Intentional Coronary Revascularization Versus Conservative Therapy in Patients After Peripheral Artery Revascularization Due to Critical Limb Ischemia: the INCORPORATE Trial

Overview

Journal Clin Res Cardiol

Specialty Cardiology & Vascular Diseases

Date 2024 Jul 11

PMID 38990250

Authors

Gabor G Toth

Marianne Brodmann

Sadeek S Kanoun Schnur

Stanislaw Bartus

Mislav Vrsalovic

Oleg Krestianinov

Petr Kala

Jacek Bil

Robert Gil

Jan Kanovsky

Luigi Di Serafino

Luca Paolucci

Emanuele Barbato

Fabio Mangiacapra

Zoltan Ruzsa

Affiliations

Soon will be listed here.

Abstract

Objectives: INCORPORATE trial was designed to evaluate whether default coronary-angiography (CA) and ischemia-targeted revascularization is superior compared to a conservative approach for patients with treated critical limb ischemia (CLI). Registered at clinicaltrials.gov (NCT03712644) on October 19, 2018.

Background: Severe peripheral artery disease is associated with increased cardiovascular risk and poor outcomes.

Methods: INCORPORATE was an open-label, prospective 1:1 randomized multicentric trial that recruited patients who had undergone successful CLI treatment. Patients were randomized to either a conservative or invasive approach regarding potential coronary artery disease (CAD). The conservative group received optimal medical therapy alone, while the invasive group had routine CA and fractional flow reserve-guided revascularization. The primary endpoint was myocardial infarction (MI) and 12-month mortality.

Results: Due to COVID-19 pandemic burdens, recruitment was halted prematurely. One hundred eighty-five patients were enrolled. Baseline cardiac symptoms were scarce with 92% being asymptomatic. Eighty-nine patients were randomized to the invasive approach of whom 73 underwent CA. Thirty-four percent had functional single-vessel disease, 26% had functional multi-vessel disease, and 90% achieved complete revascularization. Conservative and invasive groups had similar incidences of death and MI at 1 year (11% vs 10%; hazard ratio 1.21 [0.49-2.98]). Major adverse cardiac and cerebrovascular events (MACCE) trended for hazard in the Conservative group (20 vs 10%; hazard ratio 1.94 [0.90-4.19]). In the per-protocol analysis, the primary endpoint remained insignificantly different (11% vs 7%; hazard ratio 2.01 [0.72-5.57]), but the conservative approach had a higher MACCE risk (20% vs 7%; hazard ratio 2.88 [1.24-6.68]).

Conclusion: This trial found no significant difference in the primary endpoint but observed a trend of higher MACCE in the conservative arm.

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