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Biodegradable Polymer-Based Sirolimus-Eluting Stents With Differing Elution and Absorption Kinetics: The PANDA III Trial.
- Source :
-
Journal of the American College of Cardiology (JACC) . May2016, Vol. 67 Issue 19, p2249-2258. 10p. - Publication Year :
- 2016
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Abstract
- <bold>Background: </bold>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.<bold>Objectives: </bold>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.<bold>Methods: </bold>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.<bold>Results: </bold>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).<bold>Conclusions: </bold>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). [ABSTRACT FROM AUTHOR]
- Subjects :
- *DRUG-eluting stents
*RAPAMYCIN
*BIODEGRADABLE plastics
*DRUG absorption
*POLYLACTIC acid
*CARDIAC arrest
*CORONARY heart disease treatment
*CARDIOVASCULAR system
*COMPARATIVE studies
*LONGITUDINAL method
*RESEARCH methodology
*MEDICAL care
*MEDICAL cooperation
*MYOCARDIAL infarction
*MYOCARDIAL revascularization
*POLYESTERS
*POLYMERS
*PROSTHETICS
*RESEARCH
*THROMBOSIS
*EVALUATION research
*RANDOMIZED controlled trials
Subjects
Details
- Language :
- English
- ISSN :
- 07351097
- Volume :
- 67
- Issue :
- 19
- Database :
- Academic Search Index
- Journal :
- Journal of the American College of Cardiology (JACC)
- Publication Type :
- Academic Journal
- Accession number :
- 115067823
- Full Text :
- https://doi.org/10.1016/j.jacc.2016.03.475