Department of Cardiology, Amsterdam UMC, Location VU University Medical Center, Amsterdam, the Netherlands.
Department of Radiology and Nuclear Medicine, Amsterdam UMC, Location VU University Medical Center, Amsterdam, the Netherlands.
JACC Cardiovasc Interv. 2019 May 27;12(10):967-979. doi: 10.1016/j.jcin.2019.03.004. Epub 2019 Apr 24.
The randomized clinical VANISH (Impact of Vascular Reparative Therapy on Vasomotor Function and Myocardial Perfusion: A Randomized [O]HO 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.
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.
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 [O]HO 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.
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).
The hypothesized beneficial effects of scaffold resorption did not translate to improved MBF during maximal hyperemia or endothelium-dependent vasodilation by CPT.
随机对照临床试验 VANISH（血管修复治疗对血管舒缩功能和心肌灌注的影响：一项随机[O]HO PET/CT 研究）旨在评估正电子发射断层扫描灌注成像在植入生物可吸收依维莫司洗脱支架后与药物洗脱支架相比，在静息、充血和冷加压试验（CPT）期间定量测量心肌血流（MBF）。
生物可吸收依维莫司洗脱支架的长期吸收恢复了正常的血管几何形状，允许新形成的内皮细胞自然再生，恢复血管舒缩功能。
60 名年龄在 18 至 65 岁之间、单支血管疾病和 A 或 B1 病变的患者以 1:1 的比例随机分组。在器械植入后约 1 个月、1 年和 3 年，患者接受[O]HO 心脏正电子发射断层扫描。主要终点是设备类型和充血性 MBF、冠状动脉血流储备或 CPT 储备的时间演变之间的相互作用。在 3 年随访时，进行了对照性侵入性冠状动脉造影和光学相干断层扫描。
59 名（98%）、56 名（93%）和 51 名（85%）患者分别成功完成了 1 个月、1 年和 3 年的正电子发射断层扫描随访，随访期间无罪犯血管事件发生。主要研究终点（即设备类型和时间之间的相互作用）在充血性 MBF、CPT 储备和冠状动脉血流储备方面均无统计学意义（所有 p 值>0.05）。在所有患者中，充血性 MBF 从 1 年到 3 年下降（p=0.02），而在 3 年随访时的冠状动脉血流储备低于 1 个月和 1 年随访时（p 值均为 0.03）。3 年后，光学相干断层扫描测量的生物可吸收依维莫司洗脱支架内的百分比面积狭窄高于药物洗脱支架（p=0.03）。
支架吸收的假设有益效果并未转化为最大充血或 CPT 时内皮依赖性血管舒张的 MBF 改善。
