Heart Team risk assessment with angiography‐derived fractional flow reserve determining the optimal revascularization strategy in patients with multivessel disease: Trial design and rationale for the DECISION QFR randomized trial

Abstract

In patients with multivessel disease (MVD), functional information on lesions improves the prognostic capability of the SYNTAX score. Quantitative flow ratio (QFR®) is an angiography‐derived fractional flow reserve (FFR) that does not require a pressure wire or pharmacological hyperemia. We aimed to investigate the feasibility of QFR‐based patient information in Heart Teams' discussions to determine the optimal revascularization strategy for patients with MVD. We hypothesized that there is an acceptable agreement between treatment recommendations based on the QFR approach and recommendation based on the FFR approach. The DECISION QFR study is a prospective, multicenter, randomized controlled trial that will include patients with MVD who require revascularization. Two Heart Teams comprising cardiologists and cardiac surgeons will be randomized to select a revascularization strategy (percutaneous coronary intervention or coronary artery bypass graft) according to patient information either based on QFR or on FFR. All 260 patients will be assessed by both teams with reference to the anatomical and functional SYNTAX score/SYNTAX score II 2020 derived from the allocated physiological index (QFR or FFR). The primary endpoint of the trial is the level of agreement between the treatment recommendations of both teams, assessed using Cohen's κ. As of March 2022, the patient enrollment has been completed and 230 patients have been discussed in both Heart Teams. The current trial will indicate the usefulness of QFR, which enables a wireless multivessel physiological interrogation, in the discussions of Heart Teams to determine the optimal revascularization strategy for MVD.

Current status and future perspectives of fractional flow reserve derived from invasive coronary angiography

“…Online measurements, while the patient is still in the cath lab, usually do not have such a limitation. Finally, the potential role of QFR in heart team decisions is being investigated in ongoing DECISION QFR randomized trial ( 51 ).…”

Can routine quantitative flow ratio guide coronary artery bypass grafting?

“…These elements have been leveraged in the multi-center FAVOR trials which remain in longer-term follow-up but have shown promising early results in guiding PCI ( 21 , 22 ). The ease of performing QFR also lends itself to strategy trials such as DECISION-QFR which is evaluating the agreement of a Heart Team discussion using QFR-based information compared with FFR-based information ( 23 ). Further studies could trial a precision-based strategy to conduit choice—for example, vessels with a QFR ≤0.80 would receive arterial conduit and those with QFR >0.80 would receive venous conduit—compared with standard of care.…”