Coronary Physiology Guidance vs. Conventional Angiography for Optimization of Percutaneous Coronary Intervention: the AQVA II Trial

Background: The debate surrounding the efficacy of coronary physiology guidance, compared to conventional angiography, in achieving optimal post-percutaneous coronary intervention (PCI) fractional flow reserve (FFR) values persists. Objectives: First, demonstrating the superiority of physiology-guided PCI, using either angiography or microcatheter-derived FFR, over conventional angiography-based PCI in complex and high-risk procedures (CHIP). Second, establishing the non-inferiority of angiography-derived FFR guidance compared to microcatheter-derived FFR guidance. Methods: Patients showing obstructive coronary lesions and meeting CHIP criteria were randomized 2:1 to receive either a physiology- or angiography-based PCI. Those assigned to the former were randomly allocated to angiography- or microcatheter derived FFR guidance. CHIP criteria were long lesion (>28 mm), tandem lesions, severe calcifications, severe tortuosity, true bifurcation, in-stent restenosis, left main stem disease. The primary outcome was invasive post-PCI FFR value. Optimal post-PCI FFR value was defined as >0.86. Results: A total of 305 patients (331 study vessels) were enrolled in the study (101 undergoing conventional angiography-based PCI and 204 physiology-based PCI). Optimal post-PCI FFR values were more frequent in the physiology-based PCI group compared to the conventional angiography-based PCI group (77% vs. 54%; absolute difference 23%, relative difference 30%, p<0.0001). The occurrence of the primary outcome did not differ between the two physiology-based PCI subgroups, demonstrating the non-inferiority of angiography- vs. microcatheter-derived FFR (p<0.01). Conclusions: In CHIP patients, procedural planning and guidance based on physiology (either through angiography-or microcatheter-derived FFR) are superior to conventional angiography for achieving optimal post-PCI FFR values.