Comparison between two biodegradable polymer-based sirolimus-eluting stents with differing drug elution and polymer absorption kinetics: two-year clinical outcomes of the PANDA III trial.

Aims: In the PANDA III trial, the novel poly-lactide-co-glycolide polymer-based BuMA sirolimus-eluting stent (SES) was non-inferior to the polylactide polymer-based Excel SES for the primary endpoint of one-year target lesion failure (TLF), with a lower incidence of stent thrombosis. We sought to investigate whether the effectiveness profile of BuMA SES, with more rapid drug elution and polymer absorption kinetics, would persist at two years.
Methods and Results: A total of 2,348 patients (mean age, 61.2±10.6 years; 24.3% diabetics; 31.2% with acute myocardial infarction within one month) were randomly assigned to receive either BuMA SES (n=1,174) or Excel SES (n=1,174) in the "all-comer" PANDA III trial. Two-year clinical follow-up was available for 2,262 (96.3%) patients. The incidence of TLF and the patient-oriented composite endpoint (PoCE) was low and similar between the BuMA and Excel groups (7.4% vs. 6.9%, p=0.67, and 13.1% vs. 10.9%, p=0.11, respectively). The rate of any revascularisation was significantly higher with the BuMA SES (6.8% vs. 4.6%, p=0.03). Definite and probable thrombosis occurred in 0.7% and 1.4% of patients in the BuMA and Excel groups, respectively (p=0.10).
Conclusions: Two-year rates of TLF and PoCE events were low and similar between the two biodegradable polymer-based SES.