Traditionally, stent thrombosis has been regarded as a complication of percutaneous coronary interventions during the first 30 postprocedural days. However, delayed endothelialization associated with the implantation ...Traditionally, stent thrombosis has been regarded as a complication of percutaneous coronary interventions during the first 30 postprocedural days. However, delayed endothelialization associated with the implantation of drug-eluting stents may extend the risk of thrombosis beyond 30 days. Data are limited regarding the risks and the impact of this phenomenon outside clinical trials. Abstract: To evaluate the incidence, predictors, and clinical outcome of stent thrombosis after implantation of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice. Design, Setting, and Patients: Prospective observational cohort study conducted at 1 academic hospital and 2 community hospitals in Germany and Italy. A total of 2229 consecutive patients underwent successful implantation of sirolimus-eluting(1062 patients, 1996 lesions, 2272 stents) or paclitaxel-eluting(1167 patients, 1801 lesions, 2223 stents) stents between April 2002 and January 2004. Interventions: Implantation of a drug-eluting stent(sirolimus or paclitaxel). All patients were pretreated with ticlopidine or clopidogrel and aspirin. Aspirin was continued indefinitely and clopidogrel or ticlopidine for at least 3 months after sirolimus-eluting and for at least 6 months after paclitaxeleluting stent implantation. Main Outcome Measures: Subacute thrombosis(from procedure end through 30 days), late thrombosis( >30 days), and cumulative stent thrombosis. Results: At 9- month follow-up, 29 patients(1.3% ) had stent thrombosis(9[0.8% ] with sirolimus and 20[1.7% ] with paclitaxel; P=.09). Fourteen patients had subacute thrombosis(0.6% ) and 15 patients had late thrombosis(0.7% ). Among these 29 patients, 13 died(case fatality rate, 45% ). Independent predictors of stent thrombosis were premature antiplatelet therapy discontinuation(hazard ratio[HR], 89.78; 95% CI, 29.90- 269.60; P< .001), renal failure(HR, 6.49; 95% CI, 2.60- 16.15; P< .001), bifurcation lesions(HR, 6.42; 95% CI, 2.93- 14.07; P< .001), diabetes(HR, 3.71; 95% CI, 1.74- 7.89; P=.001), and a lower ejection fraction(HR, 1.09; 95% CI, 1.05- 1.36; P< .001 for each 10% decrease). Conclusions: The cumulative incidence of stent thrombosis 9 months after successful drug-eluting stent implantation in consecutive “ real-world” patients was substantially higher than the rate reported in clinical trials. Premature antiplatelet therapy discontinuation, renal failure, bifurcation lesions, diabetes, and low ejection fraction were identified as predictors of thrombotic events.展开更多
Thienopyridines and aspirin are beneficial in patients undergoing bare-metal stent implantation, and aspirin and clopidogrel treatment have also been proved effective after drug-eluting stent(DES) implantation. Howeve...Thienopyridines and aspirin are beneficial in patients undergoing bare-metal stent implantation, and aspirin and clopidogrel treatment have also been proved effective after drug-eluting stent(DES) implantation. However, despite the common substitution of clopidogrel with ticlopidine because of cost or patient intolerance, there are no data on the comparison of ticlopidine vs. clopidogrel after DES implantation. We hereby compare ticlopidine vs. clopidogrel after paclitaxel-eluting stent implantation in subjects enrolled in the prospective multicenter Taxus in Real-life Usage Evaluation(TRUE) Study. Across the 505 analyzed patients(112 treated with ticlopidine and 393 with clopidogrel), similar rates of early and mid-term(7 months) adverse thrombotic events were found with either antiplatelet regimen, with the notable exception of 2 cases of late stent thrombosis in patients who had prematurely withdrawn ticlopidine treatment just 3 months after the procedure. These findings thus support the overall safety and effectiveness of ticlopidine after DES implantation, and also confirm the increased risk of late thrombosis when premature withdrawal of thienopyridines occurs.展开更多
Randomized trials have shown that implantation of sirolimus-eluting stents(SESs) and paclitaxel-eluting stents(PESs) reduce the incidence of major adverse cardiac events(MACEs) compared with bare metal stents. We comp...Randomized trials have shown that implantation of sirolimus-eluting stents(SESs) and paclitaxel-eluting stents(PESs) reduce the incidence of major adverse cardiac events(MACEs) compared with bare metal stents. We compared the impact of SESs and PESs on clinical outcome in medically treated diabetic patients with multivessel stents. In this study, the in-hospital and 9-month clinical outcomes of 260 consecutive diabetic patients who underwent implantation of SESs(147 patients) or PESs(113 patients) were compared. MACEs were defined as death, nonfatal myocardial infarction, and clinically driven target vessel revascularization. The baseline demographic and angiographic characteristics were well matched. An average of 3.0±1.3 versus 2.8±1.2 lesions were treated in the SES and PES groups, respectively(p=0.34), with a mean stented length per patient of 73±43 versus 61±36 mm(p=0.08). No significant difference was observed between the SES and PES groups for in-hospital(6.1%vs 3.5%, p=0.34) or 9-month MACE(24.5%vs 19.5%, p=0.34) rates or for subacute(1.4%vs 0.9%, p=0.72) or late(0.7%vs 0.9%, p=0.85)stent thrombosis. Insulin-requiring diabetic patients treated with SESs and PESs also had similar demographic and angiographic characteristics and rates of in-hospital(4.7%vs 7.7%, p=0.57) and 9-month(28.0%vs 38.4%, p=0.44) MACEs. Insulin-dependent diabetes was the only independent predictor of MACEs(odds ratio 2.68, 95%confidence interval 1.46 to 4.89, p=0.001). In conclusion, our results demonstrated a relatively high incidence of MACEs in a diabetic population with multivessel disease, despite treatment with drug-eluting stents. In addition, we could not find any clear advantage of 1 type of stent versus the other.展开更多
Background The safety and efficacy of drug-eluting stents （DES） implantation in unprotected left main （LM） bifurcation lesions has yet to be determined. The aim of the present report was to evaluate the long-term ...Background The safety and efficacy of drug-eluting stents （DES） implantation in unprotected left main （LM） bifurcation lesions has yet to be determined. The aim of the present report was to evaluate the long-term outcome following implantation of DES in unprotected LM bifurcation lesions.Methods We identified 70 consecutive patients treated with DES in unprotected LM bifurcation lesions from April 2003 to January 2005. Of them, 42 patients were treated with sirolimus-eluting stent （SES） and 28 patients were treated with paclitaxel-eluting stent （PES）. Results Stents to the left anterior descending and to the circumflex were implanted in 62 patients. During 1-year follow-up, 3 （4.3%） patients died of cardiac causes. One of them had myocardial infarction and adjudicated as possibly due to stent thrombosis. Angiographic follow-up was available in 80% of patients. The per lesion restenosis rate was 13.4% in the entire cohort, of which 10.7% occurred in lesions treated with SES and 16.1% in those treated with PES （P=0.58）. All restenosis was focal and occurred in the lesions treated with a stent with stent size to post-procedural reference vessel diameter ratio 〈1.0 （17.6% vs 0, P=0.04）. The per patient target lesion revascularization rate at 1 year was 17.1%. One year survival free from major adverse cardiac events was 77.1%. Conclusions Treatment of LM bifurcation lesions using DES is a safe and feasible way with a low one-year mortality. The need for revascularization in 17% of patients demands for improvement.展开更多
文摘Traditionally, stent thrombosis has been regarded as a complication of percutaneous coronary interventions during the first 30 postprocedural days. However, delayed endothelialization associated with the implantation of drug-eluting stents may extend the risk of thrombosis beyond 30 days. Data are limited regarding the risks and the impact of this phenomenon outside clinical trials. Abstract: To evaluate the incidence, predictors, and clinical outcome of stent thrombosis after implantation of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice. Design, Setting, and Patients: Prospective observational cohort study conducted at 1 academic hospital and 2 community hospitals in Germany and Italy. A total of 2229 consecutive patients underwent successful implantation of sirolimus-eluting(1062 patients, 1996 lesions, 2272 stents) or paclitaxel-eluting(1167 patients, 1801 lesions, 2223 stents) stents between April 2002 and January 2004. Interventions: Implantation of a drug-eluting stent(sirolimus or paclitaxel). All patients were pretreated with ticlopidine or clopidogrel and aspirin. Aspirin was continued indefinitely and clopidogrel or ticlopidine for at least 3 months after sirolimus-eluting and for at least 6 months after paclitaxeleluting stent implantation. Main Outcome Measures: Subacute thrombosis(from procedure end through 30 days), late thrombosis( >30 days), and cumulative stent thrombosis. Results: At 9- month follow-up, 29 patients(1.3% ) had stent thrombosis(9[0.8% ] with sirolimus and 20[1.7% ] with paclitaxel; P=.09). Fourteen patients had subacute thrombosis(0.6% ) and 15 patients had late thrombosis(0.7% ). Among these 29 patients, 13 died(case fatality rate, 45% ). Independent predictors of stent thrombosis were premature antiplatelet therapy discontinuation(hazard ratio[HR], 89.78; 95% CI, 29.90- 269.60; P< .001), renal failure(HR, 6.49; 95% CI, 2.60- 16.15; P< .001), bifurcation lesions(HR, 6.42; 95% CI, 2.93- 14.07; P< .001), diabetes(HR, 3.71; 95% CI, 1.74- 7.89; P=.001), and a lower ejection fraction(HR, 1.09; 95% CI, 1.05- 1.36; P< .001 for each 10% decrease). Conclusions: The cumulative incidence of stent thrombosis 9 months after successful drug-eluting stent implantation in consecutive “ real-world” patients was substantially higher than the rate reported in clinical trials. Premature antiplatelet therapy discontinuation, renal failure, bifurcation lesions, diabetes, and low ejection fraction were identified as predictors of thrombotic events.
文摘Thienopyridines and aspirin are beneficial in patients undergoing bare-metal stent implantation, and aspirin and clopidogrel treatment have also been proved effective after drug-eluting stent(DES) implantation. However, despite the common substitution of clopidogrel with ticlopidine because of cost or patient intolerance, there are no data on the comparison of ticlopidine vs. clopidogrel after DES implantation. We hereby compare ticlopidine vs. clopidogrel after paclitaxel-eluting stent implantation in subjects enrolled in the prospective multicenter Taxus in Real-life Usage Evaluation(TRUE) Study. Across the 505 analyzed patients(112 treated with ticlopidine and 393 with clopidogrel), similar rates of early and mid-term(7 months) adverse thrombotic events were found with either antiplatelet regimen, with the notable exception of 2 cases of late stent thrombosis in patients who had prematurely withdrawn ticlopidine treatment just 3 months after the procedure. These findings thus support the overall safety and effectiveness of ticlopidine after DES implantation, and also confirm the increased risk of late thrombosis when premature withdrawal of thienopyridines occurs.
文摘Randomized trials have shown that implantation of sirolimus-eluting stents(SESs) and paclitaxel-eluting stents(PESs) reduce the incidence of major adverse cardiac events(MACEs) compared with bare metal stents. We compared the impact of SESs and PESs on clinical outcome in medically treated diabetic patients with multivessel stents. In this study, the in-hospital and 9-month clinical outcomes of 260 consecutive diabetic patients who underwent implantation of SESs(147 patients) or PESs(113 patients) were compared. MACEs were defined as death, nonfatal myocardial infarction, and clinically driven target vessel revascularization. The baseline demographic and angiographic characteristics were well matched. An average of 3.0±1.3 versus 2.8±1.2 lesions were treated in the SES and PES groups, respectively(p=0.34), with a mean stented length per patient of 73±43 versus 61±36 mm(p=0.08). No significant difference was observed between the SES and PES groups for in-hospital(6.1%vs 3.5%, p=0.34) or 9-month MACE(24.5%vs 19.5%, p=0.34) rates or for subacute(1.4%vs 0.9%, p=0.72) or late(0.7%vs 0.9%, p=0.85)stent thrombosis. Insulin-requiring diabetic patients treated with SESs and PESs also had similar demographic and angiographic characteristics and rates of in-hospital(4.7%vs 7.7%, p=0.57) and 9-month(28.0%vs 38.4%, p=0.44) MACEs. Insulin-dependent diabetes was the only independent predictor of MACEs(odds ratio 2.68, 95%confidence interval 1.46 to 4.89, p=0.001). In conclusion, our results demonstrated a relatively high incidence of MACEs in a diabetic population with multivessel disease, despite treatment with drug-eluting stents. In addition, we could not find any clear advantage of 1 type of stent versus the other.
文摘Background The safety and efficacy of drug-eluting stents （DES） implantation in unprotected left main （LM） bifurcation lesions has yet to be determined. The aim of the present report was to evaluate the long-term outcome following implantation of DES in unprotected LM bifurcation lesions.Methods We identified 70 consecutive patients treated with DES in unprotected LM bifurcation lesions from April 2003 to January 2005. Of them, 42 patients were treated with sirolimus-eluting stent （SES） and 28 patients were treated with paclitaxel-eluting stent （PES）. Results Stents to the left anterior descending and to the circumflex were implanted in 62 patients. During 1-year follow-up, 3 （4.3%） patients died of cardiac causes. One of them had myocardial infarction and adjudicated as possibly due to stent thrombosis. Angiographic follow-up was available in 80% of patients. The per lesion restenosis rate was 13.4% in the entire cohort, of which 10.7% occurred in lesions treated with SES and 16.1% in those treated with PES （P=0.58）. All restenosis was focal and occurred in the lesions treated with a stent with stent size to post-procedural reference vessel diameter ratio 〈1.0 （17.6% vs 0, P=0.04）. The per patient target lesion revascularization rate at 1 year was 17.1%. One year survival free from major adverse cardiac events was 77.1%. Conclusions Treatment of LM bifurcation lesions using DES is a safe and feasible way with a low one-year mortality. The need for revascularization in 17% of patients demands for improvement.
