An analysis of patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary artery disease in the COMPLETE trial showed that those with more severe stenosis of nonculprit lesions gained bigger benefits from complete revascularization, in terms of cardiovascular outcomes.
The subgroup study was published in the Sept. 15 issue of the Journal of the American College of Cardiology.
Whether to revascularize all lesions – including nonculprit lesions – has been controversial in recent years, since the American College of Cardiology ranked routine percutaneous coronary intervention (PCI) of nonculprit arteries during primary PCI for stable STEMI as the most wasteful and unnecessary of cardiac tests and procedures. Studies since have polarized, with some, including CULPRIT-SHOCK finding those with revascularized multiple nonculprit lesions at higher risk than those with PCI of only the culprit lesion. Others, such as the 627-patient Danish study DANAMI-3-PRIMULTI, hail the potential benefits of complete revascularization.
The latest analysis of the COMPLETE trial signaled benefits to complete revascularization but found it depended on stenosis severity.
Together with co-investigators, Tej Sheth, MD, of the Population Health Research Institute, Hamilton, Ontario, and McMaster University, Hamilton Health Sciences, Hamilton, Ontario, measured nonculprit lesion stenosis severity using quantitative coronary angiography (QCA) in 3,851 patients out of the total 4,041 randomized for the study. The QCA-measured patients had a total of 5,355 nonculprit lesions.
The investigators randomized 2,479 patients with QCA stenosis of 60% or more to be given either complete revascularization or culprit-lesion-only PCI. They found that the fully revascularized patients had better outcomes in cardiovascular death or new myocardial infarction (MI); the first co-primary outcome measure (2.5% per year vs. 4.2% per year; hazard ratio [HR], 0.61; 95% confidence interval [CI], 0.47 to 0.79).
However, the same was not true for the 1,372 less-severe patients with QCA stenosis of less than 60%. Those randomized to complete revascularization had a 3% per year incidence rate of the first coprimary endpoint versus a 2.9% per year rate for those randomized to culprit-lesion-only revascularization (HR, 1.04; 95% CI, 0.72 to 1.50).
It meant a significant interaction for the effects of stenosis severity on the first co-primary outcome (p-interaction = 0.02).
There was also a significant association between stenosis severity and the second coprimary outcome measures of cardiovascular death, new MI or ischemia-driven revascularization (IDR) (p-interaction = 0.04). The outcome measure was reduced in patients with QCA stenosis of more than 60% by 2.9% per year in patients randomized to complete revascularization versus 6.9% per year in those given culprit-lesion-only PCI.
The reduction was higher than in patients with QCA stenosis of less than 60%, although those randomized to complete revascularization still had better coprimary secondary outcomes at 3.3%, versus 5.2% per year in those randomized to culprit-lesion-only PCI.
Clinical trials are still needed to compare angiographically versus physiologically guided assessments of nonculprit coronary lesions in patients with STEMI and multivessel coronary artery disease undergoing PCI, however, the researchers noted.
In an accompanying editorial comment, Sanjay Kaul, MD, of Cedars-Sinai Medical Center, Los Angeles, said the trial is “large, statistically persuasive and clinically important”, and points to a “desirable” benefit-risk ratio in favor of complete revascularization.
Yet he raised concerns, including that the perceived benefit is driven by reduction in MI and repeat revascularization but not cardiovascular death. Kaul also called the 60% QCA stenosis cut-off between moderate and severe “arbitrary” and questioned whether this was a pre-specified subgroup analysis as the authors claim. There is no mention of nonculprit lesion stenosis severity of 60% or more by QCA alone in the design paper, he said, adding that all subgroup analyses should, in any case, be considered exploratory because the “potential for false positive errors is quite common”.
He added: “A key question now confronting guideline committees is whether the totality of evidence is sufficient to endorse complete revascularization in STEMI as a Class I recommendation.”
Sheth T, Pinilla-Echeverri N, Moreno R, et al. Nonculprit Lesion Severity and Outcome of Revascularization in Patients With STEMI and Multivessel Coronary Disease. J Am Coll Cardiol 2020;76:1277-86.
Kaul S. On the Credibility of Subgroup Analyses in the COMPLETE Trial. J Am Coll Cardiol 2020;76:1287-90.