OrbusNeich has announced the initiation of GATEWAY, an investigator-led, multicentre registry in the United Kingdom to explore the usage of the company’s Genous Stent in patients with acute coronary syndrome undergoing percutaneous coronary intervention who are considered to be at significant risk of bleeding based on a pre-procedural review.
The government approved GATEWAY study protocol recommends that these patients undergo three months of dual anti-platelet therapy or less following stent implantation.
The non-randomised, observational prospective registry will enrol 280 patients at eight sites. The primary endpoint of the registry is the occurrence of net adverse clinical events (NACE) at 30 days and one year follow-up. The NACE rate is defined as a composite of major post-procedural bleeding and major adverse cardiac events consisting of death, myocardial re-infarction and target vessel revascularisation for ischaemia or stroke.
“High-risk patients who present with non-ST segment elevation myocardial infarction (NSTEMI) remain a challenge,” said David Smith, Regional Cardiac Centre at Morriston Hospital, Swansea, UK, and principal investigator of the trial. “Identification of patients with a higher propensity for bleeding may lead to improvements in NSTEMI care by prompting clinicians to make judicious treatment selections, carefully dose antithrombotic medications and proceed with strategies to optimise individual patient care. In patients with high risk of bleeding, this enhanced balance between anti-ischaemic efficacy and bleeding safety is obviously attractive and may improve survival.”