Physiology- or Imaging-Guided Strategies for Intermediate Coronary Stenosis

Abstract

Importance: Treatment strategies for intermediate coronary lesions guided by fractional flow reserve (FFR) and intravascular ultrasonography (IVUS) have shown comparable outcomes. Identifying low-risk deferred vessels to ensure the safe deferral of percutaneous coronary intervention (PCI) and high-risk revascularized vessels that necessitate thorough follow-up can help determine optimal treatment strategies.

Objectives: To investigate outcomes according to treatment types and FFR and IVUS parameters after FFR- or IVUS-guided treatment.

Design, setting, and participants: This cohort study included patients with intermediate coronary stenosis from the Fractional Flow Reserve and Intravascular Ultrasound-Guided Intervention Strategy for Clinical Outcomes in Patients With Intermediate Stenosis (FLAVOUR) trial, an investigator-initiated, prospective, open-label, multicenter randomized clinical trial that assigned patients into an IVUS-guided strategy (which recommended PCI for minimum lumen area [MLA] ≤3 mm2 or 3 mm2 to 4 mm2 with plaque burden [PB] ≥70%) or an FFR-guided strategy (which recommended PCI for FFR ≤0.80). Data were analyzed from November to December 2022.

Exposures: FFR or IVUS parameters within the deferred and revascularized vessels.

Main outcomes and measures: The primary outcome was target vessel failure (TVF), a composite of cardiac death, target vessel myocardial infarction, and revascularization at 2 years.

Results: A total of 1619 patients (mean [SD] age, 65.1 [9.6] years; 1137 [70.2%] male) with 1753 vessels were included in analysis. In 950 vessels for which revascularization was deferred, incidence of TVF was comparable between IVUS and FFR groups (3.8% vs 4.1%; P = .72). Vessels with FFR greater than 0.92 in the FFR group and MLA greater than 4.5 mm2 or PB of 58% or less in the IVUS group were identified as low-risk deferred vessels, with a decreased risk of TVF (hazard ratio [HR], 0.25 [95% CI, 0.09-0.71]; P = .009). In 803 revascularized vessels, the incidence of TVF was comparable between IVUS and FFR groups (3.6% vs 3.7%; P = .95), which was similar in the revascularized vessels undergoing PCI optimization (4.2% vs 2.5%; P = .31). Vessels with post-PCI FFR of 0.80 or less in the FFR group or minimum stent area of 6.0 mm2 or less or with PB at stent edge greater than 58% in the IVUS group had an increased risk for TVF (HR, 7.20 [95% CI, 3.20-16.21]; P < .001).

Conclusions and relevance: In this cohort study of patients with intermediate coronary stenosis, FFR- and IVUS-guided strategies showed comparable outcomes in both deferred and revascularized vessels. Binary FFR and IVUS parameters could further define low-risk deferred vessels and high-risk revascularized vessels.

Figure 1.. Study Recruitment Flowchart

DCB indicates drug-coated balloon; FFR, fractional flow reserve; IVUS, intravascular ultrasonography; and PCI, percutaneous coronary intervention.

Figure 2.. Risk of Target Vessel Failure (TVF) in Deferred Vessels by Binary Fractional Flow Reserve (FFR) and Intravascular Ultrasonography (IVUS) Parameters

A, Two-year rate of TVF in low-risk and high-risk deferred vessels defined by optimal cutoff values for estimating risk of TVF. Low-risk deferred vessels were defined as those with FFR greater than 0.92 or minimum lumen area (MLA) greater than 4.5 mm² or plaque burden (PB) of 58% or less. B, Two-year rate of TVF of low-risk deferred vessels, high-risk deferred vessels, FFR-guided revascularized vessels, and IVUS-guided revascularized vessels.

Figure 3.. Risk of Target Vessel Failure (TVF) in Revascularized Vessels by Binary Fractional Flow Reserve (FFR) and Intravascular Ultrasonography (IVUS) Parameters After Percutaneous Coronary Intervention (PCI)

A, Two-year rate of TVF in low-risk and high-risk revascularized vessels, defined by optimal cutoff values for estimating risk of TVF. High-risk revascularized vessels were defined as those with post-PCI FFR 0.80 or less or minimum stent area (MSA) 6.0 mm² or less and plaque burden (PB) at stent edge greater than 58%. B, Two-year rate of TVF of low-risk revascularized vessels, high-risk revascularized vessels, FFR-guided deferred vessels, and IVUS-guided deferred vessels.