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At presentation, females with peripheral arterial disease (PAD) are older, have smaller vessels, and additional comorbidities, all contributing to more severe disease. Compared with males, females have marginally worse outcomes including limb salvage, morbidity, and mortality after lower extremity revascularization procedures. Female gender may be associated with an increased risk of adverse events after endovascular treatment of PAD.
CONFIRM I, II, and III are large, multi-center, non-randomized, all-comers registries of over 3,000 patients with PAD who were treated in the U.S. with the Orbital Atherectomy System (OAS) (Cardiovascular Systems, Inc., St. Paul, MN). In the CONFIRM series, 60% of patients were male compared to 40% female. This analysis compared the final residual stenosis achieved after treatment with OAS as well as the rate of acute procedural complications in female and male patients in the CONFIRM series.
Females were older (73.2 ± 10.7 vs. 70.4 ± 10.2, p<0.001) and had a trend towards higher prevalence of critical limb ischemia (Rutherford Categories 4-6: 46% vs. 42%, p=0.075). The final percent stenosis in females and males was 9% ± 11% and 11% ± 11%, respectively (p<0.001). Females had a higher rate of total dissection, including flow-limiting, non-flow limiting, and unknown type (13.3% vs. 9.9%, p<0.001). However, females and males had similar rates of flow-limiting dissection (1.6% vs. 1.4%, p=0.62). Females and males had similar rates of perforation (0.8% vs. 0.7%, p=0.57), slow flow (4.4% vs. 4.5%, p=0.96), vessel closure (1.8% vs. 1.2%, p=0.11), spasm (6.8% vs. 6.0%, p=0.24) and thrombus formation (1.3% vs. 1.2%, p=0.74). Females had a trend towards increased embolism (2.8% vs. 1.9%, p=0.07).
The gender analysis of the CONFIRM registries revealed that there was successful lesion modification with orbital atherectomy in both female and male patients; however, females had a higher rate of dissection (all types). This difference is likely due to the older age and higher percentage of critical limb ischemia in females versus males in this study. These results, however, suggest that additional studies should be completed to further understand the increased risks for females versus males during endovascular procedures.