Pivotal Trial to Evaluate the Safety and Efficacy of the Orbital Atherectomy System in Treating De Novo, Severely Calcified Coronary Lesions (ORBIT II)

Authors

J. W. Chambers
R. L. Feldman
S. I. Himmelstein
R. Bhatheja
A. E. Villa
K. C. Patel
J. A. Puma, Northwell Health
P. Makam
B. D. Bertolet
G. Y. Nseir
+10 additional authors

Publication Date

2014

Journal Title

JACC Cardiovasc Interv

Abstract

Objectives The ORBIT II (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) trial evaluated the safety and efficacy of the coronary Orbital Atherectomy System (OAS) to prepare de novo, severely calcified coronary lesions for stent placement. Background Despite advances in interventional techniques, treatment of calcified coronary lesions remains a challenge. Stent placement in these lesions may result in stent underexpansion, malapposition, and procedural complications. Methods ORBIT II is a prospective, multicenter, nonblinded clinical trial that enrolled 443 consecutive patients with severely calcified coronary lesions at 49 U.S. sites from May 25, 2010, to November 26, 2012. Investigators used the centrifugal action of the OAS diamond-coated crown to modify calcified lesions prior to stent placement. Results The pre-procedure mean minimal lumen diameter of 0.5 mm increased to 2.9 mm after the procedure. The primary safety endpoint was 89.6% freedom from 30-day major adverse cardiac events compared with the performance goal of 83%. The primary efficacy endpoint (residual stenosis

Volume Number

7

Issue Number

5

Pages

510-518

Document Type

Article

Status

Northwell Researcher

Facility

Northwell Health

Primary Department

Radiology

PMID

24852804

DOI

10.1016/j.jcin.2014.01.158