Department of Cardiology, Keio University School of Medicine, Tokyo, Japan.
Duke Clinical Research Institute, Duke University Medical Center, Durham, NC.
J Am Heart Assoc. 2017 Oct 27;6(11):e006529. doi: 10.1161/JAHA.117.006529.
Whereas composite end points are often used in clinical trials of percutaneous coronary interventions (PCI), the impact of individual components on subsequent survival is incompletely defined. We evaluated the association of subsequent acute coronary syndromes (ACS) and unplanned coronary revascularization post-PCI with long-term survival.
From 2009 to 2011, the KiCS-PCI (Keio interhospital Cardiovascular Studies) consecutively enrolled patients undergoing PCI in 14 Japanese teaching hospitals. We identified patients who experienced ACS or unplanned coronary revascularization following their index PCI and compared subsequent survival during the 2-year follow-up period using propensity-matched cohorts of patients who did and did not experience these events. Cox proportional hazard models were used to assess 2-year all-cause mortality. Because unstable angina is less severe than acute myocardial infarction, we also generated a separate propensity-matched cohort for UA post-PCI. Among 3348 PCI patients (mean age, 67.5±10.7 years; 79.7% male), 214 (6.4%) experienced a subsequent ACS (168 events [78.5%] were unstable angina), and 198 (5.9%) underwent unplanned revascularization. In the propensity-matched cohorts, patients with a subsequent ACS admission had an increased risk of mortality as compared with those without (hazard ratio, 4.73; 95% confidence interval=1.35-16.6; =0.015), whereas those with an unplanned revascularization did not have significantly higher risk (hazard ratio, 2.97; 95% confidence interval=0.57-14.3; =0.19). Among unstable angina events, no association with mortality was observed (hazard ratio, 1.39; 95% confidence interval=0.48-4.00; =0.54).
In the KiCS-PCI registry, the incidence of a subsequent ACS was associated with higher mortality, but this association was less apparent after unplanned coronary revascularization or unstable angina. The prognostic implications of different outcomes in a composite end point should be considered when interpreting the results of clinical trials in PCI.
在经皮冠状动脉介入治疗(PCI)的临床试验中,常使用复合终点,但各组成部分对后续生存的影响尚未完全明确。我们评估了 PCI 后后续发生急性冠状动脉综合征(ACS)和计划外冠状动脉血运重建与长期生存的相关性。
2009 年至 2011 年,KiCS-PCI(庆应义塾大学医院间心血管研究)连续纳入 14 家日本教学医院行 PCI 的患者。我们确定了在索引 PCI 后发生 ACS 或计划外冠状动脉血运重建的患者,并使用未发生这些事件的患者的倾向性匹配队列比较了 2 年随访期间的后续生存情况。Cox 比例风险模型用于评估 2 年全因死亡率。由于不稳定型心绞痛比急性心肌梗死程度较轻,我们还为 PCI 后发生 UA 生成了一个单独的倾向性匹配队列。在 3348 名 PCI 患者(平均年龄 67.5±10.7 岁;79.7%为男性)中,214 名(6.4%)发生了后续 ACS(168 例事件[78.5%]为不稳定型心绞痛),198 名(5.9%)接受了计划外血运重建。在倾向性匹配队列中,与未发生 ACS 住院的患者相比,发生 ACS 住院的患者死亡风险增加(风险比 4.73;95%置信区间=1.35-16.6;=0.015),而计划外血运重建的患者风险没有显著升高(风险比 2.97;95%置信区间=0.57-14.3;=0.19)。在不稳定型心绞痛事件中,与死亡率无相关性(风险比 1.39;95%置信区间=0.48-4.00;=0.54)。
在 KiCS-PCI 登记研究中,后续 ACS 的发生率与死亡率升高相关,但在计划外冠状动脉血运重建或不稳定型心绞痛后,这种相关性不太明显。在解释 PCI 临床试验结果时,应考虑复合终点不同结局的预后意义。