Novel Micro Crown Orbital Atherectomy for Severe Lesion Calcification: Coronary Orbital Atherectomy System Study (COAST)

Björn Redfors, Samin K Sharma, Shigeru Saito, Annapoorna S Kini, Arthur C Lee, Jeffrey W Moses, Ziad A Ali, Robert L Feldman, Rohit Bhatheja, Gregg W Stone, Björn Redfors, Samin K Sharma, Shigeru Saito, Annapoorna S Kini, Arthur C Lee, Jeffrey W Moses, Ziad A Ali, Robert L Feldman, Rohit Bhatheja, Gregg W Stone

Abstract

Background: Percutaneous coronary intervention of severely calcified lesions carries a high risk of adverse events despite the use of contemporary devices. The Classic Crown Orbital Atherectomy System (OAS) was safe and effective for severely calcified lesion preparation in the ORBIT II study (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) but was not optimized for tight lesions. COAST (Coronary Orbital Atherectomy System Study) evaluated the safety and efficacy of calcified lesion preparation before stent implantation with the Diamondback 360 Micro Crown Coronary OAS, designed for use in tighter lesions.

Methods: COAST was a prospective, multicenter, single-arm study that enrolled 100 patients with severely calcified de novo coronary lesions at 17 sites in the United States and Japan. The primary effectiveness end point was procedural success, defined as stent delivery with residual stenosis <50% without in-hospital major adverse cardiac events (MACE), and the primary safety end point was freedom from MACE (composite of cardiac death, myocardial infarction, or target vessel revascularization) at 30 days.

Results: The OAS Micro Crown was inserted in all patients. A stent was delivered with a residual stenosis <50% in all except one patient (99.0%). Procedural success was achieved in 85 (85.0%) subjects versus 391 (88.9%) in ORBIT II (P=0.30), and freedom from MACE at 30 days was achieved in 85.0% versus 89.6% in ORBIT II (P=0.21). Freedom from MACE was 77.8% at 1 year.

Conclusions: Prestent preparation of severely calcified lesions using the novel Micro Crown OAS resulted in similar rates of procedural success and freedom from MACE compared with the Classic Crown OAS. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02132611.

Keywords: atherectomy; percutaneous coronary intervention; safety; stents.

Figures

Figure 1.
Figure 1.
The Diamondback 360 Micro Crown and Classic Crown Orbital Atherectomy Systems. The size of the diamond-coated crown is 1.25 mm for both devices, but the diamond-coated distal tip allows the second generation Micro Crown Orbital Atherectomy System (top) to more easily traverse a 0.5 mm diameter channel, representing a 60% reduction in the minimum lesion size the device is able to treat compared with the previous Classic Crown device (bottom). Other design characteristics incorporated into the Micro Crown are described in the Table in the Data Supplement.
Figure 2.
Figure 2.
One-year Kaplan-Meier failure rate for the primary safety end point. Major adverse cardiac events, defined as the composite of cardiac death, myocardial infarction, or target vessel revascularization, occurred in 15.0% of patients at 30 d and in 22.2% of patients at 1 y in patients with heavily calcified lesions treated with the Micro Crown orbital atherectomy system followed by percutaneous coronary intervention (PCI) in the COAST study (Coronary Orbital Atherectomy System Study) or with the Classic Crown orbital atherectomy system followed by PCI in the ORBIT II study (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions).

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