Bioresorbable polymer-based
drug-eluting stents (BP-EES) are comparable to durable polymer-based
drug-eluting stents (DP-ZES), suggested
the results from TRANSFORM-OCT, a prospective, randomized trial using
optical coherence tomography (OCT) to evaluate strut coverage and
neoatherosclerosis (NA).
Findings were reported 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.
‘High rate of strut coverage and low rates of neoatherosclerosis with thin strut bioresorbable polymer-based and durable polymer-based drug-eluting stents has been observed in imaging studies.’
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 ą
3.1 for BP-EES versus 2.5 ą 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 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."
Source: Eurekalert
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