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SORT-OUT VI: Biocompatible zotarolimus-eluting stent noninferior to biodegradable biolimus-eluting stent

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SAN FRANCISCO — New data presented at TCT 2013 indicate that a zotarolimus-eluting stent with a biocompatible polymer was associated with low rates of major adverse cardiac events and was noninferior to a biolimus-eluting stent with a biodegradable polymer in patients undergoing PCI.

Bent Raungaard

In the multicenter, prospective, all-comers, noninferiority SORT-OUT VI trial, Bent Raungaard, MD, chief physician and associate professor at Aalborg University Hospital in Denmark, and colleagues randomly assigned 2,999 patients with ACS or stable CAD to receive a zotarolimus-eluting stent with a biocompatible polymer (ZES; Resolute Integrity, Medtronic; n=1,502) or a biolimus-eluting stent with a biodegradable polymer (BioMatrix Flex, Biosensors Europe SA; n=1,497). The primary endpoint was a composite of major adverse cardiac events, including cardiac death, MI and target lesion revascularization, at 12 months.

At 12 months, the composite endpoint occurred in 5.3% of the ZES group and 5.1% of the biolimus-eluting stent group (P=.006 for noninferiority).

Results also showed that more patients in the biolimus-eluting stent group had undergone prior PCI (22% vs. 18.7%; P=.03), and more patients in the ZES group had undergone prior CABG (8.4% vs. 6.8%; P=.09). Stable angina was the most common indication for PCI in both groups.

More patients in the ZES group had more than one lesion (25.3% vs. 22.1%; P=.04), more lesions of type B2/C (61.5% vs. 58.2%; P=.06) and more than one stent (35.9% vs. 32.6%; P=.06). Stent length per patient also was longer in the ZES group compared with the biolimus-eluting stent group (21 mm vs. 18 mm; P<.01).

The trial was performed within the framework of the Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT-OUT) and incorporated patient-driven clinical event detection through use of several Danish health care registries, including the Danish Civil Registration system, the National Patient Registry and the Western Denmark Heart Registry.

“In the SORT-OUT VI all-comers, randomized controlled trial using patient-driven clinical event detection, we found that both the zotarolimus-eluting stents and the biolimus-eluting stents were associated with low major adverse cardiac events,” Raungaard said at a press conference. “The zotarolimus-eluting stent was found to be noninferior to the biolimus-eluting stent for patients treated with percutaneous coronary intervention.”

For more information:

Raungaard B. Plenary Session IV: Late breaking clinical trials I. Presented at: TCT 2013; Oct. 27-Nov. 1, 2013; San Francisco.

Disclosure: The trial was supported by unrestricted grants from Biosensors Interventional Technologies Pte Ltd. and Medtronic CardioVascular Inc. Raungaard reported no relevant financial disclosures.