Plaque modification of severely calcified coronary lesions via orbital atherectomy: Single-center observations from a complex Veterans Affairs cohort

Abstract

Background: Orbital atherectomy (OA) is a known alternative to other atherectomy devices. However, some complex patient demographics (eg, left ventricular ejection fraction <25%) were excluded from the first-in-human trial (ORBIT I) and the pivotal FDA device approval trial (ORBIT II) which evaluated the safety and efficacy of OA in severely calcified de novo coronary lesions. This single-operator cohort study aimed to examine the impact of OA on a real-world complex Veterans Affairs patient subset. Methods: Retrospective analysis was completed on 40 consecutive patients with severely calcified coronary lesions who underwent OA prior to drug-eluting stent placement at the Atlanta Veterans Affairs Medical Center from January 2015 to June 2017. Results: Orbital atherectomy plus drug-eluting stent placement was successful in all 40 cases. Chocolate focal force balloon angioplasty was the most commonly used post-atherectomy balloon (N = 34, 85%). Few complications were observed, including one case (2.5%) of perforation and one case (2.5%) of no-reflow. Neither acute stent thrombosis nor emergent coronary artery bypass grafting was observed. The intravascular ultrasound (IVUS)-determined median [IQR] pre-procedure minimum lumen area and post-procedure minimum stent area (MSA) were 2.8 [2.2, 3.0] mm2 and 8.7 [7.7, 10.0] mm2, respectively (P < 0.0001, Mann-Whitney test). Major adverse cardiovascular events, including all-cause mortality, at 30 days and at a median [IQR] follow-up of 197.5 [35.5, 461.3] days, was 5% and 10%, respectively. During that period, one target vessel revascularization (2.5%) was observed. Conclusions: This study indicates that OA is a useful tool in performing high-risk percutaneous coronary intervention effectively in VA patients with severely calcified coronary lesions. OA plaque modification in combination with a high utilization rate of IVUS and Chocolate focal force angioplasty facilitates stent delivery and optimal stent expansion, resulting in a large MSA.