Objectives: The purpose of this studywas to evaluate predictors of an adverse outcome after “crush”bifurcation stenting. Background: The “crush”technique is a recently introduced strategy with limited data regardi...Objectives: The purpose of this studywas to evaluate predictors of an adverse outcome after “crush”bifurcation stenting. Background: The “crush”technique is a recently introduced strategy with limited data regarding long-term outcomes. Methods: We identified 231 consecutive patients treated with drug-eluting stent implantation with the “crush”technique for 241 de novo bifurcation lesions. Clinical follow-up was obtained in 99.6%. Results: The in-hospital major adverse cardiac event(MACE) rate was 5.2%. At 9 months, 10(4.3%) patients had an event consistent with possible post-procedural stent thrombosis. Survival free of target lesion revascularization(TLR) was 90.3%; the only independent predictor of TLR was left main stem(LMS) therapy(odds ratio[OR] 4.97; 95%confidence interval[CI] 2.00 to 12.37, p=0.001). Survival free of MACE was 83.5%and independent predictors of MACE were LMS therapy(OR 3.79; 95%CI 1.76 to 8.14, p=0.001) and treatment of patients with multivessel disease(OR 4.21; 95%CI 0.95 to 18.56, p=0.058). Angiographic follow-up was obtained in 77%of lesions at 8.3±3.7 months. The mean late loss of the main vessel and side branch were 0.30±0.64 mm and 0.41±0.67 mm, respectively, with binary restenosis rates of 9.1%and 25.3%. Kissing balloon post-dilation significantly reduced the side branch late lumen loss(0.24±0.50 mm vs. 0.58±0.77 mm, p< 0.001). Conclusions: The crush technique of bifurcation stenting with drug-eluting stents is associated with favorable outcomes for most lesions; however, efficacy appears significantly reduced in LMS bifurcations, and further research is needed before the technique can be routinely recommended in this group. Furthermore, the incidence of possible stent thrombosis is of concern and requires further investigation. Kissing balloon post-dilatation is mandatory to reduce side branch restenosis.展开更多
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
文摘Objectives: The purpose of this studywas to evaluate predictors of an adverse outcome after “crush”bifurcation stenting. Background: The “crush”technique is a recently introduced strategy with limited data regarding long-term outcomes. Methods: We identified 231 consecutive patients treated with drug-eluting stent implantation with the “crush”technique for 241 de novo bifurcation lesions. Clinical follow-up was obtained in 99.6%. Results: The in-hospital major adverse cardiac event(MACE) rate was 5.2%. At 9 months, 10(4.3%) patients had an event consistent with possible post-procedural stent thrombosis. Survival free of target lesion revascularization(TLR) was 90.3%; the only independent predictor of TLR was left main stem(LMS) therapy(odds ratio[OR] 4.97; 95%confidence interval[CI] 2.00 to 12.37, p=0.001). Survival free of MACE was 83.5%and independent predictors of MACE were LMS therapy(OR 3.79; 95%CI 1.76 to 8.14, p=0.001) and treatment of patients with multivessel disease(OR 4.21; 95%CI 0.95 to 18.56, p=0.058). Angiographic follow-up was obtained in 77%of lesions at 8.3±3.7 months. The mean late loss of the main vessel and side branch were 0.30±0.64 mm and 0.41±0.67 mm, respectively, with binary restenosis rates of 9.1%and 25.3%. Kissing balloon post-dilation significantly reduced the side branch late lumen loss(0.24±0.50 mm vs. 0.58±0.77 mm, p< 0.001). Conclusions: The crush technique of bifurcation stenting with drug-eluting stents is associated with favorable outcomes for most lesions; however, efficacy appears significantly reduced in LMS bifurcations, and further research is needed before the technique can be routinely recommended in this group. Furthermore, the incidence of possible stent thrombosis is of concern and requires further investigation. Kissing balloon post-dilatation is mandatory to reduce side branch restenosis.
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.
