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Direct Stenting in Patients Treated with Orbital Atherectomy: An ORBIT II Subanalysis
Institution:1. MedStar Washington Hospital Center, 110 Irving St. NW, Suite 4B1, Washington, D.C. 20010, USA;2. Cardiovascular Systems, Inc., 1225 Old Highway 8 NW, St. Paul, MN 55112, USA;3. Cardiovascular Research Foundation (CRF), 1700 Broadway, New York, NY 10019, USA;4. Columbia University Medical Center, 177 Fort Washington Ave, 6th Floor, New York, NY 10032, USA;5. UCLA Medical Center, 100 Medical Plaza Suite 630, Los Angeles, CA 90095, USA;6. Mount Sinai, First Avenue at 16th Street, New York, NY 10003, USA;7. St. Francis Hospital, 100 Port Washington Blvd., Suite 105, Roslyn, NY 11576, USA;8. Metropolitan Heart and Vascular Institute, The Heart Center, Suite 120, 4040 Coon Rapids Boulevard, Minneapolis, MN 55433, USA;1. San Carlo Clinic, Milano, Italy;2. Universitá degli Studi Milano-Bicocca, Milan, Italy;3. Radboud UMC, Nijmegen, Netherlands
Abstract:BackgroundDirect stenting offers many potential advantages in appropriately selected lesions. Coronary artery calcification increases the complexity and risk of adverse events associated with percutaneous coronary intervention. This study aimed to examine the feasibility of direct stenting after treatment with orbital atherectomy (OA).MethodsORBIT II was a single-arm trial enrolling 443 subjects with de novo severely calcified coronary lesions treated with OA; direct stenting was utilized in 59.0% of cases. Procedural outcomes and 3-year major adverse cardiac event (MACE) rates were compared in subjects treated with pre-stent balloon dilatation versus direct stenting after OA.ResultsProcedural success (84.2% vs. 93.3%; p = 0.004) was significantly higher in the direct stenting cohort. 3-year MACE occurred less frequently in the direct stenting cohort (29.9% vs. 19.1%; p = 0.006), driven by lower rates of myocardial infarction and target lesion revascularization. In a propensity matched analysis, procedural success and 3-year MACE rates were similar in the pre-stent balloon dilatation and direct stenting groups (85.0% vs. 91.8%; p = 0.122 and 28.2% vs. 19.6%; p = 0.078, respectively).ConclusionsOrbital atherectomy facilitates direct stenting and is associated with high procedural success and favorable 3-year outcomes in carefully selected patients. Randomized studies are needed to assess the optimal strategy after lesion preparation with OA.
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