Long-Term outcome of drug-eluting stents compared with bare metal stents in ST-segment elevation myocardial infarction: results of the paclitaxel- or sirolimus-eluting stent versus bare metal stent in Primary Angioplasty (PASEO) Randomized Trial.
Long-Term outcome of drug-eluting stents compared with bare metal stents in ST-segment elevation myocardial infarction: results of the paclitaxel- or sirolimus-eluting stent versus bare metal stent in Primary Angioplasty (PASEO) Randomized Trial.
复制标题
ST 段抬高型心肌梗死中药物洗脱支架与裸金属支架的长期结果：初次血管成形术 (PASEO) 随机试验中紫杉醇或西罗莫司洗脱支架与裸金属支架的结果。
DOI：
10.1161/circulationaha.108.830372
复制
发表时间：
2009
期刊：
影响因子：
37.8
通讯作者：
G. De Luca
中科院分区：
文献类型：
--
作者：
E. Di Lorenzo;R. Sauro;A. Varricchio;G. Carbone;G. Cortese;M. Capasso;T. Lanzillo;F. Manganelli;Ciro Mariello;F. Siano;M. Pagliuca;Giovanni Stanco;G. Rosato;G. De Luca
背景
药物洗脱支架可能在重复血运重建方面提供受益，但可能会被潜在的较高支架血栓形成风险抵消，尤其是在ST段抬高型心肌梗死（STEMI）患者中。到目前为止，还没有关于药物洗脱支架在STEMI中的长期受益和安全性的数据报告。因此，本研究的目的是评价西罗莫司洗脱支架（SES）和紫杉醇洗脱支架（PES）与裸金属支架（BMS）相比在接受初次血管成形术的患者中的短期和长期获益。
方法和结果
在症状发作12小时内入院并在具有24小时直接经皮冠状动脉介入治疗能力的三级中心接受直接血管成形术和支架植入术的连续性STEMI患者被随机分配至BMS、PES或SES组。所有患者均接受上游糖蛋白IIb/IIIa抑制剂治疗。主要终点是1年随访时的靶病变血运重建。次要终点是长期随访（长达4 - 6年）时的死亡和/或再梗死、支架内血栓形成和主要不良心脏事件（合并死亡和/或再梗死和/或靶病变血运重建）。研究终点的累积发生率。无患者失访。从2003年10月1日至2005年12月31日，270例STEMI患者被随机分配至BMS组（n=90）、PES组（n=90）或SES组（n=90）。93%-95%的患者获得了手术成功。所有患者的随访数据均可用。与BMS相比（14.4%），两种PES（4.4%;风险比，0.29; 95%置信区间，0.095至0.89; P=0.023）和SES（3.3%;风险比，0.21; 95%置信区间，0.06至0.75; P=0.016）与1年随访（主要研究终点）时靶病变血运重建显著减少相关。长期随访时（4.3年;第25至第75百分位数，3.7至5年），在死亡、再梗死和合并死亡和/或再梗死方面未观察到差异，但与BMS相比，（22.2%），两种PES（6.7%;风险比，0.27; 95%置信区间，0.11至0.68; P=0.005）和SES（5.6%;风险比，0.22; 95%置信区间，0.083 - 0.59; P=0.003）与靶病变血运重建的显著减少相关。
结论
本研究表明，在接受直接血管成形术的STEMI患者中，与BMS相比，SES和PES在长期随访时靶病变血运重建方面均具有显著受益，且无血栓并发症的过度风险。因此，在进一步的大型随机试验和长期随访的结果可用之前，药物洗脱支架可考虑用于行直接血管成形术的STEMI患者。
BACKGROUND
Drug-eluting stents may offer benefits in terms of repeat revascularization that may be counterbalanced by a potential higher risk of stent thrombosis, especially among ST-segment elevation myocardial infarction (STEMI) patients. No data have been reported so far on the long-term benefits and safety of drug-eluting stents in STEMI. Thus, the aim of the present study was to evaluate the short- and long-term benefits of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) compared with bare metal stents (BMS) in patients undergoing primary angioplasty.
METHODS AND RESULTS
Consecutive STEMI patients admitted within 12 hours of symptom onset and undergoing primary angioplasty and stent implantation at a tertiary center with 24-hour primary percutaneous coronary intervention capability were randomly assigned to BMS, PES, or SES. All patients received upstream glycoprotein IIb/IIIa inhibitors. The primary end point was target lesion revascularization at the 1-year follow-up. Secondary end points were death and/or reinfarction, in-stent thrombosis, and major adverse cardiac events (combined death and/or reinfarction and/or target lesion revascularization) at long-term follow-up (up to 4 to 6 years). Cumulative incidence of end points was investigated. No patient was lost to follow-up. From October 1, 2003, to December 31, 2005, 270 patients with STEMI were randomized to BMS (n=90), PES (n=90), or SES (n=90). Procedural success was obtained in 93% to 95% of patients. Follow-up data were available for all patients. Compared with BMS (14.4%), both PES (4.4%; hazard ratio, 0.29; 95% confidence interval, 0.095 to 0.89; P=0.023) and SES (3.3%; hazard ratio, 0.21; 95% confidence interval, 0.06 to 0.75; P=0.016) were associated with a significant reduction in target lesion revascularization at the 1-year follow-up (primary study end point). At the long-term follow-up (4.3 years; 25th to 75th percentile, 3.7 to 5 years), no difference was observed in terms of death, reinfarction, and combined death and/or reinfarction, but compared with BMS (22.2%), both PES (6.7%; hazard ratio, 0.27; 95% confidence interval, 0.11 to 0.68; P=0.005) and SES (5.6%; hazard ratio, 0.22; 95% confidence interval, 0.083 to 0.59; P=0.003) were associated with a significant reduction in target lesion revascularization.
CONCLUSIONS
This study shows that among STEMI patients undergoing primary angioplasty, both SES and PES are associated with significant benefits in terms of target lesion revascularization at the long-term follow-up compared with BMS with no excess risk of thrombotic complications. Thus, until the results of further large randomized trials with long-term follow-up become available, drug-eluting stents may be considered among STEMI patients undergoing primary angioplasty.