http://repub.eur.nl/res/aut/794/ List of Publications en http://repub.eur.nl/static-eur/img/logo.png http://repub.eur.nl http://repub.eur.nl/res/pub/24411/ 2009-07-01T00:00:00Z Objectives: We investigated the impact of sex on outcomes after percutaneous coronary intervention (PCI) with drug-eluting stent (DES). Background: Women have a higher risk of adverse outcomes after PCI than do men. However, long-term outcomes of women after contemporary PCI with DES have not been fully investigated. Methods: We performed a retrospective cohort study of 4,936 consecutive patients (28.2% women) who underwent PCIs between 2000 and 2004, before and after introduction of DES (bare-metal stent [BMS] group: n = 2,131, DES group: n = 2,805), to assess the impact of sex on long-term PCI outcomes and to compare outcome after PCI of women between the DES and BMS eras. Results: Compared with men, women undergoing PCIs were 5 years older and more frequently have comorbidities such as diabetes mellitus and hypertension. In patients treated throughout the BMS and DES eras, there were no differences by sex for risk of all-cause death, myocardial infarction, or target vessel revascularization 3 years after procedure. The procedural complexity was higher in the DES era, nevertheless, risk for target vessel revascularization and major adverse cardiac event at 3 years were significantly lower in women treated with DES than in women treated with BMS (adjusted hazard ratio [HR] for target vessel revascularization: 0.52 [95% confidence interval (CI): 0.36 to 0.75], adjusted HR for major adverse cardiac event: 0.63 [95% CI: 0.48 to 0.83]). Conclusions: Although women had worse baseline characteristics, no differences in 3-year outcomes were observed between men and women. Compared with BMS use, DES use has decreased revascularization rate equally in women and men. http://repub.eur.nl/res/pub/24447/ 2009-07-01T00:00:00Z Objective: It remains unclear whether feelings of being disabled are a relevant psychological factor that determines outcome after percutaneous coronary intervention (PCI). Therefore, we evaluated "feelings of being disabled" as an independent risk factor for mortality 4 years post-PCI. Methods: As part of the Taxus-Stent Evaluated At Rotterdam Cardiology Hospital (T-SEARCH) Registry, 658 consecutive patients (age 63 years, 75% male) completed the subscale "feelings of being disabled" of the Heart Patients Psychological Questionnaire (HPPQ), within the first month after PCI. Results: At 4-year follow-up, 8% of the patients (n=55) had died, 2% (n=16) underwent a myocardial infarction (MI), 13% (n=90) had a target-vessel revascularization (TVR), and 21% (n=137) had one or more major adverse cardiac events (MACE). One-third of the patients (32%) had high scores on "feelings of being disabled" at baseline. After adjusting for baseline characteristics, including symptoms of anxiety and depression, patients with a high score on "feelings of being disabled" had an increased risk for all cause mortality (HR=2.9, 95% CI=1.5-5.6), the composite end point mortality/MI (HR=2.4, 95% CI=1.3-4.4), and the occurrence of MACE (HR=1.7, 95% CI=1.1-2.7). Conclusion: Feelings of being disabled were an independent predictor of all-cause mortality, mortality/MI, and MACE 4 years post-PCI. These patients should be identified in clinical practice, as they warrant additional treatment, e.g., of a psychosocial nature, in addition to the standard medical treatment. http://repub.eur.nl/res/pub/24412/ 2009-06-01T00:00:00Z Objectives: We aimed to evaluate the risk of definite stent thrombosis with bare-metal stents (BMS) and drug-eluting stents (DES) in patients treated for acute coronary syndromes. Background: Acute coronary syndromes (ACS) have been reported as increasing the risk for stent thrombosis. Methods: Between January 2000 and December 2005, 5,816 consecutive patients underwent percutaneous coronary intervention for de novo lesions with a single stent type. These patients consisted of 3 sequential groups of BMS (n = 2,248), sirolimus-eluting stents (n = 822) and paclitaxel-eluting stents (n = 2,746). In total, 3,485 patients presented with an ACS. Results: After a median follow-up of 1,394 days, patients with ACS had a definite stent thrombosis rate of 2.5% versus 1.0% in patients with stable angina (propensity score-adjusted hazard ratio [HR]: 2.80, 95% confidence interval [CI]: 1.72 to 4.56). ACS patients had a higher risk of early and late stent thrombosis, although the increased risk of very late stent thrombosis was only present in ACS patients treated with DES. In stable patients, any stent thrombosis resulted in a significant increase in mortality (adjusted HR: 4.0, 95% CI: 1.7 to 9.3), although this was particularly evident for late or very late stent thrombosis; in contrast only early stent thrombosis significantly increased mortality in patients with acute coronary syndrome patients (adjusted HR: 2.0, 95% CI: 1.0 to 4.1). Conclusions: Patients with acute coronary syndromes are at higher risk of early and late stent thrombosis with either BMS or DES, although very late stent thrombosis seems to be uniquely associated with DES. The clinical sequelae of late and very late stent thrombosis are more pronounced in stable patients. http://repub.eur.nl/res/pub/15333/ 2009-01-15T00:00:00Z Drug-eluting stents (DESs) have been shown to reduce the rate of repeat revascularization compared with bare-metal stents (BMSs) after multivessel percutaneous coronary intervention in carefully selected patients. However, the long-term safety and efficacy of DESs in patients with multivessel disease outside the setting of randomized trials was unknown. Therefore, all patients undergoing multivessel percutaneous coronary intervention with BMSs, sirolimus-eluting stents (SESs), or paclitaxel-eluting stents (PESs) from January 2000 to December 2005 were investigated. The primary end point was all-cause mortality. A total of 1,720 patients were recruited in 3 consecutive sequential groups of BMS (n = 701; January 2000 to April 2002), SES (n = 293; April 2002 to February 2003), and PES (n = 726; February 2003 to December 2005). Overall median follow-up was 1,440 days. There was improved 3-year survival in the SES group (93.7%) compared with both the BMS (86.1%) and PES groups (87.3%), which remained significant after propensity score adjustment for differences in baseline and procedural characteristics (SES vs BMS, adjusted hazard ratio 0.53, 95% confidence interval 0.30 to 0.94; SES vs PES, adjusted hazard ratio 0.49, 95% confidence interval 0.28 to 0.87). There was no difference in mortality between the PES and BMS groups. Both DES types significantly reduced the need for clinically driven target-vessel and target-lesion revascularization without an excess in myocardial infarction or stent thrombosis. In conclusion, both SESs and PESs significantly reduced the need for repeated revascularization in these patients with no excess in mortality. SESs might reduce mortality in patients undergoing multivessel percutaneous coronary intervention. http://repub.eur.nl/res/pub/27090/ 2009-01-01T00:00:00Z http://repub.eur.nl/res/pub/29780/ 2008-12-09T00:00:00Z Objectives: The purpose of this study was to assess the 3-year outcome of coronary artery bypass graft surgery (CABG) and percutaneous coronary intervention (PCI) using sirolimus-eluting stents (SES) in patients who had multivessel coronary artery disease with and without diabetes mellitus. Background: The optimal method of revascularization in diabetic patients remains in dispute. Methods: The ARTS-II (Arterial Revascularization Therapies Study-Part II) trial is a single-arm study (n = 607) that included 159 diabetic patients treated with SES whose 3-year clinical outcome was compared with that of the historical diabetic and nondiabetic arms of the randomized ARTS-I trial (n = 1,205, including 96 diabetic patients in the CABG arm and 112 in the PCI arm). Results: At 3 years, among nondiabetic patients, the incidence of the primary composite of death, CVA, myocardial infarction (MI), and repeat revascularization (major adverse cardiac and cerebrovascular events [MACCE]), was significantly lower in ARTS-II than in ARTS-I PCI (adjusted odds ratio [OR]: 0.41; 95% confidence interval [CI]: 0.26 to 0.64) and similar to ARTS-I CABG. The ARTS-II patients were at significantly lower risk for death, CVA, and MI as compared with both the ARTS-I PCI (adjusted OR: 0.55; 95% CI: 0.34 to 0.91) and ARTS-I CABG patients (adjusted OR: 0.56; 95% CI: 0.35 to 0.92). Among diabetic patients, the incidence of MACCE in ARTS-II was similar to that of both PCI and CABG in ARTS-I. Conversely, the incidence of death, CVA, and MI was significantly lower in ARTS-II than in ARTS-I PCI (adjusted OR: 0.67; 95% CI: 0.27 to 1.65) and was similar to that of ARTS-I CABG. Conclusions: At 3 years, PCI using SES for patients with multivessel coronary artery disease seems to be safer and more efficacious than PCI using bare-metal stents, irrespective of the diabetic status of the patient. Hence, PCI using SES appears to be a valuable alternative to CABG for both diabetic and nondiabetic patients. http://repub.eur.nl/res/pub/14039/ 2008-11-14T00:00:00Z Coronary heart disease has been the leading cause of death in developed countries for many years. At the same time, the developments in the field of interventional cardiology occurred at an incredible speed and it took no more than 15 years for the first balloon-mounted stent by Palmaz et al. in 1985 to evolve into a modern first generation drug-eluti ng stent (DES). As early as 1999, stenting comprised 84.2% of percutaneous coronary interventions (PCI). In the same year, several preclinical studies reported that sirolimus (rapamycin), a macrocyclic lactone that inhibits cytokine-mediated and growth-factor–mediated proliferation of lymphocytes and smooth-muscle cells, reduced neointimal proliferation (i.e. renarrowing of the vascular lumen at the site of stent implantation, leading to recurrence of angina - the largest limitation of stenting thus far). In 2002, the first DES, coated with sirolimus, were introduced into clinical practice in order to reduce restenosis which occurred in 15% to 25% of patients receiving bare-metal stents.6, 7 Subsequent trials with different types of DES confirmed their efficacy in this regard.8 In 2002, the pivotal RAVEL trial reported that none of the patients in the sirolimus-stent group, as compared with 26.6% of those in the standard-stent group, had restenosis of 50 percent or more of the luminal diameter (P<0.001). http://repub.eur.nl/res/pub/29340/ 2008-10-13T00:00:00Z Background: Percutaneous treatment of stenoses involving aorto-ostial lesions is technically demanding and has been associated with lower procedural success and poorer clinical and angiographic outcomes when compared with non-ostial lesions. This study evaluated the immediate and long-term (2-year) outcome of aorto-ostial stenoses treated with paclitaxel-eluting stents (PES). Methods: From February 2003 to December 2004, a total of 76 consecutive patients with 76 lesions underwent percutaneous intervention with PES for aorto-ostial lesions (right coronary artery, 37; left main, 26; saphenous vein graft, 13). All patients were clinically followed for the occurrence of major adverse cardiac events (MACE), defined as cardiac death, non-fatal myocardial infarction (MI), target lesion revascularization (TLR) or target vessel revascularization (TVR). Results: All stents (1.7/lesion) were successfully deployed. Three lesions (3.9%) were pre-treated with debulking devices. Thirty-seven lesions (48.7%) were post-dilated with non-compliant balloons (balloon/artery ratio, 1.2). Stents were positioned protruding into the aortic lumen in 29 lesions (38.2%). Cumulative 2-year event-free survival was 68.4%. There was one angiographically-proven stent thrombosis occurring 427 days after TLR for restenosis after the index procedure. The restenosis rate at 7 months (median) was 20.0% and in-stent late lumen loss was 0.48 mm in 40 patients with angiographic follow-up. Conclusions: Utilization of PES in this complex lesion subset is feasible and associated with favorable angiographic results at 7 months. However, the gradual increase in later events up to 2 years suggests that aorto-ostial disease remains problematic even in the era of drug-eluting stents. http://repub.eur.nl/res/pub/29765/ 2008-09-30T00:00:00Z Objectives: We sought to determine the risk of late stent thrombosis (ST) during long-term follow-up beyond 3 years, searched for predictors, and assessed the impact of ST on overall mortality. Background: Late ST was reported to occur at an annual rate of 0.6% up to 3 years after drug-eluting stent (DES) implantation. Methods: A total of 8,146 patients underwent percutaneous coronary intervention with a sirolimus-eluting stent (SES) (n = 3,823) or paclitaxel-eluting stent (PES) (n = 4,323) and were followed up to 4 years after stent implantation. Dual antiplatelet treatment was prescribed for 6 to 12 months. Results: Definite ST occurred in 192 of 8,146 patients with an incidence density of 1.0/100 patient-years and a cumulative incidence of 3.3% at 4 years. The hazard of ST continued at a steady rate of 0.53% (95% confidence interval [CI]: 0.44 to 0.64) between 30 days and 4 years. Diabetes was an independent predictor of early ST (hazard ratio [HR]: 1.96; 95% CI: 1.18 to 3.28), and acute coronary syndrome (HR: 2.21; 95% CI: 1.39 to 3.51), younger age (HR: 0.97; 95% CI: 0.95 to 0.99), and use of PES (HR: 1.67; 95% CI: 1.08 to 2.56) were independent predictors of late ST. Rates of death and myocardial infarction at 4 years were 10.6% and 4.6%, respectively. Conclusions: Late ST occurs steadily at an annual rate of 0.4% to 0.6% for up to 4 years. Diabetes is an independent predictor of early ST, whereas acute coronary syndrome, younger age, and PES implantation are associated with late ST. http://repub.eur.nl/res/pub/29131/ 2008-09-09T00:00:00Z Background - Randomized trials that studied clinical outcomes after percutaneous coronary intervention (PCI) with bare metal stenting versus coronary artery bypass grafting (CABG) are underpowered to properly assess safety end points like death, stroke, and myocardial infarction. Pooling data from randomized controlled trials increases the statistical power and allows better assessment of the treatment effect in high-risk subgroups. Methods and Results - We performed a pooled analysis of 3051 patients in 4 randomized trials evaluating the relative safety and efficacy of PCI with stenting and CABG at 5 years for the treatment of multivessel coronary artery disease. The primary end point was the composite end point of death, stroke, or myocardial infarction. The secondary end point was the occurrence of major adverse cardiac and cerebrovascular accidents, death, stroke, myocardial infarction, and repeat revascularization. We tested for heterogeneities in treatment effect in patient subgroups. At 5 years, the cumulative incidence of death, myocardial infarction, and stroke was similar in patients randomized to PCI with stenting versus CABG (16.7% versus 16.9%, respectively; hazard ratio, 1.04, 95% confidence interval, 0.86 to 1.27; P=0.69). Repeat revascularization, however, occurred significantly more frequently after PCI than CABG (29.0% versus 7.9%, respectively; hazard ratio, 0.23; 95% confidence interval, 0.18 to 0.29; P<0.001). Major adverse cardiac and cerebrovascular events were significantly higher in the PCI than the CABG group (39.2% versus 23.0%, respectively; hazard ratio, 0.53; 95% confidence interval, 0.45 to 0.61; P<0.001). No heterogeneity of treatment effect was found in the subgroups, including diabetic patients and those presenting with 3-vessel disease. Conclusions - In this pooled analysis of 4 randomized trials, PCI with stenting was associated with a long-term safety profile similar to that of CABG. However, as a result of persistently lower repeat revascularization rates in the CABG patients, overall major adverse cardiac and cerebrovascular event rates were significantly lower in the CABG group at 5 years. http://repub.eur.nl/res/pub/33104/ 2008-06-12T00:00:00Z http://repub.eur.nl/res/pub/28975/ 2008-06-01T00:00:00Z The differential safety and efficacy profiles of sirolimus-eluting stents when implanted in patients with multivessel coronary artery disease who have increased body mass indexes (BMIs) compared with those with normal BMIs are largely unknown. This study evaluated the impact of BMI on 1-year outcomes in patients with multivessel coronary artery disease treated with sirolimus-eluting stents as part of the Arterial Revascularization Therapies Study Part II (ARTS II). From February to November 2003, 607 patients were included at 45 centers; 176 patients had normal BMIs (<25 kg/m2), 289 were overweight (≥25 and ≤30 kg/m2), and 142 were obese (>30 kg/m2). At 30 days, the cumulative incidence of the primary combined end point of death, myocardial infarction, cerebrovascular accident, and repeat revascularization (major adverse cardiac and cerebrovascular events) was 3.4% in the group with normal BMIs, 3.1% in overweight patients, and 2.8% in obese patients (p = 0.76). At 1 year, the cumulative incidence of major adverse cardiac and cerebrovascular events was 10.8%, 11.8%, and 7.0% in the normal BMI, overweight, and obese groups, respectively (p = 0.31). In conclusion, BMI had no impact on 1-year clinical outcomes in patients with multivessel coronary artery disease treated with sirolimus-eluting stents in ARTS II. http://repub.eur.nl/res/pub/28875/ 2008-04-15T00:00:00Z Although the safety of drug-eluting stents has been under considerable scrutiny, limited real-world follow-up data extending up to 4 years are available. The randomized clinical trials carefully selected patients and are not reflective of everyday practice. From April to October 2002, 508 consecutive patients treated with sirolimus-eluting stents (SES) were enrolled. The control group consisted of 450 patients treated with bare-metal stents during the preceding 6 months. After 4 years of follow-up, the incidence of composite major adverse clinical events (all-cause death, myocardial infarction, or target vessel revascularization) was found to be significantly lower in the SES group (23.0% vs 28.7%, adjusted hazard ratio 0.66, 95% confidence interval 0.51 to 0.86), as were rates of target vessel revascularization (12.2% vs 17.8%, adjusted hazard ratio 0.57, 95% confidence interval 0.39 to 0.83). There were no differences in all-cause mortality (10.5% for SES vs 10.6% for bare-metal stents, p = 0.9) or in the rates of cardiac death (4.5% vs 6.9%, p = 0.1). Although there was no difference in overall stent thrombosis (2.3% vs 2.2%, p = 1.0), SES had a higher rate of very late stent thrombosis (1.4% vs 0%, p = 0.02), balanced by a lower rate of early stent thrombosis (0.4% vs 1.8%, p = 0.05). In conclusion, after 4 years, SES were found to remain safe and effective compared with bare-metal stents. Nevertheless, the higher rate of very late stent thrombosis remains a concern. Longer term follow-up will be required to determine the extent of this problem. http://repub.eur.nl/res/pub/30101/ 2008-03-01T00:00:00Z This review aims to provide a glimpse into the future of drug-eluting stents (DES). Since their arrival in 2002, DES have transformed the practice of interventional cardiology by drastically reducing restenosis and the need for repeat revascularization. However, data about the potentially fatal long-term risk of stent thrombosis have spurred on research and development to improve upon the first generation of devices. The initial commercially available DES used a stainless steel platform coated with a permanent polymer to provide controlled release of the anti-restenotic drug. The platform, polymer and drug are all targets for improvement. More advanced metallic and fully biodegradable stent platforms are currently under investigation. The permanent polymer coating, a likely contributor adverse events, is being superseded by biocompatible and bioabsorbable alternatives. New drugs and drug combinations are also a research goal, as interventional cardiologists and the industry strive towards safer anti-restenotic DES. http://repub.eur.nl/res/pub/29937/ 2008-02-01T00:00:00Z Objective. Emotional distress has been related to clinical events in patients with coronary artery disease, but the influence of positive affect (i.e. mood states such as activity, joy and cheerfulness) has received little attention. Therefore, we wanted to investigate the role of positive affect on clinical outcome after percutaneous coronary intervention (PCI) with stent implantation in these patients. Design. Prospective follow-up study. At baseline, patients from the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry completed measures of positive affect, depression and anxiety post-PCI. Patients with reduced positive affect scored 1 SD below the mean score. Setting. University Hospital; Thoraxcenter of the Department of Cardiology. Subjects. 874 patients (72% men; 62.2 ± 10.9 years) from the RESEARCH registry. Main outcome measure. Death or myocardial infarction (MI) 2 years post-PCI. Results. At follow-up, there were 52 clinical events (deaths n = 27, MIs n = 25). Reduced positive affect and depression/anxiety were associated with poor prognosis, but reduced positive affect was the only independent predictor of events. The incidence of death/MI in adequate versus reduced positive affect patients was 4% (29/663) vs. 11% (23/211); HR = 2.55 (95% CI 1.46-4.34, P = 0.001), adjusting for clinical variables. Reduced positive affect and diabetes were independent prognostic factors, and patients with one (HR = 2.84, 95% CI 1.58-5.10) or both (HR = 5.61, 95% CI 2.25-13.99) of these factors had a higher risk when compared with nondiabetic patients with adequate positive affect, P ≤ 0.003. Conclusions. Reduced positive affect independently predicted death/MI following stent implantation, and improved risk stratification above and beyond diabetes. http://repub.eur.nl/res/pub/36960/ 2007-11-01T00:00:00Z Background: We previously reported that the 1-year survival-free from target lesion revascularization was 97.4% in patients with chronic total occlusion (CTO) treated with sirolimus-eluting stents (SES). There are currently no long-term results of the efficacy of SES in this subset of lesions. We assessed the 3-year clinical outcomes of 147 patients with CTO treated with either SES or bare metal stents (BMS). Methods and Results: A total of 147 (BMS = 71, SES = 76) patients were included. Four patients died in the BMS group while five patients died in the SES group, P = 0.8; two myocardial infarctions occurred in both groups, P = 0.9; and target vessel revascularization was performed in nine patients in the BMS and seven in the SES group, P = 0.5. The cumulative event-free survival of MACE was 81.7% in BMS group and 84.2% in SES group, P = 0.7. Two patients of the SES group had a coronary aneurism at 3-year angiographic follow-up. Conclusions: The use of SES was no longer associated with significantly lower rates of target vessel revascularization and major adverse cardiac events in patients with CTOs after 3 years of followup compared with BMSs. http://repub.eur.nl/res/pub/36188/ 2007-08-14T00:00:00Z Objectives: This study sought to investigate the impact of thrombus burden on the clinical outcome and angiographic infarct-related artery stent thrombosis (IRA-ST) in patients routinely treated with drug-eluting stent (DES) implantation for ST-segment elevation myocardial infarction (STEMI). Background: There are limited data for the safety and effectiveness of DES in STEMI. Methods: We retrospectively analyzed 812 consecutive patients treated with DES implantation for STEMI. Intracoronary thrombus burden was angiographically estimated and categorized as large thrombus burden (LTB), defined as thrombus burden ≥2 vessel diameters, and small thrombus burden (STB) to predict clinical outcomes. Major adverse cardiac events (MACE) were defined as death, repeat myocardial infarction, and IRA reintervention. Results: Mean duration of follow-up was 18.2 ± 7.8 months. Large thrombus burden was an independent predictor of mortality (hazard ratio [HR] 1.76, p = 0.023) and MACE (HR 1.88, p = 0.001). The cumulative angiographic IRA-ST was 1.1% at 30 days and 3.2% at 2 years, and continued to augment beyond 2 years. It was significantly higher in the LTB compared with the STB group (8.2% vs. 1.3% at 2 years, respectively, p < 0.001). Significant independent predictors for IRA-ST were LTB (HR 8.73, p < 0.001), stent thrombosis at presentation (HR 6.24, p = 0.001), bifurcation stenting (HR 4.06, p = 0.002), age (HR 0.55, p = 0.003), and rheolytic thrombectomy (HR 0.11, p = 0.03). Conclusions: Large thrombus burden is an independent predictor of MACE and IRA-ST in patients treated with DES for STEMI. http://repub.eur.nl/res/pub/35304/ 2007-08-01T00:00:00Z http://repub.eur.nl/res/pub/35339/ 2007-07-01T00:00:00Z BACKGROUND - The presence of a lumen narrowing at the ostium and the body of an unprotected left main coronary artery but does not require bifurcation treatment is a class I indication of surgical revascularization. METHODS AND RESULTS - A total of 147 consecutive patients who had a stenosis in the ostium and/or the midshaft of an unprotected left main coronary artery (treatment of the bifurcation not required) and were electively treated with percutaneous coronary intervention and sirolimus-eluting stents (n=107) or paclitaxel-eluting stents (n=40) in 5 centres were included in this registry. In 72 patients (almost 50%), intravascular ultrasound guidance was performed. Procedural success was achieved in 99% of the patients; in 1 patient with stenosis in the left main coronary artery ostium, a >30% residual stenosis persisted at the end of the procedure, and the patient was referred for coronary artery bypass graft surgery. During hospitalization, no patients experienced a Q-wave myocardial infarction or died. One patient died 19 days after the procedure because of pulmonary infection. At long-term clinical follow-up (886±308 days), 5 patients had died; 7 patients had target vessel revascularization (5 repeat percutaneous coronary interventions and 2 coronary artery bypass graft surgeries), and of these only 1 patient had a target lesion revascularization. Angiographic follow-up was performed in 106 patients (72%) with a late loss of -0.01 mm. Restenosis in the left main trunk occurred only in 1 patient (0.9%). CONCLUSIONS - Percutaneous coronary intervention with sirolimus-eluting stents or paclitaxel-eluting stents implantation in nonbifurcation left main coronary artery lesions appears safe with a long-term major adverse clinical event rate of 7.4% and a restenosis rate of 0.9%. http://repub.eur.nl/res/pub/35359/ 2007-07-01T00:00:00Z http://repub.eur.nl/res/pub/37003/ 2007-07-01T00:00:00Z Objective: To compare the postprocedural and long-term clinical outcomes of two groups of patients, all presenting with chronic saphenous vein graft (SVG) occlusion, who underwent either SVG or native vessel reopening. Background: Chronic total occlusions (CTO) treatment in patients who underwent previous surgical revascularization is a dilemma and the choice of performing native vessel or SVG recanalization is not always easy. Methods: Between July 2002 and October 2004, a total of 260 patients were successfully treated for a CTO. Of them, we selected all patients (n = 24) who had previous bypass surgery with graft occlusion. Of this final group, 13 patients underwent a percutaneous graft recanalization while 11 underwent native vessel reopening. Results: Primary end points were in-hospital and 3-year rates of death, myocardial infarction, target lesion revascularization, and target vessel revascularization. No events occurred in either group during the in-hospital period. Cumulative 3-year event-free survival in the native vessel and SVG group was 81.8% and 83.9% respectively (P = NS). One death and one TVR occurred in each group. Conclusion: In selected cases, SVG reopening instead of the native vessel is feasible. In such a high-risk population, drug-eluting stent implantation in both SVG and native CTO lesions is associated with good long-term outcomes. http://repub.eur.nl/res/pub/36088/ 2007-06-01T00:00:00Z Several meta-analyses have demonstrated the superiority of drug-eluting stents (DES) in reducing the incidence of restenosis, target vessel revascularization and target lesion revascularization compared to their predecessor, the bare-metal stent. In comparing Cypher® and Taxus™ stents, the two most recent meta-analyses have given the edge to the Cypher®. However, it must be stressed that the superiority of one DES over another remains debatable due to ever changing "real-world data" compared to those attained from randomized trials. The newer sirolimus analogs and selective inhibitors are challenging the old guard in their quest to further limit restenosis. So too are the newer "high-tech" polymers and additionally by using more biodegradable material in the stent's design. Stents aimed at targeting lesions are a new armament in the battle against restenosis and together with combination therapies are exciting key areas to watch. The ideal way to treat a DES in-stent restenosis is still a challenge and hence the impetus is to avoid it from happening in the first place. http://repub.eur.nl/res/pub/35798/ 2007-05-26T00:00:00Z http://repub.eur.nl/res/pub/35470/ 2007-04-15T00:00:00Z Sirolimus-eluting stents (SESs) recently proved to be superior to bare metal stents (BMSs) in decreasing the need for repeat revascularization in patients with ST-segment elevation myocardial infarction (STEMI) at 1 year. Whether this also holds for paclitaxel-eluting stents (PESs) is currently unclear and the long-term relatively efficacy of the 2 drug-eluting stents is currently unknown. We investigated the 3-year efficacy of SESs and PESs versus BMSs in patients with STEMI. Primary angioplasty was performed in a consecutive group of 505 patients (BMSs in 183, SESs in 186, PESs in 136). At 3 years, the cumulative mortality rate was comparable in the 3 groups: 13.3% in the BMS group, 11.5% in the SES group, and 12.4% in the PES group (nonsignificant for all). The rate of target vessel revascularization (TVR) was 12.0% in the BMS group compared with 8.0% and 7.7% in the SES and PES groups, respectively (p = 0.12 for BMS vs SES, 0.30 for BMS vs PES, 0.62 for SES vs PES). The cumulative incidence of death, MI, or TVR was 25.5% in the BMS group compared with 17.9% and 20.6% in the SES and PES groups, respectively (p = 0.06 for BMS vs SES, 0.32 for BMS vs PES, 0.45 for SES vs PES). Angiographic stent thrombosis occurred in 2.4% of all patients (BMS 1.6%, SES 2.7%, PES 2.9%). In conclusion, in this relatively small consecutive patient cohort, the use of SESs and PESs was no longer associated with significantly lower rates of TVR and major adverse cardiace events in patients with STEMI after 3 years of follow-up. A high frequency of stent thrombosis was observed in the 2 drug-eluting stent groups. http://repub.eur.nl/res/pub/35509/ 2007-04-01T00:00:00Z Objective: Vital exhaustion is associated with the pathogenesis of cardiovascular disease (CVD), but its prevalence after percutaneous coronary intervention (PCI) with drug-eluting stent implantation, as well as the impact of personality on exhaustion, is not known. In PCI patients, we examined (a) the prevalence of exhaustion, (b) the impact of type-D personality on exhaustion over time, and (c) the clinical significance of type-D personality compared with gender and age as predictors of exhaustion. Methods: Consecutive patients (n=419) with stable or unstable angina treated with PCI with drug-eluting stent implantation completed the Type-D Scale (DS14) at baseline and the Maastricht Questionnaire (which assesses exhaustion) at baseline and at 1 year. Results: Of all patients, 53% were exhausted at baseline and at 1 year, with 41% experiencing chronic symptoms. Type-D patients [F(1, 417)=98.688; P<.001] had significantly higher exhaustion levels than non type-D patients both at the time of the index PCI and at 1 year. There was a general improvement in symptoms of exhaustion over time [F(1, 417)=5.005; P=.03], but type-D exerted a stable effect on exhaustion (P=.06). In multivariable analysis, type-D (OR=3.53; 95% CI=1.88-6.64) remained an independent predictor of exhaustion at 1 year, adjusting for demographic and clinical risk factors and exhaustion at baseline. The impact of type-D on exhaustion was large compared with a small effect for gender and age, as measured by Cohen's effect size index. Conclusions: Symptoms of exhaustion were still highly prevalent in PCI patients 1 year post-PCI despite treatment with the latest technique in interventional cardiology. Type-D exerted a large and stable effect on exhaustion compared with that of gender and age. CVD research and clinical practice may benefit by adopting a personality approach in order to identify high-risk patients. http://repub.eur.nl/res/pub/35510/ 2007-04-01T00:00:00Z Objective: We investigated the relative effects of fatigue, depressive symptoms, and hopelessness on prognosis at 2-year follow-up in percutaneous coronary intervention (PCI) patients. Methods: Consecutively admitted PCI patients (n=534) treated with paclitaxel-eluting stent as the default strategy completed the Maastricht Questionnaire (MQ) at baseline. Apart from an overall vital exhaustion score, the MQ also assesses fatigue (seven items; Cronbach's α=.87) and depressive symptoms (seven items; Cronbach's α=.83), with hopelessness (one item) comprised in the depressive symptom items. Patients were followed up for adverse clinical events (mortality and nonfatal myocardial infarction) at 2 years. Results: At 2-year follow-up, there were 31 clinical events. In univariable analyses, overall vital exhaustion and depressive symptoms, but not fatigue, were associated with adverse prognosis; in multivariable analysis, depressive symptoms [hazard ratio (HR)=2.69; 95% confidence interval (95% CI)=1.31-5.55] remained the only predictor of clinical outcome. Among the depressive symptoms, hopelessness (HR=3.44; 95% CI=1.65-7.19) was the most cardiotoxic symptom. The incidence of clinical events was higher in the high-hopelessness patients (11% vs. 3%; P=.001) than in the low-hopelessness patients. Hopelessness (HR=3.36; 95% CI=1.58-7.14; P=.002) remained an independent predictor of clinical outcome at 2 years in adjusted analysis. Conclusion: Symptoms of depression, but not fatigue, predicted adverse clinical events. Hopelessness was the most cardiotoxic symptom, associated with a more than three-fold risk of clinical events 2 years post-PCI. Screening for hopelessness may lead to the identification of high-risk patients. http://repub.eur.nl/res/pub/35532/ 2007-03-08T00:00:00Z BACKGROUND: Although randomized studies have shown a beneficial effect of drug-eluting stents in reducing the risk of repeated revascularization, these trials were underpowered to compare rates of death and myocardial infarction. The long-term safety of drug-eluting stents has been questioned recently. METHODS: We performed a pooled analysis of 1748 patients in four randomized trials evaluating the safety of sirolimus-eluting stents as compared with bare-metal stents. Patient-level data were obtained and analyzed by independent statisticians at two academic institutions. The primary safety end point was survival at 4 years. We tested for heterogeneities in treatment effect in patient subgroups. RESULTS: The survival rate at 4 years was 93.3% in the sirolimus-stent group, as compared with 94.6% in the bare-metal-stent group (hazard ratio for death, 1.24; 95% confidence interval [CI], 0.84 to 1.83; P=0.28). In the 428 patients with diabetes, a significant difference in the survival rate was observed in favor of the bare-metal-stent group over the sirolimus-stent group (95.6% vs. 87.8%; hazard ratio for death in the sirolimus-stent group, 2.9; 95% CI, 1.38 to 6.10; P=0.008). The lower survival rate among patients with diabetes who were treated with sirolimus-eluting stents was due to increased numbers of deaths from both cardiovascular and noncardiovascular causes. No difference in survival rate was detected among the patients without diabetes. Rates of myocardial infarction and stent thrombosis were similar in the two groups. CONCLUSIONS: In a pooled analysis of data from four trials comparing sirolimus-eluting stents and bare-metal stents, no significant differences were found between the two treatments in rates of death, myocardial infarction, or stent thrombosis. Copyright http://repub.eur.nl/res/pub/35535/ 2007-03-01T00:00:00Z http://repub.eur.nl/res/pub/35842/ 2007-02-24T00:00:00Z Background: Stent thrombosis is a safety concern associated with use of drug-eluting stents. Little is known about occurrence of stent thrombosis more than 1 year after implantation of such stents. Methods: Between April, 2002, and Dec, 2005, 8146 patients underwent percutaneous coronary intervention with sirolimus-eluting stents (SES; n=3823) or paclitaxel-eluting stents (PES; n=4323) at two academic hospitals. We assessed data from this group to ascertain the incidence, time course, and correlates of stent thrombosis, and the differences between early (0-30 days) and late (>30 days) stent thrombosis and between SES and PES. Findings: Angiographically documented stent thrombosis occurred in 152 patients (incidence density 1·3 per 100 person-years; cumulative incidence at 3 years 2·9%). Early stent thrombosis was noted in 91 (60%) patients, and late stent thrombosis in 61 (40%) patients. Late stent thrombosis occurred steadily at a constant rate of 0·6% per year up to 3 years after stent implantation. Incidence of early stent thrombosis was similar for SES (1·1%) and PES (1·3%), but late stent thrombosis was more frequent with PES (1·8%) than with SES (1·4%; p=0·031). At the time of stent thrombosis, dual antiplatelet therapy was being taken by 87% (early) and 23% (late) of patients (p<0·0001). Independent predictors of overall stent thrombosis were acute coronary syndrome at presentation (hazard ratio 2·28, 95% CI 1·29-4·03) and diabetes (2·03, 1·07-3·83). Interpretation: Late stent thrombosis was encountered steadily with no evidence of diminution up to 3 years of follow-up. Early and late stent thrombosis were observed with SES and with PES. Acute coronary syndrome at presentation and diabetes were independent predictors of stent thrombosis. http://repub.eur.nl/res/pub/37066/ 2007-01-01T00:00:00Z Objectives: To evaluate long-term outcomes after drug-eluting stents (DES) implantation in small coronary vessels. Background: Sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) have been reported to improve both the angiographic and clinical outcomes compared with bare metal stents even in 'real world' settings. Currently, no data is available on long-term outcomes after DES implantation in small vessels. Methods: Since April 2002, our institution has implanted DES, either SES or PES, as a default strategy in all patients irrespective of their clinical presentation. Between October 2002 and September 2003, 197 consecutive patients were enrolled: 107 consecutive patients received at least one 2.25-mm SES (SES group) and 90 consecutive patients received at least one 2.25-mm PES (PES group). Results: The two cohorts presented with high-risk characteristics. At 2 years, the cumulative incidence of major adverse cardiac events (MACE) in the SES group was significantly lower than that in the PES group (10.3% vs. 23.3%, P = 0.02). There were two subacute angiographic stent thromboses in the PES group and none in the SES group. By multivariate analysis, PES utilization (HR 2.37, 95% CI 1.07-5.26), presentation with acute coronary syndromes (ACS) (HR 3.34, 95% CI 1.44-7.70) and multi-vessel disease (MVD) (HR 3.91, 95% CI 1.27-12.0) were identified as independent predictors of MACE. Conclusions: In an unselected population treated for small vessel disease, SES were associated with significantly better 2-year clinical outcomes than PES. The use of PES and the presentation with ACS and MVD were identified as independent predictors of MACE. http://repub.eur.nl/res/pub/13630/ 2005-04-01T00:00:00Z AIMS: Sirolimus-eluting stents (SES) have recently been shown to reduce restenosis in selected patients. The impact of this new stent on the use of coronary bypass graft (CABG) surgery or percutaneous coronary intervention (PCI) in clinical practice is yet unknown. Therefore, we investigated the impact of SES on the clinical practice of CABG and PCI in a series of unselected consecutive patients. METHODS AND RESULTS: Between April and October 2002, a policy of SES implantation for all procedures has been instituted in our hospital. In total, 798 patients were referred to PCI and 275 to CABG (SES group). A control group was composed of all interventions (806 PCI and 314 CABG) performed during the preceding 6 months (pre-SES). The main outcome was the occurrence of major adverse cardiac events (MACE) at 15 months. In the SES era, a significant shift was noted in the PCI group towards more multi-vessel stenting (28 vs. 24%; P<0.05), more bifurcation stenting (18 vs. 7%; P<0.0001), and the use of more stents (1.9 vs. 1.5; P<0.05). In the PCI elective patients, a shift was noted towards more three-vessel disease (pre-SES: 16% vs. SES: 23%; P=0.02). Furthermore, we observed a shift in the CABG group towards more impaired LV function (pre-SES: 34% vs. SES: 41%; P=0.02) and towards more three-vessel disease (pre-SES: 67% vs. SES: 75%; P=0.03). Overall, the cumulative MACE percentages at 1 year after coronary revascularization (PCI and CABG combined) decreased from 16.8 to 13.8% (P=0.03). The cumulative MACE percentages in the pure SES group and the pre-SES bare metal stent group at 12 months were 15.6 and 19.8%, respectively (P<0.01). CONCLUSION: The introduction of the SES has certainly had an impact on the treatment strategy of coronary artery disease (CAD). Increased use of these stents allows more complex coronary anatomy to be treated by PCI, and results in lower repeat revascularization rates. http://repub.eur.nl/res/pub/4646/ 2004-09-01T00:00:00Z Objectives: We investigated the effect of Type D personality on the occurrence of adverse events at nine months in patients with ischemic heart disease (IHD) after percutaneous coronary intervention (PCI) with sirolimus-eluting stents (SESs) or bare stents. Type D patients experience increased negative emotions and tend not to express these emotions in social interactions. Background: The SES is a new advent in interventional cardiology that reduces the restenosis rate and the risk of a major adverse cardiac event, but the SES has not been shown to confer any benefits on death or myocardial infarction (MI). Methods: Consecutive patients with IHD (n = 875) enrolled in the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry completed the Type D Personality Scale (DS14) six months after PCI. The end point was a composite of death and MI. Events occurring before administration of the DS14 were excluded from analyses. Results: At nine months' follow-up, there were 20 events. Type D patients were at a cumulative increased risk of adverse outcome compared with non-Type D patients: 5.6% versus 1.3% (p < 0.002). Type D personality (odds ratio [OR] 5.31; 95% confidence interval [CI] 2.06 to 13.66) remained an independent predictor of adverse outcome adjusting for all other variables, including SES versus bare-stent implantation. Conclusions: Type D personality was an independent predictor of adverse events in patients optimally treated with the latest advent in interventional cardiology. The DS14 could be used as a screening instrument in routine clinical practice to optimize risk stratification in IHD patients. 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/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/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.