medwireNews: Guiding percutaneous coronary intervention (PCI) with quantitative coronary angiography (QCA) may be a feasible alternative to intravascular ultrasonography (IVUS) guidance in patients undergoing drug-eluting stent implantation for coronary artery stenosis, research suggests.
Cheol Whan Lee (University of Ulsan, Seoul, Korea) and colleagues explain that although IVUS guidance “promotes favorable outcomes after [PCI], many catheterization laboratories worldwide lack access.”
They therefore tested whether systematic implementation of QCA, which “is readily available at every catheterization laboratory and provides reliable and reproducible quantitative measures of coronary vessels,” could be an alternative strategy to IVUS guidance during stent implantation.
The GUIDE-DES trial included 1528 adults, who had chronic or acute coronary syndrome and significant native coronary artery stenosis requiring PCI, from six cardiac centers in Korea.
After successful guidewire crossing of the first target lesion, the patients were randomly assigned to receive either QCA-guided PCI (n=763; mean age 64.1 years, 75.2% men) or IVUS-guided PCI (n=765; mean age 64.6 years, 81.3% men). Following the procedure, the mean minimum lumen diameter was similar between the two groups, at 2.57 mm and 2.60 mm, respectively.
Lee and co-authors report in JAMA Cardiology that, at 12 months, the proportion of patients with target lesion failure, defined as a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization, was also similar between the two arms.
Specifically, 29 patients in each arm experienced target lesion failure, at rates of 3.81% and 3.80% with QCA and IVUS guidance, respectively.
However, Lee et al note that the incidence of target lesion failure was lower than the assumed 8% event rate.
JAMA Cardiology Associate Editors Ajay Kirtane (Columbia University Irving Medical Center/New York-Presbyterian Hospital, USA) and Roxana Mehran (Icahn School of Medicine at Mount Sinai, New York, USA) say that “the extremely low event rates (similar in both study arms) unfortunately preclude an assessment of noninferiority based on the prespecified hypothesis,” even though the study was originally designed to measure noninferiority.
Nonetheless, the researchers also showed that there were no significant differences between QCA-guided and IVUS-guided PCI in the rates of secondary outcomes including stent edge dissection (1.2 vs 0.7%), coronary perforation (0.2 vs 0.4%), stent thrombosis (0.5 vs 0.7%), and major or minor bleeding (2.2 vs 2.3%).
Lee et al conclude that the lower-than-expected rates of target lesion failure mean the results “should be interpreted with caution” and acknowledge that the “trial lacked a third conventional angiography-guided PCI arm or a blinded post-PCI IVUS examination in the QCA guidance group.”
They therefore suggest that “[t]he role of QCA-guided PCI should be further determined by meticulously designed clinical trials.”
Kirtane and Mehran say that the “data are intriguing and are certainly consistent with the empirical hypothesis that a rigorously performed systematic, quantitative assessment of the vessel and lesion being treated might be the key element common among various forms of adjunctive lesion assessment—whether this occurs through use of angiography-based or catheter-based intravascular imaging.
They continue: “In short, the current state of the evidence continues to confirm that clinical practice needs to evolve, going beyond subjective visual guesstimates to achieve the goal of truly optimizing PCI outcomes.”
medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2024 Springer Healthcare Ltd, part of the Springer Nature Group
JAMA Cardiol 2024; doi:10.1001/jamacardio.2024.0059
JAMA Cardiol 2024; doi:10.1001/jamacardio.2024.0071