TOTH, Gabor G, Marianne BRODMANN, Sadeek S KANOUN SCHNUR, Stanislaw BARTUS, Mislav VRSALOVIC, Oleg KRESTIANINOV, Petr KALA, Jacek BIL, Robert GIL, Jan KAŇOVSKÝ, Di Serafino LUIGI, Luca PAOLUCCI, Emanuele BARBATO, Fabio MANGIACAPRA a Zoltan RUZSA. Intentional coronary revascularization versus conservative therapy in patients after peripheral artery revascularization due to critical limb ischemia: the INCORPORATE trial. Clinical Research in Cardiology. Heidelberg: Springer, 2024, 9 s. ISSN 1861-0684. Dostupné z: https://dx.doi.org/10.1007/s00392-024-02487-2.
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Základní údaje
Originální název Intentional coronary revascularization versus conservative therapy in patients after peripheral artery revascularization due to critical limb ischemia: the INCORPORATE trial
Autoři TOTH, Gabor G, Marianne BRODMANN, Sadeek S KANOUN SCHNUR, Stanislaw BARTUS, Mislav VRSALOVIC, Oleg KRESTIANINOV, Petr KALA, Jacek BIL, Robert GIL, Jan KAŇOVSKÝ, Di Serafino LUIGI, Luca PAOLUCCI, Emanuele BARBATO, Fabio MANGIACAPRA a Zoltan RUZSA.
Vydání Clinical Research in Cardiology, Heidelberg, Springer, 2024, 1861-0684.
Další údaje
Originální jazyk angličtina
Typ výsledku Článek v odborném periodiku
Obor 30201 Cardiac and Cardiovascular systems
Stát vydavatele Německo
Utajení není předmětem státního či obchodního tajemství
WWW URL
Impakt faktor Impact factor: 5.000 v roce 2022
Organizační jednotka Lékařská fakulta
Doi http://dx.doi.org/10.1007/s00392-024-02487-2
UT WoS 001266248700001
Klíčová slova anglicky Critical limb ischemia; Coronary artery disease; Fractional flow reserve; Coronary angiography
Štítky 14110211
Příznaky Mezinárodní význam, Recenzováno
Změnil Změnila: Mgr. Tereza Miškechová, učo 341652. Změněno: 5. 8. 2024 11:01.
Anotace
ObjectivesINCORPORATE 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.BackgroundSevere peripheral artery disease is associated with increased cardiovascular risk and poor outcomes.MethodsINCORPORATE 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.ResultsDue 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]).ConclusionThis trial found no significant difference in the primary endpoint but observed a trend of higher MACCE in the conservative arm.Graphical AbstractA graphical abstract illustrating the key highlights of the design and comparisons
VytisknoutZobrazeno: 23. 8. 2024 12:27