SMILE: One-stage PCI superior to multistage PCI in multivessel non-STEMI
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Complete one-stage PCI appears to be a superior strategy compared with multistage PCI for the treatment of patients with multivessel non-STEMI, yielding significantly lower rates of MACCE, according to results of the SMILE trial.
In the two-center, unmasked, randomized clinical trial, researchers evaluated 542 consecutive non-STEMI patients slated to undergo an early invasive revascularization procedure (PCI within 24 hours) between September 2011 and August 2013. Participants were aged at least 18 years, diagnosed with non-STEMI, presented with multivessel disease, had a glomerular filtration rate greater than 60 mL/min and planned early invasive treatment.
Participants were randomly assigned 1:1 to one-stage PCI (n = 264) or multistage PCI (n = 263). The second-stage procedure in multistage PCI was performed between 3 and 7 days of the original procedure.
The study’s primary endpoint was the occurrence of MACCE, defined as cardiac death, death, reinfarction, rehospitalization due to unstable angina, repeat coronary revascularization, target vessel revascularization and stroke, at 1 year.
Kaplan-Meier curves revealed that the primary endpoint was lower in the one-stage PCI group (P = .004). Compared with the one-stage group, there was significantly higher occurrence of the 1-year primary endpoint in the multistage group (one-stage PCI: n = 36 [13.63%] vs. multistage PCI: n = 61 [23.19%]; HR = 0.549; 95% CI, 0.363-0.828).
Additionally, there was a significantly higher 1-year rate of TVR in the multistage PCI group vs. the one-stage PCI group (one-stage PCI: n = 22 [8.33%] vs. multistage PCI: n = 40 [15.2%]; HR = 0.522; 95% CI, 0.31-0.878). No significant differences between the groups were seen when the analysis was confined to the two main components of the primary outcome, cardiac death (one-stage PCI: n = 9 [3.41%] vs. multistage PCI: n = 14 [5.32%]; HR = 0.624; 95% CI, 0.27-1.441) and MI (one-stage PCI: n = 7 [2.65%] vs. multistage PCI: n = 10 [3.8%]; HR = 0.678; 95% CI, 0.156-2.657)
“On the basis of near-term outcomes in patients with [non]-STEMI and multivessel [CAD], single-session complete coronary interventional procedures are preferred over multistage methods of percutaneous revascularization,” the researchers wrote. “Longer-term follow-up studies are needed to assess the comparative mortality benefit of performing complete coronary revascularization during index procedures, rather than delaying intervention on lesions in non-culprit vessels in patients with [non]-STEMI.” – by Jennifer Byrne
Disclosure: The researchers report no relevant financial disclosures.