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Compared to non-calcified lesions, the presence of calcification at the target lesion leads not only to a higher incidence of major adverse cardiac events (MACE) during percutaneous coronary intervention but is also associated with a high frequency of inadequate stent expansion, stent fracture, restenosis or revascularization, and a higher treatment cost.
ORBIT II (49 U.S. sites, 443 subjects) is the first prospective trial to exclusively study severely calcified lesions, and included high-risk patients usually excluded from large trials such as those on dialysis or with a low left ventricular ejection fraction (>25%). Investigators utilized the Diamondback 360° Coronary Orbital Atherectomy System (OAS) to modify and prepare severely calcified lesions before stent placement. The OAS utilizes a centrifugal sanding action and is the first novel technology to receive FDA approval to treat severely calcified lesions. The ORBIT II trial 2-year follow-up assessed the following MACE components: 1) cardiac death, 2) myocardial infarction (MI), and 3) target vessel revascularization (TVR).
The ORBIT II 2 year MACE rate and its components will be presented for the first time. We anticipate that the rates will be lower compared to the literature. Low rates of ORBIT II 1-year MACE (16.4%), cardiac death (3.0%), MI (9.7%), and TVR (5.9%) were previously reported.
Modification of severely calcified plaque with the OAS improves outcomes in this difficult-to-treat patient population. Thus, using the OAS as a lesion preparation tool prior to stent implantation offers patients with severely calcified coronary lesions a new treatment option.