PCI did not improve outcomes in patients with severe LV systolic dysfunction, CAD
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In patients with severe left ventricular systolic dysfunction on optimal medical therapy for HF, undergoing PCI did not improve rates of all-cause death or HF hospitalization, according to the results of the REVIVED-BCIS2 trial.
For the trial, presented at the European Society of Cardiology Congress and simultaneously published in The New England Journal of Medicine, the researchers randomly assigned 700 patients with LV ejection fraction 35% or less, extensive CAD appropriate to be treated with PCI and demonstrable myocardial viability to PCI plus optimal medical therapy for HF or optimal medical therapy alone. At baseline, 16% of the PCI group and 26% of the control group were taking sacubitril/valsartan (Entresto, Novartis).
“Coronary artery disease is the most common cause of heart failure, and for this reason, it’s long been assumed that treating the coronary artery disease would be a good treatment for heart failure,” Divaka Perera, MD, professor of cardiology in the School of Cardiovascular Medicine & Sciences at King’s College London and consultant cardiologist at Guy's and St Thomas’ NHS Foundation Trust, said during a press conference. “Although there is no randomized evidence to support it, percutaneous coronary intervention is frequently undertaken to treat and improve left ventricular dysfunction. The ESC guidelines give this a class IIa recommendation, but acknowledge that it’s without any randomized evidence to support it. The American [societies] don’t even offer any guidelines for this very reason. REVIVED was the first randomized controlled trial in this arena.”
The primary outcome was all-cause death or HF hospitalization. Median follow-up was 41 months.
No difference in outcomes
During the study period, the primary outcome occurred in 37.2% of patients in the PCI group and 38% of patients in the control group (HR = 0.99; 95% CI, 0.78-1.27; P = .96).
“Approximately 40% of patients in the control arm either died or had been admitted to the hospital for heart failure during the follow-up period,” Perera said. “This is not a problem that has been addressed already by medical therapy. But PCI failed to reduce that outcome rate.”
LVEF did not differ between the groups at 6 months (mean difference, –1.6 percentage points; 95% CI, –3.7 to 0.5) or at 12 months (mean difference, –0.9 percentage points; 95% CI, –1.7 to 3.4), according to the researchers.
“This is now a definitive result,” Perera said during the press conference. “We have [randomized controlled trial] evidence that allow the guidelines to be strengthened on the one hand and for clinical practice to be rationalized around the world in the other.”
The Kansas City Cardiomyopathy Questionnaire (KCCQ) score favored the PCI group at 6 months (difference in mean scores, 6.5 points; 95% CI, 3.5-9.5) and at 12 months (difference in mean scores, 4.5 points; 95% CI, 1.4-7.7), but not at 24 months (difference in mean scores, 2.6 points; 95% CI, –0.7 to 5.8), Perera and colleagues found.
Among the individual components of the KCCQ score, all favored the PCI group early on, but by 24 months, the quality of life domain score still favored the PCI group (difference in mean scores, 4.2 points; 95% CI, 0.4-8.1), but the other domains did not, according to the researchers.
“There is a signal that patients feel better [after PCI],” Perera said during the press conference.
There were no differences between the groups during the study period in all-cause death, HF hospitalization, CV death or acute MI. Unplanned revascularization occurred less often in the PCI group than in the control group (2.9% vs. 10.5%; HR = 0.27; 95% CI, 0.13-0.53), and major bleeding was more common in the PCI group at 1 year (3.1% vs. 0.6%; RR = 4.95; 95% CI, 1.09-22.43) but not at 2 years (3.4% vs. 2.4%; RR = 1.42; 95% CI, 0.55-3.68).
In the PCI group, the mean age was 70 years and 87% were men. In the control group, the mean age was 69 years and 88% were men.
Questions remain
In a related editorial published in NEJM, Ajay J. Kirtane, MD, SM, professor of medicine at Columbia University Vagelos College of Physicians and Surgeons and interventional cardiologist at NewYork-Presbyterian/Columbia University Irving Medical Center, wrote that “many questions remain.”
He wrote that more information on the location and extent of CAD in the patient population is necessary, and that: “Despite considerable ventricular dysfunction, approximately half the patients had only two-vessel disease, and a median of two lesions and vessels were treated per patient. 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.”
During the press conference, Perera said the cohort did not have modest CAD, noting that the British Cardiovascular Intervention Society jeopardy score, a more granular way of assessing CAD severity, was at least 6 on a scale of 0 to 12 in each patient, and the median score was 10. He also noted the cohort included patients with left main disease, “which has never been done in any randomized trial where one arm is medical therapy.”
In addition, Kirtane wrote, “It is also probable, given the previously observed mortality benefit seen in the STICH trial, that patients with the most extensive and severe coronary artery disease were offered surgical revascularization outside the trial rather than being enrolled, a factor that could dilute a treatment effect.”
Of note, he added, increases in EF and low rates of HF hospitalization in both groups point to the strength of optimal medical therapy in this population.
“More than anything, this trial supports the importance of guideline-directed medical therapies for the management of left ventricular dysfunction, irrespective of whether revascularization is considered,” Kirtane wrote.
References:
- Kirtane AJ. N Engl J Med. 2022;doi:10.1056/NEJMe2210183.
- Perera D, et al. N Engl J Med. 2022;doi:10.1056/NEJMoa2206606.
Perspective
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REVIVED was a very important trial because the popular medical thought has been that you can revascularize patients with ischemic LV dysfunction, particularly those shown to have myocardial viability by imaging studies, and they would have improved outcomes over time and they would have fewer hospitalizations for HF secondary to their LV dysfunction. However, in this study there were a sizable number of patients in each group randomly assigned to have PCI for complex coronary disease or optimal medical therapy, and over time, there was no difference in outcomes. There were no reductions of hospitalization for HF or all-cause death in the PCI group. There was some improvement early on in symptoms, but over 2 years there was no significant change compared with optimal medical therapy there, either.
The results of REVIVED are in alignment with the ISCHEMIA trial, in which in patients with stable ischemic heart disease, an invasive approach, often with PCI, did not improve outcomes vs. optimal medical therapy. REVIVED is another example of a patient population, in this case those with LV dysfunction, in which revascularization did not reduce significant clinical endpoints. A heart team approach to these patients, in which the possibility of temporary improvement in symptoms from revascularization could be discussed, may be helpful.
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Perera D, et al. Hot Line 3. Presented at: European Society of Cardiology Congress; Aug. 26-29, 2022; Barcelona, Spain (hybrid meeting).
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