From the Academic Medical Center, University of Amsterdam, the Netherlands (Y.S., R.J.d.W., J.J.W.); ThoraxCenter, Erasmus Medical Center, Rotterdam, the Netherlands (Y.O., R.C.); Heart Institute, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.-M.A., C.W.L., S.-J.P.); Department of Public Health, Erasmus Medical Centre, Rotterdam, the Netherlands (D.v.K., E.W.S.); Institute of Cardiovascular Sciences, Manchester Academic Health Sciences Centre, University of Manchester and Manchester Heart Centre, Manchester Royal Infirmary, Central Manchester University Hospitals NHS Trust, United Kingdom (V.F.); Institut Cardiovasculaire Paris Sud, Générale de Santé, Hôpital Privé Jacques Cartier, Massy, France (M.-C.M.); and International Centre for Circulatory Health, NHLI, Imperial College London, United Kingdom (P.W.S.).
Circ Cardiovasc Interv. 2017 May;10(5). doi: 10.1161/CIRCINTERVENTIONS.117.005027.
The impact of sex on clinical outcomes of percutaneous coronary intervention and coronary artery bypass graft for patients with multivessel coronary disease and unprotected left main disease could be dissimilar between Western and Asian populations.
To assess clinical outcomes after percutaneous coronary intervention or coronary artery bypass graft in women and men with multivessel coronary disease and unprotected left main disease, a pooled analysis (n=3280) was performed using the patient-level data from 3 large randomized trials: SYNTAX (Synergy between PCI with Taxus and Cardiac Surgery), PRECOMBAT (Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease), and BEST (Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients with Multivessel Coronary Artery Disease) trials. The primary end point was all-cause death. Of 3280 patients, 794 patients (24.2%) were women. The median follow-up period was 1806 days (1611-1837 days). In women, a high heterogeneity of the treatment effect among the 3 trials was found for all-cause death (>50%), whereas in men, it was consistent across the 3 trials. In the Western trial (SYNTAX), female sex favored coronary artery bypass graft compared with percutaneous coronary intervention (hazard ratio 2.213; 95% confidence interval, 1.242-3.943; =0.007), whereas in the Asian women (PRECOMBAT and BEST), the treatment effect was neutral between both strategies. Sex interaction with treatment strategy was evident in the Western trial (=0.019) but not in the Asian trials (PRECOMBAT =0.469 and BEST =0.472; =58%).
The present meta-analysis suggested the presence of the heterogeneous sex-treatment interaction across Asian and Western trials. Considering the ongoing globalization of our medical practice, the heterogeneity of the sex-treatment interaction needs to be well recognized and taken into account during the decision making of the treatment strategy.
URL: https://www.clinicaltrials.gov. Unique identifiers: NCT00114972, NCT00997828, NCT00422968.
在西方和亚洲人群中,性别对多支血管病变和无保护左主干病变患者经皮冠状动脉介入治疗和冠状动脉旁路移植术的临床结局的影响可能不同。
为了评估多支血管病变和无保护左主干病变患者经皮冠状动脉介入治疗或冠状动脉旁路移植术后的临床结局,使用来自 3 项大型随机试验(SYNTAX[紫杉醇与心脏手术联合的协同作用]、PRECOMBAT[左主干冠状动脉疾病患者使用西罗莫司洗脱支架的旁路手术与血管成形术]和 BEST[多支冠状动脉疾病患者的旁路手术和依维莫司洗脱支架植入治疗])的患者水平数据进行了汇总分析(n=3280)。主要终点是全因死亡。在 3280 例患者中,794 例(24.2%)为女性。中位随访时间为 1806 天(1611-1837 天)。在女性中,3 项试验中全因死亡的治疗效果存在高度异质性(>50%),而在男性中,3 项试验的治疗效果一致。在西方试验(SYNTAX)中,与经皮冠状动脉介入治疗相比,女性性别更倾向于冠状动脉旁路移植术(风险比 2.213;95%置信区间,1.242-3.943;=0.007),而在亚洲女性(PRECOMBAT 和 BEST)中,两种策略之间的治疗效果为中性。在西方试验(=0.019)中观察到性别与治疗策略的交互作用,但在亚洲试验(PRECOMBAT =0.469 和 BEST =0.472;=58%)中未观察到。
本荟萃分析表明,亚洲和西方试验存在性别-治疗相互作用的异质性。考虑到我们医疗实践的全球化,需要充分认识到这种性别-治疗相互作用的异质性,并在治疗策略的决策中考虑到这一点。
网址:https://www.clinicaltrials.gov。唯一标识符:NCT00114972、NCT00997828、NCT00422968。