FFR-guided treatment fails to lower risk of death, CV events in multivessel CAD

A fractional flow reserve (FFR)-guided treatment strategy falls short of decreasing the risk of ischaemic cardiovascular (CV) events or death in patients with multivessel coronary artery disease (CAD) at 1-year follow-up, reveals a study.

This prospective, randomized, open-label superiority trial examined multivessel CAD candidates who were randomly assigned to treatment strategy based on FFR in all stenotic (≥50 percent) coronary arteries or to a traditional strategy without FFR. Revascularization (percutaneous coronary intervention or surgery) was indicated for FFR ≤0.80 lesions among those in the FFR arm. A composite of major adverse cardiac or cerebrovascular events at 1 year was the primary endpoint.

The data safety and monitoring board stopped the trial prematurely after a safety analysis and enrolling a total of 927 patients. By intention to treat, no significant differences were noted in major adverse cardiac or cerebrovascular event rates between groups at 1-year follow-up (14.6 percent in the FFR group vs 14.4 percent in the control group; hazard ratio [HR], 0.97, 95 percent confidence interval [CI], 0.69–1.36; p=0.85).

The difference in all-cause mortality was nonsignificant (3.7 percent vs 1.5 percent; HR, 2.34, 95 percent CI, 0.97–5.18; p=0.06), which was confirmed with an extended follow-up for 24 months. In addition, FFR significantly reduced the proportion of revascularized patients, with more being referred to exclusively medical treatment (p=0.02).

This study was conducted because of limited evidence that FFR is effective in guiding therapeutic strategy in multivessel CAD beyond prespecified percutaneous coronary intervention or coronary graft surgery candidates, according to the investigators.