http://repub.eur.nl/res/aut/1321/ List of Publications en http://repub.eur.nl/static-eur/img/logo.png http://repub.eur.nl http://repub.eur.nl/res/pub/28531/ 2010-05-01T00:00:00Z Aim: The purpose of this study was to define the in-vitro and in-vivo effects of intracoronary enhancement on the absolute density values of coronary plaques during multislice computed tomography. Methods: We studied seven ex-vivo left coronary artery specimens surrounded by olive oil and filled with isotonic saline and four solutions with decreasing dilutions of contrast material: control (isotonic saline), 1/200, 1/80, 1/50, and 1/20. The multislice computed tomography protocol was: slice/collimation 32 × 2 × 0.6 mm and rotation time 330 ms. The attenuation (Hounsfield units) value of atherosclerotic plaques was measured for each dilution in lumen, plaque (noncalcified coronary wall thickening), calcium, and surrounding oil. In-vivo assessment was performed in 12 patients (nine men; mean age 58.7 ± 9.9 years) who underwent two subsequent multislice computed tomography scans (arterial and delayed) after intravenous administration of a single bolus of contrast material. The attenuation values of lumen and plaques during arterial and delayed computed tomography were compared. The results were compared with one-way analysis of variance and correlated with Pearson's test. Results: Mean lumen (45 ± 38-669 ± 151 HU) and plaque (11 ± 35-101 ± 72 HU) attenuation differed significantly (P < 0.001) among the different dilutions. The attenuation of lumen and plaque of coronary plaques showed moderate correlation (r = 0.54, P < 0.001). The mean attenuation value in vivo for the arterial and delayed phase scans differed significantly (P < 0.001) for lumen (325 ± 70 and 174 ± 46 HU, respectively) and plaque (138 ± 71 and 100 ± 52 HU, respectively). Conclusion: Coronary plaque attenuation values are significantly modified by differences in lumen contrast densities both ex vivo and in vivo. This should be taken into account when considering the distinction between lipid and fibrous plaques. http://repub.eur.nl/res/pub/27731/ 2010-04-05T00:00:00Z http://repub.eur.nl/res/pub/27783/ 2010-01-08T00:00:00Z Background: Everolimus-eluting and paclitaxel-eluting stents, compared with bare metal stents, reduced the risk of restenosis in clinical trials with strict inclusion and exclusion criteria. We compared the safety and efficacy of the second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice. Methods: We randomly assigned 1800 consecutive patients (aged 18-85 years) undergoing percutaneous coronary intervention at one centre to treatment with everolimus-eluting or paclitaxel-eluting stents. The primary endpoint was a composite of safety and efficacy (all-cause mortality, myocardial infarction, and target vessel revascularisation) within 12 months. Patients were not told which stent they had been allocated. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT01016041. Findings: Follow-up was completed in 1797 patients. The primary endpoint occurred in 56 (6%) of 897 patients in the everolimus-eluting stent group versus 82 (9%) of 903 in the paclitaxel-eluting stent group (relative risk 0·69 [95% CI 0·50-0·95], p value for superiority=0·02). The difference was attributable to a lower rate of stent thrombosis (6 [<1%] vs 23 [3%], 0·26 [0·11-0-64], p=0·002), myocardial infarction (25 [3%] vs 48 [5%], 0·52 [0·33-0·84], p=0·007), and target vessel revascularisation (21 [2%] vs 54 [6%], 0·39 [0·24-0·64], p=0·0001). Cardiac death, non-fatal myocardial infarction, or target lesion revascularisation occurred in 44 [5%] patients in the everolimus-eluting stent group versus 74 [8%] patients in the paclitaxel-eluting stent group, p value for superiority was 0·005. Interpretation: The everolimus-eluting stent is better than the second generation paclitaxel-eluting stent in unselected patients in terms of safety and efficacy. On the basis of our results, we suggest that paclitaxel-eluting stents should no longer be used in everyday clinical practice. Funding: Unrestricted grants from Abbott Vascular and Boston Scientific. http://repub.eur.nl/res/pub/35764/ 2007-08-01T00:00:00Z Aims: To determine the adjunctive value of CT coronary angiography (CTCA) in the diagnostic work-up of patients with typical angina pectoris. Methods and results: CTCA was performed in 62 consecutive patients (45 male, mean age 58.8 ± 7.7 years) with typical angina undergoing diagnostic work-up including exercise-ECG and conventional coronary angiography. Only patients with sinus heart rhythm and ability to breath hold for 20 s were included. Patients with initial heart rates ≥70 beats/min received β-blockers. We determined the post-test likelihood ratios, to detect or exclude patients with significant (≥50% lumen diameter reduction) stenoses, of exercise-ECG and CTCA separately, and of CT performed after exercise-ECG testing. The prevalence of patients with significant coronary artery disease (CAD) was 74%. Positive and negative likelihood ratios for exercise-ECG were 2.3 [95% confidence interval (CI): 1.0-5.3] and 0.3 (95% CI: 0.2-0.7) and for CTCA 7.5 (95% CI: 2.1-27.1) and 0.0 (95% CI: 0.0-8), respectively. CTCA increased the post-test probability of significant CAD after a negative exercise-ECG from 58 to 91%, and after a positive exercise-ECG from 89 to 99%, while CT correctly identified patients without CAD (probability 0%). Conclusion: Non-invasive CTCA is a potentially useful tool, in the diagnostic work-up of patients with typical angina pectoris, both to detect and to exclude significant CAD. http://repub.eur.nl/res/pub/35429/ 2007-05-01T00:00:00Z BACKGROUND - Although most clinical trials of coronary stents have measured nominally identical safety and effectiveness end points, differences in definitions and timing of assessment have created confusion in interpretation. METHODS AND RESULTS - The Academic Research Consortium is an informal collaboration between academic research organizations in the United States and Europe. Two meetings, in Washington, DC, in January 2006 and in Dublin, Ireland, in June 2006, sponsored by the Academic Research Consortium and including representatives of the US Food and Drug Administration and all device manufacturers who were working with the Food and Drug Administration on drug-eluting stent clinical trial programs, were focused on consensus end point definitions for drug-eluting stent evaluations. The effort was pursued with the objective to establish consistency among end point definitions and provide consensus recommendations. On the basis of considerations from historical legacy to key pathophysiological mechanisms and relevance to clinical interpretability, criteria for assessment of death, myocardial infarction, repeat revascularization, and stent thrombosis were developed. The broadly based consensus end point definitions in this document may be usefully applied or recognized for regulatory and clinical trial purposes. CONCLUSION - Although consensus criteria will inevitably include certain arbitrary features, consensus criteria for clinical end points provide consistency across studies that can facilitate the evaluation of safety and effectiveness of these devices. http://repub.eur.nl/res/pub/35661/ 2007-01-01T00:00:00Z To assess the temporal effect of statin therapy on coronary atherosclerotic plaque volume measured by intravascular ultrasound (IVUS), we searched PubMed for eligible studies published between 1990 and January 2006. Inclusion criteria for retrieved studies were (1) IVUS volume analysis at baseline and follow-up and (2) statin therapy in ≥1 group of patients. All data of interest were abstracted in prespecified structured collection forms. Statistical analysis was performed with Review Manager 4.2. Random-effect weighted mean difference (WMD) was used as summary statistics for comparison of continuous variables. Nine studies of 985 patients (with 11 statin treatment arms) were selected. After a mean follow-up of 9.8 ± 4.9 months, we found a significant decrease in coronary plaque volume (WMD -5.77 mm3, 95% confidence interval -10.36 to -1.17, p = 0.01), with no significant heterogeneity across studies (p = 0.47). Prespecified subgroup analyses showed similar trends. Studies in which the achieved low-density lipoprotein (LDL) cholesterol level was <100 mg/dl showed a trend for plaque regression (WMD -7.88 mm3, 95% confidence interval -16.31 to 0.55, p = 0.07), whereas studies in which the achieved level of LDL cholesterol was ≥100 mg/dl, the trend was less evident (WMD -4.22 mm3, 95% confidence interval -10.27 to 1.82, p = 0.17). Plaque volume remained essentially unchanged in patients not treated with statins (WMD 0.13 mm3, 95% confidence interval -4.42 to 4.68, p = 0.96). In conclusion, statin therapy, particularly when achieving the target LDL level, appears to promote a significant regression of coronary plaque volume as measured by IVUS. http://repub.eur.nl/res/pub/13936/ 2005-10-11T00:00:00Z BACKGROUND: The diagnostic performance of the latest 64-slice CT scanner, with increased temporal (165 ms) and spatial (0.4 mm3) resolution, to detect significant stenoses in the clinically relevant coronary tree is unknown. METHODS AND RESULTS: We studied 52 patients (34 men; mean age, 59.6+/-12.1 years) with atypical chest pain, stable or unstable angina pectoris, or non-ST-segment elevation myocardial infarction scheduled for diagnostic conventional coronary angiography. All patients had stable sinus rhythm. Patients with initial heart rates > or =70 bpm received beta-blockers. Mean scan time was 13.3+/-0.9 seconds. The CT scans were analyzed by 2 observers unaware of the results of invasive coronary angiography, which was used as the standard of reference. All available coronary segments, regardless of size, were included in the evaluation. Lesions with > or =50 luminal narrowing were considered significant stenoses. Invasive coronary angiography demonstrated the absence of significant disease in 25% (13 of 52), single-vessel disease in 31% (16 of 52), and multivessel disease in 45% (23 of 52) of patients. One unsuccessful CT scan was classified as inconclusive. Ninety-four significant stenoses were present in the remaining 51 patients. Sensitivity, specificity, and positive and negative predictive values of CT for detecting significant stenoses on a segment-by-segment analysis were 99% (93 of 94; 95% CI, 94 to 99), 95% (601 of 631; 95% CI, 93 to 96), 76% (93 of 123; 95% CI, 67 to 89), and 99% (601 of 602; 95% CI, 99 to 100), respectively. CONCLUSIONS: Noninvasive 64-slice CT coronary angiography accurately detects coronary stenoses in patients in sinus rhythm and presenting with atypical chest pain, stable or unstable angina, or non-ST-segment elevation myocardial infarction. http://repub.eur.nl/res/pub/13872/ 2005-08-01T00:00:00Z The institutional review board approved this study, and all patients gave written informed consent. One hundred twenty-five patients scheduled to undergo retrospectively electrocardiographically gated 16-detector row computed tomographic coronary angiography were prospectively randomized into the following five groups with respect to the intravenous administration of a 140-mL bolus of contrast material at 4 mL/sec: group 1 (iohexol [300 mg of iodine per milliliter]), group 2 (iodixanol [320 mg I/mL]), group 3 (iohexol [350 mg I/mL]), group 4 (iomeprol [350 mg I/mL]), and group 5 (iomeprol [400 mg I/mL]). Attenuation was measured in the descending aorta and coronary arteries. One-way analysis of variance was used to compare groups. Mean attenuation values in the descending aorta were significantly (P < .05) lower in group 1 and higher in group 5 compared with the mean values in the other three groups. The same pattern was observed in the coronary arteries. Contrast materials with higher iodine concentrations yield significantly higher attenuation in the descending aorta and coronary arteries. http://repub.eur.nl/res/pub/13658/ 2005-05-01T00:00:00Z AIMS: To compare, by meta-analytical techniques, the clinical impact of bare-metal stenting vs. balloon angioplasty for the treatment of lesions in small coronary arteries. METHODS AND RESULTS: We included trials with random allocation and prospective comparison of angioplasty vs. stenting, reference vessel diameter<3 mm, and follow-up>or=6 months. Random effect odds ratios (OR) for death, myocardial infarction (MI), repeat revascularization (RR), and major adverse cardiac events (MACEs) were computed. In a pre-specified subgroup analysis, we compared stenting with optimal (post-procedural stenosis<20%) and suboptimal (>20%) angioplasty. Thirteen studies (4383 patients) were selected. No differences were found in terms of death and MI, while MACEs, mainly driven by RR, were significantly less common after stenting (17.6%) than after angioplasty (22.7%), OR 0.71 (0.57-0.90). Heterogeneity among trials was present. When considering only optimal angioplasty, MACE rates were homogeneously similar, 17.9 vs. 21.1%, OR 0.86 (0.66-1.11). If angioplasty were suboptimal, MACEs were significantly more common after angioplasty (24%) than after stenting (17.3%), OR 0.62 (0.44-0.88). CONCLUSION: Stenting is superior to balloon angioplasty for the treatment of small vessels, in particular after suboptimal angioplasty. However, MACE and RR rates remain high after stenting, and the advantage of stent over angioplasty is moderate. An optimal balloon angioplasty strategy (with provisional stenting) may achieve results not inferior to routine stenting. http://repub.eur.nl/res/pub/13728/ 2005-03-22T00:00:00Z BACKGROUND: The impact of drug-eluting stent (DES) implantation on the incidence of major adverse cardiovascular events in patients undergoing percutaneous intervention for left main (LM) coronary disease is largely unknown. METHODS AND RESULTS: From April 2001 to December 2003, 181 patients underwent percutaneous coronary intervention for LM stenosis at our institution. The first cohort consisted of 86 patients (19 protected LM) treated with bare metal stents (pre-DES group); the second cohort comprised 95 patients (15 protected LM) treated exclusively with DES. The 2 cohorts were well balanced for all baseline characteristics. At a median follow-up of 503 days (range, 331 to 873 days), the cumulative incidence of major adverse cardiovascular events was lower in the DES cohort than in patients in the pre-DES group (24% versus 45%, respectively; hazard ratio [HR], 0.52 [95% CI, 0.31 to 0.88]; P=0.01). Total mortality did not differ between cohorts; however, there were significantly lower rates of both myocardial infarction (4% versus 12%, respectively; HR, 0.22 [95% CI, 0.07 to 0.65]; P=0.006) and target vessel revascularization (6% versus 23%, respectively; HR, 0.26 [95% CI, 0.10 to 0.65]; P=0.004) in the DES group. On multivariate analysis, use of DES, Parsonnet classification, troponin elevation at entry, distal LM location, and reference vessel diameter were independent predictors of major adverse cardiovascular events. CONCLUSIONS: When percutaneous coronary intervention is undertaken at LM lesions, routine DES implantation, which reduces the cumulative incidence of myocardial infarction and the need for target vessel revascularization compared with bare metal stents, should currently be the preferred strategy. http://repub.eur.nl/res/pub/8328/ 2005-01-01T00:00:00Z OBJECTIVE: To compare clinical outcome of paclitaxel eluting stents (PES) versus sirolimus eluting stents (SES) for the treatment of acute ST elevation myocardial infarction. DESIGN AND PATIENTS: The first 136 consecutive patients treated exclusively with PES in the setting of primary percutaneous coronary intervention for acute myocardial infarction in this single centre registry were prospectively clinically assessed at 30 days and one year. They were compared with 186 consecutive patients treated exclusively with SES in the preceding period. SETTING: Academic tertiary referral centre. RESULTS: At 30 days, the rate of all cause mortality and reinfarction was similar between groups (6.5% v 6.6% for SES and PES, respectively, p = 1.0). A significant difference in target vessel revascularisation (TVR) was seen in favour of SES (1.1% v 5.1% for PES, p = 0.04). This was driven by stent thrombosis (n = 4), especially in the bifurcation stenting (n = 2). At one year, no significant differences were seen between groups, with no late thrombosis and 1.5% in-stent restenosis (needing TVR) in PES versus no reinterventions in SES (p = 0.2). One year survival free of major adverse cardiac events (MACE) was 90.2% for SES and 85% for PES (p = 0.16). CONCLUSIONS: No significant differences were seen in MACE-free survival at one year between SES and PES for the treatment of acute myocardial infarction with very low rates of reintervention for restenosis. Bifurcation stenting in acute myocardial infarction should, if possible, be avoided because of the increased risk of stent thrombosis. http://repub.eur.nl/res/pub/13459/ 2004-07-14T00:00:00Z Electrophysiological mapping and ablation techniques are increasingly used to diagnose and treat many types of supraventricular and ventricular tachycardias. These procedures require an intimate knowledge of intracardiac anatomy and their use has led to a renewed interest in visualization of specific structures. This has required collaborative efforts from imaging as well as electrophysiology experts. Classical imaging techniques may be unable to visualize structures involved in arrhythmia mechanisms and therapy. Novel methods, such as intracardiac echocardiography and three-dimensional echocardiography, have been refined and these technological improvements have opened new perspectives for more effective and accurate imaging during electrophysiology procedures. Concurrently, visualization of these structures noticeably improved our ability to identify intracardiac structures. The aim of this review is to provide electrophysiologists with an overview of recent insights into the structure of the heart obtained with intracardiac echocardiography and to indicate to the echo-specialist which structures are potentially important for the electrophysiologist. http://repub.eur.nl/res/pub/13390/ 2004-06-08T00:00:00Z BACKGROUND: Rupture of thin-cap fibroatheromatous plaques is a major cause of acute myocardial infarction (AMI). Such plaques can be identified in vitro by 3D intravascular palpography with high sensitivity and specificity. We used this technique in patients undergoing percutaneous intervention to assess the incidence of mechanically deformable regions. We further explored the relation of such regions to clinical presentation and to C-reactive protein levels. METHOD AND RESULTS: Three-dimensional palpograms were derived from continuous intravascular ultrasound pullbacks. Patients (n=55) were classified by clinical presentation as having stable angina, unstable angina, or AMI. In every patient, 1 coronary artery was scanned (culprit vessel in stable and unstable angina, nonculprit vessel in AMI), and the number of deformable plaques assessed. Stable angina patients had significantly fewer deformable plaques per vessel (0.6+/-0.6) than did unstable angina patients (P=0.0019) (1.6+/-0.7) or AMI patients (P<0.0001) (2.0+/-0.7). Levels of C-reactive protein were positively correlated with the number of mechanically deformable plaques (R2=0.65, P<0.0001). CONCLUSIONS: Three-dimensional intravascular palpography detects strain patterns in human coronary arteries that represent the level of deformation in plaques. The number of highly deformable plaques is correlated with both clinical presentation and levels of C-reactive protein. Further studies will assess the potential role of the technique to identify patients at risk of future clinical events http://repub.eur.nl/res/pub/13380/ 2004-06-01T00:00:00Z BACKGROUND: We evaluated the clinical and angiographic outcomes of patients presenting with restenosis after sirolimus-eluting stent (SES) implantation treated with repeated percutaneous intervention. METHODS AND RESULTS: A total of 24 consecutive patients have undergone repeated percutaneous intervention to treat post-SES restenosis (27 lesions). The restenosis was located within the stent in 93% of lesions. From the 27 lesions, 1 (4%) was re-treated with a bare stent, 3 (11%) were treated with balloon dilatation, and the remaining 23 lesions (85%) were treated with repeated drug-eluting stent implantation (SES in 12 lesions [44%], paclitaxel-eluting stents in 11 lesions [41%]). The event-free survival rate was 70.8% after a median follow-up of 279 days from the post-SES treatment. The overall recurrent restenosis rate was 42.9%. The risk of recurrent restenosis was increased for patients with hypercholesterolemia, previous angioplasty, failed brachytherapy, post-SES restenosis needing early (<6 months) treatment, and post-SES restenosis treated with balloon dilatation. The recurrent restenosis rate of originally de novo lesions re-treated with drug-eluting stents was 18.2%. CONCLUSIONS: Even though de novo lesions treated with SES at baseline and re-treated with drug-eluting stents had reasonably better outcomes than other lesion types and strategies, our study shows that the treatment of post-SES restenosis is currently suboptimal and warrants further investigation. http://repub.eur.nl/res/pub/4666/ 2004-04-01T00:00:00Z Long-length stenting has a poor outcome when bare metal stents are used. The safety and efficacy of the sirolimus-eluting stent (SES) in long lesions has not been evaluated. Therefore, the aim of the present study was to evaluate the clinical and angiographic outcomes of SES implantation over a very long coronary artery segment. Since April 2002, all patients treated percutaneously at our institution received a SES as the device of choice as part of the Rapamycin Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry. During the RESEARCH registry, stents were available in lengths of 8, 18, and 33 mm. The present report includes a predefined study population consisting of patients treated with >36-mm-long stented segments. Patients had a combination of >or=2 overlapping stents at a minimum length of 41 mm (i.e., one 33-mm SES overlapping an 8-mm SES) to treat native de novo coronary lesions. The incidence of major cardiac adverse events (death, nonfatal myocardial infarction, and target lesion revascularization) was evaluated. The study group comprised 96 consecutive patients (102 lesions). Clinical follow-up was available for all patients at a mean of 320 days (range 265 to 442). In all, 20% of long-stented lesions were chronic total occlusions, and mean stented length per lesion was 61.2 +/- 21.4 mm (range 41 to 134). Angiographic follow-up at 6 months was obtained in 67 patients (71%). Binary restenosis rate was 11.9% and in-stent late loss was 0.13 +/- 0.47 mm. At long-term follow-up (mean 320 days), there were 2 deaths (2.1%), and the overall incidence of major cardiac events was 8.3%. Thus, SES implantation appears safe and effective for de novo coronary lesions requiring multiple stent placement over a very long vessel segment. http://repub.eur.nl/res/pub/4667/ 2004-04-01T00:00:00Z The purpose of this study was to assess the safety and effectiveness of sirolimus-eluting stent (SES) postdilatation with largely oversized balloons. We evaluated the clinical outcome of 68 consecutive patients enrolled in the Rapamycin-Eluting Stent Evaluated at Rotterdam Cardiology Hospital (RESEARCH) registry who underwent percutaneous coronary intervention with SES implantation and further postdilatation with balloons > 1 mm larger than the stent nominal size. Angiographic follow-up was either scheduled for selected subgroups or clinically driven. Overall, 75 lesions were treated. The procedure was successful in 98.5% of the cases. One patient (1.5%) underwent emergency coronary bypass surgery for acute vessel occlusion. During 10.1 +/- 1.7 months of follow-up, three patients (4.5%) died, one (1.5%) had acute myocardial infarction, and four (6%) had target vessel revascularization. At angiographic follow-up, loss index was 0.13 +/- 0.34 and restenosis rate was 7.7%. Although not routinely recommended in every patient, SES postdilatation with largely oversized balloons appears a safe and effective strategy for selected patients. http://repub.eur.nl/res/pub/13314/ 2004-03-23T00:00:00Z BACKGROUND: The factors associated with the occurrence of restenosis after sirolimus-eluting stent (SES) implantation in complex cases are currently unknown. METHODS AND RESULTS: A cohort of consecutive complex patients treated with SES implantation was selected according to the following criteria: (1) treatment of acute myocardial infarction, (2) treatment of in-stent restenosis, (3) 2.25-mm diameter SES, (4) left main coronary stenting, (5) chronic total occlusion, (6) stented segment >36 mm, and (7) bifurcation stenting. The present study population was composed of 238 patients (441 lesions) for whom 6-month angiographic follow-up data were obtained (70% of eligible patients). Significant clinical, angiographic, and procedural predictors of post-SES restenosis were evaluated. Binary in-segment restenosis was diagnosed in 7.9% of lesions (6.3% in-stent, 0.9% at the proximal edge, 0.7% at the distal edge). The following characteristics were identified as independent multivariate predictors: treatment of in-stent restenosis (OR 4.16, 95% CI 1.63 to 11.01; P<0.01), ostial location (OR 4.84, 95% CI 1.81 to 12.07; P<0.01), diabetes (OR 2.63, 95% CI 1.14 to 6.31; P=0.02), total stented length (per 10-mm increase; OR 1.42, 95% CI 1.21 to 1.68; P<0.01), reference diameter (per 1.0-mm increase; OR 0.46, 95% CI 0.24 to 0.87; P=0.03), and left anterior descending artery (OR 0.30, 95% CI 0.10 to 0.69; P<0.01). CONCLUSIONS: Angiographic restenosis after SES implantation in complex patients is an infrequent event, occurring mainly in association with lesion-based characteristics and diabetes mellitus. http://repub.eur.nl/res/pub/4672/ 2004-03-01T00:00:00Z A total of 91 patients with 112 lesions received 2.25-mm sirolimus-eluting stents (SESs), and these lesions were compared with those treated with SESs of ≥2.5-mm diameter in the same procedure (n = 109). The reference diameters were 1.88 ± 0.34 and 2.52 ± 0.57 mm, respectively (p <0.01). At follow-up, the late lumen loss was 0.07 ± 0.48 mm for the 2.25-mm SES versus 0.03 ± 0.38 mm for the larger SES (p = 0.5), and the binary restenosis rate was 10.7% versus 3.9%, respectively (p = 0.1). The 12-month target lesion revascularization rate was 5.5%. In conclusion, 2.25-mm SESs were associated with low rates of clinical and angiographic late complications. http://repub.eur.nl/res/pub/13279/ 2004-01-20T00:00:00Z BACKGROUND: The effectiveness of sirolimus-eluting stents in unselected patients treated in the daily practice is currently unknown. METHODS AND RESULTS: Sirolimus-eluting stent implantation has been used as the default strategy for all percutaneous procedures in our hospital as part of the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry. Consecutive patients with de novo lesions (n=508) treated exclusively with sirolimus-eluting stents (SES group) were compared with 450 patients who received bare stents in the period just before (pre-SES group). Patients in the SES group more frequently had multivessel disease, more type C lesions, received more stents, and had more bifurcation stenting. At 1 year, the cumulative rate of major adverse cardiac events (death, myocardial infarction, or target vessel revascularization) was 9.7% in the SES group and 14.8% in the pre-SES group (hazard ratio [HR], 0.62 [95% CI, 0.44 to 0.89]; P=0.008). The 1-year risk of clinically driven target vessel revascularization in the SES group and in the pre-SES group was 3.7% versus 10.9%, respectively (HR, 0.35 [95% CI, 0.21 to 0.57]; P<0.001). CONCLUSIONS: Unrestricted utilization of sirolimus-eluting stents in the "real world" is safe and effective in reducing both repeat revascularization and major adverse cardiac events at 1 year compared with bare stent implantation. http://repub.eur.nl/res/pub/4673/ 2004-01-01T00:00:00Z http://repub.eur.nl/res/pub/13250/ 2003-10-21T00:00:00Z BACKGROUND: Sirolimus-eluting stents (SES) have recently been proven to reduce restenosis and reintervention compared with bare stents. Safety and effectiveness of SES in acute myocardial infarction remain unknown. METHODS AND RESULTS: Since April 16, 2002, a policy of routine SES implantation has been instituted in our hospital, with no clinical or anatomic restrictions, as part of the RESEARCH (Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital) registry. During 6 months of enrollment, 96 patients with ST-elevation acute myocardial infarction underwent percutaneous recanalization and SES implantation; these patients comprise the study population. The incidence of major adverse cardiac events (death, nonfatal myocardial infarction, reintervention) was evaluated. Six-month angiographic follow-up was scheduled per protocol. At baseline, diabetes mellitus was present in 12.5% and multivessel disease in 46.9%. Primary angioplasty was performed in 89 patients (92.7%). Infarct location was anterior in 41 (42.7%) of the cases, and 12 patients (12.5%) had cardiogenic shock. Postprocedural TIMI-3 flow was achieved in 93.3% of the cases. In-hospital mortality was 6.2%. One patient (1.1%) had reinfarction and target lesion reintervention the first day as a result of distal dissection and acute vessel occlusion. During follow-up (mean follow-up of 218+/-75 days), 1 patient died (1.1%), no patient had recurrent myocardial infarction, and there were no additional reinterventions. No early or late stent thromboses were documented. At angiographic follow-up (70%), late loss was -0.04+/-0.25, and no patient presented angiographic restenosis. CONCLUSIONS: In this study, sirolimus-eluting stent implantation for patients with ST-elevation acute myocardial infarction was safe without documented angiographic restenosis at 6 months. http://repub.eur.nl/res/pub/13177/ 2003-07-22T00:00:00Z BACKGROUND: We describe the clinical and morphological patterns of restenosis after sirolimus-eluting stent (SES) implantation. METHODS AND RESULTS: From 121 patients with coronary angiography obtained >30 days after SES implantation, restenosis (diameter stenosis >50%) was identified in 19 patients and 20 lesions (located at the proximal 5-mm segment in 30% or within the stent in 70%). Residual dissection after the procedure or balloon trauma outside the stent was identified in 83% of the proximal edge lesions. Lesions within the stent were focal, and stent discontinuity was identified in some lesions evaluated by intravascular ultrasound. CONCLUSIONS: Sirolimus-eluting stent edge restenosis is frequently associated with local trauma outside the stent. In-stent restenosis occurs as a localized lesion, commonly associated with a discontinuity in stent coverage. Local conditions instead of intrinsic drug-resistance to sirolimus are likely to play a major role in post-SES restenosis. http://repub.eur.nl/res/pub/10039/ 2002-01-01T00:00:00Z http://repub.eur.nl/res/pub/12883/ 2000-09-01T00:00:00Z The clinical presentations of ischaemic heart disease include stable angina pectoris, silent ischaemia, unstable angina, myocardial infarction, heart failure, and sudden death. For many years, unstable angina has been con- sidered as an intermediate ‘syndrome’ between chronic stable angina and acute myocardial infarction. In recent years, its physiopathology has been clarified and there have been major advances in management.