{Reference Type}: Journal Article
{Title}: Intentional coronary revascularization versus conservative therapy in patients after peripheral artery revascularization due to critical limb ischemia: the INCORPORATE trial.
{Author}: Toth GG;Brodmann M;Kanoun Schnur SS;Bartus S;Vrsalovic M;Krestianinov O;Kala P;Bil J;Gil R;Kanovsky J;Di Serafino L;Paolucci L;Barbato E;Mangiacapra F;Ruzsa Z;
{Journal}: Clin Res Cardiol
{Volume}: 0
{Issue}: 0
{Year}: 2024 Jul 11
{Factor}: 6.138
{DOI}: 10.1007/s00392-024-02487-2
{Abstract}: <B>OBJECTIVE: </B>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.<BR><B>BACKGROUND: </B>Severe peripheral artery disease is associated with increased cardiovascular risk and poor outcomes.<BR><B>METHODS: </B>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.<BR><B>RESULTS: </B>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]).<BR><B>CONCLUSIONS: </B>This trial found no significant difference in the primary endpoint but observed a trend of higher MACCE in the conservative arm.