Imaging Study Shows High Rate of Strut Coverage and Low Rates of Neoatherosclerosis with Thin Strut Bioresorbable Polymer-Based and Durable Polymer-Based Drug-Eluting Stents
Results from the TRANFORM-OCT Study Reported at TCT 2016
WASHINGTON – November 2, 2016 – Results from TRANSFORM-OCT, a prospective, randomized trial using optical coherence tomography (OCT) to evaluate strut coverage and neoatherosclerosis (NA) found that bioresorbable polymer-based drug-eluting stents (BP-EES) are comparable to durable polymer-based drug-eluting stents (DP-ZES).
Findings were reported today at the 28th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world’s premier educational meeting specializing in interventional cardiovascular medicine.
To mitigate the risk related to durable polymer (DP), bioabsorbable polymers (BP) that coat only the abluminal side of the stent, avoiding contact with circulating blood, and render stent surface similar to those of BMS after complete absorption, have been developed. Whether BP abluminal coating may counteract in-vivo delayed healing and NA development in current thin-strut DES is unknown. TRANSFORM-OCT randomized 90 patients with multivessel disease (1:1) to a BP everolimus-eluting stent (BP-EES, Synergy) or a DP zotarolimus-eluting stent (DP-ZES, Resolute Integrity). The primary endpoints were maximum length of consecutive frames with uncovered struts at three months (powered for non-inferiority of BP-EES) and the percentage of patients presenting with frames of NA at 18 months (powered for superiority of BP-EES) as measured by OCT. The three-month median percentage of covered struts was 79.1 (IQR 60.4, 89.8) for BP-EES and 78.4 (IQR 62.1, 87.8) for DP-ZES, P=0.93. The 18-month median percentage of covered struts was 99.4 (IQR 96.6-100) for BP-EES and 98.0 (IQR 94.4-99.8) for DP-ZES, P=0.14. The co-primary endpoint of in-stent NA at 18 months from 98.9% of all eligible patients was 11.6 % for BP-EES versus 15.9% in DP-ZES (P=0.59) with low percentage of frames with NA in both stent types (1.1 ± 3.1 for BP-EES versus 2.5 ± 9.1 for DP-ZES, P=0.33)
“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,” said Giulio Guagliumi, MD with Ospedale Giovanni XXIII in Bergamo, Italy. “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.”
The TRANSFORM-OCT trial was designed, promoted and implemented by Ospedale Papa Giovanni XXIII, Bergamo (Italy) with unrestricted financial support provided by Boston Scientific International. The company was not involved with any of the study processes, including site selection, data collection, analysis, and drafting of the present abstract. Dr. Guagliumi reported consultant agreements with Boston Scientific and St. Jude Medical and receive research grants through the hospital by Abbott Vascular, St Jude Medical and Boston Scientific.
About CRF and TCT
The Cardiovascular Research Foundation (CRF) is a nonprofit research and educational organization dedicated to helping doctors improve survival and quality of life for people suffering from heart and vascular disease. For over 25 years, CRF has helped pioneer innovations in interventional cardiology and has educated doctors on the latest treatments for heart disease.
Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of CRF and the world’s premier educational meeting specializing in interventional cardiovascular medicine. Now in its 28th year, TCT features major medical research breakthroughs and gathers leading researchers and clinicians from around the world to present and discuss the latest evidence-based research in the field.
For more information, visit www.crf.org and www.tctconference.com.