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Aims: Patients undergoing percutaneous coronary intervention (PCI), with a history of coronary artery bypass grafting (CABG), may be at increased risk for mortality and repeat revascularization, compared with patients without prior CABG. In this post-hoc analysis of the ORBIT II trial, safety and efficacy of coronary orbital atherectomy (OA) to modify severe coronary artery calcium, prior to stent placement, was evaluated in subjects based on history of CABG.Methods and Results: Comorbidities: diabetes, dyslipidemia, hypertension, and history of myocardial infarction (MI) were more prevalent in the CABG group. The in-hospital major adverse cardiac event (MACE) rate, defined as a composite of cardiac death, MI (CK-MB>3× ULN), and target vessel revascularization (TVR), was higher in the CABG group (16.9% vs. 8.5%, p=0.04), driven primarily by a higher incidence of MI (16.9% vs. 8.0%, p=0.03); however, Q-wave rates were low at 1.5% vs 0.5%, (p=0.38). There was no significant difference in rates of cardiac death (6.2% vs. 2.7%, p=0.17) and TVR (7.9% vs. 5.5%, p=0.47).Conclusions: Low rates of TVR, cardiac death, and Q-wave MI, suggest OA treatment to facilitate stent delivery is successful and provides durable outcomes in subjects with and without prior CABG.Condensed Abstract: Patients with history of CABG have extensive coronary artery disease. Those who undergo PCI may be at increased risk for mortality and repeat revascularization, compared with patients without prior CABG. This post-hoc analysis of ORBIT II trial evaluated safety and efficacy of coronary OA to modify severe coronary artery calcium, prior to stent placement, based on subject history of CABG. The MACE rate was higher in the CABG group, driven by higher incidence of MI; however, Q-wave rates were low. OA treatment to facilitate stent delivery is successful, but higher incidence of non-Q-wave MI in CABG patients warrants further study. [ABSTRACT FROM AUTHOR]

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.Results: 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%.Conclusions: 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.Summary: 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. [ABSTRACT FROM AUTHOR]