Scientific Publications

AQVA Trial: QFR-Based Virtual PCI Outperforms Angiography-Based PCI

Simone Biscaglia, Filippo Maria Verardi, Matteo Tebaldi, Vincenzo Guiducci, Serena Caglioni, Roberta Campana, Antonella Scala, Andrea Marrone, Graziella Pompei, Federico Marchini, Davide Scancarello, Gianluca Pignatelli, Sergio Musto D’Amore, Iginio Colaiori, Pierluigi Demola, Luigi Di Serafino, Carlo Tumscitz, Carlo Penzo, Andrea Erriquez, Marco Manfrini, and Gianluca Campo (2023)

In the field of interventional cardiology, post-percutaneous coronary intervention (PCI) quantitative flow ratio (QFR) values ≥0.90 have emerged as reliable indicators of a reduced risk of adverse events. The AQVA (Angio-based Quantitative Flow Ratio Virtual PCI Versus Conventional Angio-guided PCI in the Achievement of an Optimal Post-PCI QFR) trial was conceived to assess whether QFR-based virtual PCI could offer superior results compared to the conventional approach of angiography-guided PCI in achieving optimal post-PCI QFR outcomes.

The AQVA trial, conducted as an investigator-initiated, randomized, controlled, parallel-group clinical study, involved 300 patients and 356 study vessels undergoing PCI. These patients were randomized in a 1:1 ratio, with one group receiving QFR-based virtual PCI and the other undergoing angiography-based PCI, which is considered the standard of care. The primary endpoint of the trial was the rate of study vessels achieving a post-PCI QFR value less than 0.90. Secondary outcome measures encompassed procedure duration, stent length per lesion, and stent count per patient.

Among the study vessels, a total of 38 (10.7%) did not meet the predefined post-PCI QFR target. Notably, the primary endpoint was achieved significantly more frequently in the angiography-based PCI group (n = 26, 15.1%) in comparison to the QFR-based virtual PCI group (n = 12 [6.6%]). This finding translated to an absolute difference of 8.5% and a relative difference of 57%, with a statistically significant result (P = 0.009).

The primary reason for suboptimal outcomes in the angiography-based PCI group was the inadequate assessment of disease extent outside the stented region. Concerning the secondary outcomes, no statistically significant disparities were observed, although there were numerical advantages in stent length per lesion and stent count per patient in the virtual PCI group (P = 0.06 and P = 0.08, respectively). It is noteworthy that procedure duration was marginally longer in the virtual PCI group (P = 0.06).

In summary, the findings from the AQVA trial provide compelling evidence of the superiority of QFR-based virtual PCI over angiography-based PCI in achieving optimal physiological outcomes following PCI. While these results are promising, further extensive randomized clinical trials are imperative to validate this approach in terms of clinical outcomes.

This study signifies a potential advancement in interventional cardiology practices, with the potential to minimize the risk of suboptimal post-PCI QFR values and ultimately enhance patient care. The results of the AQVA trial encourage continued exploration of QFR-based virtual PCI in future research endeavors.

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