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Randomized Controlled Trial
. 2021 Jul;36(3):273-280.
doi: 10.1007/s12928-020-00680-4. Epub 2020 Jun 26.

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

Shigeru Saito  1 , Seiji Yamazaki  2 , Satoru Otsuji  3 , Shigeru Nakamura  4 , Akihiko Takahashi  5 , Tomohiro Kawasaki  6 , Kotaro Hasegawa  7 , David Edward Kandzari  8 , Melek Ozgu Ozan  9 , Mengdan Liu  9 , Gidon Yehuda Perlman  10 , Ori Ben-Yehuda  9   11
Affiliations
Randomized Controlled Trial

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

Shigeru Saito et al. Cardiovasc Interv Ther. 2021 Jul.

Abstract

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.

Keywords: Japan; PCI; Ridaforolimus eluting stent.

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References

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