Faculty Opinions recommendation of Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease.

Abstract Introduction International guidelines recommend performing percutaneous coronary intervention (PCI) on stable coronary lesions with a positive fractional flow reserve (FFR) to improve clinical outcomes. It remains unclear if FFR positive lesions with preserved coronary flow reserved (CFR) might be better treated medically. Purpose This study compared clinical outcomes between PCI and medical therapy for stable FFR-positive lesions with preserved CFR. Methods We performed a substudy of the randomized, multicenter COMPARE-ACUTE trial in which treated ST-elevation myocardial infarction patients with stable non-culprit lesions were randomized to either FFR-guided PCI or medical therapy. Based on baseline and hyperaemic pressure gradients, we computed the so-called pressure bounded-CFR (pb-CFR) and classified lesions as low (<2) or preserved (≥2). Our primary end point was a composite of death from any cause, non-fatal myocardial infarction, revascularization, or cerebrovascular events (MACCE) at 12 months. Results A total of 980 lesions from 885 subjects were included in this sub-study due to availability of baseline and hyperaemic pressure gradients. For the 462 lesions with FFR≤0.80, 249 had a pb-CFR<2 while 29 had a preserved CFR (pb-CFR≥2). The rate of MACCE at 1 year did not differ significantly between subjects with FFR≤0.80 and pb-CFR<2 versus FFR≤0.80 and pb-CFR≥2 (24% vs. 30%, p=0.44). Because of randomization, baseline characteristics were well balanced between subjects with FFR≤0.80 and pb-CFR≥2 who were treated by PCI or medical therapy. Importantly for subjects with FFR≤0.80 and pb-CFR≥2, MACCE occurred more frequently when treated medically compared with PCI (50% vs. 0% respectively, p=0.01). Conclusions In this post-hoc substudy from a large randomized controlled trial of 885 subjects with 980 lesions, a preserved pb-CFR≥2 did not associate with an improved clinical outcome when FFR≤0.80. Subjects with FFR-positive coronary lesions but a preserved pb-CFR experienced significantly worse clinical outcomes when treated medically instead of with PCI. These data suggest that a stenosis with a FFR≤0.80, even when pb-CFR remains preserved, benefits from treatment with PCI. Acknowledgement/Funding Maasstad Cardiovascular Research, Abbott Vascular and St. Jude Medical

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Abstract 14304: Assessing the Association of Adherence to Fractional Flow Reserve Treatment Thresholds and Outcomes of Patients With Coronary Artery Disease

Circulation ◽

10.1161/circ.142.suppl_3.14304 ◽

2020 ◽

Vol 142 (Suppl_3) ◽

Author(s):

Maneesh Sud ◽

Lu Han ◽

Maria Koh ◽

Peter Austin ◽

Michael E Farkouh ◽

...

Keyword(s):

Medical Therapy ◽

Fractional Flow Reserve ◽

Coronary Intervention ◽

Routine Practice ◽

Cardiac Events ◽

Fractional Flow ◽

St Segment Elevation ◽

Single Vessel ◽

Flow Reserve

Background: Although fractional flow reserve (FFR) thresholds have been established to guide the use of percutaneous coronary intervention (PCI) or medical therapy, little is known about the adherence to FFR thresholds for PCI in clinical practice and their association with clinical outcomes. Methods: Adults undergoing FFR assessment in a single vessel (excluding ST-segment elevation myocardial infarction [MI]) from April 1, 2013 to March 31, 2018 in Ontario, Canada were included. Patients were divided into two cohorts based on FFR ≤ 0.80 (ischemic) and > 0.80 (non-ischemic). Inverse probability of treatment weighting was used to balance confounders between patients treated with PCI vs. no PCI in each cohort. The primary outcome was major adverse cardiac events (MACE) defined by death, MI, unstable angina, or urgent revascularization. Results: We identified 9,106 patients who underwent single-vessel FFR measurement. Among the 2,693 patients with an ischemic FFR (mean age 65, 27.0% female), 75.3% of patients received PCI and 24.7% were treated only with medical therapy. Over a median follow-up of 2.6 years in the ischemic cohort, PCI was associated with a 20% lower rate of MACE compared to no PCI (24.0% vs. 31.6%; hazard ratio [HR]: 0.80, 95% CI: 0.66-0.96). However, among 6,413 patients with a non-ischemic FFR (mean age 66, 38.9% female), 12.6% received PCI and 87.4% were treated only with medical therapy. Over a median follow-up of 2.8 years in the non-ischemic cohort, PCI was associated with a 42% higher rate of MACE compared to no PCI (25.6% vs. 17.6%; HR: 1.42, 95% CI: 1.18-1.70). The increased rate of MACE was driven mainly by MI (HR 1.67, 95% CI: 1.20-2.31) but not death (HR 0.99, 95% CI: 0.72-1.35). Conclusions: In routine practice, we found 1 in 4 patients did not receive PCI for ischemic lesions while 1 in 8 received PCI for non-ischemic lesions. Performing PCI procedures according to recommended FFR cutoffs was associated with lower rates of clinical events.

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