Sirolimus-eluting stents with biodegradable polymer did not offer better outcomes compared with instant-classic (and undoubtedly valid) everolimus-eluting stents with durable polymer such as Xience.
New-generation drug-eluting stents (DES) offer better outcomes than first-generation devices after a 10-year follow-up, according to the ISAR-TEST 4 trial presented at the American Heart Association (AHA) Congress Scientific Sessions and published simultaneously in Circulation. This study also investigated the potential late benefit of using a biodegradable versus durable polymer, which could not be confirmed.
Two stents reduced the rates of combined events and all-cause death compared with first-generation sirolimus-eluting stent Cypher: everolimus-eluting stent Xience and sirolimus-eluting stent Yukon Choice PC.
Read also: AHA 2018 | More Evidence for the Impella Device, But Larger Trials Are Necessary.
Long-term data beyond 5 years comparing new-generation DES with biodegradable polymer and older stents with durable polymer were unclear, and this work was the first to provide information in this regard.
ISAR-TEST 4 was initiated in 2007 and included 2603 patients with ischemic symptoms or evidence of myocardial ischemia and lesions in a native coronary artery, who were randomized 2:1:1 to stenting with Yukon Choice PC, Xience, or Cypher. About 29% of patients had diabetes, and 86% presented multivessel disease. Additionally, 40% experienced acute coronary syndromes.
The 10-year follow-up was available in 83% of patients, with a mean follow-up of 10.6 years. At this extended follow-up, there were significant differences in terms of combined events (death, infarction, target-vessel revascularization) and all-cause death in all subgroups, featuring lower rates with the two new-generation stents.
Read also: AHA 2018 | Canakinumab Reduces Hospitalization for Cardiac Failure in Respondents.
The rate for combined events was 47.7% with Yukon Choice PC, 46.0% with Xience, and 54.9% with Cypher, thus demonstrating relative risk reductions of 18% to 21% with new devices. Mortality rates were 31.8%, 30.3%, and 37.2%, respectively, indicating relative risk reductions of 18% to 22% with the new devices vs. Cypher.
Original title: Ten-Year Clinical Outcomes from a Trial of Three Limus-Eluting Stents with Different Polymer Coatings in Patients with Coronary Artery Disease: Results from the ISAR-TEST 4 Randomized Trial.
Reference: Kufner S et al. Circulation. 2018; Epub ahead of print.
ISAR-TEST-4-DES-ultima-generacion
Get the latest scientific articles on interventional cardiologySubscribe to our weekly newsletter
We are interested in your opinion. Please, leave your comments, thoughts, questions, etc., below. They will be most welcome.
