{"id":"707f6df0b2ea","type":"article","url":"https://hartvaat.nl/2016/05/17/biodegradeerbare-sirolimus-eluting-stents-de-panda-iii-trial/","title":"Biodegradeerbare sirolimus-eluting stents: de PANDA III-trial","title_en":"Biodegradable Polymer-Based Sirolimus-Eluting Stents With Differing Elution and Absorption Kinetics: The PANDA III Trial.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2016.03.475","source_url":"https://doi.org/10.1016/j.jacc.2016.03.475","authors":["Bo Xu","Runlin Gao","Yuejin Yang","Xuebin Cao","Lei Qin","Yi Li","Zhanquan Li","Xueqi Li","Hailong Lin","Yong Guo","Yitong Ma","Jian'an Wang","Shaoping Nie","Liang Xu","Eric Cao","Changdong Guan","Gregg W Stone"],"significance":5,"published":"2016-05-17","source_date":"2016-05-17","image":"","kennis":[],"congress":"","summary_en":"The PANDAS III randomized trial compared two biodegradable polymer sirolimus-eluting stents with different drug elution and polymer absorption kinetics, testing whether these design parameters affect clinical outcomes.","created":"2026-07-03T10:26:07Z","updated":"2026-07-03T13:25:28Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Gerandomiseerde trial die twee biodegradeerbare polymer-gebaseerde sirolimus-eluting stents met verschillende elutie- en absorptiekinetiek vergeleek. Onderzoekt de invloed van stentontwerp op klinische uitkomsten.","abstract_original":"BACKGROUND: Whether the rate of drug elution and polymer absorption affects clinical outcomes of biodegradable polymer-based drug-eluting stents (DES) is unknown. The widely used polylactide polymer-based Excel stent (JW Medical, Weihai, China) elutes sirolimus within 180 days, and the polylactide polymer is completely absorbed within 6 to 9 months. In contrast, the poly-lactide-co-glycolide polymer-based BuMA stent (Sino Medical, Tianjin, China) elutes sirolimus within 30 days, and the poly-lactide-co-glycolide polymer is completely absorbed within 3 months. Thus, both metallic DES elute sirolimus, isolating major differences to the polymer and elution kinetics. OBJECTIVES: The goal of this study was to compare the safety and effectiveness between the BuMA sirolimus-eluting stent (SES) and Excel SES in an \"all-comers\" population. METHODS: PANDA III was a multicenter trial with few exclusion criteria, powered for sequential noninferiority and superiority testing. The primary endpoint was 1-year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization. RESULTS: Between December 2013 and August 2014, 2,348 patients were randomly assigned to treatment with BuMA (n = 1,174) or Excel SES (n = 1,174). The 1-year primary endpoint of TLF occurred in 6.4% of patients in each group (difference: 0.06%; 95% confidence interval: 1.93% to 2.04%; pnoninferiority = 0.0003; psuperiority = 0.95). There were no significant between-group differences in any of the secondary endpoints other than the incidence of definite/probable stent thrombosis, which occurred less frequently with the BuMA stent (0.5% vs. 1.3%; log-rank p = 0.048). CONCLUSIONS: The BuMA SES was demonstrated to be noninferior to the Excel SES for 1-year TLF, with a lower incidence of stent thrombosis. (Comparison of BuMA eG Based BioDegradable Polymer Stent With EXCEL Biodegradable Polymer Sirolimus-eluting Stent in \"Real-World\" Practice [PANDA-III]; NCT02017275)."}