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Previous studies have shown a negative correlation between female gender and adverse events after percutaneous coronary intervention (PCI). In this analysis, we evaluate the procedural and 30-day outcomes of male and female patients 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 male patients (N=286) were compared to female patients (N=157). The primary safety endpoint was freedom from major adverse cardiac events (MACE) at 30 days post-procedure. The primary efficacy endpoint was procedural success defined as stent delivery with a residual stenosis of <50% without the occurrence of an in-hospital MACE.
Compared to males, females were older (p=0.0011) and had lower eGFR at baseline (p=0.0024). However males had a higher rate of previous coronary artery bypass graft (p=0.0048). Both males and females met the primary safety endpoint goal of 83% (89.2% [95% CI: 85.5%-92.8%] vs. 90.4% [95% CI: 85.7%-95.2%]) and primary efficacy endpoint of 82% (88.4% [95% CI: 84.1%-91.9%] vs. 89.7% [95% CI: 83.9%-94.0%]). As estimated by Kaplan Meier at 30-days, males and females had similar low rates of MACE (10.8% vs. 9.6%, p=0.6613), myocardial infarction (MI) (10.1% vs. 8.9%, p=0.666), target vessel revascularization/target lesion revascularization (TVR/TLR) (1.8% vs. 0.6%, p=0.3584) and cardiac death (0% vs. 0.7%, p=0.9976).
This sub-analysis of the ORBIT II study demonstrates that males and females treated with orbital atherectomy for severely calcified coronary arteries (generally regarded as high-risk revascularization) demonstrate similar 30-day outcomes. In the context of the larger study, one can presume that the novel coronary Orbital Atherectomy System is a safe and effective adjunctive therapy for severely calcified coronary lesions in both men and women.