Clinical performance of a drug-eluting stent with a biodegradable polymer in an unselected patient population: the NOBORI 2 study

DANZI, Gian Battista, Bernard CHEVALIER, Philip URBAN, Farzin FATH-ORDOUBADI, Didier CARRIE, Marcus WIEMER, Antonio SERRA, William WIJNS, Petr KALA, Amerigo STABILE, Javier GOICOLEA RUIGOMEZ, Dragan SAGIC, Peep LAANMETS, Gerhard STRUPP, Nick WEST a Dragica PAUNOVIC. Clinical performance of a drug-eluting stent with a biodegradable polymer in an unselected patient population: the NOBORI 2 study. EUROINTERVENTION. EUROPA EDITION, 2012, roč. 8, č. 1, s. 109-116. ISSN 1774-024X. Dostupné z: https://dx.doi.org/10.4244/EIJV8I1A17.

Základní údaje

• Originální název: Clinical performance of a drug-eluting stent with a biodegradable polymer in an unselected patient population: the NOBORI 2 study
• Autoři: DANZI, Gian Battista, Bernard CHEVALIER, Philip URBAN, Farzin FATH-ORDOUBADI, Didier CARRIE, Marcus WIEMER, Antonio SERRA, William WIJNS, Petr KALA, Amerigo STABILE, Javier GOICOLEA RUIGOMEZ, Dragan SAGIC, Peep LAANMETS, Gerhard STRUPP, Nick WEST a Dragica PAUNOVIC.
• Vydání: EUROINTERVENTION, EUROPA EDITION, 2012, 1774-024X.

Další údaje

• Originální jazyk: angličtina
• Typ výsledku: Článek v odborném periodiku
• Obor: 30201 Cardiac and Cardiovascular systems
• Stát vydavatele: Francie
• Utajení: není předmětem státního či obchodního tajemství
• Impakt faktor: Impact factor: 3.173
• Organizační jednotka: Lékařská fakulta
• Doi: http://dx.doi.org/10.4244/EIJV8I1A17
• UT WoS: 000305593300017
• Klíčová slova anglicky: drug-eluting stent; biodegradable polymer; off-label indication
• Příznaky: Mezinárodní význam

Anotace

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.