PCI in setting of severe LV dysfunction does not improve survival or HF hospitalizations: NEJM study

Whether revascularization by PCI can improve event-free survival and LV function in patients with severe ischemic LV systolic dysfunction, as compared with optimal medical therapy alone, is unknown. Contrary to the results of STICH trial that showed benefit of surgical revascularisation in this setting, the results of REVIVED-BCIS2 trial published recently in NEJM have shown no benefit of PCI in reducing all-cause mortality and HF hospitalization. However, the Quality-of-life scores at 6 and 12 months appeared to favor the PCI group.

PCI is an alternative mode of revascularization, but most randomized comparisons between CABG and PCI among patients with chronic coronary syndromes have excluded patients with severe left ventricular systolic dysfunction. Whether PCI might allow the benefits of revascularization to be realized without the early hazard associated with CABG in patients with ischemic left ventricular dysfunction is not known.

To explore the possibility of a comparable benefit with PCI in this subset of patients, REVIVED-BCIS2 investigators randomly assigned patients with a left ventricular ejection fraction of 35% or less, extensive coronary artery disease amenable to PCI, and demonstrable myocardial viability to a strategy of either PCI plus optimal medical therapy (PCI group) or optimal medical therapy alone (optimal-medical-therapy group).

The primary composite outcome was death from any cause or hospitalization for heart failure. Major secondary outcomes were left ventricular ejection fraction at 6 and 12 months and quality-of-life scores.

Over a median of 41 months, a primary-outcome event occurred in 37.2% in the PCI group and 38.0% in the optimal-medical-therapy group.The left ventricular ejection fraction was similar in the two groups at 6 months and at 12 months. Quality-of-life scores at 6 and 12 months appeared to favor the PCI group, but the difference had diminished at 24 months.

However, there were no signs of diverging or improved outcomes with PCI over a median follow-up of 3.4 years, a finding that differed from what was observed with surgical revascularization in the STICH trial and that was later confirmed in its extension trial.

"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. The observed increases in the ejection fraction and the relatively low percentage of patients with hospitalization for heart failure in both treatment groups would only be expected to improve further with the use of more contemporary therapies for congestive heart failure" notes Ajay J. Kirtane, M.D in an accompanying editorial.

While the results of requisite additional analyses and follow-up data from the REVIVED trial are awaited, the prevailing dictum should be to diagnose the joint conditions of CHF and CAD and to provide therapies that are known to be effective for both of these conditions.

Source: NEJM:

1. DOI: 10.1056/NEJMoa2206606

2. DOI: 10.1056/NEJMe2210183