Myocardial Blood Flow and Coronary Flow Reserve During 3 Years Following Bioresorbable Vascular Scaffold Versus Metallic Drug-Eluting Stent Implantation: The VANISH Trial |
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Authors: | Wijnand J. Stuijfzand Stefan P. Schumacher Roel S. Driessen Adriaan A. Lammertsma Amber L. Bakker Mischa T. Rijnierse Albert C. van Rossum Peter M. van de Ven Alexander Nap Yolande Appelman Niels van Royen Maarten A. van Leeuwen Jorrit S. Lemkes Pieter G. Raijmakers Paul Knaapen |
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Affiliation: | 1. Department of Cardiology, Amsterdam UMC, Location VU University Medical Center, Amsterdam, the Netherlands;2. Department of Radiology and Nuclear Medicine, Amsterdam UMC, Location VU University Medical Center, Amsterdam, the Netherlands;3. Department of Epidemiology and Biostatistics, Amsterdam UMC, Location VU University Medical Center, Amsterdam, the Netherlands;4. Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands;5. Department of Cardiology, Isala Heart Center, Zwolle, the Netherlands |
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Abstract: | ObjectivesThe randomized clinical VANISH (Impact of Vascular Reparative Therapy on Vasomotor Function and Myocardial Perfusion: A Randomized [15O]H2O PET/CT Study) trial was conducted to assess quantitative myocardial blood flow (MBF) during resting, hyperemia, and cold pressor testing (CPT) with positron emission tomographic perfusion imaging after the implantation of a bioresorbable everolimus-eluting scaffold compared with a drug-eluting stent.BackgroundLong-term resorption of the bioresorbable everolimus-eluting scaffold reinstates normal vessel geometry, allowing natural regeneration of the newly formed endothelium with revival of vasomotor function.MethodsSixty patients (18 to 65 years of age) with single-vessel disease and type A or B1 lesions were randomized in a 1-to-1 fashion. Approximately 1 month, 1 year, and 3 years after device implantation, patients underwent [15O]H2O cardiac positron emission tomography. The primary endpoint was the interaction of device type and evolution over time of hyperemic MBF, coronary flow reserve, or CPT reserve. At 3-year follow-up, control invasive coronary angiography with optical coherence tomography was performed.ResultsFifty-nine (98%), 56 (93%), and 51 (85%) patients successfully completed 1-month, 1-year, and 3-year follow-up positron emission tomography, respectively, and no culprit vessel events were registered during follow-up time. The primary study endpoint (i.e., interaction between device type and time) was nonsignificant for hyperemic MBF, CPT reserve, and coronary flow reserve (p > 0.05 for all). In all patients, hyperemic MBF decreased from 1 to 3 years (p = 0.02), while coronary flow reserve was lower at 3-year follow-up compared with 1-month and 1-year follow-up (p = 0.03 for both). After 3 years, percentage area stenosis measured with optical coherence tomography was higher within the bioresorbable everolimus-eluting scaffold compared with the drug-eluting stent (p = 0.03).ConclusionsThe hypothesized beneficial effects of scaffold resorption did not translate to improved MBF during maximal hyperemia or endothelium-dependent vasodilation by CPT. |
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Keywords: | bioresorbable vascular scaffold myocardial perfusion percutaneous coronary intervention position emission tomography %AS percentage area stenosis %DS percentage diameter stenosis BVS bioresorbable everolimus-eluting scaffold CAD coronary artery disease CFR coronary flow reserve CPT cold pressor test DES drug-eluting stent ICA invasive coronary angiography MBF myocardial blood flow MLA minimal luminal area MLD minimal luminal diameter OCT optical coherence tomography PCI percutaneous coronary intervention PET positron emission tomographic QCA quantitative coronary angiography RPP rate-pressure product |
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