Making complete revascularization the routine goal of percutaneous coronary intervention (PCI) conferred a benefit in hard outcomes for ST-segment myocardial infarction (STEMI) patients with multivessel disease, according to the COMPLETE trial.
The first coprimary composite outcome of cardiovascular death or MI reached 7.8% over a median 3 years follow-up among those who had complete revascularization of all angiographically significant lesions, compared with 10.5% for peers getting culprit lesion-only stenting (HR 0.74, 95% CI 0.60-0.91, P=0.004).
Notably, this was driven by fewer MIs — there was still no reduction in cardiovascular death in particular, reported Shamir Mehta, MD, of the Population Health Research Institute at McMaster University and Hamilton Health Sciences in Hamilton, Ontario.
“COMPLETE is the first randomized trial to show that complete revascularization reduces hard cardiovascular events compared to culprit-lesion only PCI in patients with STEMI and multivessel coronary artery disease,” Mehta said in a statement.
Findings from the multinational randomized trial were presented here at the 2019 European Society of Cardiology (ESC) congress and simultaneously published in the New England Journal of Medicine.
Looking at the second coprimary endpoint — combined cardiovascular death, MI, or ischemia-driven revascularization — also handed complete revascularization the edge over culprit lesion-only PCI (8.9% vs 16.7%, HR 0.51, 95% CI 0.43-0.61, P<0.001).
And there were no difference in safety events between the complete- and incomplete-revascularization arms.
“Should the consistent lack of benefit with respect to all-cause mortality discourage the strategy of routine complete revascularization?” said Lars Køber, MD, and Thomas Engstrøm, MD, both of Rigshospitalet, University of Copenhagen, in an editorial that accompanied the publication.
“It appears to be appropriate to recommend complete revascularization for patients similar to those included in the COMPLETE trial,” they wrote. “We hope that the investigators will be able to obtain data from longer follow-up in order to evaluate whether the tendency toward a small reduction in all-cause mortality becomes significant over time.”
Complete revascularization was beneficial no matter if the non-culprit lesion PCI was done during the index hospitalization or weeks after discharge (up to 45 days), Mehta said during a press briefing. The benefit also became apparent over time, with continued divergence of the Kaplan-Meier curves.
Mehta’s group reported that “over a period of 3 years, the number needed to treat to prevent cardiovascular death or MI from occurring in 1 patient is 37 patients, and the number needed to treat to prevent cardiovascular death, MI, or ischemia-driven revascularization from occurring in 1 patient is 13 patients.”
Guidelines in the U.S. and Europe currently give class IIb recommendations for PCI in non-culprit lesions.
“This is an important study which confirms our prior knowledge and is consistent with current ESC guidelines,” commented Marco Valgimigli, MD, PhD, of Inselspital University Hospital in Bern, Switzerland. [MORE]
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