Author + information
Patients with diabetes mellitus (DM) are at increased risk for severe coronary artery calcification. Severely calcified lesions make successful balloon angioplasty and stent delivery more difficult during percutaneous coronary intervention (PCI) and treatment may lead to serious procedural complications. Compared to non-diabetics, diabetics have increased incidence of major adverse cardiac events (MACE) after PCI. In this analysis, we compared 1-year safety outcomes in ORBIT II patients with or without DM treated with the Diamondback 360 Coronary Orbital Atherectomy System (OAS) (Cardiovascular Systems, Inc., St. Paul, MN).
ORBIT II, a prospective, multi-center trial conducted in the US, was designed to evaluate the safety and efficacy of the Diamondback 360 Coronary OAS to prepare de novo, severely calcified coronary lesions for stent deployment. Freedom from 1-year MACE (defined as cardiac death, myocardial infarction (MI, CK-MB>3X ULN), and target vessel revascularization (TVR)) was compared in patients with history of DM (DM group, N=160) versus patients without history of DM (no-DM group, N=283).
Patients in the DM group were younger (70.3 ± 0.7 vs 72.0 ± 0.6, p=0.02), had higher BMI (31.0 ± 0.5 vs 28.5 ± 0.3, p<0.0001), higher prevalence of hypertension (96.3% vs 89.0%, p=0.01), and higher rate of previous coronary artery bypass graft (20.0% vs 11.7%, p=0.02). As estimated by Kaplan-Meier, at one one-year both DM and non-DM patients had similar high freedom from MACE (83.5% vs 83.6%, p=0.98), cardiac death (96.8% vs 97.1%, p=0.84), MI (91.9% vs 89.4%, p=0.40), Q-wave MI (100.0% vs 98.6%, p=1.0), non-Q-wave MI (91.9% vs 90.8%, p=0.70), and TVR (94.1% vs 94.2%, p=0.98).
Using the OAS as a lesion preparation tool prior to stent deployment in both diabetics and non-diabetics may offer patients with severely calcified coronary lesions a new treatment option, with low rates of MACE at one-year post-procedure.