title: Clinical performance of a drug-eluting stent with a biodegradable polymer in an unselected patient population: the NOBORI 2 study.
abstract: OBJECTIVE
  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.
  
  
  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.
authors.affiliation: Ospedale Maggiore Policlinico, Milan, Italy. gbdanzi@tin.it
authors.forename: Gian Battista
authors.initials: GB
authors.lastname: Danzi
authors.forename: Bernard
authors.initials: B
authors.lastname: Chevalier
authors.forename: Philip
authors.initials: P
authors.lastname: Urban
authors.forename: Farzin
authors.initials: F
authors.lastname: Fath-Ordoubadi
authors.forename: Didier
authors.initials: D
authors.lastname: Carrie
authors.forename: Marcus
authors.initials: M
authors.lastname: Wiemer
authors.forename: Antonio
authors.initials: A
authors.lastname: Serra
authors.forename: William
authors.initials: W
authors.lastname: Wijns
authors.forename: Petr
authors.initials: P
authors.lastname: Kala
authors.forename: Amerigo
authors.initials: A
authors.lastname: Stabile
authors.forename: Javier Goicolea
authors.initials: JG
authors.lastname: Ruigomez
authors.forename: Dragan
authors.initials: D
authors.lastname: Sagic
authors.forename: Peep
authors.initials: P
authors.lastname: Laanmets
authors.forename: Gerhard
authors.initials: G
authors.lastname: Strupp
authors.forename: Nick
authors.initials: N
authors.lastname: West
authors.forename: Dragica
authors.initials: D
authors.lastname: Paunovic
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D000704:Analysis of Variance; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D001208:Asia; D002317:Cardiovascular Agents / Q000008:administration & dosage; D003324:Coronary Artery Disease / Q000401:mortality / Q000628:therapy*; D054855:Drug-Eluting Stents; D005060:Europe; D005260:Female; D019983:Guideline Adherence; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D011108:Polymers; D017410:Practice Guidelines as Topic; D011356:Product Labeling; D011446:Prospective Studies; D011474:Prosthesis Design; D012042:Registries; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives; D013927:Thrombosis / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D011108:Polymers; C518022:umirolimus; D020123:Sirolimus