Why the study?
Does a biodegradable polymer sirolimus-eluting stent prevent cardiac death, target vessel MI, or target lesion revascularization compared to permanent polymer stents in patients undergoing coronary stenting?
RCT (n=2,603)
Does a biodegradable polymer sirolimus-eluting stent prevent cardiac death, target vessel MI, or target lesion revascularization compared to permanent polymer stents in patients undergoing coronary stenting?
The ISAR-TEST-4 trial investigated whether biodegradable polymer sirolimus-eluting stents are noninferior to permanent polymer stents for clinical safety and efficacy at 12 months.
Truncated abstract omits primary results; leaves open whether biodegradable polymer sirolimus-eluting stents are noninferior for the composite endpoint.
Biodegradable polymer drug-eluting stent (DES) platforms have the potential to enhance long-term clinical outcomes following coronary stenting. The concept of controlled drug elution by means of a polymer that, subsequent to serving its useful function, degrades to inert monomers is inherently attractive, although data concerning their efficacy are limited to date. In the Intracoronary Stenting and Angiographic Restenosis Test Efficacy of 3 Limus-Eluting Stents (ISAR-TEST)-4 study, we hypothesized that at 12 months, clinical safety and efficacy with a biodegradable polymer DES would be noninferior to that of permanent polymer DES. Patients were randomly assigned to treatment with biodegradable polymer DES (sirolimus-eluting; n = 1299) or permanent polymer DES (n = 1304; sirolimus-eluting, Cypher, n = 652; or everolimus-eluting, Xience-V, n = 652). The primary end point was a composite of cardiac death, myocardial infarction related to the target vessel or revascularisation related to the target lesion. Th...
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Byrne et al. (2010) conducted an RCT in Coronary artery disease requiring stenting (n=2,603). Biodegradable polymer drug-eluting stent (sirolimus-eluting) vs. Permanent polymer drug-eluting stent (sirolimus-eluting or everolimus-eluting) was evaluated on Composite of cardiac death, myocardial infarction related to the target vessel or revascularisation related to the target lesion.
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