Author + information
- Received July 5, 2015
- Revision received September 28, 2015
- Accepted October 20, 2015
- Published online January 26, 2016.
- Gennaro Sardella, MD∗∗ (, )
- Luigi Lucisano, MD∗,
- Roberto Garbo, MD†,
- Mauro Pennacchi, MD∗,
- Erika Cavallo, MD∗,
- Rocco Edoardo Stio, MD∗,
- Simone Calcagno, MD∗,
- Fabrizio Ugo, MD†,
- Giacomo Boccuzzi, MD†,
- Francesco Fedele, MD∗ and
- Massimo Mancone, MD, PhD∗
- ∗Department of Cardiovascular, Respiratory, Nephrology, Anesthesiology, and Geriatric Sciences, “Sapienza” University of Rome, Rome, Italy
- †Interventional Cardiology, San Giovanni Bosco Hospital, Turin, Italy
- ↵∗Reprint requests and correspondence:
Dr. Gennaro Sardella, Department of Cardiovascular, Respiratory, Nephrology, Anesthesiology, and Geriatric Sciences, Policlinico “Umberto I,” “Sapienza” University of Rome, Viale del Policlinico 155, 00161 Rome, Italy.
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)
- acute coronary syndrome
- coronary artery disease
- intention-to-treat analysis
- myocardial infarction
- myocardial ischemia
Dr. Garbo has received consulting fees and/or honoraria from Terumo, Volcano Europe, Abbott, Asahi Intecc, and St. Jude Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. Sardella and Mancone contributed equally to this work.
- Received July 5, 2015.
- Revision received September 28, 2015.
- Accepted October 20, 2015.
- American College of Cardiology Foundation