Stenting versus non-stenting treatment of intermediate stenosis culprit lesion in acute ST-segment elevation myocardial infarction: a multicenter random-ized clinical trial
Department of Cardiology, Capital Medical University Affiliated Beijing Anzhen Hospital, Beijing Institute of Heart Lung and Blood Vessel Diseases, Beijing, China
Department of Cardiology, Chinese PLA General Hospital, Beijing, China
Department of Cardiology, the First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China
Department of Cardiology, the First Bethune Hospital of Jilin University, Changchun, Jilin, China
Department of Cardiology, Daqing Oilfield General Hospital, Daqing, Heilongjiang, China
Department of Cardiology, the First Affiliated Hospital of Xinjiang Medical University, Urumchi, Xinjiang Uygur Autonomous Region, China
Department of Cardiology, Peking Union Medical College Hospital, Beijing, China
Department of Cardiology, Peking University Third Hospital, Beijing, China
Department of Cardiology, the First Hospital of Lanzhou University, Lanzhou, Gansu, China
Funds:
This study was supported by the Ministry of Science and Technology of the People’s Republic of China, State Science and Technology Support Program (No.2011BAI11B05). We thank all investigators and participants of this study for their valuable contributions. We appreciate the valuable help of Dr. Roberto Patarca for polish of the manuscript. The authors declare no commercial conflicts of interest.
Background The benefit/risk ratio of stenting in acute ST-segment elevation myocardial infarction (STEMI) patients with single vessel intermediate stenosis culprit lesions merits further study, therefore the subject of the present study. Methods and results It was a prospective, multicenter, randomized controlled trial. Between April 2012 and July 2015, 399 acute STEMI patients with single vessel disease and intermediate (40%–70%) stenosis of the culprit lesion before or after aspiration thrombectomy and/or intracoronary tirofiban (15 μg/kg) were enrolled and were randomly assigned (1: 1) to stenting group (n = 201) and non-stenting group (n = 198). In stenting group, patients received pharmacologic therapy plus standard percutaneous coronary intervention (PCI) with stent implantation. In non-stenting group, patients received pharmacologic therapy and PCI (thrombectomy), but without dilatation or stenting. Primary endpoint was 12-month rate of major adverse cardiac and cerebrovascular events (MACCE), a composite of cardiac death, non-fatal myocardial infarction (MI), repeat revascularization and stroke. Secondary endpoints were 12-month rates of all cause death, ischemia driven admission and bleeding complication. Median follow-up time was 12.4 ± 3.1 months. At 12 months, MACCE occurred in 8.0% of the patients in stenting group, as compared with 15.2% in the non-stenting group (adjusted HR: 0.42, 95% CI: 0.19–0.89, P = 0.02). The stenting group had lower non-fatal MI rate than non-stenting group, (1.5% vs. 5.5%, P = 0.03). The two groups shared similar cardiac death, repeat revascularization, stroke, all cause death, ischemia driven readmission and bleeding rates at 12 months. Conclusions Stent implantation had better efficacy and safety in reducing MACCE risks among acute STEMI patients with single vessel intermediate stenosis culprit lesions.
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