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

Danzi, Gian Battista; Chevalier, Bernard; Urban, Philip; Fath‐Ordoubadi, Farzin; Carrié, Didier; Wiemer, Marcus; Serra, Antonio; Wijns, William; Kala, Petr; Stabile, Amerigo; Ruigómez, Javier Goicolea; Sagić, Dragan; Laanmets, Peep; Strupp, Gerhard; West, Nick E.J.; Paunovic, Dragica

doi:10.4244/eijv8i1a17

Cited by 47 publications

(35 citation statements)

References 28 publications

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“…38 Preclinical and imaging data were also supportive for the biocompatibility of the Nobori BES, because a lower inflammatory response in the stented segments, and rapid recovery of endothelial function with preserved endotheliumdependent vasomotion at adjacent stent segments were demonstrated for the Nobori BES as compared with the SES. 39, 40 The results of this meta-analysis are also in line with the 1-year data from the NOBORI 2 registry, 41 in which a total of 3,067 patients were enrolled. Indeed, TLR and definite/probable ST rates were 2.2% and 0.7% in the NOBORI 2 registry, compared with 3.2% and 0.55%, respectively in the present study.…”

Section: As Reported Insupporting

confidence: 64%

Nobori Biolimus-Eluting Stent vs. Permanent Polymer Drug-Eluting Stents in Patients Undergoing Percutaneous Coronary Intervention

Danzi

Piccolo

Galasso

et al. 2014

Circ J

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Section: As Reported Insupporting

confidence: 64%

Nobori Biolimus-Eluting Stent vs. Permanent Polymer Drug-Eluting Stents in Patients Undergoing Percutaneous Coronary Intervention

Danzi

Piccolo

Galasso

et al. 2014

Circ J

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“…At one-year, the primary endpoint (MACE) occurred in 4 (1.6%) patients. This is significantly lower than the 5.0% that was observed in the Nobori DES system (p = 0.014) and the 4.5% that was noted in BioMatrix stent (p = 0.028) [15] [16]. Moreover, ST was reported in only one patient (0.4%).…”

Section: Discussioncontrasting

confidence: 41%

One-Year Clinical Outcomes of Biodegradable Polymer-Coated Sirolimus-Eluting Coronary Stent System in Patients with Coronary Artery Disease

Kasturi¹,

Singh²,

Shanivaram³

et al. 2017

WJCD

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Background: The biodegradable polymer-coated sirolimus-eluting coronary stent (SES) system for the treatment of coronary artery disease (CAD) has been implanted in a real-world patient population. Aim: The present study was designed to evaluate the safety and performance of Metafor™ sirolimuseluting coronary stent (SES) system in consecutive patients with CAD in a real-world patient population. Methods: All the consecutive 251 patients who underwent percutaneous coronary interventions with the use of Metafor sirolimus-eluting stents were included in this study. Patients were clinically/telephonically followed-up at one-year from August 2015 to August 2016. We observed and analyzed major adverse cardiac event (MACE) defined as the aggregate of cardiac death, myocardial infarction (MI), and any target lesion revascularization (TLR) at one-year. Also, stent thrombosis (ST) was observed at one-year patients follow-up. Results: We collected and analyzed the data for 251 patients. Out of 251 participants, 191 (76.1%) were males, 95 (37.8%) patients had diabetes, 117 (46.6%) had ST-segment-elevation myocardial infarction (STEMI), and 134 (53.4%) had hypertension. Mean patient age was 56.35 ± 11.23 years. A total of 295 lesions were treated, out of which 13.6% of the lesions were the long lesion of ≥40 mm. At one-year, MACE occurred in 4 (1.6%) of 251 patients, consisting of 2 (0.8%) cardiac deaths, 2 (0.8%) MI, and 0 (0%) TLR. Stent thrombosis was reported in one patient (0.4%). Conclusions: This retrospective data demonstrated excellent safety and performance of Metafor SES in a "real-world" consecutive CAD patient, indicating low rates of MACE and ST at one-year follow-up.

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“…of 12 months is too short to off er a complete description of the safety profi le of the biolimus-eluting stent. In the NOBORI 2 study, 26 which assessed the biolimus-eluting Nobori stent, very low stent thrombosis rates were seen 12-24 months (0·10%) 26 and 24-36 months (0·10%) after implantation. 27 By contrast, results of the LEADERS trial showed that the sirolimus-eluting Cypher stent has a yearly incidence of very late stent thrombosis of about 0·6%.…”

Section: Discussionmentioning

confidence: 99%

Biolimus-eluting biodegradable polymer-coated stent versus durable polymer-coated sirolimus-eluting stent in unselected patients receiving percutaneous coronary intervention (SORT OUT V): a randomised non-inferiority trial

Christiansen¹,

Jensen²,

Thayssen³

et al. 2013

The Lancet

176

110

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

Cited by 47 publications

References 28 publications

Nobori Biolimus-Eluting Stent vs. Permanent Polymer Drug-Eluting Stents in Patients Undergoing Percutaneous Coronary Intervention

Nobori Biolimus-Eluting Stent vs. Permanent Polymer Drug-Eluting Stents in Patients Undergoing Percutaneous Coronary Intervention

One-Year Clinical Outcomes of Biodegradable Polymer-Coated Sirolimus-Eluting Coronary Stent System in Patients with Coronary Artery Disease

Biolimus-eluting biodegradable polymer-coated stent versus durable polymer-coated sirolimus-eluting stent in unselected patients receiving percutaneous coronary intervention (SORT OUT V): a randomised non-inferiority trial

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