老年心肌梗死患者的完全或罪犯病变血运重建治疗。
Complete or Culprit-Only PCI in Older Patients with Myocardial Infarction.
机构信息
From the Cardiology Unit, Azienda Ospedaliero Universitaria di Ferrara, Ferrara (S.B., V. Lodolini, R.P., P.C., C.T., A.E., C.P., G. Campo), the Cardiology Unit, Azienda Unità Sanitaria Locale (USL) IRCCS Reggio Emilia, S. Maria Nuova Hospital, Reggio Emilia (V.G., G.P.), the Cardiology Unit, Ospedale Maggiore (V. Lanzilotti, G. Casella, G.I.), and the Department of Biomedical and Neuromotor Sciences, University of Bologna (E.M.), Bologna, the Cardiovascular Department, Infermi Hospital, Rimini (A.S., M.M.), the Interventional Cardiology Unit, San Luigi Gonzaga University Hospital, Orbassano, and Rivoli Infermi Hospital ASL TO3, Turin (E.C., F.V.), the Cardiology Unit, Umberto I Hospital, ASP Siracusa, Siracusa (G.S.), S.C. Cardiologia, Ospedale Sant'Andrea, ASL5 Liguria, La Spezia (A.M., G. Caretta), the Cardiology Unit, Ospedale Civile di Baggiovara, Baggiovara (M.R.), Interventional Cardiology, Department of Cardio-Thoracic and Vascular Sciences, Ospedale dell'Angelo, Venice (M.B.), the Department of Cardiology, S. Maria delle Croci Hospital, Ravenna (L.F.), the Cardiovascular Department, Azienda USL Toscana Sud-Est, Misericordia Hospital, Grosseto (A.P.), the Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome (G.B.-Z.), and the Cardiology Unit, Ospedale Santa Maria Goretti, Latina (I.C.), Mediterranea Cardiocentro, Naples (G.B.-Z.), Maria Cecilia Hospital, Cotignola (P.C., D.D.), the Department of Clinical and Molecular Medicine, Sapienza University of Rome, Rome (E.B.), and the Interventional Cardiology Unit, Presidio Ospedaliero San Salvatore di Pesaro, Pesaro (M.T.) - all in Italy; Hospital Clínico San Carlos, Complutense University of Madrid (J.E.), Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), and Instituto de Investigación Hospital La Paz, University Hospital La Paz (R.M., A.J.-R.), Madrid, CIBERCV, Department of Cardiology, Hospital Clínico Universitario, Valladolid (I.A.S.), and CIBERCV, Cardiology Department, H. Universitario y Politécnico La Fe, Valencia (J.L.D.G.) - all in Spain; and the Institute of Cardiology, Jagiellonian University Medical College, Krakow, Poland (D.D.).
出版信息
N Engl J Med. 2023 Sep 7;389(10):889-898. doi: 10.1056/NEJMoa2300468. Epub 2023 Aug 26.
BACKGROUND
The benefit of complete revascularization in older patients (≥75 years of age) with myocardial infarction and multivessel disease remains unclear.
METHODS
In this multicenter, randomized trial, we assigned older patients with myocardial infarction and multivessel disease who were undergoing percutaneous coronary intervention (PCI) of the culprit lesion to receive either physiology-guided complete revascularization of nonculprit lesions or to receive no further revascularization. Functionally significant nonculprit lesions were identified either by pressure wire or angiography. The primary outcome was a composite of death, myocardial infarction, stroke, or any revascularization at 1 year. The key secondary outcome was a composite of cardiovascular death or myocardial infarction. Safety was assessed as a composite of contrast-associated acute kidney injury, stroke, or bleeding.
RESULTS
A total of 1445 patients underwent randomization (720 to receive complete revascularization and 725 to receive culprit-only revascularization). The median age of the patients was 80 years (interquartile range, 77 to 84); 528 patients (36.5%) were women, and 509 (35.2%) were admitted for ST-segment elevation myocardial infarction. A primary-outcome event occurred in 113 patients (15.7%) in the complete-revascularization group and in 152 patients (21.0%) in the culprit-only group (hazard ratio, 0.73; 95% confidence interval [CI], 0.57 to 0.93; P = 0.01). Cardiovascular death or myocardial infarction occurred in 64 patients (8.9%) in the complete-revascularization group and in 98 patients (13.5%) in the culprit-only group (hazard ratio, 0.64; 95% CI, 0.47 to 0.88). The safety outcome did not appear to differ between the groups (22.5% vs. 20.4%; P = 0.37).
CONCLUSIONS
Among patients who were 75 years of age or older with myocardial infarction and multivessel disease, those who underwent physiology-guided complete revascularization had a lower risk of a composite of death, myocardial infarction, stroke, or ischemia-driven revascularization at 1 year than those who received culprit-lesion-only PCI. (Funded by Consorzio Futuro in Ricerca and others; FIRE ClinicalTrials.gov number, NCT03772743.).
背景
对于患有心肌梗死和多支血管疾病的老年患者（≥75 岁），完全血运重建的益处尚不清楚。
方法
在这项多中心、随机试验中，我们将接受经皮冠状动脉介入治疗（PCI）罪犯病变的老年心肌梗死和多支血管疾病患者随机分为接受生理学指导的非罪犯病变完全血运重建或不进行进一步血运重建的两组。通过压力导丝或血管造影术确定有功能意义的非罪犯病变。主要终点是 1 年时的死亡、心肌梗死、卒中和任何血运重建的复合终点。主要次要终点是心血管死亡或心肌梗死的复合终点。安全性评估为造影剂相关急性肾损伤、卒中和出血的复合终点。
结果
共有 1445 名患者接受了随机分组（720 名接受完全血运重建，725 名接受罪犯病变血运重建）。患者的中位年龄为 80 岁（四分位距，77 岁至 84 岁）；528 名患者（36.5%）为女性，509 名（35.2%）因 ST 段抬高型心肌梗死入院。完全血运重建组中有 113 例（15.7%）患者发生主要结局事件，罪犯病变血运重建组中有 152 例（21.0%）患者发生主要结局事件（风险比，0.73；95%置信区间[CI]，0.57 至 0.93；P=0.01）。完全血运重建组中有 64 例（8.9%）患者发生心血管死亡或心肌梗死，罪犯病变血运重建组中有 98 例（13.5%）患者发生心血管死亡或心肌梗死（风险比，0.64；95%CI，0.47 至 0.88）。两组安全性结局无显著差异（22.5% vs. 20.4%；P=0.37）。
结论
在年龄≥75 岁、患有心肌梗死和多支血管疾病的患者中，与接受罪犯病变血运重建的患者相比，接受生理学指导的完全血运重建的患者在 1 年内的死亡、心肌梗死、卒中和缺血驱动的血运重建的复合终点风险较低。（由 Consorzio Futuro in Ricerca 等资助；FIRE ClinicalTrials.gov 编号，NCT03772743。）
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