Intentional coronary revascularization versus conservative therapy in patients after peripheral artery revascularization due to critical limb ischemia: the INCORPORATE trial
Status Publisher Jazyk angličtina Země Německo Médium print-electronic
Typ dokumentu časopisecké články
PubMed
38990250
DOI
10.1007/s00392-024-02487-2
PII: 10.1007/s00392-024-02487-2
Knihovny.cz E-zdroje
- Klíčová slova
- Coronary angiography, Coronary artery disease, Critical limb ischemia, Fractional flow reserve,
- Publikační typ
- časopisecké články MeSH
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.
2 Dept of Cardiology Medical College Jagiellonian University Krakow Poland
Department of Advanced Biomedical Sciences University of Naples Federico 2 Naples Italy
Department of Cardiology University Heart Center Graz Medical University Graz Graz Austria
Department of Clinical and Molecular Medicine Sapienza University of Rome Rome Italy
Department of Invasive Cardiology Centre of Postgraduate Medical Education Warsaw Poland
Division of Angiology Department of Internal Medicine Medical University Graz Graz Austria
National Medical Institute of the Internal Affairs and Administration Ministry Warsaw Poland
Royal Cornwall Hospitals NHS Trust Truro UK
University Hospital Brno and Medical Faculty of Masaryk University Brno Czech Republic
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ClinicalTrials.gov
NCT03712644