Key Points
- REVIVED is the first large scale clinical trial to assess the effect of routine PCI in patients with severe left ventricular dysfunction, when compared to optimal medical therapy alone.
- 700 patients with myocardial viability were randomized to receive PCI of indicated vessels (assessed by cardiac MR or echocardiography), or continue with optimal heart failure therapy alone.
- At 2 years, there were no differences in all-cause mortality or heart failure hospitalization between the two groups. Furthermore, there was no significant difference in LVEF between the two strategies.
Patients with ischemic cardiomyopathy often undergo coronary revascularization in the hope of improving ventricular function. Prior data from the STICH trial demonstrated benefit of coronary artery bypass grafting in patients with low left ventricular ejection fraction. Given the delayed benefit and early risk of surgery, percutaneous coronary intervention was seen as a feasible alternative to CABG in such patients. The benefit of PCI in this population, however, had yet to be studied in a large cohort. In a Hot Line session at the 2022 European Society of Cardiology Congress, today, Dr. Divaka Perera (King’s College, London), presented the results of the REVIVED trial, which attempted to study this exact question.
In this multi-center, randomized, open-label trial, 700 patients with ischemic heart disease and severe left ventricular dysfunction (LVEF ≤35%) were initiated on optimal medical therapy for heart failure, and underwent noninvasive assessment of myocardial viability. If ≥ 4 segments were deemed viable, patients were randomized to undergo PCI of the indicated vessel in addition to medical therapy versus continuation of medical therapy alone. Those with recent acute coronary syndromes (within 4 weeks of enrollment) or recent heart failure exacerbation (within 3 days of enrollment) were excluded from the trial. After excluding for the above criteria, 347 patients were randomized to PCI and 353 to optimal medical therapy. The mean age of participants was 70 years. Participants were mostly male (88%, white 88%, and with a median LVEF of 27%). Multivessel coronary disease was seen in at least half the patients, with 40% in each group demonstrating three vessel disease.
Participants were followed for a mean of 3.4 years after randomization. The primary outcome, a composite of death from any cause or heart failure exacerbation was not different between the two groups (37.2% versus 38.0%, Hazard Ratio 0.99 95% CI 0.78 to 1.27 p=0.96). The major secondary outcome, change in LVEF assessed by echocardiogram, was also not different (difference = 0.9%, 95% CI: -1.7 to 3.4). There was a difference in the perceived quality of life favoring PCI, with an improvement in KCCQ score of 6.5 when assessed at six months. This benefit, however, did not hold at 2 years, with no significant difference in quality of life between the two groups (difference: 2.6, 95% CI: -0.7 to 5.8). The primary outcome was assessed in various subgroup analyses, none of which demonstrated a significant benefit of one therapy over the other.
In presenting the findings, Dr. Perera addressed some of the most controversial aspects of the trial, namely, that routine PCI does not appear to have any effect on what was once perceived to be hibernating myocardium, given that all patients underwent viability assessment before enrollment. Given the results, she concluded “PCI should not be offered to stable patients with ischemic left ventricular dysfunction if the sole purpose is to provide prognostic benefit.” She did make note that patients with recent acute coronary syndrome and severe angina were excluded from the trial, and should still be considered for PCI.
The findings were simultaneously published in the New England Journal of Medicine.
