随机比较载药无聚合物的依维莫司洗脱支架与载持久聚合物的依维莫司洗脱支架在糖尿病患者中的应用：RESERVOIR 临床试验。
A Randomized Comparison of Reservoir-Based Polymer-Free Amphilimus-Eluting Stents Versus Everolimus-Eluting Stents With Durable Polymer in Patients With Diabetes Mellitus: The RESERVOIR Clinical Trial.
机构信息
Heart Diseases Institute, Hospital de Bellvitge-IDIBELL, University of Barcelona, Barcelona, Spain.
Heart Diseases Institute, Hospital de Bellvitge-IDIBELL, University of Barcelona, Barcelona, Spain.
出版信息
JACC Cardiovasc Interv. 2016 Jan 11;9(1):42-50. doi: 10.1016/j.jcin.2015.09.020.
OBJECTIVES
The aim of this study was to compare the efficacy of amphilimus-eluting stents (AES) with that of everolimus-eluting stents (EES) in patients with diabetes mellitus (DM).
BACKGROUND
The AES is a polymer-free drug-eluting stent that elutes sirolimus formulated with an amphiphilic carrier from laser-dug wells. This technology could be associated with a high efficacy in patients with DM.
METHODS
This was a multicenter, randomized, noninferiority trial. Patients with DM medically treated with oral glucose-lowering agents or insulin and de novo coronary lesions were randomized in a 1:1 fashion to AES or EES. The primary endpoint was the neointimal (NI) volume obstruction assessed by optical coherence tomography at 9-month follow-up.
RESULTS
A total of 116 lesions in 112 patients were randomized. Overall, 40% were insulin-treated patients, with a median HbA1c of 7.3% (interquartile range: 6.7% to 8.0%). The primary endpoint, NI volume obstruction, was 11.97 ± 5.94% for AES versus 16.11 ± 18.18% for EES, meeting the noninferiority criteria (p = 0.0003). Pre-specified subgroup analyses showed a significant interaction between stent type and glycemic control (p = 0.02), with a significant reduction in NI hyperplasia in the AES group in patients with the higher HbA1c (p = 0.03). By quantitative coronary angiography, in-stent late loss was 0.14 ± 0.24 for AES versus 0.24 ± 0.57 mm for EES (p = 0.27), with a larger minimal lumen diameter at follow-up for AES (p = 0.02), mainly driven by 2 cases of occlusive restenosis in the EES group.
CONCLUSIONS
AES are noninferior to EES for the coronary revascularization of patients with DM. These results suggest a high efficacy of the AES and may support the potential benefit of this stent in patients with DM. (A Randomized Comparison of Reservoir-Based Polymer-Free Amphilimus-Eluting Stents Versus Everolimus-Eluting Stents With Durable Polymer in Patients With Diabetes Mellitus [RESERVOIR]; NCT01710748).
目的
本研究旨在比较雷帕霉素洗脱支架（EES）和依维莫司洗脱支架（AES）在糖尿病患者中的疗效。
背景
AES 是一种无聚合物药物洗脱支架，它从激光打孔的槽中洗脱亲脂性载体包埋的西罗莫司。这种技术可能与糖尿病患者的高疗效有关。
方法
这是一项多中心、随机、非劣效性试验。接受口服降糖药物或胰岛素治疗的糖尿病患者，以及新出现的冠状动脉病变，按 1:1 比例随机分为 AES 或 EES 组。主要终点是 9 个月随访时光学相干断层扫描（OCT）评估的新生内膜（NI）体积阻塞。
结果
共纳入 112 例患者的 116 处病变，其中 40%的患者接受胰岛素治疗，中位糖化血红蛋白（HbA1c）为 7.3%（四分位间距：6.7%~8.0%）。主要终点，即 AES 的 NI 体积阻塞为 11.97±5.94%，EES 为 16.11±18.18%，符合非劣效性标准（p=0.0003）。预先设定的亚组分析显示，支架类型与血糖控制之间存在显著的交互作用（p=0.02），在 HbA1c 较高的患者中，AES 组的 NI 增生显著减少（p=0.03）。定量冠状动脉造影显示，AES 的支架内晚期丢失为 0.14±0.24mm，EES 为 0.24±0.57mm（p=0.27），AES 的随访时最小管腔直径较大（p=0.02），主要是由于 EES 组的 2 例闭塞性再狭窄。
结论
AES 与 EES 用于糖尿病患者的冠状动脉血运重建效果相当。这些结果提示 AES 具有较高的疗效，可能支持这种支架在糖尿病患者中的潜在获益。（基于储库的无聚合物依维莫司洗脱支架与含持久聚合物的依维莫司洗脱支架在糖尿病患者中的随机比较[RESERVOIR]；NCT01710748）
Zotero 插件