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Optical Coherence Tomography Predictors for Recurrent Restenosis After Paclitaxel-Coated Balloon Angioplasty for Drug-Eluting Stent Restenosis Percutaneous coronary intervention with drug-coated balloon-only strategy in stable coronary artery disease and in acute coronary syndromes: An all-comers registry study Comparison of the safety and efficacy of two types of drug-eluting balloons (RESTORE DEB and SeQuent® Please) in the treatment of coronary in-stent restenosis: study protocol for a randomized controlled trial (RESTORE ISR China) Multicentre, randomized comparison of two-stent and provisional stenting techniques in patients with complex coronary bifurcation lesions: the DEFINITION II trial Sustainable Antirestenosis Effect With a Low-Dose Drug-Coated Balloon: The ILLUMENATE European Randomized Clinical Trial 2-Year Results Comparison of new-generation drug-eluting stents versus drug-coated balloon for in-stent restenosis: a meta-analysis of randomised controlled trials Applications of left ventricular strain measurements to patients undergoing chemotherapy Long-term clinical outcomes after treatment of stent restenosis with two drug-coated balloons Angiographic quantitative flow ratio-guided coronary intervention (FAVOR III China): a multicentre, randomised, sham-controlled trial Orbital atherectomy for the treatment of small (2.5mm) severely calcified coronary lesions: ORBIT II sub-analysis
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Clinical Trial2016 Sep;28(9):364-9.

JOURNAL：J Invasive Cardiol. Article Link

Outcomes After Orbital Atherectomy of Severely Calcified Left Main Lesions: Analysis of the ORBIT II Study

Lee MS, Shlofmitz E, Shlofmitz R et al. Keywords: orbital atherectomy; LM artery lesions

ABSTRACT

OBJECTIVES - The ORBIT II trial reported excellent outcomes in patients with severely calcified coronary lesions treated with orbital atherectomy. Severe calcification of the left main (LM) artery represents a complex coronary lesion subset. This study evaluated the safety and efficacy of coronary orbital atherectomy to prepare severely calcified protected LM artery lesions for stent placement.


METHODS - The ORBIT II trial was a prospective, multicenter clinical trial that enrolled 443 patients with severely calcified coronary lesions in the United States. The major adverse cardiac event (MACE) rate through 2 years post procedure, defined by cardiac death, myocardial infarction (CK-MB >3x upper limit of normal with or without a new pathologic Q-wave) and target-vessel revascularization, was compared in the LM and non-left main (NLM) groups.

RESULTS - Among the 443 patients, a total of 10 underwent orbital atherectomy of protected LM artery lesions. At 2 years, there was no significant difference in the 2-year MACE rate in the LM and NLM groups (30.0% vs 19.1%, respectively; P=.36). Cardiac death was low in both groups (0% vs 4.4%, respectively; P=.99). Myocardial infarction occurred within 30 days in both groups (10.0% vs 9.7%, respectively; P=.99). Severe dissection, perforation, persistent slow flow, and persistent no reflow did not occur in the LM group. Abrupt closure occurred in 1 patient in the LM group.

CONCLUSIONS - Orbital atherectomy for patients with heavily calcified LM coronary artery lesions is safe and feasible. Further studies are needed to assess the safety and efficacy of orbital atherectomy in patients with severely calcified LM artery lesions.
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