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Orbital atherectomy safe in diabetes
Patients with diabetes treated with an orbital atherectomy system for severely calcified coronary lesions prior to stenting had low rates of adverse clinical events at 1 year that were similar to outcomes in patients without diabetes, according to a subanalysis of the ORBIT II study.
“Compared to patients in general, diabetic patients have a higher prevalence of severe coronary artery calcification, which increases the complexity of PCI and is associated with higher risk of coronary procedural complications including death and MI,” Michael S. Lee, MD, associate professor of medicine in the division of cardiology at UCLA Medical Center, and colleagues wrote in Catheterization and Cardiovascular Interventions.
Lee and colleagues focused on 443 patients with severe coronary artery calcium (CAC) to analyze safety and efficacy of the Coronary Orbital Atherectomy System (Cardiovascular Systems Inc.) prior to stent placement. Most patients received second-generation drug-eluting stents. Overall, 36% of patients had diabetes (majority type 2 diabetes) and 64% had no diabetes. The mean age was about 71 years and most patients were white.
The left anterior descending artery was the target lesion vessel for half of patients in both groups. Most lesions treated were classified as American College of Cardiology/American Heart Association class B2. The majority of calcification was determined by angiography only (total length of calcium: 27.8 mm diabetes group vs. 29 mm no-diabetes group) and all patients had calcium visible on both sides of the vessel.
Procedural success was similar for patients with and without diabetes (89.3% vs. 88.6%, respectively; P = .88).
At 30 days and 1 year after treatment with orbital atherectomy, the rate of MACE, defined as cardiac death, MI and target vessel revascularization, was not significantly different among patients with and without diabetes:
30 days: 8.8% vs. 11.3% (P = .4)
1 year: 17.1% vs. 16.7% (P = .97)
Moreover, individual components of the primary outcome of MACE at 1 year were similar despite the presence or absence of diabetes:
Cardiac death: 3.9% vs. 2.9% (P = .58)
MI: 9.4% vs. 11.3% (P = .52)
TVR (5.9% vs. 5.8% (P = .99).
“In this subanalysis of diabetic patients in the largest clinical study of orbital atherectomy, clinical outcomes were similar to their nondiabetic counterparts at 30 days and 1 year follow-up,” Lee and colleagues concluded. “Randomized trials are needed to determine the ideal revascularization strategy for diabetic patients with severe CAC.” – by Dave Quaile
Disclosure: Lee reports receiving consultant fees from Cardiovascular Systems Inc.