A multicenter, prospective, observational study found that the 1-year restenosis rates after femoropopliteal endovascular therapy with fluoropolymer-based drug-eluting stents (FP-DESs) was clinically acceptable but that there was documented occurrence of aneurysmal degeneration. These findings were published in JACC: Cardiovascular Interventions.
The Contemporary outcomes After Paclitaxel-eluting peripheral Stent implantation for symptomatic lower limb IsCemia with sUperficial femoral or proximal popliteal lesion (CAPSICUM) study was conducted from 2019 to 2020 at 60 centers in Japan. Patients (N=1097) with symptomatic peripheral artery disease (PAD) with femoropopliteal lesions with 50% or more stenosis undergoing drug-eluting stent implantation with an Eluvia FP-DES were evaluated for outcomes at 1 year.
Patients were 69.4% men, aged mean 75±9 years, 60.8% had diabetes mellitus, 66.2% chronic kidney disease, 51.3% coronary artery disease, and 57.8% used statins. Of the 1204 limbs included in this study, 34.8% had chronic limb-threatening ischemia, 53.2% had chronic total occlusion, 16.7% a history of revascularization, 41.9% had bilateral wall calcification, 23.6% had popliteal involvement, and lesions were 18.6±9.9 cm in length.
After a median follow-up duration of 12 months, the 1-year overall survival rate was 91.3%. At 1 year, the most common outcomes were aneurysmal degeneration (16.8%), restenosis (12.9%), occlusive restenosis (9.2%), major limb adverse events (7.1%), and target lesion revascularization (6.2%).
Aneurysmal degeneration at 1 year was associated with subintimal wire passage (adjusted odds ratio [aOR], 2.83; 95% CI, 1.38-5.78; P =.006) and intravascular ultrasound use (aOR, 2.30; 95% CI, 1.03-5.12; P =.042). The presence of both risk factors increased risk for 1-year occurrence compared with 1 risk factor alone.
Restenosis at 1 year was associated with spot stenting (aOR, 2.44; 95% CI, 1.54-3.86; P <.001), chronic limb-threatening ischemia (aOR, 2.12; 95% CI, 1.33-3.38; P =.002), history of revascularization (aOR, 2.03; 95% CI, 1.28-3.23; P =.003), chronic total occlusion (aOR, 1.87; 95% CI, 1.19-2.92; P =.006), end-stage renal disease (aOR, 1.71; 95% CI, 1.10-2.65; P =.018), and reference vessel diameter of less than 4.5 mm (aOR, 0.75; 95% CI, 0.58-0.96; P =.024). Risk for 1-year occurrence of restenosis increased with accumulating risk factors.
These findings may not be generalizable among non-Japanese patients.
The study authors concluded that after implantation of FP-DES for femoropopliteal lesions among patients with symptomatic PAD, the 1-year reoccurrence of restenosis in the real-world setting was similar to what was reported at clinical trials, however, the incidence of aneurysmal degeneration was clinically significant.
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Iida O, Takahara M, Soga Y, et al. 1-Year outcomes of fluoropolymer-based drug-eluting stent in femoropopliteal practice: Predictors of restenosis and aneurysmal degeneration. JACC Cardiovasc Interv. Published online March 28, 2022. doi:10.1016/j.jcin.2022.01.019