Impact of Different Treatment in Multivessel NSTEMI Patients: One Stage vs. Multistaged PCI - SMILE
The goal of the trial was to evaluate complete revascularization during the index procedure compared with culprit-only revascularization during the index procedure plus deferred complete revascularization within 3-7 days among patients with non–ST-segment elevation myocardial infarction (NSTEMI).
Contribution to the Literature: The SMILE trial showed that complete revascularization of NSTEMI patients during the index procedure is superior to delayed complete revascularization.
Patients with NSTEMI were randomized to complete revascularization during the index procedure (i.e., 1-stage revascularization; n = 264) versus culprit-only revascularization during the index procedure plus deferred complete revascularization within 3-7 days (i.e., 2-stage revascularization; n = 263). The use of intravascular ultrasound/optical coherence tomography/fractional flow reserve was left to operator discretion.
- Total number of enrollees: 542
- Duration of follow-up: 1 year
- Mean patient age: 72 years
- Percentage female: 22%
- Percentage diabetics: 34%
Other salient features/characteristics:
- Mean number of vessels treated: 2.4 in the 1-stage group vs. 2.3 in the 2-stage group (p = 0.71)
- Mean number of stents per patient: three in the 1-stage group vs. three in the 2-stage group (p = 0.56)
- NSTEMI with multivessel disease and planned early invasive strategy
- Cardiogenic shock
- Chronic total occlusion
- Previous coronary artery bypass grafting
- SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) score >32
- Candidate for bypass surgery
- Severe valvular heart disease
The primary outcome of death, MI, rehospitalization for unstable angina, target vessel revascularization, or stroke at 1 year occurred in 13.6% of the 1-stage group versus 23.2% of the 2-stage group (p = 0.004). The composite outcome was similar between treatment groups at 1 month (p = 0.78); however, at 6 months, there was benefit favoring 1-stage revascularization (p = 0.04).
- MI: 2.7% vs. 3.8% (p = 0.01), respectively, for 1-stage vs. 2-stage
- Target vessel revascularization: 8.3% vs. 15.2% (p = 0.01), respectively, for 1-stage vs. 2-stage
Among NSTEMI patients, complete revascularization during the index procedure was superior to delayed complete revascularization within 3-7 days. Superiority was achieved by a reduction in major adverse cardiovascular and cerebrovascular events, especially in target vessel revascularization. It is unclear why complete revascularization during the index procedure would be superior since the mean number of treated vessels and stents received was the same. Moreover, benefit occurred long after both groups were completely revascularized. Therefore, it is possible that these findings are the result of chance. The optimal timing for complete revascularization of NSTEMI patients remains unknown.
Sardella G, Lucisano L, Garbo R, et al. Single-Staged Compared With Multi-Staged PCI in Multivessel NSTEMI Patients: The SMILE Trial. J Am Coll Cardiol 2016;67:264-72.
Editorial Comment: Henriques JP, Claessen BE. A SMILE and a Frown: One-Stage or Multistage PCI in NSTEMI Patients With Multivessel Disease. J Am Coll Cardiol 2016;67:273-4.
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