Why the study?
Do bioresorbable polymer-coated everolimus-eluting stents (SYNERGY) improve clinical outcomes in complex patients compared to durable polymer-coated everolimus-eluting stents (XIENCE)?
Do bioresorbable polymer-coated everolimus-eluting stents (SYNERGY) improve clinical outcomes in complex patients compared to durable polymer-coated everolimus-eluting stents (XIENCE)?
Bioresorbable polymer-coated everolimus-eluting stents demonstrate comparable safety and efficacy to durable polymer-coated stents at 1 year in real-world complex patients.
Comparable one-year MACE rates in complex patients do not favor bioresorbable over durable polymer stents; leaves open longer-term randomized comparisons.
AIMS: The aim of this study was to evaluate the safety and efficacy profile of new-generation, SYNERGY everolimus-eluting stents (S-EES) as compared to XIENCE everolimus-eluting stents (X-EES) with a durable polymer coating in "complex patients". METHODS AND RESULTS: We included 2,001 consecutive patients treated with S-EES (n=400) or X-EES (n=1,601) at two Italian centres between May 2013 and May 2015. We used propensity score matching to obtain two cohorts of patients with similar baseline risk profiles. Patients were stratified according to baseline complexity based on the EVOLVE II trial exclusion criteria. The primary outcome was major adverse cardiac events (MACE), defined as the composite of all-cause death, myocardial infarction (MI), and target lesion revascularisation (TLR), at one year. Among 391 matched pairs of patients treated with S-EES or X-EES, we identified 253 (63%) as complex. At one-year follow-up, among "complex" patients, MACE rates did not differ between the S-EES and X-EES groups (9.9% vs. 9.5%, p=0.830, HR 1.04, CI: 0.72-1.48). Similarly, death, MI, and TLR, stratified for complexity, were comparable between S-EES and X-EES treated patients at one year. Of note, no definite ST was observed in either the S-EES or the X-EES cohort. CONCLUSIONS: New-generation S-EES with a bioresorbable polymer coating appear to be safe and effective irrespective of patient complexity as compared to X-EES.
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Mennuni et al. (2017) studied this question.
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