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Benefits of femoropopliteal stenting in women weaker after 3 years
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Both men and women treated with a peripheral stent system exhibited clinical improvement after endovascular intervention, but the benefits were more pronounced and persistent among men, according to new data from the DURABILITY II trial.
Researchers evaluated data from 287 adults with stenotic, restenotic or occluded lesions who were enrolled in the prospective, multicenter, nonrandomized DURABILITY II trial. All patients underwent femoropopliteal stenting via the Protégé EverFlex self-expanding peripheral stent system (Covidien).
The main outcomes were primary patency at 3 years and target lesion restenosis. Secondary outcomes included primary assisted and secondary patency, along with changes to ankle-brachial index and walking impairment questionnaire responses at 1, 2 and 3 years of follow-up.
Evaluable 3-year data were available for 146 men and 74 women.
At 3 years, primary patency was 62.5% among women compared with 58.8% among men; assisted primary patency was 68.5% vs. 64.9%; and secondary patency was 72.1% vs. 67.2%. However, these differences at 3 years did not achieve statistical significance, according to the results.
The researchers observed similar rates of freedom from target lesion revascularization (67.4% among women vs. 70.9% among men), overall survival (90.7% vs. 90.1%, respectively) and limb salvage (98.9% vs. 99.4%, respectively) at 3 years.
Both men and women exhibited significant improvements to ankle-brachial index during follow-up. However, absolute scores were higher among men (0.92 vs. 0.85 among women; P = .03), and 85.2% of men maintained the observed improvements to ankle-brachial index between baseline and 3 years compared with 78.8% of women.
Results of treadmill tests indicated lower walking distance scores among women compared with men at baseline (13.6 vs. 25.7; P < .001). Both sexes had achieved similar distances by 2 years of follow-up (51.6 vs. 60.8; P = .103), but this trend did not persist at 3 years, with lower walking distance again observed among women compared with men (37.3 vs. 58.8; P < .001). Walking speed and stair climbing scores also were consistently lower among women vs. men at all evaluated time points. However, the researchers noted that despite having lower scores overall compared with men, women exhibited significant improvements at 3 years compared with baseline with regard to walking distance (37.3 vs. 13.6; P < .0001), walking speed (27.9 vs. 15.3; P = .0004) and stair climbing (42.5 vs. 25.3; P = .0137).
Both men and women exhibited significant improvements to symptoms of pain, aching and cramping. These improvements persisted for up to 3 years of follow-up, but occurred more gradually among women, the researchers wrote. For example, at 1 year, women had lower pain scores than men (68. vs. 78.7; P = .017), but scores were comparable between the groups at 2 and 3 years.
“Women continue to see clinical improvement after intervention, achieving comparable [ankle-brachial indexes] and walking distance to men at 2 years,” Daniel K. Han, MD, from the division of vascular surgery at Mount Sinai Hospital in New York, and colleagues wrote. “These benefits are diminished at 3-year follow-up, with women achieving lower absolute [ankle-brachial index] and [walking impairment questionnaire] parameters compared with men, but improved overall compared with scores at presentation.” – by Adam Taliercio
Disclosure: Cardiology Today was unable to obtain relevant financial disclosures.
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