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A RANDOMIZED COMPARISON OF NOBORI BIOLIMUS A9 ELUTING STENT WITH CYPHER SIROLIMUS ELUTING STENT FOR CORONARY REVASCULARIZATION IN JAPANESE POPULATION
A192.E1800 JACC March 9, 2010 Volume 55, issue 10A
i2 SUMMIT A RANDOMIZED COMPARISON OF NOBORI BIOLIMUS A9 ELUTING STENT WITH CYPHER SIROLIMUS ELUTING STENT FOR CORONARY REVASCULARIZATION IN JAPANESE POPULATION i2 Poster Contributions Georgia World Congress Center, Hall B5 Sunday, March 14, 2010, 3:30 p.m.-4:30 p.m.
Session Title: DES II, Restenosis, Left Main and Outcomes Abstract Category: PCI - DES Presentation Number: 2502-420 Authors: Toshiya Muramatsu, Masashi Iwabuchi, Shigeru Saito, Yasuhiko Hayashi, Yuji Ikari, Kenshi Fujii, Shinsuke Nanto, Naoto Inoue, Takeshi Kimura, Atsuo Namiki, Haruo Hirayama, Osamu Doi, Mitsuo Kashida, Junji Yajima, Kazuaki Mitsudo, Saiseikai Yokohama-city Eastern Hospital, Yokohama, Japan Background: The newly developed Nobori stent coated with a bioabsorbable polymer, poly-lactic acid and the anti-proliferative agent Biolimus A9 has compared to Paclitaxel Eluting Stent (PES) by RCT in Europe and showed non-inferiority. However, there is no data of this new Nobori stent and Sirolimus Eluting Stent (SES). This is the world first RCT report of Nobori Biolimus Eluting stent compared to SES (Cypher) to know the level of efficacy and safety in a Japanese population. Methods: We performed double blind, randomized trial (3:2) comparing Nobori and SES in 335 patients (Nobori 198 : SES 137) at 15 centers in Japan. Patients of single, primary lesions in up to two native coronary arteries were treated. The primary end point was Target Vessel Failure (TVF) at 9 months after procedure. The secondary end points included in-stent late lumen loss(LL), percentage of diameter stenosis(%DS) and restenosis rate(RR) at 8 months after procedure. We also analyzed Major Adverse Cardiac Events (MACE) at 9 months after procedure. Results: As for the primary end point, TVF rate of Nobori group was non-inferior compared to SES group at 9 months (7.4% versus 6.3%; noninferiority test (P<0.001)) As for secondary end point at 8months, LL of Nobori group showed 0.12 ± 0.31 mm versus SES group 0.14± 0.34 mm (95%CI, -0.08 to 0.05). %DS of Nobori group showed 12.2% ± 9.3% versus SES group 15.4% ± 13.5% (95%CI, -5.7 to 0.9). RR of Nobori group showed 1.9% versus SES group 2.9% (95%CI, -4.3~2.4). MACE was 5.2% in Nobori group and 6.1% in SES group (95%CI, -7.2 to 3.9). No stent thrombosis defined as definite or probable in ARC definition was occurred up to 9 months in both groups. Conclusions: The primary end point, TVF showed this first Japanese Good Clinical Practice regulated RCT confirmed Nobori group is non interior compare to SES group (Cypher). Long term clinical follow-up is undergoing and expect to be investigated.
i2 SUMMIT A RANDOMIZED COMPARISON OF NOBORI BIOLIMUS A9 ELUTING STENT WITH CYPHER SIROLIMUS ELUTING STENT FOR CORONARY REVASCULARIZATION IN JAPANESE POPULATION i2 Poster Contributions Georgia World Congress Center, Hall B5 Sunday, March 14, 2010, 3:30 p.m.-4:30 p.m.
Session Title: DES II, Restenosis, Left Main and Outcomes Abstract Category: PCI - DES Presentation Number: 2502-420 Authors: Toshiya Muramatsu, Masashi Iwabuchi, Shigeru Saito, Yasuhiko Hayashi, Yuji Ikari, Kenshi Fujii, Shinsuke Nanto, Naoto Inoue, Takeshi Kimura, Atsuo Namiki, Haruo Hirayama, Osamu Doi, Mitsuo Kashida, Junji Yajima, Kazuaki Mitsudo, Saiseikai Yokohama-city Eastern Hospital, Yokohama, Japan Background: The newly developed Nobori stent coated with a bioabsorbable polymer, poly-lactic acid and the anti-proliferative agent Biolimus A9 has compared to Paclitaxel Eluting Stent (PES) by RCT in Europe and showed non-inferiority. However, there is no data of this new Nobori stent and Sirolimus Eluting Stent (SES). This is the world first RCT report of Nobori Biolimus Eluting stent compared to SES (Cypher) to know the level of efficacy and safety in a Japanese population. Methods: We performed double blind, randomized trial (3:2) comparing Nobori and SES in 335 patients (Nobori 198 : SES 137) at 15 centers in Japan. Patients of single, primary lesions in up to two native coronary arteries were treated. The primary end point was Target Vessel Failure (TVF) at 9 months after procedure. The secondary end points included in-stent late lumen loss(LL), percentage of diameter stenosis(%DS) and restenosis rate(RR) at 8 months after procedure. We also analyzed Major Adverse Cardiac Events (MACE) at 9 months after procedure. Results: As for the primary end point, TVF rate of Nobori group was non-inferior compared to SES group at 9 months (7.4% versus 6.3%; noninferiority test (P<0.001)) As for secondary end point at 8months, LL of Nobori group showed 0.12 ± 0.31 mm versus SES group 0.14± 0.34 mm (95%CI, -0.08 to 0.05). %DS of Nobori group showed 12.2% ± 9.3% versus SES group 15.4% ± 13.5% (95%CI, -5.7 to 0.9). RR of Nobori group showed 1.9% versus SES group 2.9% (95%CI, -4.3~2.4). MACE was 5.2% in Nobori group and 6.1% in SES group (95%CI, -7.2 to 3.9). No stent thrombosis defined as definite or probable in ARC definition was occurred up to 9 months in both groups. Conclusions: The primary end point, TVF showed this first Japanese Good Clinical Practice regulated RCT confirmed Nobori group is non interior compare to SES group (Cypher). Long term clinical follow-up is undergoing and expect to be investigated.