Intentional coronary revascularization versus conservative
therapy in patients after peripheral artery revascularization
due to critical limb ischemia: the INCORPORATE trial

J 2024

Intentional coronary revascularization versus conservative therapy in patients after peripheral artery revascularization due to critical limb ischemia: the INCORPORATE trial

TOTH, Gabor G, Marianne BRODMANN, Sadeek S KANOUN SCHNUR, Stanislaw BARTUS, Mislav VRSALOVIC et. al.

Basic information

Original name

Intentional coronary revascularization versus conservative therapy in patients after peripheral artery revascularization due to critical limb ischemia: the INCORPORATE trial

Authors

Edition

Clinical Research in Cardiology, Heidelberg, Springer, 2024, 1861-0684

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30201 Cardiac and Cardiovascular systems

Country of publisher

Germany

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 5.000 in 2022

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1007/s00392-024-02487-2

UT WoS

001266248700001

Keywords in English

Critical limb ischemia; Coronary artery disease; Fractional flow reserve; Coronary angiography

Abstract

V originále

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

Citovat

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 and 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 pp. ISSN 1861-0684. Available from: https://dx.doi.org/10.1007/s00392-024-02487-2.

@article{2421677,
   author = {Toth, Gabor G and Brodmann, Marianne and Kanoun Schnur, Sadeek S and Bartus, Stanislaw and Vrsalovic, Mislav and Krestianinov, Oleg and Kala, Petr and Bil, Jacek and Gil, Robert and Kaňovský, Jan and Luigi, Di Serafino and Paolucci, Luca and Barbato, Emanuele and Mangiacapra, Fabio and Ruzsa, Zoltan},
   article_location = {Heidelberg},
   doi = {http://dx.doi.org/10.1007/s00392-024-02487-2},
   keywords = {Critical limb ischemia; Coronary artery disease; Fractional flow reserve; Coronary angiography},
   language = {eng},
   issn = {1861-0684},
   journal = {Clinical Research in Cardiology},
   title = {Intentional coronary revascularization versus conservative therapy in patients after peripheral artery revascularization due to critical limb ischemia: the INCORPORATE trial},
   url = {https://link.springer.com/article/10.1007/s00392-024-02487-2},
   year = {2024}
}

TY  - JOUR
ID  - 2421677
AU  - Toth, Gabor G - Brodmann, Marianne - Kanoun Schnur, Sadeek S - Bartus, Stanislaw - Vrsalovic, Mislav - Krestianinov, Oleg - Kala, Petr - Bil, Jacek - Gil, Robert - Kaňovský, Jan - Luigi, Di Serafino - Paolucci, Luca - Barbato, Emanuele - Mangiacapra, Fabio - Ruzsa, Zoltan
PY  - 2024
TI  - Intentional coronary revascularization versus conservative therapy in patients after peripheral artery revascularization due to critical limb ischemia: the INCORPORATE trial
JF  - Clinical Research in Cardiology
PB  - Springer
SN  - 18610684
KW  - Critical limb ischemia
KW  - Coronary artery disease
KW  - Fractional flow reserve
KW  - Coronary angiography
UR  - https://link.springer.com/article/10.1007/s00392-024-02487-2
N2  - 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
ER  -

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 and Zoltan RUZSA. Intentional coronary revascularization versus conservative therapy in patients after peripheral artery revascularization due to critical limb ischemia: the INCORPORATE trial. \textit{Clinical Research in Cardiology}. Heidelberg: Springer, 2024, 9 pp. ISSN~1861-0684. Available from: https://dx.doi.org/10.1007/s00392-024-02487-2.

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