Data from a multicentre trial show that the Genous stent (OrbusNeich) is safe when accompanied by only 10 days of dual antiplatelet therapy. Results were published in the November issue of EuroIntervention.
From 49 patients treated with Genous, none of them had died or had reached the study’s primary endpoint of sudden cardiac death, myocardial infarction or angiographic evidence of stent thrombosis ascribable to the study stent at three-month follow-up. At this time, three patients had undergone repeat revascularisation, with target lesion revascularisation in two patients.
“Despite this very short-term dual antiplatelet therapy regimen, we observed only one case of stent thrombosis at 26 days in a patient who had previously undergone percutaneous coronary intervention and stenting in the mid-left anterior descending artery with a bare metal stent,” said Giuseppe M Sangiorgi, corresponding author of the study, University of Rome Tor Vergata, Rome, Italy. “Coronary angiography disclosed thrombotic occlusion in this stent, while the nearby Genous stent appeared patent and devoid of thrombus. This supports the case for Genous as a safe and effective treatment alternative for patients who cannot comply with a four-week-or-longer course of dual antiplatelet therapy due to either bleeding risk or the need for a near-term invasive non-cardiac procedure.”
Antonio Colombo, EMO GVM Centro Cuore Columbus and the Interventional Cardiology Unit, S Raffaele Hospital, Milan, Italy, and principal investigator of the study, added, “The data obtained are encouraging and may justify the launch of a larger study powered to test the possibility to utilise the Genous stent with reduced duration of dual antiplatelet therapy.”
The study included patients with de novo lesions in vessels able to receive a 2.5 mm Genous stent. Patients received clopidogrel for 10 days, accompanied by lifelong aspirin administration. Seventy per cent of the patients discontinued clopidogrel nine to 11 days after stenting. For the patients treated, the average age was 64.2 years, with 83.4% male patients and 18.7% of patients having been diagnosed with diabetes mellitus. Approximately half of the patients (55.1%) were diagnosed with multivessel disease, and the left anterior descending artery branches were the most commonly treated (61.2% of cases). A total of 55 Genous stents were implanted.