Three-year follow-up results of patients treated with the Supera stent show that nominal deployment or slight compression of the device delivers the best outcomes in terms of durability, and that severe stent elongation provides the lowest durability through three years. With nominal deployment, the freedom from reintervention rate was 97% at one year and 94% at three years – a “minimal decrease”, according to Lawrence Garcia, who presented the results at the VEITHsymposium (18–22 November, New York, USA).
Garcia, chief, Section Interventional Cardiology, St Elizabeth’s Medical Center, Boston, USA, presented the results of the SUPERB trial on behalf of the study investigators. In the investigation, the Supera stent continued to show a low rate of stent fracture (0.6%), with only one event at three years. This is a “remarkably low” fracture rate and demonstrates the durability of the device, according to Garcia.
He explained that the study was a prospective, single-arm, multicentre investigation of the Supera stent (Abbott Vascular) for the treatment of single superficial femoral artery/proximal popliteal lesion (>60% stenosis or total occlusion) with primary safety and efficacy endpoints being compared to VIVA Performance Goal. The study enrolled 264 patients at 34 sites.
The primary safety endpoint was a composite of death, target lesion revascularisation or any amputation of the index limb to 30 days (compared to VIVA Performance Goal of 88%), and the primary efficacy endpoint was vessel patency at 12 months, defined as freedom from restenosis and compared to VIVA Performance Goal of 66%.
The patients enrolled in the study were in the majority Rutherford-Becker category 3, mean age 68.7 years, and 63.6% were males. Over 70% had moderate or severe calcification. The results showed that the safety endpoint was achieved in 99.2% (p<0.001) and the efficacy endpoint in 78.9% (p<0.001).
Garcia told delegates that 177 were available for follow-up at three years. Freedom from target lesion revascularisation was 89% at one year, 84% at two years and 82% at three years. He highlighted that the rates of reintervention were similar across the different lesion length groups and showed the benefit of Supera in patients with lesions longer than 10cm.
In the study, results were better when nominal deployment was performed or there was slight compression. In addition, severe stent elongation (>40%) had the smallest durability through three years, with 40% reduction compared with nominal stent deployment. With nominal deployment, the freedom from reintervention rate was 97% at one year and 94% at three years.
In conclusion, Garcia said, “Proper vessel preparation and stent deployment are critical to outcome and durability with Supera. The device shows strong result in complex lesions regardless of lesion length and a remarkably low fracture rate after three years.”