Abstract
BackgroundEarlier vascular healing after drug-eluting stent (DES) implantation may reduce the incidence of late stent thrombosis and provide theoretical evidence to shorten dual antiplatelet therapy duration in patients with high bleeding risks. The BuMA supreme stent is a newly developed DES-coated with the sirolimus by using the international patent electronic grafted eG™ technology. Previous randomized trials showed that BuMA stents had better stent-strut coverage at 3-month follow-ups, which were evaluated by optical coherence tomography (OCT). However, there have been a limited number of studies that are directly evaluating the extent of neointima formation at the first and second months after stent implantation in high-bleeding-risk patients with coronary artery disease. This clinical trial is designed to demonstrate the non-inferiority of the BuMA supreme stent compared to the XIENCE stent in early neointimal formation.Methods/designThis is a prospective, multicenter, randomized trial. Forty patients will be assigned into the first-month OCT group, and another 40 patients into the second-month OCT group. The patients in each cohort will be randomized again into two groups in a 1:1 ratio, either being implanted with the BuMA Supreme stent or the Xience V/Prime/Xpedition stent. The primary endpoint is stent-strut neointimal coverage rate (%) at the first and second months, respectively. Secondary endpoints include neointimal hyperplasia area/volume, neointimal hyperplasia thickness, stent-strut malapposition rate, late lumen loss (LLL), restenosis rate, device/lesion/clinical success rate, device-oriented composite endpoints at the first and second months, stent thrombosis and other serious adverse events and bleeding events at follow-up.DiscussionThe results will provide the first accurate imaging evidence on neointimal formation of the BuMA Supreme stent and the Xience stent at 1–2 months post PCI. The result should inspire further exploration and adjustment of DAPT treatments.Trial registrationClinicalTrials.gov, ID: NCT02747329. Registered on 21 April 2016. Last updated 17 May 2018.
Highlights
Earlier vascular healing after drug-eluting stent (DES) implantation may reduce the incidence of late stent thrombosis and provide theoretical evidence to shorten dual antiplatelet therapy duration in patients with high bleeding risks
This study can provide accurate imaging evidence on early neointimal formation of the BuMA and Xience stents, and provide evidence for further exploration and adjustment of dual anti-platelet therapy (DAPT) treatment. Study design This is a prospective, multicenter, randomized clinical trial that should demonstrate the non-inferiority of the BuMA Supreme stent compared with the Xience stent on neointimal healing response evaluated by optical coherence tomography (OCT)
percutaneous coronary intervention (PCI) is widely used for patients with coronary artery disease (CAD) all over the world
Summary
PCI is widely used for patients with CAD all over the world. Compared with BMS, DES reduce the rate of restenosis from 20–35% to 10% and reduce the consequent need for TLR. For BuMA stents that used international-patent, electronic-grafted (eG) technology, common problems, such as stent surface cracking and residue after drug release, are solved successfully, leading to rapid and complete endometrial healing and inhibition of late stent thrombosis This feature is more conducive to helping patients with a relatively high risk of bleeding to adjust their DAPT treatment regimen. The thinner stent strut may further benefit the endothelium healing, which will bring the patients more safety benefits This is the first study 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) 1 or 2 months after implantation; and it will give us accurate imaging evidence on neointimal formation of the BuMA Supreme stent and the Xience stent at 1–2 months post PCI.
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