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4-Step Protocol for Disparities in STEMI Care and Outcomes in Women Overall and Cause-Specific Mortality in Randomized Clinical Trials Comparing Percutaneous Interventions With Coronary Bypass Surgery: A Meta-analysis Comparison of Stenting Versus Bypass Surgery According to the Completeness of Revascularization in Severe Coronary Artery Disease: Patient-Level Pooled Analysis of the SYNTAX, PRECOMBAT, and BEST Trials Complete or Culprit-Only Revascularization for Patients With Multivessel Coronary Artery Disease Undergoing Percutaneous Coronary Intervention: A Pairwise and Network Meta-Analysis of Randomized Trials Update in the Percutaneous Management of Coronary Chronic Total Occlusions Early Natural History of Spontaneous Coronary Artery Dissection Radial versus femoral access and bivalirudin versus unfractionated heparin in invasively managed patients with acute coronary syndrome (MATRIX): final 1-year results of a multicentre, randomised controlled trial Transcatheter Laceration of Aortic Leaflets to Prevent Coronary Obstruction During Transcatheter Aortic Valve Replacement: Concept to First-in-Human Effect of Pre-Hospital Crushed Prasugrel Tablets in Patients with STEMI Planned for Primary Percutaneous Coronary Intervention: The Randomized COMPARE CRUSH Trial Multivessel PCI Guided by FFR or Angiography for Myocardial Infarction

Clinical Trial2018 Apr;19(3 Pt A):268-272.

JOURNAL:Cardiovasc Revasc Med. Article Link

Orbital atherectomy for the treatment of small (2.5mm) severely calcified coronary lesions: ORBIT II sub-analysis

Lee MS, Shlofmitz RA, Shlofmitz E et al. Keywords: Atherectomy; Calcification; Cardiovascular intervention; Coronary artery disease

ABSTRACT


OBJECTIVES - We assessed the safety and efficacy of orbital atherectomy to modify severely calcified coronary plaque prior to stent implantation in patients with small vessel (2.5mm) disease.


BACKGROUND - Severe coronary artery calcification increases the risk of adverse clinical events during percutaneous coronary intervention (PCI). Patients who undergo PCI of small vessels have worse clinical outcomes including higher rates of perforation and dissection. The outcomes of orbital atherectomy of small diameter vessels (2.5mm) are unknown.

METHODS - ORBIT II was a single-arm, multicenter trial which prospectively enrolled patients with severely calcified coronary lesions treated with orbital atherectomy prior to stenting in 49U.S. sites. The primary endpoint was the 3year rate of major adverse cardiac events, which was the composite of cardiac death, myocardial infarction, and target vessel revascularization.

RESULTS - Of the 443 patients, 55 (12.4%) had reference vessel diameters (RVD) of 2.5mm and 388 (87.6%) had RVD >2.5. The rates of severe angiographic complications were similar in both groups. The primary endpoint was similar in both groups (30.6% vs. 22.5%, p=0.22), as were the rates of cardiac death (9.8% vs. 6.3%, p=0.33) and myocardial infarction (12.8% vs. 10.9%, p=0.67). Target vessel revascularization was numerically higher in the small vessel group (16.8% vs. 9.3%, p=0.13).

CONCLUSIONS - Patients with small coronary vessel disease had comparable clinical outcomes compared to the larger diameter group following orbital atherectomy. Subsequent studies are required to establish the optimal revascularization approach for such patients with small coronary vessel disease burdened by heavily calcified lesions.

Copyright © 2017 Elsevier Inc. All rights reserved.