Percutaneous coronary intervention (PCI) with optimal medical therapy (OMT) does not prolong survival or improve ventricular function compared with OMT alone in patients with severe ischemic cardiomyopathy, according to results from the REVIVED-BCIS2 trial.
The primary composite outcome of all-cause death or heart failure hospitalization occurred in 37.2% of the PCI group and 38% of the OMT group (hazard ratio [HR], 0.99; P = .96) over a median of 3.4 years follow-up. The treatment effect was consistent across all subgroups.
There were no significant differences in left ventricular ejection fraction (LVEF) at 6 and 12 months.
Quality of life scores favored PCI early on but there was catch-up over time with medical therapy, and this advantage disappeared by 2 years, principal investigator Divaka Perera, MD, King's College London, United Kingdom, reported today at the European Society of Cardiology (ESC) 2022 Congress.
"The takeaway is that we should not be offering PCI to patients who have stable, well-medicated left ventricular dysfunction," Perera told theheart.org | Medscape Cardiology. "But we should still consider revascularization in patients presenting with acute coronary syndromes or who have lots of angina, because they were not included in the trial."
The study, published simultaneously in the New England Journal of Medicine, provides the first randomized evidence on PCI for ischemic cardiomyopathy.
Revascularization guidelines in the United States make no recommendation for PCI, whereas those in Europe recommend coronary artery bypass grafting (CABG) first for patients with multivessel disease (class 1) and have a class 2a, level of evidence C indication for PCI in select patients. US and European heart failure guidelines also support guideline directed therapy and CABG in select patients with ejection fractions of 35% or less.
This guidance is based on consensus opinion and the STICH trial, in which CABG plus OMT failed to provide a mortality benefit over OMT alone at 5 years but improved survival at 10 years in the extension STICHES study.
"Medical therapy for heart failure works and this trial's results are another important reminder of that," said Eric Velazquez, MD, who led STICH and was invited to comment on the findings.
Mortality will only get better with the use of SGLT2 inhibitors, he noted, which were not included in the trial. Utilization of ACE inhibitors/ARBs/ARNIs and beta blockers was similar to STICH and excellent in REVIVED. "They did do a better job in utilization of ICD and CRTs than the STICH trial and I think that needs to be explored further about the impact of those changes."
Nevertheless, ischemic cardiomyopathy patients have "unacceptably high mortality," with the observed mortality about 20% at 3 years and about 35% at 5 years, said Velazquez, with Yale University in New Haven, Connecticut.
In most heart failure trials, HF hospitalization drives the primary composite endpoint but the opposite was true here and in STICH, he observed. "You had twice the risk of dying during the 3.4 years than you did of being hospitalized for heart failure, and it's important that that is a distinction we must realize is evident in our ischemic cardiomyopathy patients.”
The findings will likely not lead to a change in the guidelines, Velazquez added. "I think we continue as status quo for now and get more data."
Despite the lack of randomized evidence, he cautioned that PCI is increasingly performed in patients with ischemic cardiomyopathy, with registry data suggesting nearly 60% of patients received the procedure.
Reached for comment, Clyde Yancy, MD, chief of cardiology and vice dean of diversity & inclusion at Northwestern University Feinberg School of Medicine in Chicago, said, "For now, the current guidelines are correct. Best application of guideline-directed medical and device therapy is the gold standard for heart failure and that includes heart failure due to ischemic etiologies.
"Do these data resolve the question of revascularization in the setting of coronary disease and reduced EF heart failure? Hardly," he added. "Clinical judgment must prevail and where appropriate, coronary revascularization remains a consideration. But it is not a panacea."
Between August 2013 and March 2020, REVIVED-BCIS2 enrolled 700 patients at 40 UK centers who had an LVEF of 35% or less, extensive CAD (defined by a British Cardiovascular Intervention Society myocardial Jeopardy Score [BCIS-JS] of at least 6), and viability in at least four myocardial segments amenable to PCI. Patients were evenly randomly assigned to individually adjusted pharmacologic and device therapy for heart failure alone or with PCI.
The average age was about 70, only 12.3% women, 344 patients had 2-vessel CAD, and 281 had 3-vessel CAD. The mean LVEF was 27% and median BCIS-JS score 10.
During follow-up, which reached 8.5 years in some patients due to the long enrollment, 31.7% of patients in the PCI group and 32.6% patients in the OMT group died from any cause and 14.7% and 15.3%, respectively, were admitted for heart failure.
LVEF improved by 1.8% at 6 months and 2% at 12 months in the PCI group and by 3.4% and 1.1%, respectively, in the OMT group. The mean between-group difference was -1.6% at 6 months and 0.9% at 12 months.
With regard to quality of life, the Kansas City Cardiomyopathy Questionnaire overall summary score favored the PCI group by 6.5 points at 6 months and by 4.5 points at 12 months, but by 24 months the between-group difference was 2.6 points (95% CI, -0.7 to 5.8). Scores on the EuroQol Group 5-Dimensions 5-Level Questionnaire followed a similar pattern.
Unplanned revascularization was more common in the OMT group (HR, 0.27; 95% CI, 0.13 - 0.53). Acute myocardial infarction rates were similar in the two groups (HR, 1.01, 95% CI, 0.64 - 1.60), with the PCI group having more periprocedural infarcts and slightly fewer spontaneous infarcts.
Possible reasons for the discordant results between STICH and REVIVED are the threefold excess mortality within 30 days of CABG, whereas no such early hit occurred with PCI, lead investigator Perera said in an interview. Medical therapy has also evolved over time and REVIVED enrolled a more "real-world" population, with a median age close to 70 years vs 59 in STICH.
"Modest" Degree of CAD?
An accompanying editorial, however, points out that despite considerable ventricular dysfunction, about half the patients in REVIVED had only 2-vessel disease and a median of two lesions treated.
"This relatively modest degree of coronary artery disease seems unusual for patients selected to undergo revascularization with the hope of restoring or normalizing ventricular function,” writes Ajay Kirtane, from Columbia University Irving Medical Center, NewYork-Presbyterian Hospital, New York City.
He said more details are needed on completeness of the revascularization, severity of stenosis, physiologic assessment of the lesion and, "most importantly, the correlation of stenosis with previous ischemic or viability testing."
Asked about the editorial, Perera agreed that information on the type of revascularization and myocardial viability are important and said they hope to share analyses of the only recently unblinded data at the American College of Cardiology meeting next spring. Importantly, about 71% of viability testing was done by cardiac MR and the rest largely by dobutamine stress echocardiogram.
He disagreed, however, that participants had relatively modest CAD based on the 2- or 3-vessel classification and said the median score on the more granular BCIS-JS was 10, with maximum 12 indicating the entire myocardium is supplied by diseased vessels.
The trial also included almost 100 patients with left main disease, a group not included in previous medical therapy trials including STICH and ISCHEMIA, Perera noted. "So, I think it was pretty, pretty severe coronary disease but a cohort that was better treated medically."
George Dangas, MD, PhD, a professor of medicine at Icahn School of Medicine at Mount Sinai in New York City, said the study provides valuable information but also expressed concerns that the chronic heart failure in the trial was much more advanced than the CAD.
"Symptoms are low level and this is predominantly related to CHF, and if you manage the CHF the best way with advanced therapies, assist device or transplant or any other way, that might take priority over the CAD lesions," said Dangas, who was not associated with REVIVED. "I would expect CAD lesions would have more importance if we move into the class 3 or higher of symptomatology, and, again in this study, that was not [present] in over 70% of the patients."
The study was funded by the National Institute for Health and Care Research's Health Technology Assessment Program. Perera, Velazquez and Dangas report no relevant financial relationships.
Kirtane reports grants, nonfinancial support and other from Medtronic, Abbott Vascular, Boston Scientific, Abiomed, CathWorks, Siemens, Philips, ReCor Medical, Cardiovascular Systems Incorporated, Amgen, and Chiesi. He reports grants and other from Neurotronic, Magental Medical, Canon, SoniVie, Shockwave Medical, and Merck. He also reports nonfinancial support from Opsens, Zoll, Regeneron, Biotronik, and Bolt Medical, and personal fees from IMDS.
European Society of Cardiology Congress 2022. Presented August 27, 2022.
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Cite this: PCI Fails to Beat OMT in Ischemic Cardiomyopathy: REVIVED-BCIS2 - Medscape - Aug 27, 2022.