Key result
Single-stage PCI cuts 1-year MACCE ~45% vs. multistage PCI in multivessel NSTEMI.
Why the study?
A lack of clarity exists about the role of complete coronary revascularization strategies in patients with non-ST-segment elevation myocardial infarction and multivessel coronary artery disease.
Does 1-stage percutaneous coronary intervention reduce major adverse cardiovascular and cerebrovascular events in patients with NSTEMI and multivessel coronary artery disease compared to multistage percutaneous coronary intervention?
RCT (n=584)
1:1
Does 1-stage percutaneous coronary intervention reduce major adverse cardiovascular and cerebrovascular events in patients with NSTEMI and multivessel coronary artery disease compared to multistage percutaneous coronary intervention?
Hazard Ratio: 0.549 (95% CI 0.363–0.828)
Absolute Event Rate: 13.63% vs 23.19%
p-value: p=0.004
In patients with NSTEMI and multivessel disease, single-stage complete revascularization significantly reduces the 1-year risk of major adverse cardiovascular and cerebrovascular events compared to multistage revascularization during the index hospitalization.
BACKGROUND: A lack of clarity exists about the role of complete coronary revascularization in patients presenting with non-ST-segment elevation myocardial infarction. OBJECTIVES: The aim of our study was to compare long-term outcomes in terms of major adverse cardiovascular and cerebrovascular events of 2 different complete coronary revascularization strategies in patients with non-ST-segment elevation myocardial infarction and multivessel coronary artery disease: 1-stage percutaneous coronary intervention (1S-PCI) during the index procedure versus multistage percutaneous coronary intervention (MS-PCI) complete coronary revascularization during the index hospitalization. METHODS: In the SMILE (Impact of Different Treatment in Multivessel Non ST Elevation Myocardial Infarction Patients: One Stage Versus Multistaged Percutaneous Coronary Intervention) trial, 584 patients were randomly assigned in a 1:1 manner to 1S-PCI or MS-PCI. The primary study endpoint was the incidence of major adverse cardiovascular and cerebrovascular events, which were defined as cardiac death, death, reinfarction, rehospitalization for unstable angina, repeat coronary revascularization (target vessel revascularization), and stroke at 1 year. RESULTS: The occurrence of the primary endpoint was significantly lower in the 1-stage group (1S-PCI: n = 36 [13.63%] vs. MS-PCI: n = 61 [23.19%]; hazard ratio [HR]: 0.549 [95% confidence interval (CI): 0.363 to 0.828]; p = 0.004). The 1-year rate of target vessel revascularization was significantly higher in the MS-PCI group (1S-PCI: n = 22 [8.33%] vs. MS-PCI: n = 40 [15.20%]; HR: 0.522 [95% CI: 0.310 to 0.878]; p = 0.01; p log-rank = 0.013). When the analyses were limited to cardiac death (1S-PCI: n = 9 [3.41%] vs. MS-PCI: n = 14 [5.32%]; HR: 0.624 [95% CI: 0.270 to 1.441]; p = 0.27) and myocardial infarction (1S-PCI: n = 7 [2.65%] vs. MS-PCI: n = 10 [3.80%]; HR: 0.678 [95% CI: 0.156 to 2.657]; p = 0.46), no significant differences were observed between groups. CONCLUSIONS: In multivessel non-ST-segment elevation myocardial infarction patients, complete 1-stage coronary revascularization is superior to multistage PCI in terms of major adverse cardiovascular and cerebrovascular events. (Impact of Different Treatment in Multivessel Non ST Elevation Myocardial Infarction [NSTEMI] PATIENTS: One Stage Versus Multistaged Percutaneous Coronary Intervention [PCI] [SMILE]: NCT01478984).
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Sardella et al. (2016) conducted an RCT in non-ST-segment elevation myocardial infarction and multivessel coronary artery disease (n=584). 1-stage percutaneous coronary intervention (1S-PCI) vs. multistage percutaneous coronary intervention (MS-PCI) was evaluated on major adverse cardiovascular and cerebrovascular events (cardiac death, death, reinfarction, rehospitalization for unstable angina, repeat coronary revascularization, and stroke at 1 year) (HR 0.549, 95% CI 0.363 to 0.828, p=0.004). In multivessel NSTEMI patients, 1-stage PCI significantly reduced major adverse cardiovascular and cerebrovascular events at 1 year compared to multistage PCI (13.63% vs 23.19%; HR 0.549; P=0.004).
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