Medizinische Universität Graz - Research portal
Selected Publication:
SHR Neuro Cancer Cardio Lipid Metab Microb
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.
Intentional coronary revascularization versus conservative therapy in patients after peripheral artery revascularization due to critical limb ischemia: the INCORPORATE trial.
Clin Res Cardiol. 2024;
Doi: 10.1007/s00392-024-02487-2
Web of Science
PubMed
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- Leading authors Med Uni Graz
- Toth-Gayor Gabor
- Co-authors Med Uni Graz
- Brodmann Marianne
- Kanoun Schnur Sadeek Sidney
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- 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.
- Find related publications in this database (Keywords)
- Critical limb ischemia
- Coronary artery disease
- Fractional flow reserve
- Coronary angiography