Novel DES associated with very low rate of stent thrombosis

ORLANDO, Fla. — Patients implanted with a novel drug-eluting stent had a very low rate of early stent thrombosis and no late or very late stent thrombosis, according to registry data presented at the Society for Cardiovascular Angiography and Interventions Scientific Sessions.

Researchers conducted a study of the sirolimus-eluting stent (Abluminus, Envision Scientific), which has an abluminal surface coated with a matrix of biodegradable polymers, in 1,330 patients who required 1,709 stents in 1,576 lesions. The patients’ mean age was 58 years, 20% were women and 55% had ACS.

Patients were enrolled the registry between January 2012 and November 2015. Julio Marchini, MD, PhD, from Heart Institute University of Sao Paolo Medical School, Sao Paolo, reported interim results for the 53% of patients who completed 24-month follow-up. Final follow-up will occur by November 2017, he said.

The primary outcome was early (30 days), late and very late (after 12 months) stent thrombosis. The secondary outcome was MACE at 24 months. The primary outcome was stent thrombosis because “we were worried that all this extra sirolimus coating … would impact re-endothelialization and consequently, stent thrombosis,” Marchini said during a presentation.

At 30 days, there were four cases of definite stent thrombosis and one case of probable stent thrombosis, for an early stent thrombosis rate of just 0.38%, Marchini said. There were no cases of late or very late stent thrombosis, he said.

The rates are lower than observed in clinical studies of other SES (overall rate of stent thrombosis, 1.5%) and paclitaxel-eluting stents (overall rate of stent thrombosis, 1.8%), according to Marchini.

The MACE rate at 2 years was 2%: death 0.2%, MI 0.2% and new ischemia-driven revascularization 1.6%, Marchini said. MACE was much more common in patients with multivessel disease (almost 5%) than single-vessel disease (approximately 1.5%), he said.

The stent “has presented a very encouraging safety profile out to 2 years, despite the fact that we treated [patients with multivessel disease], diabetic patients and long lesions,” Marchini said.

If the full follow-up remains encouraging, a randomized controlled trial will be conducted, Marchini said. – by Erik Swain

Reference:

Marchini J, et al. Featured Clinical Research – Part 1. Presented at: Society for Cardiovascular Angiography and Interventions Scientific Sessions; May 4-7, 2016; Orlando, Fla.

Disclosure: Marchini reports no relevant financial disclosures.