Lee Michael S, Martinsen Brad J, Lee Arthur C, Behrens Ann N, Shlofmitz Richard A, Kim Christopher Y, Chambers Jeffrey W
Division of Cardiology, UCLA Medical Center, Los Angeles, California.
Clinical Department, Cardiovascular Systems Inc., St. Paul, Minnesota.
Catheter Cardiovasc Interv. 2018 May 1;91(6):1018-1025. doi: 10.1002/ccd.27208. Epub 2017 Jul 22.
The goal of the study was to investigate the safety and efficacy of the coronary orbital atherectomy system to treat severe coronary artery calcification (CAC) prior to stent placement in diabetic and non-diabetic patients.
The ORBIT II study reported the safety and efficacy of orbital atherectomy treatment in 443 patients with severe CAC. Percutaneous coronary intervention in diabetic patients is associated with an increased risk of major adverse cardiac events (MACE) compared with non-diabetics. The outcomes of diabetic patients who undergo orbital atherectomy are unknown.
Patients were sub-grouped as either diabetic (160/443, 36.1%) or non-diabetic (283/443, 63.9%). The MACE rate, defined as cardiac death, myocardial infarction (MI; CK-MB > 3X ULN), and target vessel revascularization, was examined at 30 days and 1 year after treatment.
Procedural success was similar in the diabetic and non-diabetic groups (89.3 vs. 88.6%, P = 0.88). There was no significant difference in the 30-day and 1-year MACE rates between the diabetic and non-diabetic groups (30 day: 8.8 vs. 11.3%; P = 0.40; 1 year: 17.1 vs. 16.7%, P = 0.97). The individual components of cardiac death (3.9 vs. 2.9%, P = 0.58), MI (9.4 vs. 11.3%, P = 0.52), and target vessel revascularization (5.9 vs. 5.8%, P = 0.99) were also similar in both groups at 1 year.
The rates of adverse clinical events in diabetic patients who underwent orbital atherectomy were low and similar to non-diabetic patients. This study suggests orbital atherectomy is a reasonable treatment strategy for diabetic patients with severe CAC.
本研究的目的是调查冠状动脉轨道旋磨术系统在糖尿病和非糖尿病患者支架置入术前治疗严重冠状动脉钙化（CAC）的安全性和有效性。
ORBIT II研究报告了443例严重CAC患者接受轨道旋磨术治疗的安全性和有效性。与非糖尿病患者相比，糖尿病患者经皮冠状动脉介入治疗发生主要不良心脏事件（MACE）的风险增加。接受轨道旋磨术的糖尿病患者的治疗结果尚不清楚。
患者分为糖尿病组（160/443，36.1%）和非糖尿病组（283/443，63.9%）。在治疗后30天和1年时检查MACE发生率，MACE定义为心源性死亡、心肌梗死（MI；CK-MB＞3倍正常上限）和靶血管血运重建。
糖尿病组和非糖尿病组的手术成功率相似（89.3%对88.6%，P = 0.88）。糖尿病组和非糖尿病组在30天和1年时的MACE发生率无显著差异（30天：8.8%对11.3%；P = 0.40；1年：17.1%对16.7%，P = 0.97）。两组在1年时的心源性死亡（3.9%对2.9%，P = 0.58）、MI（9.4%对11.3%，P = 0.52）和靶血管血运重建（5.9%对5.8%，P = 0.99）的个体组成部分也相似。
接受轨道旋磨术的糖尿病患者不良临床事件发生率较低，与非糖尿病患者相似。本研究表明，轨道旋磨术是治疗严重CAC糖尿病患者的一种合理治疗策略。
