Department of Cardiology, Bern University Hospital, Bern, Switzerland; Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy.
Department of Cardiology, Bern University Hospital, Bern, Switzerland.
JACC Cardiovasc Interv. 2018 Jan 8;11(1):36-50. doi: 10.1016/j.jcin.2017.09.014.
This study sought to assess whether transradial access (TRA) compared with transfemoral access (TFA) is associated with consistent outcomes in male and female patients with acute coronary syndrome undergoing invasive management.
There are limited and contrasting data about sex disparities for the safety and efficacy of TRA versus TFA for coronary intervention.
In the MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX) program, 8,404 patients were randomized to TRA or TFA. The 30-day coprimary outcomes were major adverse cardiovascular and cerebrovascular events (MACCE), defined as death, myocardial infarction, or stroke, and net adverse clinical events (NACE), defined as MACCE or major bleeding.
Among 8,404 patients, 2,232 (26.6%) were women and 6,172 (73.4%) were men. MACCE and NACE were not significantly different between men and women after adjustment, but women had higher risk of access site bleeding (male vs. female rate ratio [RR]: 0.64; p = 0.0016), severe bleeding (RR: 0.17; p = 0.0012), and transfusion (RR: 0.56; p = 0.0089). When comparing radial versus femoral, there was no significant interaction for MACCE and NACE stratified by sex (p = 0.15 and 0.18, respectively), although for both coprimary endpoints the benefit with TRA was relatively greater in women (RR: 0.73; p = 0.019; and RR: 0.73; p = 0.012, respectively). Similarly, there was no significant interaction between male and female patients for the individual endpoints of all-cause death (p = 0.79), myocardial infarction (p = 0.25), stroke (p = 0.18), and Bleeding Academic Research Consortium type 3 or 5 (p = 0.45).
Women showed a higher risk of severe bleeding and access site complications, and radial access was an effective method to reduce these complications as well as composite ischemic and ischemic or bleeding endpoints.
本研究旨在评估经桡动脉入路(TRA)与经股动脉入路(TFA)在接受介入治疗的急性冠状动脉综合征男性和女性患者中的一致性结局是否存在差异。
TRA 与 TFA 用于经皮冠状动脉介入治疗的安全性和有效性方面,性别差异的数据有限且存在差异。
在 MATRIX(经桡动脉入路和系统实施 angioX 减少不良出血事件)研究中,8404 例患者被随机分为 TRA 组或 TFA 组。30 天的主要复合终点是主要不良心脑血管事件(MACCE),定义为死亡、心肌梗死或卒中和净不良临床事件(NACE),定义为 MACCE 或大出血。
在 8404 例患者中,2232 例(26.6%)为女性,6172 例(73.4%)为男性。调整后,男性和女性之间的 MACCE 和 NACE 无显著差异,但女性的血管入路出血风险更高(男性与女性的比值比[RR]:0.64;p=0.0016)、严重出血(RR:0.17;p=0.0012)和输血(RR:0.56;p=0.0089)。当比较桡动脉与股动脉时,根据性别分层的 MACCE 和 NACE 无显著交互作用(p=0.15 和 0.18),尽管对于两个主要复合终点,TRA 的获益在女性中相对更大(RR:0.73;p=0.019;RR:0.73;p=0.012)。同样,对于所有原因死亡(p=0.79)、心肌梗死(p=0.25)、卒中和(p=0.18)以及 Bleeding Academic Research Consortium 3 型或 5 型(p=0.45)等各个终点,男性和女性患者之间也无显著交互作用。
女性发生严重出血和血管入路并发症的风险较高,桡动脉入路是一种有效的方法,可降低这些并发症以及复合缺血和缺血或出血终点事件的发生风险。