Key result
Biodegradable-polymer EES matches durable-polymer ZES for early strut coverage and 18-month neoatherosclerosis.
Why the study?
Durable polymers in drug-eluting stents may promote delayed healing, endothelial dysfunction, and neoatherosclerosis, and it was uncertain whether biodegradable polymers mitigate these issues in current-generation stents.
Do biodegradable-polymer everolimus-eluting stents improve early vascular healing (3 months) and reduce neoatherosclerosis (18 months) compared to durable-polymer zotarolimus-eluting stents in patients with multivessel coronary artery disease?
RCT (n=90)
1:1
Do biodegradable-polymer everolimus-eluting stents improve early vascular healing (3 months) and reduce neoatherosclerosis (18 months) compared to durable-polymer zotarolimus-eluting stents in patients with multivessel coronary artery disease?
Current-generation biodegradable-polymer everolimus-eluting stents and durable-polymer zotarolimus-eluting stents exhibit similar early strut coverage at 3 months and similarly low rates of neoatherosclerosis at 18 months.
Answers are grounded in this paper and cite their sources.
BP-EES non-inferior to DP-ZES for early strut coverage with similar neoatherosclerosis; confirms comparable vascular healing between polymer types in multivessel CAD.
Aims: Delayed healing and endothelial dysfunction may occur with drug-eluting stents (DES), promoting accelerated infiltration of lipids in the neointima and development of neoatherosclerosis (NA). Pathology data suggest durable polymer (DP) of DES to play a major role in this process. Whether biodegradable polymer (BP) may address these issues is uncertain. We compared in vivo vessel healing and NA of current generation BP- or DP-DES using serial optical coherence tomography (OCT) assessments. Methods and results: Ninety patients with multivessel coronary artery disease were randomized 1:1 to BP everolimus-eluting stents (EES, Synergy) or DP zotarolimus-eluting stents (ZES, Resolute Integrity). Co-primary endpoints were the maximum length of uncovered struts at 3 months (powered for non-inferiority) and the percentage of patients presenting with frames of NA at 18 months (powered for superiority) as measured by OCT. The maximum length of uncovered struts at 3 months was 10 ± 8 mm in the BP-EES group and 11 ± 7 mm in the DP-ZES group (mean difference -1 mm; upper 97.5% confidence interval +2 mm; P = 0.05 for non-inferiority; P = 0.45 for superiority). The percentage of patients presenting with frames of NA at 18 months was low and similar between BP-EES and DP-ZES groups (11.6% vs. 15.9%; P = 0.56). There was no stent thrombosis in both groups at 24 months. Conclusion: BP-EES and DP-ZES showed a similar healing response at 3 months and a low incidence of NA at 18 months. Biocompatible polymers, regardless of whether they are durable or biodegradable, may favourably impact the long-term vascular response to current-generation DES.
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Guagliumi et al. (2018) conducted an RCT in Multivessel coronary artery disease (n=90). Biodegradable-polymer everolimus-eluting stents vs. Durable-polymer zotarolimus-eluting stents was evaluated on Co-primary endpoints: maximum length of uncovered struts at 3 months and percentage of patients presenting with frames of neoatherosclerosis at 18 months as measured by OCT (MD -1 mm, 95% CI upper 97.5% CI +2 mm, p=0.05 for non-inferiority (3-month strut coverage); 0.56 (18-month neoatherosclerosis)). Biodegradable-polymer EES was non-inferior to durable-polymer ZES for 3-month uncovered strut length (10 vs 11 mm, P=0.05) with similar 18-month neoatherosclerosis (11.6% vs 15.9%, P=0.56).
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