Généreux Philippe, Bettinger Nicolas, Redfors Björn, Lee Arthur C, Kim Christopher Y, Lee Michael S, Shlofmitz Richard A, Moses Jeffrey W, Stone Gregg W, Chambers Jeff W
Columbia University Medical Center, New York, New York.
Cardiovascular Research Foundation, New York, New York.
Catheter Cardiovasc Interv. 2016 Sep;88(3):369-77. doi: 10.1002/ccd.26554. Epub 2016 Apr 16.
We report 2-year outcomes of the Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions (ORBIT II) trial, with emphasis on the impact of stent type.
The ORBIT II trial demonstrated the safety and efficacy of the Diamondback 360° Coronary Orbital Atherectomy System (OAS; Cardiovascular Systems, Inc., St. Paul, MN) in the treatment of de novo, severely calcified coronary lesions.
ORBIT II was a single-arm trial that enrolled 443 subjects with severely calcified lesions at 49 US sites. All patients were intended to be treated with OAS before stent implantation. The primary safety endpoint was 30-day major adverse cardiac events (MACE: Cardiac death, myocardial infarction, or target vessel revascularization). For the purpose of this study, we divided patients into three groups according to the type of stent implanted (i.e., bare metal stent [BMS], first-generation drug-eluting stent [DES], or second-generation DES). The 2-year MACE rate and its components were compared between groups.
In the ORBIT II study cohort, 2-year rates of MACE, cardiac death, and target vessel revascularization were 19.4%, 4.3%, and 8.1%, respectively. Two year data were available in 419 of 443 patients (94.6%) with median follow up time of 25.1 months. Stent-type data were available in 435 of the 443 patients (98.2%). Six patients received stents of more than one type and were excluded from the stent type comparisons. Among the 429 patients included in the stent comparison analyses, 43 patients (10.0%) received BMS, 74 (17.2%) received first-generation DES, and 312 (72.7%) received second-generation DES. The 1 and 2-year target lesion revascularization rates were lower among patients receiving first-generation (1.4% and 6.3%) and second-generation (3.9% and 5.0%) DES compared to patients receiving BMS (15.3% and 15.3%), respectively (1 year: P = 0.007; 2 year: P = 0.047). Higher diameter stenosis and the use of BMS were independently associated with the occurrence of MACE and TVR at 2 years.
OAS remained safe and effective for patients with de novo, severely calcified lesions at 2 years in the ORBIT II study. Adverse ischemic events were significantly higher with BMS compared with DES. © 2016 Wiley Periodicals, Inc.
我们报告了评估OAS治疗严重钙化冠状动脉病变的安全性和有效性（ORBIT II）试验的2年结果，重点关注支架类型的影响。
ORBIT II试验证明了Diamondback 360°冠状动脉旋磨系统（OAS；心血管系统公司，明尼苏达州圣保罗）在治疗初发严重钙化冠状动脉病变中的安全性和有效性。
ORBIT II是一项单臂试验，在美国49个地点招募了443例有严重钙化病变的受试者。所有患者计划在植入支架前接受OAS治疗。主要安全终点是30天主要不良心脏事件（MACE：心源性死亡、心肌梗死或靶血管血运重建）。在本研究中，我们根据植入的支架类型（即裸金属支架[BMS]、第一代药物洗脱支架[DES]或第二代DES）将患者分为三组。比较了各组之间的2年MACE发生率及其组成部分。
在ORBIT II研究队列中，MACE、心源性死亡和靶血管血运重建的2年发生率分别为19.4%、4.3%和8.1%。443例患者中有419例（94.6%）获得了2年数据，中位随访时间为25.1个月。443例患者中有435例（98.2%）获得了支架类型数据。6例患者接受了不止一种类型的支架，被排除在支架类型比较之外。在纳入支架比较分析的429例患者中，43例（10.0%）接受了BMS，74例（17.2%）接受了第一代DES，312例（72.7%）接受了第二代DES。与接受BMS的患者（15.3%和15.3%）相比，接受第一代（1.4%和6.3%）和第二代（3.9%和5.0%）DES的患者1年和2年的靶病变血运重建率较低（1年：P = 0.007；2年：P = 0.047）。较高的直径狭窄和BMS的使用与2年时MACE和TVR的发生独立相关。
在ORBIT II研究中，OAS在2年时对初发严重钙化病变患者仍然安全有效。与DES相比，BMS的不良缺血事件明显更高。©2016威利期刊公司。
