Tamburino Corrado, Di Salvo Maria Elena, Capodanno Davide, Palmerini Tullio, Sheiban Imad, Margheri Massimo, Vecchi Giuseppe, Sangiorgi Giuseppe, Piovaccari Giancarlo, Bartorelli Antonio, Briguori Carlo, Ardissino Diego, Di Pede Francesco, Ramondo Angelo, Inglese Luigi, Petronio Anna Sonia, Bolognese Leonardo, Benassi Alberto, Palmieri Cataldo, Filippone Vincenzo, De Servi Stefano
Dipartimento di Cardiologia, Ospedale Ferrarotto, Università di Catania, Italy.
Am J Cardiol. 2009 Jan 15;103(2):187-93. doi: 10.1016/j.amjcard.2008.08.059. Epub 2008 Oct 30.
The aim of this study was to compare long term clinical outcome after left main stenting in a large real world population of patients treated with drug-eluting stents (DES) or bare-metal stents (BMS) in the setting of acute coronary syndromes. The advent of DES decreased the risk of unprotected left main coronary artery restenosis as compared with BMS, but safety concerns still exist, especially when high-risk patients presenting with acute coronary syndromes are considered. The Gruppo Italiano Studi Emodinamici-Societa' Italiana di Cardiologia Invasiva (GISE-SICI) registry is a retrospective, observational multicenter registry promoted by the Italian Society of Invasive Cardiology in which 19 high-volume participating centers enrolled 1,453 consecutive patients who underwent percutaneous coronary intervention on unprotected left main coronary artery between January 2002 and December 2006. From the registry, a total of 849 consecutive patients presenting with unstable angina or non-ST-segment elevation myocardial infarction who underwent DES (n=611) or BMS (n=238) implantation were analyzed with extensive multivariable and propensity-score adjustments. At 3-year follow-up, the adjusted hazard ratio for the risk of mortality after DES implantation relative to BMS implantation was 0.90 (95% confidence intervals [CI] 0.59 to 1.38, p=0.617), and the adjusted hazard ratio for the risk of cardiac mortality was 0.75 (95% CI 0.45 to 1.27, p=0.287). DES were associated with significant reduction of myocardial infarction (hazard ratio 0.37, 95% CI 0.17 to 0.81, p=0.009) and target lesion revascularization rates (hazard ratio 0.38, 95% CI 0.21 to 0.69, p=0.001). Younger age, low ejection fraction, an increase in the cardiac biomarkers, absence of diabetes, and bifurcations showed a significant interaction with assigned treatment regarding myocardial infarction. The treatment effects on target lesion revascularization were consistent across multiple subgroups, with the possible exception of patients with nonbifurcational lesions. In conclusion, in a large population of patients with acute coronary syndromes and unprotected left main coronary artery disease DES were more effective than BMS in reducing myocardial infarction and target lesion revascularization. There was no evidence of a significant reduction in mortality with DES versus BMS.
本研究旨在比较在急性冠状动脉综合征背景下,大量接受药物洗脱支架(DES)或裸金属支架(BMS)治疗的真实世界患者群体中,左主干支架置入术后的长期临床结局。与BMS相比,DES的出现降低了无保护左主干冠状动脉再狭窄的风险,但安全性问题仍然存在,尤其是在考虑患有急性冠状动脉综合征的高危患者时。意大利心脏动力学研究组-意大利侵入性心脏病学会(GISE-SICI)注册研究是一项由意大利侵入性心脏病学会推动的回顾性、观察性多中心注册研究,其中19个高容量参与中心纳入了2002年1月至2006年12月期间连续1453例接受无保护左主干冠状动脉经皮冠状动脉介入治疗的患者。从该注册研究中,共分析了849例连续出现不稳定型心绞痛或非ST段抬高型心肌梗死且接受DES(n = 611)或BMS(n = 238)植入的患者,并进行了广泛的多变量和倾向评分调整。在3年随访时,DES植入后相对于BMS植入的死亡风险调整后危险比为0.90(95%置信区间[CI] 0.59至1.38,p = 0.617),心脏死亡风险调整后危险比为0.75(95%CI 0.45至1.27,p = 0.287)。DES与心肌梗死(危险比0.37,95%CI 0.17至0.81,p = 0.009)和靶病变血运重建率(危险比0.38,95%CI 0.21至0.69,p = 0.001)的显著降低相关。年轻、低射血分数、心脏生物标志物升高、无糖尿病以及分叉病变在心肌梗死方面显示出与指定治疗有显著相互作用。除了非分叉病变患者可能例外,治疗对靶病变血运重建的效果在多个亚组中是一致的。总之,在大量患有急性冠状动脉综合征和无保护左主干冠状动脉疾病的患者中,DES在降低心肌梗死和靶病变血运重建方面比BMS更有效。没有证据表明DES与BMS相比死亡率有显著降低。