“冠状动脉狭窄治疗的优化策略 - 药物洗脱支架和抗血小板方案的安全性和有效性”（HOST-ASSURE）试验：一项随机对照试验的研究方案。
The 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE) trial: study protocol for a randomized controlled trial.
机构信息
Department of Internal Medicine, Cardiovascular Center, Seoul National University Hospital, 101 Daehang-no, Seoul 110-744, South Korea.
出版信息
Trials. 2012 Mar 31;13:29. doi: 10.1186/1745-6215-13-29.
BACKGROUND
Second-generation drug-eluting stents (DES) have raised the bar of clinical performance. These stents are mostly made from cobalt chromium alloy. A newer generation DES has been developed from platinum chromium alloy, but clinical data regarding the efficacy and safety of the platinum chromium-based everolimus-eluting stent (PtCr-EES) is limited, with no comparison data against the cobalt chromium-based zotarolimus-eluting stent (CoCr-ZES). In addition, an antiplatelet regimen is an integral component of medical therapy after percutaneous coronary intervention (PCI). A 1-week duration of doubling the dose of clopidogrel (double-dose antiplatelet therapy (DDAT)) was shown to improve outcome at 1 month compared with conventional dose in acute coronary syndrome (ACS) patients undergoing PCI. However in Asia, including Korea, the addition of cilostazol (triplet antiplatelet therapy (TAT)) is used more commonly than doubling the dose of clopidogrel in high-risk patients.
METHODS
In the 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE) trial, approximately 3,750 patients are being prospectively and randomly assigned in a 2 × 2 factorial design according to the type of stent (PtCr-EES vs CoCr-ZES) and antiplatelet regimen (TAT vs DDAT). The first primary endpoint is target lesion failure at 1 year for the stent comparison, and the second primary endpoint is net clinical outcome at 1 month for comparison of antiplatelet therapy regimen.
DISCUSSION
The HOST-ASSURE trial is the largest study yet performed to directly compare the efficacy and safety of the PtCr-EES versus CoCr-ZES in an 'all-comers' population. In addition, this study will also compare the clinical outcome of TAT versus DDAT for 1-month post PCI.
TRIAL REGISTRATION
ClincalTrials.gov number NCT01267734.
背景
第二代药物洗脱支架（DES）提高了临床性能标准。这些支架主要由钴铬合金制成。新一代 DES 已由铂铬合金制成，但有关基于铂铬的依维莫司洗脱支架（PtCr-EES）疗效和安全性的临床数据有限，并且没有与基于钴铬的佐他莫司洗脱支架（CoCr-ZES）的比较数据。此外，抗血小板治疗是经皮冠状动脉介入治疗（PCI）后药物治疗的一个组成部分。与急性冠状动脉综合征（ACS）患者接受 PCI 时的常规剂量相比，双剂量氯吡格雷（双倍剂量抗血小板治疗（DDAT））治疗 1 周可改善 1 个月的结果。然而，在亚洲，包括韩国，与双剂量氯吡格雷相比，在高危患者中更常使用西洛他唑（三联抗血小板治疗（TAT））。
方法
在“优化策略治疗冠状动脉狭窄的协同作用 - 药物洗脱支架和抗血小板治疗方案的安全性和有效性”（HOST-ASSURE）试验中，约 3750 名患者将按照支架类型（PtCr-EES 与 CoCr-ZES）和抗血小板治疗方案（TAT 与 DDAT）进行前瞻性、随机、2×2 析因设计分配。主要一级终点是支架比较 1 年时的靶病变失败，二级主要终点是抗血小板治疗方案比较 1 个月时的净临床结局。
讨论
HOST-ASSURE 试验是迄今为止最大的一项研究，旨在直接比较在“所有患者”人群中 PtCr-EES 与 CoCr-ZES 的疗效和安全性。此外，这项研究还将比较 TAT 与 DDAT 在 PCI 后 1 个月的临床结局。
试验注册
ClinicalTrials.gov 编号 NCT01267734。
Zotero 插件