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Published on: September 22, 2020
Intentional coronary revascularization versus conservative therapy in patients after peripheral artery
Gabor G Toth1, Marianne Brodmann2, Sadeek S Kanoun Schnur1,3,4
1Department of Cardiology, University Heart Center Graz, Medical University Graz, Graz, Austria.
Insights
The INCORPORATE trial found no significant difference in myocardial infarction or mortality for critical limb ischemia patients treated invasively versus conservatively. However, the conservative approach showed a trend toward higher major adverse cardiac and cerebrovascular events.
Area of Science:
- Cardiology
- Vascular Surgery
- Clinical Trials
Background:
- Severe peripheral artery disease (PAD) significantly increases cardiovascular risk and mortality.
- Patients with critical limb ischemia (CLI) often have co-existing coronary artery disease (CAD).
Purpose of the Study:
- To compare the efficacy of routine coronary angiography and revascularization versus a conservative strategy in patients with treated CLI.
- To evaluate the impact on myocardial infarction (MI) and 12-month mortality.
Main Methods:
- Open-label, prospective, 1:1 randomized multicenter trial (INCORPORATE).
- Patients with treated CLI were randomized to a conservative (optimal medical therapy) or invasive (coronary angiography and FFR-guided revascularization) arm.
- Primary endpoint: composite of MI and 12-month mortality.
Main Results:
- Recruitment halted prematurely due to COVID-19; 185 patients enrolled.
- No significant difference in the primary endpoint (MI/mortality) between invasive and conservative groups at 1 year (11% vs. 10%).
- The conservative group showed a trend towards higher Major Adverse Cardiac and Cerebrovascular Events (MACCE) (20% vs. 10%).
Conclusions:
- Routine coronary angiography and revascularization did not significantly reduce MI or mortality in CLI patients compared to a conservative approach.
- A trend towards increased MACCE was observed in the conservative arm, suggesting potential benefits of early invasive evaluation.
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.
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