News | Stents | January 13, 2017

Study Shows High Rate of Stent Coverage, Low Restenosis With Bioresorbable Polymer Metallic Stents

Results from the TRANFORM-OCT Study Reported at TCT 2016

OCT, intravascular imaging, stent, good stent apposition on vessel wall, TRANSFORM-OCT study

An OCT image showing good stent strut apposition against the vessel wall.

OCT, intravascular imaging, transform-OCT, stent evaluation

Serial evaluation of a stented coronary lesion segment prior to stenting, and at 3 and 18 months showing the progression of neointimal growth over the stent struts. 

January 13, 2017 — Results from TRANSFORM-OCT, a prospective, randomized trial using optical coherence tomography (OCT) to evaluate strut coverage and neoatherosclerosis (NA) found that bioresorbable polymer metallic drug-eluting stents are comparable to durable polymer-based drug-eluting stents. The study compared the Boston Scientific Synergy bioresorbable polymer everolimus-eluting stent (BP-EES) to the the Medtronic Resolute Integrity durable polymer zoterolimus-eluting stent (DP-ZES). 

Findings were reported at the 2016 Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in November. 
 
To mitigate the risk related to durable polymer (DP), bioabsorbable polymers (BP) that only coat the abluminal side of the stent were developed. This avoids contact with circulating blood. The stent also becomes a bare metal stent after complete absorption of the drug-carrying polymer. It is not known if BP abluminal coatings may counteract in-vivo delayed healing. 
 
The TRANSFORM-OCT study randomized 90 patients with multivessel disease (1:1) to a 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 three-month and similar at 18-month follow-up to the durable conformal polymer Resolute zotarolimus-eluting stent,” said Giulio Guagliumi, M.D. 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. 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.  
 
For more information: www.crf.org 

Related Content

Among high-risk, chronic, coronary patients who undergo angioplasty, there were no additional benefits from ticagrelor compared to the current standard of care clopidogrel. #AHA #AHA20 #AHA2020
News | Cath Lab | November 16, 2020
November 16, 2020 — The use of the more potent antiplatelet medication ticagrelor (Brilinta) was not superior to clop
A large subgroup analysis of the VOYAGER PAD randomized clinical trial showed neither a mortality risk nor benefit associated with the use of paclitaxel drug-coated devices (DCD) in the treatment of peripheral artery disease (PAD). The study also found that the benefit of rivaroxaban use on reducing ischemic limb and cardiovascular outcomes was consistent regardless of whether a DCD was used. #TCT2020 #TCTconnect
Feature | Cath Lab | October 18, 2020
October 18, 2020 – A large subgroup analysis of a randomized clinical trial showed neither a mortality risk nor benef
A longitudinal vessel assessment may demonstrate co-existence of multiple plaque morphologies on OCT, including superficial calcification with thrombus, healed plaque, plaque rupture, lipidic plaque with a thin capped fibrous atheroma (TCFA). #TCTconnect #TCT2020

A longitudinal vessel assessment may demonstrate co-existence of multiple plaque morphologies on OCT, including superficial calcification with thrombus, healed plaque, plaque rupture, lipidic plaque with a thin cap fibro-atheroma (TCFA).

News | Cath Lab | October 18, 2020
October 18, 2020 – Data from the...
The DISRUPT CAD III study showed intravascular lithoplasty from Shockwave Medical was effective in breaking up calcified coronary lesions. #TCT2-0

The DISRUPT CAD III study showed intravascular lithoplasty from Shockwave Medical was effective in breaking up calcified coronary lesions.

Feature | Cath Lab | October 16, 2020
October 15, 2020 — Shockwave Medical's Intravascular Lithotripsy (IVL) system to treat severely calcified coronary ar
Videos | Cath Lab | October 16, 2020
This is an example pf the Shockwave Medical Intravascular Lithotripsy (IVL) catheter system designed to break up heav
Videos | Cath Lab | July 15, 2020
Richard Botto, CVT, RCSA, chief cardiovascular technologist, division of cardiology, cardiac cath lab, offers an over
Videos | Cath Lab | July 13, 2020
The Vieussens’ arterial ring (VAR) is a connection between the conus artery and the left anterior descending (LAD) co
News | Cath Lab | July 06, 2020
July 6, 2020 — Black patients who undergo percutaneous coronary intervention (PCI) are at an increased risk for major