SORT-OUT VI Shows Noninferiority Between Newer DES with Biodegradable and Biocompatible Polymers
Results of the SORT-OUT VI trial presented at TCT 2013
November 1, 2013
November 1, 2013 — A study found that both drug-eluting stents (DES) with biocompatible polymers and DES with biodegradable polymers were associated with low major adverse coronary events, demonstrating the non-inferiority of the biocompatible polymer stents in patients undergoing percutaneous coronary intervention (PCI). The findings of the SORT-OUT VI trial were presented at the 25th annual Transcatheter Cardiovascular Therapeutics scientific symposium (TCT 2013).
To date, there are no large-scale randomized comparison studies of biodegradable polymer-coated stents and biocompatible polymer-coated stents in all-comer populations. The SORT-OUT VI trial investigated the safety and efficacy of a durable but biocompatible polymer coated Resolute Integrity zotarolimus-eluting stent compared with a biodegradable polymer-coated Nobori biolimus A9-eluting stent.
SORT-OUT VI was a multicenter, all-comer, non-inferiority trial that randomized 2,999 patients with stable coronary artery disease or acute coronary syndromes. The trial was performed within the framework of the Scandinavian Organization for Randomized Trials with Clinical Outcomes and used patient-driven clinical event detection through Danish health care registries.
Patients were randomized to receive either a zotarolimus-eluting permanent polymer stent (n = 1,502) or a biolimus-eluting biodegradable stent (n = 1,497). The primary endpoint was a composite of major adverse cardiac events including cardiac death, myocardial infarction and target lesion revascularization after 12 months.
After 12 months, the percentage of patients with major adverse cardiac events was similarly low in both the zotarolimus-eluting and biolimus-eluting stent groups (5.3 percent and 5.1 percent respectively), demonstrating the non-inferiority of the zotarolimus-eluting stent.
“The SORT-OUT VI trial found that both zotarolimus-eluting and the biolimus-eluting stents were associated with low major adverse cardiac events,” said Bent Raungaard M.D., chief physician and associate professor, Aalborg University Hospital, Denmark and lead investigator of the study. “Further, the zotarolimus-eluting stent was found to be non-inferior to the biolimus-eluting stent for patients treated with PCI.”
Raungaard reports no relevant conflicts of interest. The SORT-OUT VI trial was supported by unrestricted grants from Biosensors and Medtronic CardioVascular.
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