Gabani Rami, Spione Francesco, Arevalos Victor, Grima Sopesens Nadine, Ortega-Paz Luis, Gomez-Lara Josep, Jimenez-Diaz Victor, Jimenez Marcelo, Jiménez-Quevedo Pilar, Diletti Roberto, Pineda Javier, Campo Gianluca, Silvestro Antonio, Maristany Jaume, Flores Xacobe, Oyarzabal Loreto, Bastos-Fernandez Guillermo, Iñiguez Andrés, Serra Antonio, Escaned Javier, Ielasi Alfonso, Tespili Maurizio, Lenzen Mattie, Gonzalo Nieves, Bordes Pascual, Tebaldi Matteo, Biscaglia Simone, Al-Shaibani Soheil, Romaguera Rafael, Gomez-Hospital Joan Antoni, Rodes-Cabau Josep, Serruys Patrick W, Sabaté Manel, Brugaletta Salvatore
Hospital Clínic, Cardiovascular Clinic Institute, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain.
Hospital Clínic, Cardiovascular Clinic Institute, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain; Department of Advanced Biomedical Sciences, University of Naples, Federico II, Naples, Italy.
JACC Cardiovasc Interv. 2022 Oct 10;15(19):1965-1973. doi: 10.1016/j.jcin.2022.07.038. Epub 2022 Aug 22.
Short-term outcomes following ST-segment elevation myocardial infarction (STEMI) in women are worse than in men, with a higher mortality rate. It is unknown whether sex plays a role in very long term outcomes.
The aim of this study was to assess whether very long term outcomes following STEMI treatment are influenced by sex.
EXAMINATION-EXTEND (10-Year Follow-Up of the EXAMINATION Trial) was an investigator-driven 10-year follow-up of the EXAMINATION (A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-Segment Elevation Myocardial Infarction) trial, which randomly 1:1 assigned 1,498 patients with STEMI to receive either everolimus-eluting stents or bare-metal stents. The present study was a subanalysis according to sex. The primary endpoint was the composite patient-oriented endpoint (all-cause death, any myocardial infarction, or any revascularization) at 10 years. Secondary endpoints were individual components of the primary endpoint. All endpoints were adjusted for age.
Among 1,498 patients with STEMI, 254 (17%) were women. Overall, women were older, with more arterial hypertension and less smoking history than men. At 10 years, no difference was observed between women and men for the patient-oriented composite endpoint (40.6% vs 34.2%; adjusted HR: 1.14; 95% CI: 0.91-1.42; P = 0.259). There was a trend toward higher all-cause death in women vs men (27.6% vs 19.4%; adjusted HR: 1.30; 95% CI: 0.99-1.71; P = 0.063), with no difference in cardiac death or other endpoints.
At very long term follow-up, there were no differences in the combined patient-oriented endpoint between women and men, with a trend toward higher all-cause death in women not driven by cardiac death. The present findings underline the need for focused personalized medicine in women after percutaneous revascularization aimed at both cardiovascular and sex-specific risk factor control and targeted treatment. (10-Years Follow-Up of the EXAMINATION Trial [EXAMINAT10N]; NCT04462315).
ST段抬高型心肌梗死(STEMI)女性患者的短期预后比男性差,死亡率更高。性别是否在极长期预后中起作用尚不清楚。
本研究旨在评估STEMI治疗后的极长期预后是否受性别影响。
EXAMINATION-EXTEND(EXAMINATION试验的10年随访)是一项由研究者发起的对EXAMINATION(依维莫司洗脱冠状动脉支架治疗ST段抬高型心肌梗死患者的临床评估)试验的10年随访,该试验将1498例STEMI患者按1:1随机分配接受依维莫司洗脱支架或裸金属支架。本研究是按性别进行的亚分析。主要终点是10年时以患者为导向的复合终点(全因死亡、任何心肌梗死或任何血运重建)。次要终点是主要终点的各个组成部分。所有终点均根据年龄进行了调整。
在1498例STEMI患者中,254例(17%)为女性。总体而言,女性年龄更大,高血压患者更多,吸烟史更少。在10年时,以患者为导向的复合终点在女性和男性之间未观察到差异(40.6%对34.2%;调整后HR:1.14;95%CI:0.91-1.42;P=0.259)。女性全因死亡有高于男性的趋势(27.6%对19.4%;调整后HR:1.30;95%CI:0.99-1.71;P=0.063),心脏死亡或其他终点无差异。
在极长期随访中,女性和男性在以患者为导向的复合终点方面没有差异,女性全因死亡有升高趋势,但并非由心脏死亡驱动。本研究结果强调,在经皮血运重建术后的女性中,需要有针对性的个性化医疗,以控制心血管和性别特异性危险因素并进行靶向治疗。(EXAMINATION试验的10年随访[EXAMINAT10N];NCT04462315)