Comparison of biodegradable polymer stents with durable polymer stents in treating patients with bifurcation lesion: three-year clinical outcomes of the BIO-RESORT trial.
2019
Introduction: There are several types of drug eluting stents (DES) that can be used in percutaneous
coronary intervention (PCI) to treat patients with coronary artery disease. Stents with thicker struts
and durable polymer coatings have been associated with delayed arterial healing, inflammatory
responses, restenosis and a higher incidence of adverse clinical events. Novel, thinner strut,
biodegradable polymer coated drug eluting stents might reduce these problems. This theoretical
benefit may be particularly beneficial in complex lesions like bifurcations. Stenting bifurcation lesions
has been associated with an increased clinical adverse event risk due to both anatomical and
technical challenges. This sub-study of the randomized BIO-RESORT trial assessed the three-year
clinical outcome of patients with bifurcation lesions, treated with very thin strut biodegradable
polymer drug eluting stents versus thin strut durable polymer drug-eluting stents. The research
question is: What is the difference in target vessel failure (TVF) when comparing the biodegradable
polymer everolimus-eluting stent (EES) and sirolimus-eluting stent (SES) to durable polymer
zotarolimus-eluting stents (ZES) in patients with bifurcation lesions?
Method: The BIO-RESORT trial is a prospective, multicentre, patient-blinded and investigatorinitiated randomized clinical trial with three arms, that compares the clinical outcome of 3514 allcomer patients who required PCI with DES implantation. The biodegradable polymer Synergy EES or
Orsiro SES and durable polymer Resolute Integrity ZES were randomly assigned to patients in a 1:1:1
ratio. The present sub-study assessed three-year clinical outcome of 1236 BIO-RESORT participants
who were treated in at least one bifurcation lesion. The main endpoint was target vessel failure
(TVF), a composite of cardiac death, target vessel-related myocardial infarction, or clinically indicated
target vessel revascularization
Results: There was a numeric difference in TVF between Synergy EES versus Resolute Integrity ZES
and Orsiro SES versus Resolute Integrity ZES. These differences were statistically not significant for
both Synergy EES and Orsiro SES as compared to Resolute Integrity ZES. The individual components
of TVF as well as secondary endpoints did not show significant differences between stent groups.
Discussion: At three-year follow up, this sub-study found no significant difference in the main
endpoint TVF in patients with bifurcation lesions treated with biodegradable polymer Synergy EES or
Orsiro SES versus durable polymer Resolute Integrity ZES. The safety and efficacy of the three stents
in bifurcation lesions appears to be comparable.
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