Di Lorenzo Emilio, Sauro Rosario, Varricchio Attilio, Capasso Michele, Lanzillo Tonino, Manganelli Fiore, Mariello Ciro, Siano Francesco, Pagliuca Maria Rosaria, Stanco Giovanni, Rosato Giuseppe, De Luca Giuseppe
Division of Cardiology, S.G. Moscati, Avellino, Italy.
Am Heart J. 2009 Oct;158(4):e43-50. doi: 10.1016/j.ahj.2009.03.016.
Drug-eluting stent (DES) may offer benefits in terms of repeat revascularization, which may be counterbalanced by a potential higher risk of stent thrombosis, especially among patients with STEMI. No data have been reported so far on the long-term benefits and safety of DES in STEMI. The aim of the current study was to evaluate the short- and long-term benefits of sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) as compared to bare-metal stent (BMS) in patients undergoing primary angioplasty.
Consecutive patients with STEMI 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, and SES. All patients received upstream glycoprotein IIb-IIIa inhibitors. Primary end point was target-lesion revascularization at 1-year follow-up. Secondary end points were (1) cumulative combined incidence of death and/or reinfarction; (2) cumulative incidence of in-stent thrombosis; and (3) major adverse cardiac events (MACE) (combined death and/or reinfarction and/or target lesion revascularization [TLR]) at long-term follow-up (up to 4 years). No patient was lost to follow-up.
From October 1, 2003, to December 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. As compared to BMS (14.4%), both PES (4.4%, hazard ratio [HR] 0.29, 95% CI 0.095-0.89, P = .023) and SES (3.3%, HR 0.21, 95% CI 0.06-0.75, P = .016) were associated with a significant reduction in TLR at 1-year follow-up (primary study end point). At long-term follow-up (1,233 +/- 215 days), no difference was observed in terms of death, reinfarction, and combined death and/or reinfarction, but as compared to BMS (21.1%), both PES (6.7%, HR 0.29, 95% CI 0.12-0.73, P = .008) and SES (5.6%, HR 0.24, 95% CI 0.09-0.63, P = .002), respectively, were associated with a significant reduction in TLR.
This study shows that among patients with STEMI undergoing primary angioplasty, both SES and PES are safe and associated with significant benefits in terms of TLR up to 4 years' follow-up, as compared to BMS. Thus, until the results of further large randomized trials with long-term follow-up become available, DES may be considered among patients with STEMI undergoing primary angioplasty.
药物洗脱支架（DES）在重复血管重建方面可能具有优势，但其潜在的较高支架血栓形成风险可能会抵消这一优势，尤其是在ST段抬高型心肌梗死（STEMI）患者中。目前尚无关于DES在STEMI中的长期益处和安全性的数据报道。本研究的目的是评估与裸金属支架（BMS）相比，西罗莫司洗脱支架（SES）和紫杉醇洗脱支架（PES）在接受直接血管成形术的患者中的短期和长期益处。
在一家具备24小时直接经皮冠状动脉介入治疗能力的三级中心，对症状发作后12小时内入院并接受直接血管成形术和支架植入的连续STEMI患者随机分配至BMS组、PES组和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年随访时靶病变血管重建。次要终点包括：（1）死亡和/或再梗死的累积联合发生率；（2）支架内血栓形成的累积发生率；（3）长期随访（长达4年）时的主要不良心脏事件（MACE）（联合死亡和/或再梗死和/或靶病变血管重建[TLR]）。无患者失访。
从2003年10月1日至2005年12月，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%至95%的患者手术成功。所有患者均有随访数据。与BMS组（14.4%）相比，PES组（4.4%，风险比[HR] 0.29，95%置信区间0.095 - 0.89，P = 0.023）和SES组（3.3%，HR 0.21，95%置信区间0.06 - 0.75，P = 0.016）在1年随访时（主要研究终点）的TLR均显著降低。在长期随访（1233 ± 215天）时，在死亡、再梗死以及联合死亡和/或再梗死方面未观察到差异，但与BMS组（21.1%）相比，PES组（6.7%，HR 0.29，95%置信区间0.12 - 0.73，P = 0.008）和SES组（5.6%，HR 0.24，95%置信区间0.09 - 0.63，P = 0.002）的TLR均显著降低。
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在长达4年的随访期内对于TLR而言都是安全的且具有显著益处。因此，在获得进一步长期随访的大型随机试验结果之前，对于接受直接血管成形术的STEMI患者可考虑使用DES。
