Lee Michael, Généreux Philippe, Shlofmitz Richard, Phillipson Daniel, Anose Bynthia M, Martinsen Brad J, Himmelstein Stevan I, Chambers Jeff W
UCLA Medical Center, Los Angeles, CA, United States.
Columbia University Medical Center, New York City, NY, United States; Cardiovascular Research Foundation, New York City, NY, United States; Hôpital du Sacré-Coeur de Montréal, Université de Montréal, Montréal, Québec, Canada; Morristown Medical Center, NJ, United States.
Cardiovasc Revasc Med. 2017 Jun;18(4):261-264. doi: 10.1016/j.carrev.2017.01.011. Epub 2017 Jan 23.
BACKGROUND/PURPOSE: The presence of heavy coronary artery calcification increases the complexity of percutaneous coronary intervention (PCI) and increases the incidence of major adverse cardiac events (MACE): death, myocardial infarction (MI), target vessel revascularization (TVR), and stent thrombosis. The ORBIT II (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) trial reported low rates of procedural, 30-day, 1-year, and 2-year ischemic complications after treatment of de novo, severely calcified lesions with the Diamondback 360° Coronary Orbital Atherectomy System (OAS) (Cardiovascular Systems, Inc.).
METHODS/MATERIALS: ORBIT II was a single-arm trial that enrolled 443 patients at 49U.S. sites; in this study, de novo, severely calcified coronary lesions were treated with OAS prior to stenting. The primary safety endpoint was 30-day MACE: the composite of cardiac death, MI, and TVR (inclusive of target lesion revascularization (TLR)). The primary efficacy endpoint was procedural success: stent delivery with a residual stenosis of <50% without the occurrence of in-hospital MACE.The present analysis reports the final, 3-year follow-up results from ORBIT II.
The majority of subjects (88.2%) underwent PCI with drug-eluting stents after orbital atherectomy. There were 360 (81.3%) subjects who completed the protocol-mandated 3-year visit.The overall cumulative rate of 3-year MACE was 23.5%, including cardiac death (6.7%), MI (11.2%), and TVR (10.2%). The 3-year target lesion revascularization rate was 7.8%.
In the final 3-year analysis of the ORBIT II trial, orbital atherectomy of severely calcified coronary lesions followed by stenting resulted in a low rate of adverse ischemic events compared with historical controls.Orbital atherectomy represents a safe and effective revascularization strategy for patients with severely calcified coronary lesions.
The ORBIT II trial enrolled 443 subjects to study orbital atherectomy followed by stenting for de novo severely calcified coronary lesions. The overall cumulative 3-year MACE rate was 23.5%, including cardiac death (6.7%), MI (11.2%), and TVR (10.2%); the 3-year target lesion revascularization rate was 7.8%. Orbital atherectomy of heavily calcified coronary lesions followed by stenting results in a low rate of adverse ischemic events compared with historical controls; it represents a reasonable revascularization strategy for patients with severely calcified coronary lesions.
背景/目的：严重冠状动脉钙化的存在增加了经皮冠状动脉介入治疗（PCI）的复杂性，并增加了主要不良心脏事件（MACE）的发生率，MACE包括死亡、心肌梗死（MI）、靶血管血运重建（TVR）和支架血栓形成。ORBIT II（评估OAS治疗严重钙化冠状动脉病变的安全性和有效性）试验报告称，使用Diamondback 360°冠状动脉旋磨系统（OAS，心血管系统公司）治疗初发、严重钙化病变后，手术、30天、1年和2年的缺血性并发症发生率较低。
方法/材料：ORBIT II是一项单臂试验，在美国49个地点招募了443例患者；在本研究中，初发、严重钙化的冠状动脉病变在支架置入术前先用OAS进行治疗。主要安全终点是30天MACE：心脏死亡、MI和TVR（包括靶病变血运重建（TLR））的复合终点。主要疗效终点是手术成功：成功置入支架，残余狭窄<50%，且未发生院内MACE。本分析报告了ORBIT II的最终3年随访结果。
大多数受试者（88.2%）在旋磨术后接受了药物洗脱支架的PCI治疗。有360例（81.3%）受试者完成了方案规定的3年随访。3年MACE的总体累积发生率为23.5%，包括心脏死亡（6.7%）、MI（11.2%）和TVR（10.2%）。3年靶病变血运重建率为7.8%。
在ORBIT II试验的最终3年分析中，与历史对照相比，严重钙化冠状动脉病变先行旋磨术再置入支架，不良缺血事件发生率较低。旋磨术是严重钙化冠状动脉病变患者的一种安全有效的血运重建策略。
ORBIT II试验纳入了443例受试者，研究初发严重钙化冠状动脉病变先行旋磨术再置入支架的情况。3年MACE的总体累积发生率为23.5%，包括心脏死亡（6.7%）、MI（11.2%）和TVR（10.2%）；3年靶病变血运重建率为7.8%。与历史对照相比，严重钙化冠状动脉病变先行旋磨术再置入支架，不良缺血事件发生率较低；它是严重钙化冠状动脉病变患者合理的血运重建策略。
