The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)

CORONARY INTERVENTIONS

A randomised comparison of healing response between the BuMA Supreme stent and the XIENCE stent at one-month and two-month follow-up: PIONEER-II OCT randomised controlled trial

EuroIntervention 2018;14:e1306-e1315 published online August 2018. DOI: 10.4244/EIJ-D-18-00461

1. Academic Medical Center, Amsterdam, the Netherlands; 2. St. Luke’s International Hospital, Tokyo, Japan; 3. The General Hospital of Chinese People’s Liberation Army, Beijing, China; 4. Erasmus Medical Center, Rotterdam, the Netherlands; 5. Shanghai 9th People’s Hospital, Shanghai, China; 6. Affiliated Hospital of Zunyi Medical College, Guizhou Sheng, China; 7. Wuhan Asia Heart Hospital, Wuhan, China; 8. Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Zhejiang, China; 9. 2nd Affiliated Hospital of Nanchang University, Nanchang, China; 10. 1st Affiliated Hospital of Dalian Medical University, Liaoning Sheng, China; 11. 1st Affiliated Hospital of Xi’an Jiaotong University, Shaanxi Sheng, China; 12. Imperial College London, London, United Kingdom; 13. Cardialysis, Rotterdam, the Netherlands

Aims: The aim of this study was to compare the strut coverage of the XIENCE stent with that of the BuMA Supreme sirolimus-eluting cobalt-chromium stent, which has a shorter drug elution, on optical coherence tomography (OCT) one or two months after implantation.

Methods and results: The PIONEER-II OCT trial was a multicentre, two-arm randomised trial, which comprised two cohorts: cohort-1 underwent an OCT imaging one month after coronary intervention (BuMA: 16 patients with 18 lesions, XIENCE: 15 patients with 17 lesions), whereas cohort-2 underwent OCT at two months (BuMA: 21 patients with 21 lesions, XIENCE: 23 patients with 28 lesions). The primary hypotheses were non-inferiority of the BuMA stent to the XIENCE stent in percent strut coverage at one month (cohort-1) or two months (cohort-2). In cohort-1, the BuMA stent was non-inferior to the XIENCE stent in terms of the strut coverage (83.8±10.4% for BuMA vs. 73.0±17.5% for XIENCE, pfor noninferiority <0.001), and was also significantly higher than the XIENCE (pfor superiority 0.037). In cohort-2, the BuMA stent was non-inferior to the XIENCE stent in OCT strut coverage (80.3±18.3% vs. 73.3±21.3%, pfor noninferiority 0.006, pfor superiority 0.24). Healing scores showed better healing in the BuMA stent in cohort-1 (32.36±21.59 vs. 54.88±34.65, p=0.027), whereas there was comparable healing between the BuMA and XIENCE stents in cohort-2 (39.86±37.77 vs. 53.75±42.84, p=0.25).

Conclusions: The BuMA Supreme had a faster coverage than the XIENCE at one month, presumably due to faster and shorter sirolimus elution. The difference in tissue coverage became less evident at two months. ClinicalTrials.gov Identifier: NCT02747329.

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