Novel Micro Crown Orbital Atherectomy for Severe Lesion Calcification

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.

Evaluation of the Safety and Efficacy of Coronary Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Stenoses: Evidence From the Serial Disrupt CAD Trials

“…The resulting potential clinical benefits of IVL include uniform plaque modification in which the fractured calcium remains in situ with no microcirculation embolization, thereby safely facilitating stent apposition and expansion ( 38 ). Previous long-term follow-up studies, such as ORBIT II (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) ( 39 ) and COAST (Coronary Orbital Atherectomy System Study) ( 40 ), have confirmed that the incidence of MACE increases with the extension of the follow-up time. Here, we highlight its best clinical application through appropriate patient and lesion selection, with the main objective of optimizing stent delivery and implantation and, subsequently, improved outcomes.…”

Association between coronary artery calcium score and in-stent restenosis after drug-eluting stent implantation

“…In addition, although the selection of a newer generation of DES and the optimization of postprocedural minimal lumen diameter to obtain optimal acute angiographic results could improve long-term outcomes, these approaches are required for all target lesions. Unlike other contributors, CAC could be identified and quantified before the procedure and be theoretically 'modifiable' for better stent deployment and expansion during the procedure with the use of more aggressive interventional approaches, such as cutting ballooning [21], rotational atherectomy [21,22], orbital atherectomy [23], excimer laser coronary atherectomy [24] and coronary intravascular lithotripsy [25]. These approaches could be planned even before conducting the invasive procedure.…”

Intravascular Lithotripsy for Vessel Preparation in Calcified Coronary Arteries Prior to Stent Placement ― Japanese Disrupt CAD IV Study 1-Year Results ―

“…Similar findings were reported in the Coronary Orbital Atherectomy System Study (COAST), which enrolled patients in the US and Japan under the Medical Device Harmonization by Doing program. 27 COAST evaluated the safety and effectiveness of the Micro Crown orbital atherectomy system for the treatment of calcified de novo coronary artery lesions and reported 1 year rates of MACE, TVR, and TLR of 22.2%, 9.4%, and 6.3%, respectively. 27 Although an explanation for these differences in adverse clinical outcome rates remains speculative, it has been suggested that atherectomy may cause thermal injury and induce platelet activation, which, in turn, may contribute to a higher risk of neointimal hyperplasia and restenosis.…”

“…27 COAST evaluated the safety and effectiveness of the Micro Crown orbital atherectomy system for the treatment of calcified de novo coronary artery lesions and reported 1 year rates of MACE, TVR, and TLR of 22.2%, 9.4%, and 6.3%, respectively. 27 Although an explanation for these differences in adverse clinical outcome rates remains speculative, it has been suggested that atherectomy may cause thermal injury and induce platelet activation, which, in turn, may contribute to a higher risk of neointimal hyperplasia and restenosis. 28, 29 In contrast, coronary IVL acoustic shockwaves are delivered through a low-pressure balloon (4 atm) to selectively modify superficial and deep wall calcium that remains in situ with demonstrated low risk of vascular injury and low reported angiographic complication rates.…”