The present work compared the safety and efficacy of the permanent polymer zotarolimus eluting stent vs. the biodegradable polymer biolimus eluting stent in unselected coronary artery disease patients.
The biodegradable polymer biolimus eluting stent resulted superior to the first generation durable polymer stent in long term randomized studies. However, little evidence supports this superiority when compared to the current durable polymer DES.
The study was randomized, multicenter and with no inferiority design in patients with stable coronary artery disease, acute coronary syndromes and, at least, one coronary lesion requiring stent implantation. End points included a combination of major adverse cardiac events (cardiac death and acute myocardial infarction). In addition, end point individual components were analyzed separately, including probable or definite thrombosis at 36 months.
Between March 2011 and August 2012, the study enrolled 2999 patients randomized 1:1 to receiving the zotarolimus eluting stent (1502 patients) vs. the biolimus eluting stent (1497 patients).
At three year follow up, combined events (MACE) occurred in 128 patients (8.6%) of those receiving the durable polymer stent vs. 144 patients (9.6%) of those receiving the biodegradable polymer stents (p=0.36).
Cardiac death (2.7% vs. 3.4%), acute myocardial infarction (2.7% vs 2.5%) and lesion revascularization (5.4% vs. 5.5%) did not significantly differ between both groups.
Neither did very late definite thrombosis, with 0.4% for the durable polymer and 0.7% for the biodegradable polymer (p=0.33).
Conclusion
At three years, the durable polymer zotarolimus eluting stent and the degradable polymer biolimus eluting stent saw similar adverse events rates and saw non-significant differences in safety and efficacy, including definite thrombosis.
Original Title: Comparison of Durable-Polymer Zotarolimus-Eluting and Biodegradable-Polymer Biolimus-Eluting Coronary Stents in Patients with Coronary Artery Disease. 3-Year Clinical Outcomes in the Randomized SORT OUT VI Trial.
Reference: Raungaard B et al. JACC Cardiovasc Interv. 2017 Feb 13;10(3):255-264.
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