Substantial improvement in functional status with bioresorbable scaffold at 30 days

Yesterday, at the Abbott Vascular Satellite Symposium, Johannes Lammer (Vienna, Austria) presented the 30-day data for a drug-eluting bioresorbable scaffold (Espirit; Abbott Vascular) for the management of de novo lesions in the superficial femoral or iliac arteries—the data showed that the scaffold was associated with a 100% procedural success rate and a substantial improvement in functional status.

Lammer reported that the scaffold was made from poly L-lactide, was naturally resorbed and fully metabolised, and was a hybrid between a balloon-expandable and a self-expanding stent. He added that ESPRIT I study is a single-arm, multicentre and its aim is evaluate the use of the bioresorbable scaffold in patients with a single de novo lesion in the superficial femoral or iliac arteries and who had symptomatic claudication. The trial objectives, Lammer reported, were to evaluate the safety and performance of the scaffold and the endpoints included the procedural, clinical and functional outcomes at one, six, 12 months and at two and three years.

At 30 days, in 35 patients (recruited across seven centres), there were no deaths, no scaffold thrombosis, and no target lesion revascularisations. Also, there was a 100% acute procedural success rate. Furthermore, there was a substantial improvement in functional status—Lammer commented that the percentage of severe claudicants (Rutherford category 3) dropped from 57% at baseline to 0% at 30 days. Concluding his presentation, Lammer said: “So, you can see the initial results are remarkable.”

Delegates at the Satellite Symposium also listened to Frank Vermassen, Ghent, Belgium, speaking about femoral anatomy, characteristics and challenges, and Richard Rapoza, San Francisco, USA, on evolution in superficial femoral artery technology.