TY - JOUR JO - EuroIntervention TI - 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 AB - <p class="text-1er-paragraph"><span class="abstracts-titres">Aims:</span> 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.</p><p class="text-1er-paragraph"></p><p class="text-1er-paragraph"><span class="abstracts-titres">Methods and results:</span> 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, p<span class="indice">for noninferiority</span> &lt;0.001), and was also significantly higher than the XIENCE (p<span class="indice">for superiority</span> 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%, p<span class="indice">for noninferiority</span> 0.006, p<span class="indice">for superiority</span> 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).</p><p class="text-1er-paragraph"></p><p class="text-1er-paragraph"><span class="abstracts-titres">Conclusions:</span> 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.</p> AU - Asano Taku AU - Jin Qinhua AU - Katagiri Yuki AU - Kogame Norihiro AU - Takahashi Kuniaki AU - Chang Chin Chun AU - Chichareon Ply AU - Wang ChangQian AU - Shi Bei AU - Su Xi AU - Fu Guo-Sheng AU - Wu YanQing AU - Zhou XuChen AU - Yuan Zuyi AU - Wykrzykowska Joanna J. AU - Piek J. Jan AU - Serruys Patrick W. AU - Onuma Yoshinobu AU - Chen Yundai VL - 14 IS - 12 Y1 - 20/12/2018 Y1 - 2018 DOI - 10.4244/EIJ-D-18-00461 SP - e1306 EP - e1315 KW - clinical research KW - optical coherence tomography KW - stable angina PB - Europa Digital & Publishing SE - CORONARY INTERVENTIONS UR - https://eurointervention.pcronline.com/article/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 SN - 1774-024X ER -