Purpose The use of drug eluting stents (DES) in every day clinical practice is not restricted to approved indications. The safety of this approach is not fully established. Therefore we initiated a large study to assess, in a real life setting, the usage practice and outcomes of patients treated with Nobori®, a new generation DES, coated only abluminally with a matrix of biodegradable polymer and Biolimus A9.
Methods As a part of the large NOBORI 2 study, one thousand consecutive patients treated with Nobori DES are enrolled in 125 centres across Europe and Asia. Patients were stratified in two pre-specified groups according to the risk factors and lesion characteristics. On-label, group 1 comprised patients with characteristics similar to pre-approval clinical trials; Off-label, group 2 was composed of patients with a higher complexity, which would be excluded from those trials. Primary endpoint was Target Lesion Failure (TLF), a composite of cardiac death, MI and target lesion revascularization (TLR) at 6 and 12 months, while secondary endpoints included Target Vessel Failure (TVF), stent thrombosis, death/MI, TLR, at 1, 6 and 12 months, 2, 3, 4 and 5 years. Data are entered in an electronic database and extensive on site and 100% on line monitoring for all patients are performed. Clinical events are adjudicated by an independent clinical event committee and all baseline angiograms are analysed by independent corelab.
Results In this, real-world population, 68% of patients (n=680) were treated for off-label indications. The most frequent off label use was acute myocardial infarction (37%), bifurcation stenting (26%), restenosis (8.4%), CTO (4.2%) and SVG (3.5%). Patients with off label indications had significantly more lesions treated (1.6 vs 1.1; p<0.01), more lesions in vessels smaller than 2.5 mm (39% vs 30%; p<0.01), and lesions >20 mm (52% vs 33% p<0.01) and more stents implanted (2.0 vs 1.2 p<0.01). There were no differences in cardiac risk factors. At 1-year follow-up, primary endpoint of TLF was 2.8% in on- and 4.4% in off-label treated patients, while TVF rate was 3.1% vs 5.4%. Stent thrombosis rate was similar in both groups (0.5% and 0.9%) and they were early. Abstract 102 Table 1 shows the individual component of MACE.
Conclusion Preliminary results of this large multicentre registry confirm excellent safety and efficacy profile of the Nobori stent in both groups of patients. Long term follow-up data for a large patient population as in this study, will better determine safety of current practice with this particular device.
- Drug eluting stent