Ridaforolimus eluting stent for the treatment of Japanese patients with coronary disease: 1 year outcomes of the JNIR study.

Autor: Saito S; Department of Cardiology, Shonan Kamakura General Hospital, Okamoto 1370-1, Kamakura, 247-8533, Japan. saito@shonankamakura.or.jp., Yamazaki S; Tokushukai Sapporo Higashi Hospital, Sapporo, Japan., Otsuji S; Higashi Takarazuka Satoh Hospital, Takarazuka, Japan., Nakamura S; Kyoto-Katsura Hospital, Kyoto, Japan., Takahashi A; Takahashi Hospital, Kobe, Japan., Kawasaki T; Shin Koga Hospital, Kurume, Japan., Hasegawa K; Saitama Sekishinkai Hospital, Sayama, Japan., Kandzari DE; Piedmont Heart Institute, Atlanta, GA, USA., Ozan MO; Clinical Trials Center, Cardiovascular Research Foundation, New York, NY, USA., Liu M; Clinical Trials Center, Cardiovascular Research Foundation, New York, NY, USA., Perlman GY; Medinol Ltd., Tel Aviv, Israel., Ben-Yehuda O; Clinical Trials Center, Cardiovascular Research Foundation, New York, NY, USA.; NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, NY, USA.
Jazyk: angličtina
Zdroj: Cardiovascular intervention and therapeutics [Cardiovasc Interv Ther] 2021 Jul; Vol. 36 (3), pp. 273-280. Date of Electronic Publication: 2020 Jun 26.
DOI: 10.1007/s12928-020-00680-4
Abstrakt: Background: Japanese patients have shown improved outcomes after treatment with drug eluting stents compared with Western patients. Outcomes with the ridaforolimus-eluting EluNIR stent in Japanese patients are unknown.
Methods and Results: This was a multi-center trial in Japanese patients undergoing PCI with the ridaforolimus eluting EluNIR stent. A propensity-score matched analysis was performed with the EluNIR arm of the BIONICS trial. The matched cohort was compared with the Japanese patients for the primary endpoint of target lesion failure (TLF) in a non-inferiority study. 104 Japanese patients were compared with 410 matched patients from BIONICS. Baseline characteristics were similar except for more frequent multi-vessel disease in the BIONICS cohort. Post dilation was more likely in Japanese patients (90.4% vs. 64.6%, p < 0.001). TLF at 12 months was met by 2 patients (1.9%) in the JNIR study compared with 5.3% in the BIONICS group (Pnoninf = 0.0028). Rates of MI (0% vs. 4.7%, p = 0.03), target vessel MI (0% vs. 3.7%, p = 0.04), MACE (1.0% vs. 6.2%, p = 0.03) and TVF (1.0% vs. 6.9%, p = 0.02) were all significantly lower among Japanese patients.
Conclusion: Treatment of Japanese patients with the EluNIR stent is associated with very low rates of adverse events, significantly fewer than seen in the BIONICS trial.
Databáze: MEDLINE
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