Clinical performance of a drug-eluting stent with a biodegradable polymer in an unselected patient population: the NOBORI 2 study
Por:
Danzi, GB, Chevalier, B, Urban, P, Fath-Ordoubadi, F, Carrie, D, Wiemer, M, Serra, A, Wijns, W, Kala, P, Stabile, A, Ruigomez, JG, Sagic, D, Laanmets, P, Strupp, G, West, N, Paunovic, D
Publicada:
1 may 2012
Resumen:
Aims: Previous studies for approved indications (on-label) have shown the good safety and efficacy profiles of the Nobori DES. We conducted a prospective, multicentre study to validate the clinical performance of this stent in a real-world setting.
Methods and results: A total of 3,067 consecutive patients undergoing a percutaneous coronary intervention with the Nobori DES were enrolled in the NOBORI 2 registry. At one and two years, 97% and 95% of patients, respectively, were available for follow-up. The rates of target lesion failure (TLF), cardiac death, myocardial infarction and target lesion revascularisations were: 3.9%, 1.2%, 1.9% and 2.2% at one year and 5.1%, 1.6%, 2.4% and 3.0% at two years. Overall, 2,242 patients (73%) were treated for at least one off-label indication. When comparing off-label and on-label groups, the results were: TLF 4.5% vs. 2.2%, p=0.003 at one year and 5.9% vs. 2.8%, p=0.001 at two years. The rate of stent thrombosis was 0.68%, and 0.80% at one and two years, respectively with no difference between the off-label and on-label groups (0.76% vs. 0.48%, p=0.6 and 0.89% vs. 0.61%, p=0.5).
Conclusions: The promising results previously observed in lower risk patients can be replicated in daily practice. As expected, in off-label indications, rates of adverse events were higher. Nevertheless, our results suggest the good and sustained performance of this stent system in high-risk patients with significant comorbidities and/or complex lesions. (Clinical trial registration: ISRCTN81649913; http://www.controlled-trials.com/isrctn/search.html?srch=81649913&sort=3&dir=desc&max=10)
Filiaciones:
Danzi, GB:
Osped Maggiore Policlin, Fdn IRCCS Ca Granda, Div Cardiol, I-20122 Milan, Italy
Chevalier, B:
Inst Cardiovasc Paris S, Massy Quincy, France
Urban, P:
Hop Tour, Geneva, Switzerland
Fath-Ordoubadi, F:
Royal Infirm, Manchester, Lancs, England
Carrie, D:
CHU Rangueil, F-31054 Toulouse, France
Wiemer, M:
Herz & Diabet Zentrum Bad Oeynhausen, Bad Oeynhausen, Germany
Serra, A:
Hosp Mar, Barcelona, Spain
Hospital St. Pau, Barcelona, Spain
Wijns, W:
Ctr Cardiovasc, Aalst, Belgium
Kala, P:
Univ Hosp Brno, Brno, Czech Republic
Stabile, A:
Osped Civ Arnas, Palermo, Italy
Ruigomez, JG:
Hosp Puerta de Hierro, Madrid, Spain
Sagic, D:
Inst Cardiovasc Dis Dedinje, Belgrade, Serbia
Laanmets, P:
N Estonia Reg Hosp, Tallinn, Estonia
Strupp, G:
Klinikum Fulda AG, Fulda, Germany
West, N:
Papworth Hosp, Cambridge CB3 8RE, England
Paunovic, D:
Terumo Europe NV, Louvain, Belgium
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