冠状动脉病变范围对经导管主动脉瓣置换术的影响：PRO-TAVI 子研究。
完整摘要 · 中文译文
背景：在接受经导管主动脉瓣置换术（TAVR）的患者中，有一半存在冠状动脉疾病。近期进行的随机对照PRO-TAVI（经导管主动脉瓣植入术前经皮冠状动脉介入治疗）试验表明，在1年随访时，对合并冠状动脉疾病的患者推迟经皮冠状动脉介入治疗（PCI）是安全的。SYNTAX（经皮冠状动脉介入治疗联合TAXUS与心脏外科手术之间的协同作用）评分可量化冠状动脉疾病的范围，这可能有助于指导个体化血运重建策略。 目的：本研究旨在评估接受TAVR的患者中SYNTAX评分（SS）与临床结局之间的关联。 方法：本研究为PRO-TAVI试验的亚研究，纳入466例接受TAVR的显著冠状动脉疾病患者，随机分为推迟PCI组或TAVR前PCI组。SS根据术前冠状动脉造影计算，患者按SS四分位数分层。主要结局为1年时全因死亡、心肌梗死、卒中和主要出血的复合终点。同时还评估了全因死亡、心肌梗死和卒中的缺血性复合结局。 结果：在1年随访时，推迟组和PCI组之间主要复合结局在各SS类别间无差异，除1例患者外所有患者均完成随访。在SS >17的患者中，缺血性复合结局在推迟组中发生更频繁（30.9% vs 14.8%；校正HR：2.43；95% CI ：1.04-5.64；P = 0.04），主要由全因死亡和卒中驱动。在所有SS亚组中，延迟组的出血事件较少。 结论：在接受TAVR的合并冠状动脉疾病患者中，延迟PCI降低了出血风险，并在所有SS类别中均表现安全。在冠状动脉疾病更复杂的患者（SS >17）中，延迟PCI与缺血性复合结局风险较高相关。这些事后分析结果需要在随机试验中予以证实。（经导管主动脉瓣植入前经皮冠状动脉介入治疗 [PRO-TAVI]；NCT05078619）。
完整摘要 · 英文原文
BACKGROUND: Coronary artery disease is present in one-half of patients undergoing transcatheter aortic valve replacement (TAVR). The recent randomized controlled PRO-TAVI (Percutaneous Coronary Intervention Before Transcatheter Aortic Valve Implantation) trial indicated that deferral of percutaneous coronary intervention (PCI) is safe in patients with concomitant coronary artery disease at 1-year follow-up. The SYNTAX (Synergy between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery) score quantifies the extent of coronary artery disease, which may guide individualized revascularization strategies. OBJECTIVES: The aim of this study was to evaluate the association between SYNTAX score (SS) and clinical outcomes in patients undergoing TAVR. METHODS: This study was a substudy of the PRO-TAVI trial, including 466 patients with significant coronary artery disease undergoing TAVR randomized to deferral of PCI or PCI before TAVR. SS was calculated from preprocedural coronary angiograms, and patients were stratified by SS quartiles. The primary outcome was a composite of all-cause mortality, myocardial infarction, stroke, and major bleeding at 1 year. An ischemic composite outcome of all-cause mortality, myocardial infarction, and stroke was also assessed. RESULTS: The primary composite outcome did not differ across SS categories between the deferral and PCI groups at 1-year follow-up, which was completed by all but 1 patient. In patients with SS >17, the ischemic composite outcome occurred more often in the deferral group (30.9% vs 14.8%; adjusted HR: 2.43; 95% CI: 1.04-5.64; P = 0.04), driven primarily by all-cause mortality and stroke. Bleeding events were less frequent in the deferral group across all SS subgroups. CONCLUSIONS: In patients with concomitant coronary artery disease undergoing TAVR, deferral of PCI reduced bleeding risk and appeared safe across all SS categories. Deferral of PCI in patients with more complex coronary artery disease (SS >17) was associated with higher risk for the ischemic composite outcome. These post hoc findings require confirmation in randomized trials. (Percutaneous Coronary Intervention Before Transcatheter Aortic Valve Implantation [PRO-TAVI]; NCT05078619).