Evidence map›Paper›PMID 38990250›Full record

Trial reportClinical research in cardiology : official journal of the German Cardiac Society2025

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

Gabor G Toth, Marianne Brodmann, Sadeek S Kanoun Schnur, Stanislaw Bartus, Mislav Vrsalovic, Oleg Krestianinov, Petr Kala, Jacek Bil, Robert Gil, Jan Kanovsky and 5 more

Erratum issued Registry-linked trialAbstract readMulticenter StudyRandomized Controlled TrialComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical research in cardiology : official journal of the German Cardiac Society, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03712644 (Intentional Coronary Revascularization Versus Conservative Therapy in Patients Undergoing Peripheral Artery Revascularization Due to Critical Limb Ischemia), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03712644 naunknown statusnot on this map

Intentional Coronary Revascularization Versus Conservative Therapy in Patients Undergoing Peripheral Artery Revascularization Due to Critical Limb Ischemia

TypeinterventionalSponsorMedical University of GrazRan2018 to 2022Enrolled650ConditionsObstructive Coronary Artery DiseaseArmsFFR-guided coronary revascularization
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors.

Gabor G TothDepartment of Cardiology, University Heart Center Graz, Medical University Graz, Graz, Austria.
Marianne BrodmannDivision of Angiology, Department of Internal Medicine, Medical University Graz, Graz, Austria.
Sadeek S Kanoun SchnurDepartment of Cardiology, University Heart Center Graz, Medical University Graz, Graz, Austria.
Stanislaw BartusII Dept of Cardiology, Medical College, Jagiellonian University, Krakow, Poland.
Mislav VrsalovicDepartment of Cardiology, University of Zagreb School of Medicine, Sestre Milosrdnice University Hospital Center, Zagreb, Croatia.
Oleg KrestianinovE. Meshalkin National Medical Research Center of the Ministry of Health of the Russian Federation, Novosibirsk, Russia.
Petr KalaUniversity Hospital Brno and Medical Faculty of Masaryk University, Brno, Czech Republic.
Jacek BilDepartment of Invasive Cardiology, Centre of Postgraduate Medical Education, Warsaw, Poland.
Robert GilNational Medical Institute of the Internal Affairs and Administration Ministry, Warsaw, Poland.
Jan KanovskyUniversity Hospital Brno and Medical Faculty of Masaryk University, Brno, Czech Republic.
Luigi Di SerafinoDepartment of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy.
Luca PaolucciDepartment of Medicine and Surgery, Research Unit of Cardiovascular Science, Università Campus Bio-Medico Di Roma and Fondazione Policlinico Universitario Campus Bio-Medico, Rome, Italy.
Emanuele BarbatoDepartment of Clinical and Molecular Medicine, Sapienza University of Rome, Rome, Italy.
Fabio MangiacapraDepartment of Medicine and Surgery, Research Unit of Cardiovascular Science, Università Campus Bio-Medico Di Roma and Fondazione Policlinico Universitario Campus Bio-Medico, Rome, Italy.
Zoltan RuzsaDepartment of Cardiology, Faculty of Medicine, Doctoral School of Clinical Medicine, University of Szeged, Szeged, Hungary. zruzsa25@gmail.com.ORCID http://orcid.org/0000-0002-2474-5723

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

Conservative TreatmentCoronary Artery DiseaseIschemiaPeripheral Arterial DiseaseAgedCoronary AngiographyFemaleHumansMaleMiddle AgedProspective StudiesTreatment OutcomeCoronary angiographyCoronary artery diseaseCritical limb ischemiaFractional flow reserve

Identifiers

PMID38990250
PMCPMC12283901

What Socratic holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.