Thoraxcenter, Erasmus Medical Center, Rotterdam, Netherlands.
Circ Cardiovasc Interv. 2008 Oct;1(2):103-10. doi: 10.1161/CIRCINTERVENTIONS.108.787762. Epub 2008 Sep 3.
Primary percutaneous coronary intervention (PPCI) for ST-elevation myocardial infarction with bare metal stents (BMS) is well established, while randomized trials suggest equivalent safety and reduced repeat revascularization with drug-eluting stents (DES) in this setting. However, long-term data on DES in PPCI is lacking, especially in those ineligible for inclusion in randomized trials. Our aim was to investigate the long-term outcomes of unselected patients undergoing PPCI with BMS and DES.
We analyzed all patients (n=1738) undergoing PPCI for a de novo lesion in our institution from 2000 to 2005. Patients from 3 sequential consecutive cohorts of BMS (n=531), sirolimus-eluting (SES, n=185) or paclitaxel-eluting stents (PES, n=1022) were included. The median duration of follow-up was 1185 days (interquartile range, 746 to 1675). There were no differences in all-cause mortality or repeat revascularization between DES and BMS, although there was a nonsignificant trend toward improved survival with SES compared with both BMS (propensity score-adjusted hazard ratio, 0.63; [95%CI, 0.33 to 1.18]) and PES (hazard ratio, 0.71; [95% CI, 0.40 to 1.26]). SES were associated with lower rates of the composite end point of all-cause death, nonfatal myocardial infarction, or target vessel revascularization (hazard ratio, 0.62; 95%CI, 0.40 to 0.96) when compared with PES. Very late stent thrombosis only occurred in the DES groups.
Although DES are not associated with an increase in adverse events compared with BMS when used for PPCI, neither DES reduced repeat revascularizations. Appropriately powered randomized trials with hard clinical end points and an "all-comer" design are required to further assess the benefit of DES in PPCI.
经皮冠状动脉介入治疗(PPCI)治疗 ST 段抬高型心肌梗死伴金属裸支架(BMS)已得到广泛认可,而随机试验表明,在这种情况下,药物洗脱支架(DES)的安全性相当,且再次血运重建的风险降低。然而,DES 在 PPCI 中的长期数据尚缺乏,尤其是在那些不符合随机试验纳入标准的患者中。我们旨在研究未入选随机试验的患者行 PPCI 时使用 BMS 和 DES 的长期结果。
我们分析了 2000 年至 2005 年在我们机构行 PPCI 治疗新发病变的所有患者(n=1738)。纳入了连续 3 个队列的 BMS(n=531)、西罗莫司洗脱支架(SES,n=185)或紫杉醇洗脱支架(PES,n=1022)患者。中位随访时间为 1185 天(四分位距 746 至 1675 天)。DES 和 BMS 之间的全因死亡率或再次血运重建率无差异,尽管 SES 与 BMS(倾向评分调整后的危险比,0.63;95%CI,0.33 至 1.18)和 PES(危险比,0.71;95%CI,0.40 至 1.26)相比,生存有改善的趋势,但无统计学意义。SES 与全因死亡、非致死性心肌梗死或靶血管血运重建的复合终点发生率较低相关(危险比,0.62;95%CI,0.40 至 0.96),与 PES 相比。只有 DES 组发生了极晚期支架血栓形成。
尽管与 BMS 相比,DES 用于 PPCI 并不增加不良事件,但 DES 并未减少再次血运重建。需要进行设计合理的、以硬临床终点为评估指标的、“所有患者”的随机试验,以进一步评估 DES 在 PPCI 中的获益。