Outcomes at 1 year similar for Resolute Integrity and BioMatrix Flex stents


AT TCT 2013

SAN FRANCISCO – Major adverse cardiac events were comparable at 5.3% of 1,502 patients who received a zotarolimus-eluting stent with a permanent polymer coating and 5.1% of 1,497 patients who received a biolimus-eluting stent with a biodegradable polymer coating in a population-based randomized trial.

The 1-year outcomes in the Scandinavian study, known as the SORT-OUT VI trial, showed that the Resolute Integrity zotarolimus-eluting stent is noninferior to the BioMatrix Flex Biolimus A9-eluting stent. The trial results represent the first large comparison study of the two systems that included all comers, Dr. Bent Raungaard said at the Transcatheter Cardiovascular Therapeutics annual meeting.

Dr. Bent Raungaard

The primary outcome measure was a composite of cardiac death, myocardial infarction (not clearly attributable to a nontarget lesion), or target lesion revascularization within a year of stent implantation. The study enrolled adults with chronic stable coronary artery disease or acute coronary syndromes who had at least one coronary lesion with more than 50% diameter stenosis in a vessel with a reference diameter of 2.25-4 mm and who were undergoing percutaneous coronary intervention (PCI).

At the 1-year follow-up, cardiac death rates were 1.5% with the Resolute Integrity stent and 1.7% with the BioMatrix Flex stent, and the rates of MI were 1.3% and 0.9%, respectively, reported Dr. Raungaard of Aalborg (Denmark) University Hospital and his associates. Rates of target lesion revascularization were 3.5% with the Resolute Integrity stent and 3.1% with the BioMatrix Flex stent.

Rates were similar between groups at 1 year for target vessel revascularization (4.5% with Resolute Integrity and 4.7% with BioMatrix Flex), definite stent thrombosis (0.6% and 0.4%, respectively), and definite or probable stent thrombosis (0.8% and 0.5%, respectively).

"Both the zotarolimus-eluting stents and the biolimus-eluting stents were associated with low rates of major adverse cardiac events," Dr. Raungaard said.

Dr. Gregg W. Stone, moderator of the session for Dr. Raungaard’s presentation, noted that the major cardiac event rates were about what investigators had predicted for the zotarolimus-eluting stent and lower than predicted for the biolimus-eluting stent. "The take-home message here is that event rates were very low," said Dr. Stone, director of cardiovascular research and education at the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center. "I guess this begs the fact that we may need to start looking at higher-risk populations to bring out the differences between the devices," he said.

Baseline characteristics of patients were similar between groups, except that a significantly higher proportion of patients in the BioMatrix Flex group had undergone prior PCI (22%) compared with the Resolute Integrity group (19%), he said at the meeting, cosponsored by the American College of Cardiology. A higher proportion of patients in the Resolute Integrity group had more than one coronary lesion (25%) compared with the BioMatrix Flex group (22%). Total stent length per patient was significantly longer in the Resolute Integrity group (21 mm) than in the BioMatrix Flex group (18 mm).

The trial excluded patients who were expected to die within a year, who could not provide written informed consent, or who were deemed to be at unacceptable risk if put on 12 months of dual antiplatelet treatment. It also excluded patients who were allergic to aspirin, clopidogrel, prasugrel, ticagrelor, zotarolimus, or biolimus.

The study was funded by Biosensors Interventional Technologies, which makes the biolimus-eluting biodegradable stent, and by Medtronic CardioVascular, which makes the zotarolimus-eluting permanent polymer stent. Dr. Raungaard reported having no financial disclosures.

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