Two-year safety evaluation of a biodegradable polymer sirolimus-eluting stent with increased drug elution and polymer absorption kinetics in complex patient and lesion cohort
Catheterization and Cardiovascular Interventions Feb 18, 2020
Jia S, Guan C, Yuan J, et al. - In a subgroup of complex patients and lesions, researchers compared 2-year safety results of two biodegradable polymer (BP) sirolimus-eluting stents (SESs) with distinct drug-eluting and polymer absorption kinetics, given the non-inferiority of BuMA BP SES to the Excel SES in target lesion failure has been shown in the previously published PANDA III study. To be eligible for inclusion in the PANDA III trial, the patients were required to satisfy one or more of the following criteria: small vessel disease (reference vessel diameter ≤ 2.5 mm); long lesion (lesion length ≥ 20 mm); chronic total occlusion lesion; and diabetic patients. In the PANDA III study, a total of 2,348 patients were randomly allocated to treatment with BuMA (n = 1,174) or Excel SES (n = 1,174). Of those, 858 and 855 in the BuMA group and Excel group, respectively, met the inclusion criteria. A follow-up of 2 years revealed a significantly lower incidence of definite/probable stent thrombosis in BuMA SES group vs Excel SES group. In complex patient and lesion population, the increased safety benefit of the BuMA SES was more prominently observed in two-year subgroup analysis of the all-comer PANDA III trial.
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