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In prior studies, patients with previous coronary artery bypass grafting (CABG) experienced significantly greater incidence of adverse clinical events upon subsequent repeat CABG, percutaneous coronary intervention, or medical treatment, compared to patients with no prior CABG. In this analysis, we evaluate the procedural and 30-day outcomes in patients with and without a history of previous CABG in the ORBIT II Trial.
The ORBIT II Trial, a prospective, multicenter, non-blinded clinical trial that enrolled 443 consecutive patients, was designed to evaluate the safety and efficacy of the coronary Orbital Atherectomy System to prepare de novo, severely calcified coronary lesions for stent placement. Procedural and 30-day outcomes in patients with history of previous CABG (N=65) and no history of CABG (N=378) were evaluated in this analysis.
Compared to patients without history of previous CABG, patients with history of CABG were more likely to be male (p=0.005) and have a higher prevalence of diabetes mellitus (p=0.025), history of dyslipidemia (p=0.008), hypertension (p=0.028), and myocardial infarction (MI) (p<0.0001). The rate of procedural success (stent delivery with residual stenosis <50% without the occurrence of an in-hospital major adverse cardiac event (MACE)) was similar 83.1% (previous CABG) and 89.9% (without previous CABG) (p=0.132). Statistically similar low rates of severe dissection (7.7% vs. 2.6%: p=0.054), perforation (0% vs. 2.1%: p=0.611), persistent slow flow (0% vs. 1.1%: p=1.0), and abrupt closure (3.1% vs. 1.6%: p=0.333) were observed in the history of CABG and no history of CABG groups, respectively. As estimated by Kaplan Meier at 30-days, patients had similar low rates of MACE (previous CABG: 16.9% vs. without previous CABG: 9.3%, p=0.070).
Preparation of severely calcified coronary lesions with the coronary Orbital Atherectomy System facilitated stent delivery in patients with a history of previous CABG, resulting in low rates of 30-day MACE.