Small head-to-head study pits Boston Scientific’s Synergy stent against Medtronic’s Resolute Integrity
The bioresorbable-coating Synergy stent made by Boston fared as well as the Resolute Integrity durable-polymer stent from Medtronic in a small head-to-head study presented today.
The 90-patient Transform-OCT trial used optical coherence tomography to evaluate strut coverage and neo-atherosclerosis in the stents. The primary endpoints were maximum length of consecutive frames with uncovered struts at 3 months and the percentage of patients presenting with frames of NA at 18 months. The 3-month median percentage of covered struts was 79.1% for the Synergy arm and 78.4% for the Resolute Integrity arm. The 18-month median percentage of covered struts was 99.4% in the Synergy cohort and 98.0% in the Resolute Integrity group. The co-primary endpoint of in-stent NA at 18 months from 98.9% of all eligible patients was 11.6 % for Synergy versus 15.9% for Resolute Integrity, with low percentage of frames with NA in both stent types (1.1 ± 3.1 for Synergy versus 2.5 ± 9.1 for the Medtronic device).
“In this head-to-head in vivo comparison of early and late healing response, the bioresorbable abluminal polymer Synergy everolimus-eluting stent was non-inferior at 3-month and similar at 18-month follow-up to the durable conformal polymer Resolute zotarolimus-eluting stent,” Dr. Giulio Guagliumi, of Bergamo, Italy’s Ospedale Giovanni XXIII, said in prepared remarks. “Transform-OCT adds a novel mechanistic dimension to the assessment of new-generation drug-eluting stents, consolidating the understanding that well designed and biocompatible polymers, regardless of whether they are durable or biodegradable, may favorably impact the long-term vascular response of these stents.”