ABSOLUTE study

Results presented by Martin Schillinger from Vienna at both the Friedrich Olbert workshop and ISET demonstrate that primary stenting with the ABSOLUTE nitinol stent seems to improve primary patency rates at six months compared to balloon angioplasty with optional stenting. However, larger RCTs are needed to confirm a clinical benefit.
Previous randomized controlled trials comparing PTA vs. stainless steel stents in the superficial femoral artery (SFA) demonstrated high rates of recurrences and no beneficial effect of stenting in the intermediate term. Therefore, SFA stenting was restricted to bail-out procedures in patients with significant residual stenosis after plain balloon angioplasty. Recent studies have indicated that the use of nitinol stent technology seemed to improve the durability of SFA stents with six months patency rates ranging around 80%. These promising results led the Interventional Radiology and Angiology Departments in Vienna University to initiate a randomixed controlled trial comparing primary PTA (plus selective stenting in case of PTA failure) vs. primary stenting with nitinol stents for treatment of SFA obstructions.
Preliminary results indicate that primary SFA stenting with this new nitinol stent may yield superior results to PTA plus selective stenting. Primary technical success rates were 68% after PTA and 100% after primary stenting, respectively. In all 17 patients with primary PTA failure (32%), secondary stenting was successfully performed as a bail-out procedure. Six-month restenosis rates were 45% in the plus selective stenting vs. 25% in the primary stenting group.