Angiography-derived vessel fractional flow reserve (vFFR) was noninferior to pressure wire–based fractional flow reserve (FFR) for guiding revascularization in intermediate coronary stenoses

1. In the randomized LIPSIA-STRATEGY trial, angiography-derived vessel fractional flow reserve (FFR) (vFFR) guidance was noninferior to pressure wire-based FFR guidance for 1-year major adverse cardiovascular events (MACE).

2. The company reported that the trial included 1,053 patients; numerical estimates, confidence intervals and P values were not reported in the available results.

Evidence Rating Level: 2 (Good)

2MM Brief: Pie Medical Imaging reported results from the LIPSIA-STRATEGY trial, which compared angiography-derived vFFR with conventional pressure wire-based FFR guidance for revascularization of intermediate coronary artery stenoses. The investigator-initiated, multicenter, randomized, open-label trial included 1,053 patients with intermediate coronary artery stenoses. Participants were randomized to a vFFR-guided or pressure wire-based FFR-guided treatment strategy, and the primary endpoint was MACE during the first year after randomization. The company reported that vFFR-guided revascularization was noninferior to pressure wire-based FFR-guided revascularization for the primary endpoint. Numerical estimates, confidence intervals and P values for the primary outcome were not reported in the available results. The source also did not report numerical results for secondary outcomes or safety events, although it described the vFFR strategy as involving a less invasive workflow, shorter procedure time and shorter fluoroscopy time. The study was presented during the Late-Breaking Clinical Trials session at the Transcatheter Cardiovascular Therapeutics 2026 congress and was simultaneously published in the Journal of the American College of Cardiology, according to the company. Important limitations include the open-label design and the absence of detailed outcome data in the available source. The findings suggest that angiography-derived vFFR may provide a noninferior revascularization-guidance strategy to pressure wire-based FFR for intermediate coronary stenoses, although the available report does not permit assessment of the magnitude or precision of the treatment effect.

Citation: Majunke et al. Non-invasive vessel fractional flow reserve versus fractional flow reserve guidance to revascularize intermediate coronary stenosis (LIPSIA-STRATEGY) trial: study protocol for a randomized controlled trial. Journal of the American College of Cardiology. 2026.

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Citation: Majunke N, Desch S, Kister T, Buske M, Pöss J, Feistritzer HJ, et al. Non-invasive vessel fractional flow reserve versus fractional flow reserve guidance to revascularize intermediate coronary stenosis (LIPSIA-STRATEGY) trial: study protocol for a randomized controlled trial. Trials. 2026 Apr 1;27(1):287. doi: 10.1186/s13063-026-09652-0. PMID: 41923139; PMCID: PMC13064025.

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