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Myocardial Blood Flow After BVS vs. DES Implantation
Study Questions:
What is the quantitative myocardial blood flow (MBF) during resting, hyperemia, and cold pressor testing (CPT) after implantation of a bioresorbable everolimus-eluting scaffold (BVS) as compared with drug-eluting stent (DES)?
Methods:
The VANISH trial investigators randomized 60 patients (age 18-65 years) with single-vessel disease and a type A or B1 lesion in a one-to-one fashion. Approximately 1 month, 1 year, and 3 years after device implantation, patients underwent [15O] H2O positron emission tomography (PET) perfusion imaging. The primary endpoint was the interaction of used device type and evolution over time of hyperemic MBF, coronary flow reserve (CFR), or CPT-reserve. At 3-year follow-up, a control invasive coronary angiogram with optical coherence tomography (OCT) was performed. A mixed model analysis was used to analyze PET perfusion results with a Bonferroni correction for multiple pairwise comparisons for localizing the source of the difference.
Results:
Fifty-nine (98%), 56 (93%), and 51 (85%) patients successfully completed 1-month, 1-year, and 3-year follow-up PET imaging, 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 CFR (all p > 0.05). In all patients, hyperemic MBF decreased from 1 to 3 years (p = 0.02), while CFR was lower at 3-year follow-up compared with 1-month and 1-year follow-up (both p = 0.03). After 3 years, percentage area stenosis measured with OCT was higher within the BVS stent as compared to DES (p = 0.03).
Conclusions:
The authors concluded that the hypothesized beneficial effects of scaffold resorption with BVS did not translate in improved MBF during maximal hyperemia or endothelium-dependent vasodilation by CPT.
Perspective:
This study reports no significant difference in evolution of CPT reserve, hyperemic MBF, and CFR over time after BVS versus metallic DES implantation. Furthermore, after correction for resting rate pressure product, CFR was significantly lower within the BVS treatment arm. Also, angiographic characteristics after BVS implantation seem to be inferior compared with metallic DES with a lower minimal lumen diameter and increased % diameter stenosis immediately post-percutaneous coronary intervention and a significantly higher % area stenosis within the BVS compared to DES at 3 years after implantation. Additional refinements in BVS technology are indicated with documented long-term benefit with regard to major adverse cardiac events prior to consideration of clinical use.
Clinical Topics: Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Vascular Medicine, Interventions and Imaging, Interventions and Vascular Medicine, Angiography, Computed Tomography, Nuclear Imaging
Keywords: Absorbable Implants, Constriction, Pathologic, Coronary Angiography, Drug-Eluting Stents, Endothelium, Hyperemia, Myocardial Ischemia, Percutaneous Coronary Intervention, Perfusion Imaging, Positron-Emission Tomography, Stents, Tomography, Optical Coherence, Vasodilation
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