The CAPSICUM real-world study for the Eluvia fluoropolymer-based drug-eluting stent (FP-DES)– delivered via femoropopliteal implant in Japan – found occlusive restenosis and aneurysmal degeneration rates which should be “noted,” said the researchers.
It is believed to be the first study to reveal 1-year risk of the two complications, they said.
One-year rates of restenosis and target lesion revascularization (TLR) were comparable to clinical trials in the real-world analysis, however.
The findings were published Monday online ahead of the March 28 issue of JACC: Cardiovascular Interventions, with authors led by Osamu Iida, MD, from Kansai Rosai Hospital, Amagasaki, Japan. The study received funding from Eluvia DES manufacturer Boston Scientific Japan, as well as OrbusNeich Foundation, Terumo and Kaneka Medix Corporation.
It was a response to a lack of real-world performance data for the FP-DES, the researchers said, despite favorable 1-year outcomes in clinical trials showing reduced incidence of restenosis and TLR.
Recently, the IMPERIAL study also found that the FP-DES was superior to the polymer-free paclitaxel-coated stent when it came to 1-year patency and 2-year clinically driven TLR in the treatment of femoropopliteal lesions.
Nevertheless, concerns have arisen over the risk of aneurysmal degeneration.
The aim of CAPSICUM (Contemporary outcomes After Paclitaxel-eluting peripheral Stent implantation for symptomatic lower limb IsChemia with sUperficial feMoral or proximal popliteal lesion) was to assess the 1-year risks of restenosis and aneurysmal degeneration, and to explore the associated factors after FP-DES implantation for symptomatic atherosclerotic peripheral artery disease in real-world practice.
The prospective multicenter observational study registered 1,097 adults aged 20 years or older with symptomatic atherosclerotic femoropopliteal artery disease in whom placement of an Eluvia DES was planned. Study enrollment ran in 60 sites across Japan between February 2019 and June 2020, and follow-up ran for 1 year.
Those with planned bypass surgery or major amputation were excluded.
At baseline, 69.4% of the patients were male, with a mean age of 75 ± 9 years, 60.8% had diabetes mellitus, 66.2% had chronic kidney disease, 28.4% had end-stage renal disease on dialysis, 51.3% had coronary artery disease and 57.8% were on statins.
In these patients, the researchers assessed 1,204 limbs, of which 34.8% had chronic limb-threatening ischemia, the mean lesion length was 18.6 ± 9.9 cm, 53.2% had chronic total occlusion and 41.9% had bilateral wall calcification.
The primary outcome, 1-year restenosis, occurred in 12.9%.
The secondary outcome of stent thrombosis occurred in 3.3% and TLR in 6.2%.
However, occlusive restenosis occurred in 9.2% and aneurysmal degeneration in 16.8%, which the researchers highlighted specifically.
“Multivariate analysis demonstrated that dialysis, chronic limb-threatening ischemia, history of revascularization, a smaller reference vessel diameter, chronic total occlusion, and spot stenting were significantly associated with an increased risk of 1-year restenosis, whereas intravascular ultrasound use and subintimal wire passage were significantly associated with an increased risk of 1-year aneurysmal degeneration,” they added.
“Further studies will be warranted to identify a high-risk population for occlusive restenosis and aneurysmal degeneration,” the researchers stressed.
In an accompanying editorial, REGIOMED-Vascular Center, Germany and University of Split, Croatia, colleagues Hans Krankenberg, MD, and Marcus Thieme, MD – also of Jena University Hospital, Germany – noted that concerns have already been raised over observed vessel-wall degeneration.
“Thus, before clarification on cause and effect can be provided, the use of [FP]-DES after subintimal lesion crossing or vessel wall dissection should be thoroughly debated.”
They continued: “Care should be taken not to oversize the stent. Finally, we need to specify clinical indications that justify prolonged antithrombotic medication and patient surveillance associated with FP-DES use.”
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 2022;15:630-638.
Thieme M, Krankenberg H. Femoropopliteal Paclitaxel-Eluting Stents in the Real World: Does CAPSICUM Add Hot Chili or Sweet Pepper? JACC Cardiovasc Interv 2022;15:639-641.
Image Credit: Boston Scientific