University of Twente Student Theses
Comparison of biodegradable polymer stents with durable polymer stents in treating patients with bifurcation lesion: three-year clinical outcomes of the BIO-RESORT trial.
Warta, S. (2019) Comparison of biodegradable polymer stents with durable polymer stents in treating patients with bifurcation lesion: three-year clinical outcomes of the BIO-RESORT trial.
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| Abstract: | 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. |
| Item Type: | Essay (Master) |
| Faculty: | TNW: Science and Technology |
| Subject: | 44 medicine |
| Programme: | Health Sciences MSc (66851) |
| Link to this item: | https://purl.utwente.nl/essays/78898 |
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