Complete revascularization improves angina-related quality of life in patients who have ST-segment elevation myocardial infarction (STEMI) with multivessel coronary artery disease, a new COMPLETE substudy shows.
Both complete revascularization and culprit-lesion-only percutaneous coronary intervention (PCI) improved scores at 6 months on the patient-reported Seattle Angina Questionnaire (SAQ). Four of the five subscales favored complete revascularization at 6 months, and all five did so at study end, with a median follow-up of 3 years.
Residual angina at study end was present in 12.5% of patients in the complete revascularization group and 15.7% in the culprit-only group (P = .013).
Subgroup analyses revealed the benefit was almost entirely in patients with tighter nonculprit lesions with at least 80% stenosis (P for interaction = .05), said Shamir Mehta, MD, Population Health and Research Institute, McMaster University and Hamilton Health Sciences, Ontario, Canada.
“Complete revascularization improves overall patient-reported health status in addition to its established benefit in reducing major cardiovascular events,” he said during a featured clinical research session at the American College of Cardiology (ACC) 2022 Scientific Session.
“These data also provide new information for physicians and patients to consider in the context of shared decision making as it relates to coronary artery revascularization in patients with STEMI,” Mehta added.
As previously reported, the landmark trial showed that complete revascularization reduced cardiovascular death and new myocardial infarction (MI), leading to a class 1a recommendation for complete revascularization in the multisociety 2021 guideline for coronary artery revascularization. Its effect on angina-related quality of life, however, is unclear and hasn’t previously been evaluated in a randomized trial, he said.
The trial enrolled 4041 patients with STEMI and multivessel disease who had undergone successful PCI of the culprit lesion but were found to have nonculprit lesions of at least 70% or a fractional flow reserve measurement of 0.80. Patients were then randomly assigned to complete revascularization of any additional angiographically significant nonculprit lesions or to no further revascularization. Among those allocated to intervention, 122 crossed over to culprit-lesion-only revascularization.
SAQ data were collected at baseline, 6 months, and study end, with final data available from 86.8% of the complete revascularization group and 85.0% of the culprit-only group. Mean age of the study participants was 62 years, 19% were female, and 19% had diabetes.
At baseline, 12% of patients reported weekly or daily angina but, importantly, 50% had no self-reported history of angina, Mehta pointed out.
The change in SAQ scores from baseline to 6 months for the complete revascularization and culprit-only groups was as follows:
Angina frequency: 7.3 vs 6.4 (P = .039)
Physical limitation: 3.3 vs 3.3 points (P = .18)
Treatment satisfaction: 0.7 vs –0.2 points (P < .001)
Quality of life: 13.2 vs 11.5 (P < .001)
Summary score: 13.2 vs 11.5 (P < .001)
At a median of 3 years, the change from baseline in the five subscales was:
Angina frequency: 9.8 vs 8.6 (P = .006)
Physical limitation: 4.2 vs 4.3 (P = .018)
Treatment satisfaction: 0.6 vs 0.2 (P = .028)
Quality of life: 16.3 vs 15.9 (P = .048)
Summary score: 9.8 vs 9.6 (P = .003)
When the researchers looked at total angina burden through follow-up, the absolute risk difference was 9% between the complete revascularization and culprit-only groups, with a number needed to treat of only 11 in patients with a new MI, ischemia-driven revascularization, unstable angina, or residual angina (19.8% vs 28.6%; P < .001).
Residual stenosis was reported among patients with less than 80% nonculprit-lesion stenosis in 11% with culprit-lesion-only PCI and in 14% with complete revascularization. Among those with 80% or greater nonculprit-lesion stenosis, however, 16.8% and 12.3%, respectively, reported residual angina (P for interaction = .017).
“The COMPLETE trial is the gift that keeps on giving,” said Timothy Henry, MD, invited discussant for the trial and president of the Society for Cardiovascular Angiography & Interventions.
“I must admit that when I saw this substudy, I was a little bit surprised because, number one, there was crossover in the trial already, so that the absolute difference in revascularization between the two groups is relatively small,” he said. “Number two, there are relatively low events: it’s 15.7% vs 12.5% that still have angina, so the fact you still see a difference was a little surprising to me and your analysis is tremendous.”
Given that there were patients who had over 80% stenosis in nonculprit lesions and residual angina, “should the crossover rates have been higher?” asked Henry, from Christ Hospital, Cincinnati.
In terms of major cardiovascular events, Mehta said, the benefit for the first coprimary outcome of CV death and new MI was really in patients with a tighter nonculprit lesion stenosis, but that the benefit for the second coprimary endpoint of ischemia-driven revascularization was in patients with lesser and greater degrees of stenosis.
“Here for patient-reported angina analysis, it appears that the benefit on angina specifically is really in patients with more severe nonculprit lesions,” he said.
The COMPLETE trial was funded by the Canadian Institutes of Health Research, the Population Health Research Institute, AstraZeneca, and Boston Scientific. Mehta reports consultant fees/honoraria from Amgen and research/research grants from Abbott Laboratories. Henry reports consultant fees/honoraria from Abbott Vascular, Boston Scientific, and Chiesi.
American College of Cardiology (ACC) 2022 Scientific Session. Presented March 2, 2022.
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