OCT-ORION 研究：一项比较 Resolute Integrity 与 Biomatrix 药物洗脱支架在早期支架愈合程度和晚期管腔丢失方面的随机光学相干断层扫描研究。
The OCT-ORION Study: A Randomized Optical Coherence Tomography Study Comparing Resolute Integrity to Biomatrix Drug-Eluting Stent on the Degree of Early Stent Healing and Late Lumen Loss.
机构信息
From the Division of Cardiology, Department of Medicine, University of Hong Kong, Queen Mary Hospital, Pok Fu Lam, Hong Kong (S.W.L.L., F.C.C.T., S.C.C.L., S.-L.K., C.P.S., K.K.W.C., M.K.L.W., M.P.H.C., A.Y.T.W., A.S.Y.Y., Y.-M.L., L.-W.Z., K.K.Y.W.); Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (G.S.M., A.M.); and NewYork-Presbyterian Hospital/Columbia University Medical Center (A.M.).
出版信息
Circ Cardiovasc Interv. 2018 Apr;11(4):e006034. doi: 10.1161/CIRCINTERVENTIONS.117.006034.
BACKGROUND
Durable polymers used in drug-eluting stents are considered a potential cause of hypersensitivity inflammatory response adversely affecting stent healing. Using a sequential follow-up with optical coherence tomography, we compared the differences in healing profiles of 2 drug-eluting stents with a biodegradable or durable polymer.
METHODS AND RESULTS
Sixty patients with multivessel disease were prospectively enrolled to receive both study stents, which were randomly assigned to 2 individual vessels, a Resolute Integrity zotarolimus-eluting stent with a durable BioLinx polymer and a BioMatrix NeoFlex Biolimus A9-eluting stent with a biodegradable polylactic acid polymer. Optical coherence tomography was performed at baseline, then in 5 randomly assigned monthly groups at 2 to 6 months, and at 9 months in all patients. The primary end point was the difference in optical coherence tomography strut coverage at 9 months. Key secondary end points included angiographic late lumen loss and composite major adverse cardiac events (cardiac death, myocardial infarction, target lesion revascularization, and definite or probable stent thrombosis) at 9 months. Resolute Integrity zotarolimus-eluting stent showed significantly better strut coverage than BioMatrix NeoFlex Biolimus A9-eluting stent at 2 to 6 months (<0.001) and less variance of percent coverage at 9 months, 99.7% (interquartile range, 99.1-100) versus 99.6% (interquartile range, 96.8-99.9; difference, 0.10; 95% confidence interval, 0.00-1.05; <0.001). No significant difference was observed in major adverse cardiac events or angiographic end points.
CONCLUSIONS
Despite having a durable polymer, Resolute Integrity zotarolimus-eluting stent exhibited better strut coverage than BioMatrix NeoFlex Biolimus A9-eluting stent having a biodegradable polymer; both showed similar antiproliferative efficacy. This novel, longitudinal, sequential optical coherence tomography protocol using each patient as own control could achieve conclusive results in small sample size.
CLINICAL TRIAL REGISTRATION
URL: https://www.clinicaltrials.gov. Unique identifier: NCT01742507.
背景
用于药物洗脱支架的耐用聚合物被认为是导致过敏炎症反应的潜在原因，从而对支架愈合产生不利影响。我们采用光学相干断层扫描进行序贯随访，比较了两种具有可生物降解聚合物或耐用聚合物的药物洗脱支架的愈合情况。
方法和结果
前瞻性纳入 60 例多血管病变患者，分别随机接受两种研究支架治疗，将其分别植入 2 个独立的血管内：Resolute Integrity 佐他莫司洗脱支架（耐用的 BioLinx 聚合物）和 BioMatrix NeoFlex 依维莫司 A9 洗脱支架（可生物降解的聚乳酸聚合物）。在基线时以及在 2 至 6 个月的 5 个随机分组时，以及所有患者的 9 个月时，进行光学相干断层扫描。主要终点为 9 个月时光学相干断层扫描支架覆盖率的差异。关键次要终点包括 9 个月时的血管造影晚期管腔丢失和复合主要不良心脏事件（心脏死亡、心肌梗死、靶病变血运重建和确定或可能的支架血栓形成）。Resolute Integrity 佐他莫司洗脱支架在 2 至 6 个月时显示出明显优于 BioMatrix NeoFlex 依维莫司 A9 洗脱支架的支架覆盖率（<0.001），9 个月时的覆盖率变化更小，99.7%（四分位距，99.1%至 100%）与 99.6%（四分位距，96.8%至 99.9%；差值，0.10；95%置信区间，0.00 至 1.05；<0.001）。主要心脏不良事件或血管造影终点无显著差异。
结论
尽管具有耐用聚合物，但 Resolute Integrity 佐他莫司洗脱支架的支架覆盖率明显优于具有可生物降解聚合物的 BioMatrix NeoFlex 依维莫司 A9 洗脱支架；两者均显示出相似的抗增殖效果。这种使用每个患者自身作为对照的新颖、纵向、序贯光学相干断层扫描方案，可在小样本量下获得明确的结果。
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