In a head-to-head comparison of the S.M.A.R.T. Control Nitinol Stent (Cordis) with the Luminexx 6F Stent (Bard) for the treatment of long TASC C and D superficial femoral artery (SFA) lesions, more fractures in total and significantly more fractures of the potentially clinically relevant Types III and IV were observed in the Luminexx group.
The multi-centre (12 sites), prospective, randomised, two-arm-investigation study aimed to assess the performance of both stents, as determined by binary (≥50%) restenosis rate at 12 months post-procedure. There were 199 patients enrolled and randomised 1:1 (S.M.A.R.T: n=96 and Luminexx: n=103).
Dr Stephan Duda, Berlin, Germany, presented the study at CIRSE, and explained that patients recruited were aged between 30 and 80 years, with symptomatic leg ischaemia. Lesion length ranged between 5cm and 22cm and vessel diameter ranged between 4mm and 6mm. Patients excluded were those who had an aneurysm in the SFA or popliteal artery, poor inflow inadequate to support a femoral popliteal bypass graft, and significant vessel tortuosity.
The results demonstrated that more stents were used in the S.M.A.R.T. group, with half the patients (50%) receiving two stents compared with 44.7% of patients receiving two stents in the Luminexx group (Figure 2).
In terms of stent fractures, the Luminexx group experienced more fractures (27.7%) in total compared with 21.0% in the S.M.A.R.T. group. The occurrence of single strut fractures (Type II) and complete transverse linear separation without stent displacement (Type III) was significantly higher in the Luminexx group compared with the S.M.A.R.T. group (20.9% and 17.6% vs. 12.5% and 4.5%, respectively). However, ABI and Rutherford class were similar in both groups at 12 months.
To conclude, Duda explained that patients treated with the S.M.A.R.T. stent for TASC C and D lesions had longer lesions and required a significantly higher number of stents, and more fractures of types III and IV were observed in the Luminexx group. Therefore, he said, due to its longitudinal compliance and flexibility, the S.M.A.R.T. nitinol stent appears to perform better than the Luminexx stent in treatment of long SFA lesions.
STROLL Trial to involve 250 patients at 25 US centres
The first patient enrollment in the STROLL trial was recently announced by Cordis, which will evaluate the safety and efficacy of the S.M.A.R.T. Nitinol Self-Expandable Stent System in treating patients with superficial femoral artery (SFA) disease. The STROLL trial will support a planned PMA filing with the US FDA that, if approved, will allow Cordis to market the S.M.A.R.T. Stent for this indication.
The STROLL trial will enrol approximately 250 patients at 25 centres in the US. The primary efficacy endpoint is no significant reduction of flow detectable at 12 months follow-up visit, and no further clinically driven target vessel revascularisation performed in the interim. The primary safety endpoint is 30-day freedom from all causes of death, index limb amputation and target lesion revascularisation through 30 days.
“Peripheral artery disease (PAD) remains significantly under-diagnosed and leads to increased mortality and morbidity as well as lifestyle and fitness impairment,” said Dr Charles Botti, MidWest Cardiology Research in Columbus, Ohio. “I look forward to better understanding the impact that the S.M.A.R.T. Stent may have in the treatment of SFA disease.” Botti performed the procedure on the trial’s first patient.