September 20, 2016
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Orbital atherectomy elevates 1-year MACE rate in patients with renal impairment

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Compared with those without renal impairment, patients with impaired renal function undergoing orbital atherectomy for severely calcified coronary lesions had a higher rate of periprocedural MI, which led to a higher rate of MACE at 1 year, according to a subanalysis of the ORBIT II study.

There were similar rates of cardiac death and revascularization at 1 year in patients with or without impaired renal function, according to the researchers, who said future studies are required to craft the ideal revascularization strategy for patients with renal impairment and severely calcified coronary lesions.

According to the researchers, chronic kidney disease (CKD) is associated with higher risk for MACE after PCI, but the effect of CKD on coronary orbital atherectomy treatment has not been well characterized.

Michael S. Lee, MD, from UCLA Medical Center, and colleagues compared the safety and effectiveness in 443 patients with and without impaired renal function of the atherectomy system (Diamondback 360, Cardiovascular Systems Inc.) used in severely calcified coronary lesions before stent deployment.

Michael S. Lee

The outcome of interest was MACE, a composite of cardiac death, MI and target vessel revascularization, at 1 year.

Among the 441 patients in the cohort with known estimated glomerular filtration rate (eGFR) values at baseline, 75.5% had impaired renal function, defined as eGFR less than 90 mL/min/1.73 m2. Mean eGFR at baseline in those with renal impairment was 65±0.9 mL/min/1.73 m2 vs. 109.1±2 mL/min/1.73 m2 in those without renal impairment.

There was a lower rate of freedom from MACE in renal impairment group at 30 days (87.4% vs. 96.3%, P=.02) and 1 year (80.6% vs. 90.7%, P=.02) vs. those without renal impairment, according to the researchers.

The differences in MACE were driven by higher rates in patients with renal impairment of MI at 30 days (12% vs. 2.8%; P = .01) and 1 year (13.3% vs. 2.8%; P = .008), whereas rates of cardiac death and TVR did not differ, Lee and colleagues wrote.

“Patients with renal impairment had a higher clinical event rate at 1 year due to a higher rate of MI,” the researchers wrote. “The majority of MI events occurred in-hospital and the rate of TVR was low in this group.” by James Clark

Disclosure: The ORBIT II study was sponsored by Cardiovascular Systems Inc. Lee and five other researchers report consulting for Cardiovascular Systems Inc. Two other researchers report being employed by and owning stock in Cardiovascular Systems Inc.