Better Angina Relief With Complete PCI in STEMI and MVD

WASHINGTON, DC—PCI improves angina-related quality of life (QoL) in patients with STEMI and multivessel CAD, no matter whether that involves culprit-only lesions or complete revascularization, according to a prespecified analysis of the COMPLETE trial. However, patients with complete revascularization were more likely to be angina free at 3 years than those in the culprit-lesion group.

“This analysis looked at patient-reported outcomes, so these are patients telling us how they feel and how the quality of their life has improved. I think it’s complementary to the hard outcomes [in COMPLETE] that were reported by physicians, with a very clear benefit in preventing angina,” Shamir Mehta, MD (Population Health Research Institute and McMaster University, Hamilton, Canada), told TCTMD. He presented the results today in a featured clinical research session at the American College of Cardiology (ACC) 2022 Scientific Session.

The main COMPLETE trial found that patients randomized to complete revascularization versus culprit lesion only PCI had lower risk of CV death or MI over 3 years of follow-up.

Commenting on the new analysis in the session, Timothy Henry, MD (The Christ Hospital, Cincinnati, OH), called the investigator-sponsored COMPLETE trial “the gift that keeps on giving.” But even Henry said he was surprised that a difference in angina was evident, especially since about 400 patients in the trial crossed over from the culprit-only strategy, resulting in a relatively small absolute difference between groups, as well as a low number of patients in either group at study’s end reporting any angina.

Prespecified Analysis

COMPLETE randomized 4,041 patients (mean age 62 years) with STEMI and multivessel CAD from 140 centers in 31 countries. All had undergone successful primary PCI of the culprit lesion and were randomized to complete revascularization of all angiographically significant nonculprit lesions or to no further revascularization. Health-related quality of life was assessed via the 19-item Seattle Angina Questionnaire (SAQ) at baseline, 6 months, and 3 years. At baseline, approximately 11% in each group had weekly angina, 35% had monthly angina, and nearly 50% had none.

For the primary outcome of angina frequency on the SAQ, the results at 6 months showed improvement from baseline in both groups, but with higher scores for complete versus culprit-only PCI (P = 0.039). Other subscale measures of the SAQ—treatment satisfaction, QoL score, and summary score—also favored the complete strategy. By 3 years of follow-up, all subscale measures of the SAQ, including physical limitation, favored complete versus culprit-only on the 0 to 100 scale, with higher scores indicating better angina relief.

COMPLETE Subanalysis: SAQ at a Median of 3 Years

A more clinically intuitive outcome, presence of residual angina in patients who had no angina at the end of the trial, showed a 3.2% absolute difference between groups in favor of complete revascularization (P = 0.01), with a number-needed-to-treat to prevent one patient from experiencing angina of 31.

In analysis of predefined subgroups who were angina free at 3 years, there was no differential treatment effect of complete versus culprit-only revascularization except in those with nonculprit lesion stenosis severity ≥ 80%, with a 4.5% absolute reduction favoring complete revascularization  (P = 0.017).

Mehta noted that in the main trial, which was designed to show a reduction in major CV events, the majority of the benefit of complete revascularization on CV death was in those with tighter nonculprit lesion stenosis ≥ 80%. “Here, for the patient-reported angina analysis, it appears that the benefit on angina specifically is really in the patients with more severe nonculprit lesions,” he added.

To TCTMD, Mehta said he thinks the finding is likely intuitive to many practicing interventional cardiologists, “but this is the first time we've actually shown it.”