Reason to SMILE? Single-Stage PCI Appears Safer Than Multiple Procedures for Multivessel NSTEMI

While the issue of how to revascularize STEMI patients with multivessel disease has been the focus of many a trial, new research from Italy singles out NSTEMI patients, showing a lower rate of target vessel revascularization—but similar rates of cardiac death and MI—with single-stage PCI compared with a multistage approach.

The SMILE trial, originally presented at the 2014 TCT meeting in Washington, DC, randomized 584 NSTEMI patients with multivessel CAD to undergo complete revascularization with PCI during either the index procedure (n = 264) or in 2 procedures within 3 to 7 days of each other (n = 263). Lead author Gennaro Sardella, MD, of Sapienza University of Rome in Italy, told TCTMD that his institution tends to always completely revascularize patients in a single hospitalization—hence the 7-day maximum waiting period—and that they do not usually perform only culprit-lesion PCI.

Sardella and colleagues found that MACCE (cardiac death, death, reinfarction, rehospitalization for unstable angina, repeat revascularization, and stroke) was less common in the single- vs multistage group at 1 year (P = .004). However, this finding was driven by a lower rate of TVR in patients who received single- vs multistage PCI (P = .01). There were no differences in cardiac death or MI.

Type 1 bleeding, as defined by Academic Research Consortium criteria, was halved in the single-stage PCI group (P = .03), and there were no differences in definite stent thrombosis.

IVUS, OCT, and FFR use were left to operator discretion and only used in 23.3%, 12.5%, and 11.3% of patients, respectively, with no differences between cohorts. The primary access route was transradial (84.2%).

‘Unexplained’ Findings on TVR

The “unexplained” higher incidence of TVR seen among patients treated with multiple procedures could possibly be caused by an observed higher rate of 6-month stress tests in this group (35.36%) compared with single-stage PCI patients (26.89%), according to the authors. Troponin T levels rapidly decreased in single-stage patients and increased in multistage patients, they note, and this could be related to longer ischemia times.

Longer myocardial ischemia times could also be “due to a possible erroneous identification of the culprit lesion during coronary angiography or to the presence of multiple culprit lesions and, consequently, to incomplete ischemia resolution,” Sardella and colleagues write.

In an accompanying editorial, José P. S. Henriques, MD, PhD, and Bimmer E. Claessen, MD, PhD, both of the University of Amsterdam in the Netherlands, write that the rate of TVR in the multistage group was “unprecedentedly high” given the 13.5% rate observed in the SYNTAX trial—which used “obsolete first-generation paclitaxel-eluting stents” and where the mean Syntax Score was 28 compared with 15 in SMILE.

With these factors added to the minimal FFR use and missing information concerning type of repeat revascularization and testing for ischemia, the editorialists say that when “interpreting SMILE, one may find a reason to frown.”

Complete Revascularization Not Harmful

Jeffrey A. Breall, MD, of Indiana University (Indianapolis, IN), told TCTMD that he agreed with most of the what the editorial says, adding that practice is “completely different” in the United States compared with Italy. Whereas Sardella’s group prefers to completely revascularize a patient within a single hospitalization—even at 2 separate times—Breall said he typically waits at least 4 to 5 weeks for the patient to recover before going back for a secondary procedure.

But “taking the other side of the coin,” Breall said the literature now indicates that complete revascularization should be standard practice and “makes sense from a cost standpoint.” So long as the operator recognizes evidence of ischemia and monitors the amount of contrast used, it often is a reasonable choice, he said.

SMILE demonstrates that it is not harmful to “fix everything in one setting,” Breall explained, adding that the study should be replicated in a larger population. But isolating NSTEMI from STEMI patients is not necessary, he said. “The only difference in my mind is perhaps the immediacy with which you have to fix the culprit lesion.”

Sources: 
1. 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;67:264-272.
2. Henriques JPS, Claessen BE. A SMILE and a frown: one-stage or multistage PCI in NSTEMI patients with multivessel disease [editorial]. J Am Coll Cardiol. 2016;67:273-274.

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• SMILE: One-Stage PCI Superior for Non-STEMI and Multivessel CAD
• Trials Prompt Interventionalists to Reconsider Complete Revascularization for STEMI
• Best Approach to Multivessel Disease in STEMI an Unresolved Issue