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BARCELONA -- Percutaneous coronary intervention (PCI) did not improve outcomes for ischemic cardiomyopathy patients with substantial atherosclerotic coronary artery disease in the first few years after the procedure, the REVIVED trial showed.

Over a median 3.4 years of follow-up, death from any cause or hospitalization for heart failure occurred in 37.2% of revascularized patients and 38.0% of those treated with optimal medical therapy alone (HR 0.99, 95% CI 0.78-1.27).

Nor did intervention improve what has been assumed to be the potential mechanism for benefit, left ventricular ejection fraction (mean difference -1.6 and 0.9 percentage points at 6 and 12 months, respectively; neither statistically significant), reported Divaka Perera, MD, of King's College London, at the European Society of Cardiology (ESC) meeting. The findings were simultaneously published in the (NEJM).

"This is now a definitive result," he said at an ESC press conference. "We finally have [randomized controlled trial] evidence that allows the guidelines to be strengthened on the one hand, and for clinical practice to be rationalized around the world on the other hand."

European guidelines have given PCI a class IIa recommendation in this population, although U.S. American Heart Association (AHA)/American College of Cardiology guidelines have not weighed in on the issue due to lack of evidence. As to the prevalence of the practice, ESC discussant Eric Velazquez, MD, of the Yale School of Medicine in New Haven, Connecticut, pointed to a registry from Canada showing 58% of ischemic cardiomyopathy patients got PCI.

Despite the murmur of surprise that went up when the primary outcome slide went up at the ESC session, he said that "I don't believe these results will make any changes to ESC and AHA guidelines, because of how they are reviewed. I think we continue as the status quo for now until we get more data."

Implications

"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," concluded Ajay J. Kirtane, MD, of NewYork-Presbyterian Hospital in New York City, in an accompanying NEJM .

But "the prevailing dictum should be to diagnose the joint conditions of congestive heart failure and coronary artery disease and to provide therapies that are known to be effective for both of these conditions," he added.

An argument he suggested in favor of PCI was its early advantage for quality-of-life (QoL) improvement that diminished at 24 months but remained significant for one component. Mean difference in Kansas City Cardiomyopathy Questionnaire scale score overall was 6.5 points on the 100-point scale at 6 months and 4.5 at 12 months, but dropped to a nonsignificant 2.6 points at 24 months. However, there was a 4.2-point difference in the QoL domain score (95% CI 0.4 to 8.1)

"The prompt improvements in health-related quality of life after PCI parallel those seen in several other trials of coronary revascularization and should not be discounted, particularly because of the limited symptoms that were present among the patients in the enrolled population," Kirtane argued.

But the difference longer term might not be clinically meaningful, Perera told MedPage Today.

And the lack of difference in the primary outcome might not be that surprising either, he said. "People have been doing it for so long based on conviction, but if you look across the stable coronary disease trial world -- whether you're talking COURAGE or ISCHEMIA -- no one has ever shown that revascularization of any sort, and I actually expand that even to CABG [coronary artery bypass grafting], improves survival in stable coronary disease."

Those trials had all excluded poor left ventricular function, but now there's well-powered trial evidence for that high risk cohort, Perera said.

Still, a key question is what will happen long term, given that the long-term extension of the showed a mortality advantage to CABG over optimal medical therapy alone after 10 years.

However, the event curves showed no hint of separation as in STICH, nor was there an early hit in terms of periprocedural mortality in the BOX trial that had been seen with CABG, Perera noted.

He argued that the optimal medical therapy landscape has improved substantially for patients between the initiation of STICH in the early 2000s and the BOX trial.

Trial Details

The REVIVED-BCIS2 trial included 700 patients with a left ventricular ejection fraction (LVEF) of 35% or less, extensive coronary artery disease suitable for PCI, and myocardial viability in at least four dysfunctional myocardial segments. Exclusion criteria included acute MI in the 4 weeks before randomization or acute decompensated heart failure or sustained ventricular arrhythmias within 72 hours before randomization.

They were randomized to a strategy of optimal medical therapy (both individually titrated medications and implanted device therapy) with or without PCI.

Kirtane raised issue with the population selected, noting that about half of participants had two-vessel disease and that the median number of lesions and vessels treated was two 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," he wrote, adding that "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."

Perera countered that the trial required a British Cardiovascular Intervention Society jeopardy score of ≥6 and had median of 10 on the 12-point scale. "Ten is a pretty high score," he said, adding that some 14% of the trial's patients had left main coronary artery disease, "so actually this was really a population with severe coronary artery disease."

He agreed with Kirtane's call for more information on "the anatomical location and extent of coronary artery disease and its correlation with physiological (and especially ischemic) testing," which Perera said would be forthcoming as the group digs into the data they've had access to for only a few weeks. Perera and colleagues also plan a formal health economics analysis.

Velazquez also noted that the trial was somewhat underpowered based on a lower than expected event rate, although he expressed doubt that this played an important role in the findings.

Correction: an earlier version of this article had an error in the study's median follow-up time.