1. In this randomized controlled trial, compared to culprit-lesion-only percutaneous coronary intervention (PCI), the fractional flow reserve (FFR)-guided approach did not result in superior outcomes among patients with multi-vessel coronary artery disease (CAD).
2. FFR-guided PCI also did not differ from culprit-only PCI in safety outcomes.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Many patients presenting with ST-segment elevation myocardial infarction (STEMI) have multi-vessel CAD. It is unclear whether routine revascularization of non-culprit stenoses, typically guided visually with angiography, is beneficial. Evidence exists that functional FFR assessment improved outcomes in patients with chronic coronary syndromes. However, studies investigating FFR-guided PCI in acute coronary syndromes have been conflicting. This trial compared FFR-guided complete revascularization against culprit-only PCI in patients with STEMI or very-high-risk non-STEMI and multi-vessel disease. In this comparison, FFR-guided revascularization did not result in a lower composite risk of death, myocardial infarction, or unplanned revascularization. Individual secondary outcomes, as well as safety outcomes, including acute kidney injury, stroke, major bleeding, and hospitalization for heart failure, did not differ between the groups. However, patients undergoing FFR-guided revascularization had longer hospitalization and higher radiation exposure. The study was limited by premature termination for feasibility and lack of data on race. Nevertheless, the results demonstrated that for patients with acute coronary syndromes and multi-vessel disease, FFR-guided revascularization did not impact the rate of all-cause mortality, myocardial infarction, or unplanned revascularization.
Click here to read the study in NEJM
In-Depth [randomized controlled trial]: This multi-national, open-label, randomized study compared FFR-guided complete revascularization against culprit-only PCI. Patients were eligible for inclusion if they presented with either STEMI or very-high-risk non-STEMI and underwent PCI of the culprit lesion. Additionally, they were required to have multi-vessel CAD involving at least one non-culprit artery with a stenosis of 50-99%. Exclusion criteria included prior coronary-artery bypass grafting surgery, left main disease, or cardiogenic shock. In total, 1,542 patients were randomized 1:1 to undergo culprit-lesion-only PCI or FFR-guided complete revascularization, which could be performed during the index PCI procedure or afterward during the index hospitalization. The primary outcome was a composite of death from any cause, myocardial infarction, or unplanned revascularization. Secondary outcomes included a composite of death from any cause or myocardial infarction, unplanned revascularization, and death from cardiovascular causes. After the median follow-up of 4.8 years (interquartile range 4.3-5.2), the primary outcome occurred in 19.0% in the FFR-guided revascularization group and 20.4% in the culprit-lesion-only group (hazard ratio [HR], 0.93; 95% Confidence Interval [CI], 0.74-1.17; p=0.53). The composite of death from any cause or myocardial infarction occurred in 16.5% of the FFR-guided revascularization group and 15.3% in the culprit-lesion-only group (HR, 1.12; 95% CI, 0.87-1.44). Similarly, FFR-guided revascularization also did not impact the risk of unplanned revascularization (HR, 0.76; 95% CI, 0.56-1.04) and death from cardiovascular causes (HR 0.87, 95% CI 0.55-1.39). FFR-revascularization was associated with a higher risk of stent thrombosis (HR 2.80, 95% CI 1.18-6.67), restenosis (HR 1.84, 95% CI 1.03-3.28), and target-vessel revascularization (HR 1.57, 95% CI 1.07-2.31). Overall, these results demonstrated that for patients with STEMI or very-high-risk non-STEMI and multi-vessel disease, FFR-guided revascularization was not superior to culprit-lesion-only PCI.
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