IVUS), and post-PCI creatinine kinase-MB (CK-MB) elevation. A total of 112 consecutive patients with unstable angina and a normal pre-PCI CK-MB level were imaged using VH-IVUS. Patients were divided into 2 groups according to the presence (CK-MB group, n = 22) or absence (non CK-MB group, n = 90) of a post-PCI CK-MB elevation >1.0 the upper limit of normal (3.6 ng/ml). Using Shin's method contours were drawn around the IVUS catheter (instead of the lumen), and the vessel. Mean area and volume of necrotic core and dense calcium were significantly greater in CK-MB group than in non CK-MB group (1.7 ± 0.9 mm2vs. 0.9 ± 0.6 mm2, P < 0.001; 17.2 ± 8.8 mm3vs. 8.8 ± 5.8 mm3, P < 0.001, and 0.9 ± 0.6 mm2vs. 0.4 ± 0.4 mm2, P = 0.001; 9.1 ± 5.8 mm3vs. 3.9 ± 3.7 mm3, P < 0.001, respectively). Percent necrotic core and dense calcium areas calculated by external elastic membrane (EEM) area were significantly greater in CK-MB group than in non CK-MB group (11.9 ± 5.1 vs. 6.6 ± 4.0%, P < 0.001 and 6.5 ± 4.0 vs. 3.0 ± 2.9%, P < 0.001, respectively). In the multivariate analysis, dense calcium volume and percent necrotic core to EEM at the most diseased segment were the only independent predictors of post-PCI CK-MB elevation (odds ratio: 1.22; 95% confidence interval: 1.09-1.37, P < 0.001 and odds ratio: 1.26; 95% confidence interval: 1.12-1.43, P < 0.001). Lesions with a greater amount of dense calcium volume and percent necrotic core to EEM, which can be easily identified and quantified on VH-IVUS analyzed using Shin's method, are responsible for post-PCI CK-MB elevation. With a rapid analyzing time, Shin's method may increase the identification of high risk lesions likely to induce a post-procedural myocardial injury in the catheterization laboratory facilitating on-line clinical decision making. http://repub.eur.nl/res/pub/28013/ 2010-10-19T00:00:00Z Intense investigation continues on the pathobiology of stent thrombosis (ST) because of its morbidity and mortality. Because little advance has been made in outcomes following ST, ongoing research is focused on further understanding predictive factors as well as ST frequency and timing in various patient subsets, depending upon whether a drug-eluting stent or bare-metal stent has been implanted. Although the preventive role of antiplatelet therapies remains unchallenged, new data on genomics and variability in response to antiplatelet therapy, as well as the effects of novel therapeutic agents and duration of therapy, have become available. The goal remains identification of patients at particularly increased risk of ST so that optimal prevention strategies can be developed and employed. http://repub.eur.nl/res/pub/28587/ 2010-10-13T00:00:00Z Implantation of a coronary stent results in a mechanical enlargement of the coronary lumen with stretching of the surrounding atherosclerotic plaque. Using intravascular ultrasound virtual-histology (IVUS-VH) we examined the temporal changes in composition of the plaque behind the struts (PBS) following the implantation of the everolimus eluting bioresorbable vascular scaffold (BVS). Using IVUS-VH and dedicated software, the composition of plaque was analyzed in all patients from the ABSORB B trial who were imaged with a commercially available IVUS-VH console (s5i system, Volcano Corporation, Rancho Cordova, CA, USA) post-treatment and at 6-month follow-up. This dedicated software enabled analysis of the PBS after subtraction of the VH signal generated by the struts. The presence of necrotic core (NC) in contact with the lumen was also evaluated at baseline and follow-up. IVUS-VH data, recorded with s5i system, were available at baseline and 6-month follow-up in 15 patients and demonstrated an increase in both the area of PBS (2.45 ± 1.93 mm2vs. 3.19 ± 2.48 mm2, P = 0.005) and the external elastic membrane area (13.76 ± 4.07 mm2vs. 14.76 ± 4.56 mm2, P = 0.006). Compared to baseline there was a significant progression in the NC (0.85 ± 0.70 mm2vs. 1.21 ± 0.92 mm2, P = 0.010) and fibrous tissue area (0.88 ± 0.79 mm2vs. 1.15 ± 1.05 mm2, P = 0.027) of the PBS. The NC in contact with the lumen in the treated segment did not increase with follow-up (7.33 vs. 6.36%, P = 0.2). Serial IVUS-VH analysis of BVS-treated lesions at 6-month demonstrated a progression in the NC and fibrous tissue content of PBS. http://repub.eur.nl/res/pub/28731/ 2010-09-01T00:00:00Z Percutaneous coronary intervention of unprotected left main stem lesions has been shown to be a suitable alternative to cardiac surgery in selected patients, emphasizing the need for appropriate risk stratification prior to selection of revascularization modality. Several risk models based on clinical and angiographic variables have been developed to guide patient selection, each of which has significant limitations. This paper reviews contemporary and newly proposed risk models for patients undergoing left main stem revascularization. http://repub.eur.nl/res/pub/28030/ 2010-08-31T00:00:00Z Coronary artery stents revolutionized the practice of interventional cardiology after they were first introduced in the mid-1980s. Since then, there have been significant developments in their design, the most notable of which has been the introduction of drug-eluting stents. This paper reviews the benefits, risks, and current status of Food and Drug Administration-approved drug-eluting stents. http://repub.eur.nl/res/pub/28034/ 2010-08-31T00:00:00Z Despite all the benefits of drug-eluting stents (DES), concerns have been raised over their long-term safety, with particular reference to stent thrombosis. In an effort to address these concerns, newer stents have been developed that include: DES with biodegradable polymers, DES that are polymer free, stents with novel coatings, and completely biodegradable stents. Many of these stents are currently undergoing pre-clinical and clinical trials; however, early results seem promising. This paper reviews the current status of this new technology, together with other new coronary devices such as bifurcation stents and drug-eluting balloons, as efforts continue to design the ideal coronary stent. http://repub.eur.nl/res/pub/20962/ 2010-07-20T00:00:00Z http://repub.eur.nl/res/pub/20963/ 2010-07-20T00:00:00Z Objectives: We aimed to assess the predictive value of the SYNTAX score (SXscore) for major adverse cardiac events in the all-comers population of the LEADERS (Limus Eluted from A Durable versus ERodable Stent coating) trial. Background: The SXscore has been shown to be an effective predictor of clinical outcomes in patients with multivessel disease undergoing percutaneous coronary intervention. Methods: The SXscore was prospectively collected in 1,397 of the 1,707 patients enrolled in the LEADERS trial (patients after surgical revascularization were excluded). Post hoc analysis was performed by stratifying clinical outcomes at 1-year follow-up, according to 1 of 3 SXscore tertiles. Results: The 1,397 patients were divided into tertiles based on the SXscore in the following fashion: SXscore ≤8 (SXlow) (n = 464), SXscore >8 and ≤16 (SXmid) (n = 472), and SXscore >16 (SXhigh) (n = 461). At 1-year follow-up, there was a significantly lower number of patients with major cardiac event-free survival in the highest tertile of SXscore (SXlow = 92.2%, SXmid = 91.1%, and SXhigh = 84.6%; p < 0.001). Death occurred in 1.5% of SXlow patients, 2.1% of SXmid patients, and 5.6% of SXhigh patients (hazard ratio [HR]: 1.97, 95% confidence interval [CI]: 1.29 to 3.01; p = 0.002). The myocardial infarction rate tended to be higher in the SXhigh group. Target vessel revascularization was 11.3% in the SXhigh group compared with 6.3% and 7.8% in the SXlow and SXmid groups, respectively (HR: 1.38, 95% CI: 1.1 to 1.75; p = 0.006). Composite of cardiac death, myocardial infarction, and clinically indicated target vessel revascularization was 7.8%, 8.9%, and 15.4% in the SXlow, SXmid, and SXhigh groups, respectively (HR: 1.47, 95% CI: 1.19 to 1.81; p < 0.001). Conclusions: The SXscore, when applied to an all-comers patient population treated with drug-eluting stents, may allow prospective risk stratification of patients undergoing percutaneous coronary intervention. (LEADERS Trial Limus Eluted From A Durable Versus ERodable Stent Coating; NCT00389220) http://repub.eur.nl/res/pub/20630/ 2010-07-01T00:00:00Z BACKGROUND: New-generation coronary stents that release zotarolimus or everolimus have been shown to reduce the risk of restenosis. However, it is unclear whether there are differences in efficacy and safety between the two types of stents on the basis of prospectively adjudicated end points endorsed by the Food and Drug Administration. METHODS: In this multicenter, noninferiority trial with minimal exclusion criteria, we randomly assigned 2292 patients to undergo treatment with coronary stents releasing either zotarolimus or everolimus. Twenty percent of patients were randomly selected for repeat angiography at 13 months. The primary end point was target-lesion failure, defined as a composite of death from cardiac causes, any myocardial infarction (not clearly attributable to a nontarget vessel), or clinically indicated target-lesion revascularization within 12 months. The secondary angiographic end point was the extent of in-stent stenosis at 13 months. RESULTS: At least one off-label criterion for stent placement was present in 66% of patients. The zotarolimus-eluting stent was noninferior to the everolimus-eluting stent with respect to the primary end point, which occurred in 8.2% and 8.3% of patients, respectively (P<0.001 for noninferiority). There were no significant between-group differences in the rate of death from cardiac causes, any myocardial infarction, or revascularization. The rate of stent thrombosis was 2.3% in the zotarolimus-stent group and 1.5% in the everolimus-stent group (P = 0.17). The zotarolimus-eluting stent was also noninferior regarding the degree (±SD) of in-stent stenosis (21.65±14.42% for zotarolimus vs. 19.76±14.64% for everolimus, P = 0.04 for noninferiority). In-stent late lumen loss was 0.27±0.43 mm in the zotarolimus-stent group versus 0.19±0.40 mm in the everolimusstent group (P = 0.08). There were no significant between-group differences in the rate of adverse events. CONCLUSIONS: At 13 months, the new-generation zotarolimus-eluting stent was found to be noninferior to the everolimus-eluting stent in a population of patients who had minimal exclusion criteria. http://repub.eur.nl/res/pub/28720/ 2010-06-01T00:00:00Z Objectives We investigated the long-term clinical outcomes and independent predictors of major cardiac events in unprotected left main coronary artery disease (ULMCA) patients treated by percutaneous coronary intervention with drug-eluting stent (DES). Background There is limited information on long-term (3 years) outcomes after DES implantation for ULMCA. Furthermore, bifurcation angle and SYNTAX (Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) score are emerging as parameters for patient risk stratification, and their prognostic implications have still to be elucidated. Methods One hundred forty-eight patients with ULMCA treated with DES were analyzed and compared with a historical cohort of 79 patients who received bare-metal stents for the treatment of ULMCA. Patient-oriented composite end point was defined as the occurrence of all-cause death, any myocardial infarction, or any revascularization. Results The 4-year cumulative incidence of all-cause death, any myocardial infarction, any revascularization, and patient-oriented composite were 35.6%, 3.8%, 25.2%, and 54.4%, respectively. These end points had relatively increased from 1 year to 4 years by Δ70%, Δ5%, Δ50%, and Δ68%, respectively. When compared with a historical cohort who received bare-metal stents for ULMCA treatment, landmark analysis performed after the first 2 years of follow-up demonstrated that the DES cohort had significantly higher patient-oriented composite end point over the last 2 years of follow-up (26% vs. 8%, p = 0.02). EuroSCORE (European System for Cardiac Operative Risk Evaluation), cardiogenic shock, and SYNTAX score were identified as independent predictors for the 4-year patient-oriented composite, whereas bifurcation angle was not. Conclusions Late increase in patient-oriented composite end points after DES implantation for ULMCA warrants careful and long-term follow-up. SYNTAX score and EuroSCORE appear to have a significant prognostic value in long-term patient risk. http://repub.eur.nl/res/pub/27736/ 2010-05-01T00:00:00Z http://repub.eur.nl/res/pub/28527/ 2010-05-01T00:00:00Z Objectives: To reassess the reproducibility of the SYNTAX score. Background: The SYNTAX score appears to have an important role to play in the evaluation of patients with complex coronary artery disease undergoing revascularisation. However, the calculation of the SYNTAX score relies on the subjective assessment of lesions using coronary angiography, and therefore is subject to intra-and inter-observer variability. Methods: The SYNTAX score was calculated in 100 patients randomly selected from the SYNTAX trial, on two occasions 8 weeks apart, by a team made up of three interventional cardiologists. The weighted kappa values were compared with values obtained 1 year previously, when core lab analysts assessed the intra-observer reproducibility amongst the same patient cohort. Results: The mean ± standard deviation difference in SYNTAX score was 2.1 ± 7.6. The respective weighted kappa values for the number of lesions, bifurcation lesions, ostial lesions, and total occlusions were 0.62, 0.36, 0.66, and 0.91 compared with 0.59, 0.41, 0.63, and 0.82 in the previous core lab assessment. The weighted kappa for the intra-observer reproducibility of the SYNTAX score grouped into deciles was 0.54, and according to the terciles ≤22, >22-≤32, >32 was 0.51 both indicating a moderate level of agreement beyond the level of chance. In the previous assessment, the comparative kappa values were 0.45 and 0.53. Conclusions: The SYNTAX score has moderate intra-observer reproducibility when assessed by a team of three interventional cardiologists, which is consistent with a prior evaluation performed by core lab analysts. The scoring of bifurcation lesions remains the main source of inconsistency. http://repub.eur.nl/res/pub/28553/ 2010-05-01T00:00:00Z Background: In the ABSORB study cohort A the changes in the amount of dense calcium and necrotic core have not been reported in comparison to the prestenting phase; this evaluation could be useful to better clarify the bioabsorption process. Aim of this study was therefore to evaluate the dynamic changes in plaque size and plaque tissue composition observed between 6 months and 2 years follow-up, and to compare these findings to the prestenting phase. Methods: Angiography, intravascular ultrasound and derived parameters (virtual histology, palpography, and echogenicity) were serially assessed postprocedure, at 6 months and at 2 years in 20 patients. In a subset of 8 patients the same measurements were also recorded in the prestenting phase. Results: In the total population a reduction of 18% in the plaque area was observed between 6 month and 2 year follow-up (7.56 ± 2.32 mm2at 6 months vs. 6.16 ± 2.10 mm2at 2 year follow-up; P < 0.01). In the subgroup of eight patients who underwent IVUS during the pre-stenting phase, the plaque area at 2 year follow-up was not significantly different when compared to the prestenting plaque area (7.29 ± 2.29 mm2at prestenting vs. 7.48 ± 1.45 mm2at 2 year follow-up, P 5 NS). Necrotic core area was reduced by 24% between the 6 month and 2 year follow-up (0.97 ± 0.66 mm2at 6 months vs. 0.74 ± 0.53 mm2at 2 year follow-up; P 5 NS), whilst dense calcium was reduced by 14% from 6 month to 2 year follow-up (0.83 ± 0.50 mm2at 6 months vs 0.72 ± 0.64 mm2at 2 year follow-up; P 5 NS). Whilst the necrotic core at 2 years follow-up was not significantly different when compared to the pre-stenting phase (0.62 ± 0.42 mm2prestenting vs 1.07 ± 0.56 mm2at 2 year follow-up; P 5 NS), the area of dense calcium was significantly higher at follow-up compared to prestenting (0.35 ± 0.35 mm2pre-stenting vs. 0.84 ± 0.66 mm2at 2 year follow-up; P < 0.05). Conclusions: The reduction in the necrotic core component between 6 month and two year followup could be related to a synergistic effect of the bio-absorption process and the antiinflammatory action of everolimus. http://repub.eur.nl/res/pub/28401/ 2010-04-01T00:00:00Z http://repub.eur.nl/res/pub/28035/ 2010-03-16T00:00:00Z Objectives: The purpose of this study is to compare the 5-year clinical outcomes, safety, and efficacy of sirolimus-eluting stents (SES) in the ARTS II (Arterial Revascularization Therapies Study II) with the outcomes of coronary artery bypass graft (CABG) and bare-metal stenting (BMS) from the ARTS I. Background: The long-term outcomes after SES implantation in patients with multivessel disease remains to be established. Methods: The ARTS I was a randomized trial of 1,205 patients with multivessel disease comparing CABG and BMS. The ARTS II study was a nonrandomized trial with the Cypher sirolimus-eluting stent (Cordis, a Johnson & Johnson Company, Warren, New Jersey), applying the same inclusion and exclusion criteria, end points, and protocol definitions. The ARTS II trial enrolled 607 patients, with an attempt to enroll at least one-third of patients with 3-vessel disease. Results: At 5-year, the death/stroke/myocardial infarction event-free survival rate was 87.1% in ARTS II SES, versus 86.0% (p = 0.1) and 81.9% (p = 0.007) in ARTS I CABG and BMS cohorts, respectively. The 5-year major adverse cardiac and cerebrovascular event (MACCE) rate in ARTS II (27.5%) was significantly higher than ARTS I CABG (21.1%, p = 0.02), and lower than in ARTS I BMS (41.5%, p < 0.001). The cumulative incidence of definite stent thrombosis was 3.8%. Thirty-two percent (56 of 176) of major adverse cardiac events (MACE) at 5 years were related to possible, probable, or definite stent thrombosis. Conclusions: At 5 years, SES had a safety record comparable to CABG and superior to BMS, and a MACCE rate that was higher than in patients treated with CABG, and lower than in those treated with BMS. Approximately one-third of the events seen with SES could be prevented through the elimination of early, late, and very late stent thrombosis. http://repub.eur.nl/res/pub/32763/ 2010-03-01T00:00:00Z Drug-eluting coronary stents are being used with increasing frequency in patients undergoing percutaneous coronary intervention. Although these stents have shown remarkably low rates of restenosis compared with their predecessors, there have been increasing concerns lately regarding their safety. Extensive data have been published that demonstrate a higher risk of very late stent thrombosis with drug-eluting stents; however, this has not had any impact on long-term mortality or the risk of myocardial infarction when compared with bare-metal stents. Their overall net clinical benefit therefore still favors their use. Recent research has led to a greater understanding of the multifactorial cause of stent thrombosis, which has enabled measures to be taken to reduce an individual patients risk. In the future, new stent designs and new antiplatelet agents may help to reduce this risk further. http://repub.eur.nl/res/pub/18221/ 2010-02-15T00:00:00Z The aim of this analysis was to assess the effect of body mass index (BMI) on 1-year outcomes in patients enrolled in a contemporary percutaneous coronary intervention trial comparing a sirolimus-eluting stent with a durable polymer to a biolimus-eluting stent with a biodegradable polymer. A total of 1,707 patients who underwent percutaneous coronary intervention were randomized to treatment with either biolimus-eluting stents (n = 857) or sirolimus-eluting stents (n = 850). Patients were assigned to 1 of 3 groups according to BMI: normal (<25 kg/m(2)), overweight (25 to 30 kg/m(2)), or obese (>30 kg/m(2)). At 1 year, the incidence of the composite of cardiac death, myocardial infarction, and clinically justified target vessel revascularization was assessed. In addition, rates of clinically justified target lesion revascularization and stent thrombosis were assessed. Cox proportional-hazards analysis, adjusted for clinical differences, was used to develop models for 1-year mortality. Forty-five percent of the patients (n = 770) were overweight, 26% (n = 434) were obese, and 29% (n = 497) had normal BMIs. At 1-year follow-up, the cumulative rate of cardiac death, myocardial infarction, and clinically justified target vessel revascularization was significantly higher in the obese group (8.7% in normal-weight, 11.3% in overweight, and 14.5% in obese patients, p = 0.01). BMI (hazard ratio 1.47, 95% confidence interval 1.02 to 2.14, p = 0.04) was an independent predictor of stent thrombosis. Stent type had no impact on the composite of cardiac death, myocardial infarction, and clinically justified target vessel revascularization at 1 year in the 3 BMI groups (hazard ratio 1.08, 95% confidence interval 0.63 to 1.83, p = 0.73). In conclusion, BMI was an independent predictor of major adverse cardiac events at 1-year clinical follow-up. The higher incidence of stent thrombosis in the obese group may suggest the need for a weight-adjusted dose of clopidogrel. http://repub.eur.nl/res/pub/19529/ 2010-02-01T00:00:00Z Although takotsubo cardiomyopathy is a rare entity, it is an important differential in patients presenting with symptoms, signs, and electrocardiographic changes suggestive of an acute myocardial infarction. Since it was first recognized in 1991, it has gained increasing attention worldwide; however, its etiology and consequently the optimal management still remains unclear. Here, the authors provide a review of the current literature accompanied with images of a typical case from our department. http://repub.eur.nl/res/pub/24080/ 2009-12-01T00:00:00Z Background: The use of drug eluting stents (DES) in patients with a successfully recanalized chronic total occlusion (CTO) has been associated with a significant decrease in the need for repeat revascularization, and a favorable short-term clinical outcome when compared with the use of bare metal stents (BMS). Our group, however, has previously reported similar rates of target lesion revascularisation (TLR) and major adverse cardiovascular events (MACE) at 3 years follow-up in patients with a successfully opened CTO who were treated with either a sirolimus eluting stent (SES) or a BMS. The objective of this report was to evaluate the outcomes of these patients at 5-years clinical follow-up. Methods and Results: A total of 140 (BMS 64, SES 76) patients with successfully opened CTOs were included. Seven patients died in the BMS group whilst nine patients died in the SES group (P = 0.90). Noncardiac death was the major component of all-cause mortality (11 noncardiac deaths vs. 5 cardiac). There were two and three myocardial infarctions (MI) in the BMS and SES group, respectively (P = 1.0). The composite of death and MI occurred in seven (10.9%) and eleven (14.5%) patients in the BMS and SES group, respectively (P = 0.53). Clinically driven TLR was performed in eight patients (12.5%) in the BMS group, and five (6.6%) in the SES group (P = 0.26). Non-TLR target vessel revascularization was performed in one patient in the BMS group, and four in the SES group (P = 0.37). The 5-year device-oriented cumulative MACE rate was 15.6% and 11.8% in the BMS and SES group, respectively (P = 0.56). Conclusion: In patients with a successfully treated CTO, clinical outcome after 5 years was similar between SES and BMS, however, clinically driven TLR was slightly higher in the BMS group. http://repub.eur.nl/res/pub/24414/ 2009-12-01T00:00:00Z Objectives: This paper reports the 3-year clinical outcomes of the XIENCE V (Abbott Vascular, Santa Clara, California) everolimus-eluting stent (EES) compared with the TAXUS (Boston Scientific, Natick, Massachusetts) paclitaxel-eluting stent (PES) in the randomized SPIRIT II (Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients with de novo Native Coronary Artery Lesions) study. Background: The Xience V EES is a new-generation drug-eluting stent (DES) that might offer advantages over the first-generation DES in terms of improved clinical outcomes and a better safety profile. Methods: The SPIRIT II trial was a multicenter, prospective, randomized, single-blind, clinical trial, randomizing 300 patients with de novo coronary artery lesions in a ratio of 3:1 to either EES or PES. The primary end point was in-stent late loss at 180 days. Results: At 3-year clinical follow-up cardiac death was numerically lower with EES than PES (0.5% vs. 4.3%, p = 0.056). The observed rate of myocardial infarction was 3.6% for EES and 7.2% for PES (p = 0.31). The rate of ischemia-driven target lesion revascularization was 4.6% and 10.1% for EES and PES, respectively (p = 0.14). Overall, there was a trend for lower major adverse cardiovascular events in the EES group compared with PES (7.2% vs. 15.9%, p = 0.053). The rate of stent thrombosis was low and comparable in both groups (EES 1.0% vs. PES 2.9%). Conclusions: The present study reports the favorable 3-year clinical outcomes of the EES, which are consistent with the results from other studies of the EES with shorter follow-up. http://repub.eur.nl/res/pub/27063/ 2009-04-01T00:00:00Z http://repub.eur.nl/res/pub/19332/ 2009-01-01T00:00:00Z The introduction of the coronary stent in 1986 was one of the most far-reaching changes in the practice of interventional cardiology since its inception in 1977. Despite all the benefits of the using a metallic drug eluting stent (DES), their limitations have generated interest towards biodegradable technology. These biodegradable stents, which are made of polymers or metal alloys with or without a drug coating, have the potential to scaffold the artery to allow natural healing to take place, and then biodegrade. The development of this technology has been slow, however several biodegradable stents have entered into clinical trials, with many more at the preclinical stage of development. Concurrently conventional metallic DES have tried to address their limitations; in particular they have sought to repair their damaged reputation following concerns over stent thrombosis. Accordingly, stents with a more biocompatible polymer and DES which are polymer-free have been developed, and are currently being evaluated in clinical trials. This article will review the status of biodegradable stents, and these newer DES, during this exciting period in interventional cardiology as technology strives to develop the ideal coronary stent.