麻豆传媒

PARIS -- 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 .

Findings from the multinational randomized trial were presented here at the 2019 European Society of Cardiology (ESC) congress and simultaneously published in the .

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 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 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.

Valgimigli, who was not involved in the study, said COMPLETE changes his practice because it gives operators the choice to complete revascularization in a more delayed manner, within 1 month after index PCI.

Holger Thiele, MD, of Leipzig University Hospital in Germany, noted that the trial was not powered to see a difference in mortality, and that the MI result was mainly driven by relatively small non-ST-elevation MIs. He too was not involved in the study.

COMPLETE was conducted at 140 centers in 31 countries. Trialists included 4,041 STEMI patients who received successful culprit-lesion PCI and were randomized within 72 hours to either another PCI for non-culprit lesions or no further revascularization. Mean age was 62 years and men made up 80% of the cohort.

Operators had to specify before randomization whether they would perform non-culprit-lesion PCI during the index hospitalization or after hospital discharge if the patient was to be assigned to complete revascularization (one-third of these patients ended up having their second PCI after hospital discharge at a median of 3 weeks).

Non-culprit lesions were deemed with 70% stenosis of the vessel diameter on visual estimation or with 50% to 69% stenosis accompanied by a low fractional flow reserve.

Patients in both study arms received guideline-recommended medical therapy, including dual antiplatelet therapy with aspirin and ticagrelor (Brilinta) for at least 1 year.

One complaint was that the control arm of no further revascularization doesn't really reflect clinical practice.

"In clinical practice non-culprit lesions are usually and if angina occurs or ischemia is detected, PCI is performed. This staged strategy even has been recommended in previous guidelines as the default strategy!" Thiele told 麻豆传媒.

"In this trial and in all the other previous trials, in the control arms PCI in non-culprit lesions was discouraged and only performed in rare cases," he noted, citing the 7.9% rate of ischemia-driven revascularization among controls. "Thus, the control arm was by design disadvantaged."

COMPLETE investigators noted that they did not include any patients with cardiogenic shock. Moreover, operators were so successful that other centers may not achieve the same results: complete revascularization leaving behind zero disease (SYNTAX score 0) was achieved in 90.1% of assigned cases, and crossover was below 5% in both groups.

Another limitation was that a quarter of patients received clopidogrel (Plavix), which may not be the most effective therapy in patients with acute coronary syndromes, according to Køber and Engstrøm's editorial.

"Taken together, the trial is not changing clinical practice very much in Germany. We already performed PCI of non-culprit lesion[s] before in clinical routine. Maybe we will do it now slightly more liberally based on the results of COMPLETE," Thiele said.

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