The SYNERGY bioabsorbable polymer everolimus-eluting stent resulted in similar two-year target lesion failure compared to the PROMUS Element durable polymer stent (5.5% vs 6.1%, P=0.87).
RCT (n=291)
Yes
Does a bioabsorbable polymer everolimus-eluting stent improve IVUS and clinical outcomes compared to a durable polymer everolimus-eluting stent in patients requiring percutaneous coronary intervention?
A novel bioabsorbable polymer everolimus-eluting stent demonstrated equivalent 6-month IVUS outcomes and 2-year clinical outcomes compared to a permanent polymer everolimus-eluting stent.
Absolute Event Rate: 5.5% vs 6.1%
p-value: p=0.87
AIMS: The EVOLVE FHU trial demonstrated non-inferiority of six-month late loss with two dose formulations of SYNERGY, a novel bioabsorbable polymer everolimus-eluting stent (EES) compared with the durable polymer PROMUS Element (PE) EES. The current analysis describes the six-month IVUS and clinical results through two years from the EVOLVE FHU trial. METHODS AND RESULTS: EVOLVE recruited 291 patients from 29 centres. At six months, IVUS-assessed in-stent net volume obstruction was 3.40 ± 5.06% for PROMUS Element (PE) vs. 2.68 ± 4.60% for SYNERGY (p=0.34) and 3.09 ± 4.29% for SYNERGY ½ dose (p=0.68 vs. PE). There were no significant differences between groups for any other measured IVUS parameter including resolved, persistent, and late-acquired incomplete stent apposition (ISA). At two years, target lesion failure (TLF) was 6.1% for PE vs. 5.5% for SYNERGY (p=0.87) and 5.2% for SYNERGY ½ dose (p=0.81). There were no significant differences between groups for cardiac death, repeat revascularisation, MI or stent thrombosis through two years. CONCLUSIONS: At six months, everolimus delivered from an ultrathin bioabsorbable abluminal polymer resulted in equivalent net volume obstruction and ISA compared with a permanent polymer EES. There were no significant differences between PE and either SYNERGY stent for any major cardiac endpoint through two years. Clinical trials number: NCT01135225.
Meredith et al. (Mon,) reported a rct. SYNERGY bioabsorbable polymer everolimus-eluting stent vs. PROMUS Element durable polymer everolimus-eluting stent was evaluated on Target lesion failure (TLF) at two years (p=0.87). The SYNERGY bioabsorbable polymer everolimus-eluting stent resulted in similar two-year target lesion failure compared to the PROMUS Element durable polymer stent (5.5% vs 6.1%, P=0.87).