Stenting versus non-stenting treatment of intermediate stenosis culprit lesion in acute ST-segment elevation myocardial infarction: a multicenter randomized clinical trial

Jing Dai; Shu-Zheng Lyu; Yun-Dai Chen; Xian-Tao Song; Min Zhang; Wei-Min Li; Yang Zheng; Shang-Yu Wen; Shao-Ping Nie; Yu-Jie Zeng; Hai Gao; Yi-Tong Ma; Shu-Yang Zhang; Li-Jun Guo; Zheng Zhang

doi:10.11909/j.issn.1671-5411.2017.02.005

Stenting versus non-stenting treatment of intermediate stenosis culprit lesion in acute ST-segment elevation myocardial infarction: a multicenter randomized clinical trial

J Geriatr Cardiol. 2017 Feb;14(2):108-117. doi: 10.11909/j.issn.1671-5411.2017.02.005.

Authors

Jing Dai¹, Shu-Zheng Lyu¹, Yun-Dai Chen², Xian-Tao Song¹, Min Zhang¹, Wei-Min Li³, Yang Zheng⁴, Shang-Yu Wen⁵, Shao-Ping Nie¹, Yu-Jie Zeng¹, Hai Gao¹, Yi-Tong Ma⁶, Shu-Yang Zhang⁷, Li-Jun Guo⁸, Zheng Zhang⁹

Affiliations

¹ Department of Cardiology, Capital Medical University Affiliated Beijing Anzhen Hospital, Beijing Institute of Heart Lung and Blood Vessel Diseases, Beijing, China.
² Department of Cardiology, Chinese PLA General Hospital, Beijing, China.
³ Department of Cardiology, the First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China.
⁴ Department of Cardiology, the First Bethune Hospital of Jilin University, Changchun, Jilin, China.
⁵ Department of Cardiology, Daqing Oilfield General Hospital, Daqing, Heilongjiang, China.
⁶ Department of Cardiology, the First Affiliated Hospital of Xinjiang Medical University, Urumchi, Xinjiang Uygur Autonomous Region, China.
⁷ Department of Cardiology, Peking Union Medical College Hospital, Beijing, China.
⁸ Department of Cardiology, Peking University Third Hospital, Beijing, China.
⁹ Department of Cardiology, the First Hospital of Lanzhou University, Lanzhou, Gansu, China.

PMID: 28491085
PMCID: PMC5409352
DOI: 10.11909/j.issn.1671-5411.2017.02.005

Abstract

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.

Keywords: Acute myocardial infarction; Anti-thrombotic therapy; Clinical trial; Primary percutaneous coronary intervention; ST-segment elevation myocardial infarction; Stent.