Key result
COMBINE-INTERVENE tests revascularisation of vulnerable plaques and severe ischaemia vs. standard ischaemia-guided PCI.
Why the study?
Many FFR-positive lesions, especially in the grey zone, can be safely treated medically, while lesions with vulnerable plaque features may cause events despite absence of ischaemia, creating uncertainty about optimal revascularisation strategy.
Does a combined revascularisation strategy targeting both severely ischaemic lesions and vulnerable plaques reduce future adverse events compared to revascularisation based on ischaemia alone in patients with multivessel disease?
RCT (n=1,223)
Single-blind
1:1
Yes
Does a combined revascularisation strategy targeting both severely ischaemic lesions and vulnerable plaques reduce future adverse events compared to revascularisation based on ischaemia alone in patients with multivessel disease?
Answers are grounded in this paper and cite their sources.
The COMBINE-INTERVENE trial design will determine whether treating both severely ischemic lesions and OCT-identified vulnerable plaques improves clinical outcomes compared to standard FFR-guided percutaneous coronary intervention.
Fractional flow reserve (FFR) assessment represents the most widely used revascularisation strategy of the last two decades. However, many FFR (+) lesions, particularly those in the grey zone, can be safely treated medically, while other lesions carrying vulnerable plaque (VP) features can cause future events despite the absence of ischaemia. Optical coherence tomography (OCT) can identify lesions with VP morphology. The objective of this study is to determine whether a combined revascularisation strategy - targeting only severely ischaemic lesions (FFR ≤0.75) and extending treatment to OCT-assessed VP, even in the absence of ischaemia (FFR>0.80) - could reduce future adverse events compared with the current revascularisation practice based exclusively on the presence of ischaemia (FFR ≤0.80). The COMBINE-INTERVENE Trial is a global, prospective, randomised, single-blinded, sham-controlled, superiority trial. A total of 1,223 all-comer patients with multivessel disease (≥2 lesions with a diameter of stenosis ≥50%) will be randomised 1:1 to revascularisation if the FFR is ≤0.75 or a VP is present (experimental arm) versus FFR ≤0.80 in the comparative arm. The primary endpoint is a composite of cardiac death, any myocardial infarction, or any clinically driven revascularisation within 24 months. The trial has already completed enrolment in 50 centres worldwide. COMBINE-INTERVENE is the first trial evaluating the impact of a revascularisation strategy that targets lesions that are either severely ischaemic or carry an OCT-assessed VP versus revascularisation based on ischaemia alone. The trial is powered for superiority. (ClinicalTrials.gov: NCT05333068).
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Kedhi et al. (2026) conducted an RCT in Multivessel disease (n=1,223). Revascularisation targeting severely ischaemic lesions (FFR ≤0.75) and OCT-assessed vulnerable plaque vs. Revascularisation based exclusively on the presence of ischaemia (FFR ≤0.80) was evaluated on Composite of cardiac death, any myocardial infarction, or any clinically driven revascularisation within 24 months. The COMBINE-INTERVENE trial enrolled 1,223 patients to determine if revascularisation targeting severe ischaemia and vulnerable plaques reduces adverse cardiovascular events compared to ischaemia alone.
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