Author + information
- Received December 3, 2018
- Revision received February 4, 2019
- Accepted March 5, 2019
- Published online May 20, 2019.
- Wijnand J. Stuijfzand, MDa,∗,
- Stefan P. Schumacher, MDa,∗,
- Roel S. Driessen, MDa,
- Adriaan A. Lammertsma, PhDb,
- Amber L. Bakker, BSca,
- Mischa T. Rijnierse, MD, PhDa,
- Albert C. van Rossum, MD, PhDa,
- Peter M. van de Ven, PhDc,
- Alexander Nap, MD, PhDa,
- Yolande Appelman, MD, PhDa,
- Niels van Royen, MD, PhDd,
- Maarten A. van Leeuwen, MDe,
- Jorrit S. Lemkes, MDa,
- Pieter G. Raijmakers, MD, PhDb and
- Paul Knaapen, MD, PhDa,∗ ()
- aDepartment of Cardiology, Amsterdam UMC, Location VU University Medical Center, Amsterdam, the Netherlands
- bDepartment of Radiology and Nuclear Medicine, Amsterdam UMC, Location VU University Medical Center, Amsterdam, the Netherlands
- cDepartment of Epidemiology and Biostatistics, Amsterdam UMC, Location VU University Medical Center, Amsterdam, the Netherlands
- dDepartment of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands
- eDepartment of Cardiology, Isala Heart Center, Zwolle, the Netherlands
- ↵∗Address for correspondence:
Dr. Paul Knaapen, Department of Cardiology, Amsterdam UMC, VU University Medical Center, De Boelelaan 1117, 1081 HV Amsterdam, the Netherlands.
Objectives The 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.
Background Long-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.
Methods Sixty 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.
Results Fifty-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).
Conclusions The hypothesized beneficial effects of scaffold resorption did not translate to improved MBF during maximal hyperemia or endothelium-dependent vasodilation by CPT.
- bioresorbable vascular scaffold
- myocardial perfusion
- percutaneous coronary intervention
- position emission tomography
↵∗ Drs. Stuijfzand and Schumacher contributed equally to this work.
This study was sponsored in part by Abbott Vascular and the Dutch Heart Foundation (grant 2013T078). The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received December 3, 2018.
- Revision received February 4, 2019.
- Accepted March 5, 2019.
- 2019 American College of Cardiology Foundation
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