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Previous report of the PANDA III trial has demonstrated that the novel PLGA polymer-based BuMA sirolimus-eluting stent (SES) (Sino Medical, Tianjin, China) was non-inferior to the PLA polymer-based Excel SES (JW Medical, Weihai, China) for the primary endpoint of 1-year target lesion failure (TLF), with a lower incidence of stent thrombosis (ST). We sought to investigate whether the safety and efficacy profiles of BuMA SES, a device with more rapid drug elution and polymer absorption kinetics, would persist at 2 years.
PANDA III was a randomized trial comparing 2 biodegradable polymer (BP)-based SESs with different drug elution profiles and polymer biodegradation kinetics in an “all-comer” population. The primary endpoint was 1-year TLF, a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization. Secondary endpoints included patient-oriented composite endpoint (PoCE), a composite of all-cause death, all MI, or any revascularization, TLF and PoCE components, and ST. Long-term clinical follow-up was scheduled annually up to 5 years for all enrolled patients.
A total of 2,348 eligible patients were randomly assigned to receive either the BuMA SES (n = 1,174) or the Excel SES (n = 1,174). The mean age was 61.2±10.6 years, 24.3% had diabetes, and 31.2% had acute myocardial infarction within 1 month. Baseline SYNTAX scores were 14.5±9.2 in the BuMA group and 14.8±9.3 in the Excel group (p = 0.46). One-year TLF occurred in 6.4% of patients in each group (difference: 0.06%; 95% confidence interval: -1.93% to 2.04%; p for non-inferiority = 0.0003, p for superiority = 0.95). There were no significant between-group differences in any of the secondary endpoints other than the incidence of definite/probable ST, which occurred less frequently with the BuMA stent (0.5% vs. 1.3%; p = 0.048). The 2-year clinical follow-up is ongoing and the results will be available at TCT.
Two-year follow-up is warranted to assess if there are potential differences in clinical outcomes between the 2 BP-SESs. The impact of drug elution profiles and polymer biodegradation kinetics on clinical outcomes requires further investigations.
CORONARY: Stents: Drug-Eluting