Assessing the short-term angiographic and clinical outcomes of the healing-targeted supreme drug-eluting stent: PIONEER II
Rattachement africain : cn, ph, us. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
Background and purpose: Matching the anti-proliferative drug effect with endothelial healing after drug-eluting stent (DES) implantation may help reduce cardiac events, especially stent thrombosis. A previous PIONEER II optical coherence tomography (OCT) sub-study demonstrated significantly better 1-month strut coverage with the novel healing-targeted BuMA Supreme DES, which was designed with a drug elution period of 4 to 6 weeks after implantation, compared with the XIENCE everolimus eluting stent (EES). This clinical trial aimed to evaluate whether the early endothelial healing observed in previous OCT sub-study would translate into improved intermediate-term angiographic and short-term clinical outcomes. Methods: PIONEER II was a multicenter, prospective, tandem clinical trial conducted in China. It was part of a series of clinical investigations of the BuMA Supreme DES, together with PIONEER I in Europe and PIONEER III in the United States, Canada, Europe, and Japan. The efficacy and safety of the BuMA Supreme DES were evaluated in patients with de novo coronary artery lesions. Results: From December 2015 to March 2018, 459 patients were randomly assigned to the randomized controlled trial (RCT) arm and received either the BuMA Supreme DES (n = 226) or the BuMA biodegradable polymer sirolimus-eluting stent (BP-SES; n = 233). In addition, 819 patients were enrolled in the objective performance criteria (OPC) arm. In the RCT arm, the BuMA Supreme DES was non-inferior to the BuMA BP-SES with respect to 9-month in-stent late lumen loss (LLL), with values of 0.23 ± 0.37 mm and 0.27 ± 0.36 mm, respectively (difference: −0.046 mm, 95% confidence interval: −0.107 to 0.015; P < 0.001 for non-inferiority). Furthermore, the BuMA Supreme DES demonstrated significantly lower values for secondary angiographic endpoints, including in-segment LLL and in-stent/in-segment diameter stenosis, compared with the BuMA BP-SES. In the OPC arm analysis, which combined patients from the BuMA Supreme group of the RCT arm with patients enrolled in the single-arm cohort, the 1-year target lesion failure rate was 4.17%. Both primary endpoints met the pre-specified non-inferiority criteria. Conclusion: The BuMA Supreme DES was non-inferior to the BuMA BP-SES with respect to 9-month in-stent LLL and was associated with the expected target lesion failure rate and a low incidence of stent thrombosis at 1-year follow-up.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Assessing the short-term angiographic and clinical outcomes of the healing-targeted supreme drug-eluting stent: PIONEER II
- Date Crossref
- 18/08/2026
- Éditeur
- Ovid Technologies (Wolters Kluwer Health)
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Sun Yat-sen University pays non établi dans la noticeUniversité ou école supérieure
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Fudan University Department of Cardiology pays non établi dans la noticeUniversité ou école supérieure
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Zhongshan Hospital pays non établi dans la noticeÉtablissement de santé
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Chinese Academy of Medical Sciences & Peking Union Medical College pays non établi dans la noticeUniversité ou école supérieure
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Chinese General Hospital College of Nursing and Liberal Arts pays non établi dans la noticeÉtablissement de santé
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People's Liberation Army No. 150 Hospital pays non établi dans la noticeÉtablissement de santé
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Chinese People’s Liberation Army 263 hospital pays non établi dans la noticeEntreprise
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Beijing Anzhen Hospital pays non établi dans la noticeÉtablissement de santé
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Jiangsu Province Hospital pays non établi dans la noticeÉtablissement de santé
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Nanjing Medical University pays non établi dans la noticeUniversité ou école supérieure
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First Affiliated Hospital of GuangXi Medical University pays non établi dans la noticeÉtablissement de santé
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Central South University pays non établi dans la noticeUniversité ou école supérieure
Sun Yat-sen University, Department of Cardiology — Fudan University et Zhongshan Hospital, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.