Medtronic has released clinical results of a five-year study of Endeavor program on drug-eluting stent (DES) as a treatment for coronary artery disease at American College of Cardiology’s 59th Scientific Session.
Medtronic said that the E-Pooled analysis, which includes five-year data from the Endeavor I (E-I), Endeavor II (E-II), E-II Continued Access (CA), and Endeavor III (E-III) clinical studies, and three-year data from the Endeavor IV (E-IV) and Endeavor Pharmacokinetics (E-PK) clinical studies, demonstrates striking consistency in clinical results across multiple studies.
The E-Pooled analysis includes patients who were treated with the Endeavor DES in E-I, E-PK, E-II, E-II CA, E-III and E-IV; it uses the Medtronic Driver bare-metal stent (BMS) control arm of E-II as a comparator.
The E-Pooled analysis also includes clinical data on more than 2,100 Endeavor patients from six clinical trials distinguished by 100% patient monitoring, 100% source data verification and independent, blinded event adjudication performed at the Harvard Clinical Research Institute.
The data released are the final five-year results from the Endeavor III randomised controlled trial comparing the Endeavor DES to the Cypher DES (from Johnson & Johnson’s Cordis) with a primary angiographic endpoint of late lumen loss at eight months.
The E-III five-year results show low rates of MACE, TLR and ST for Endeavor patients which are consistent with the E-Pooled analysis. They also reveal difference in rates of CD/MI as well as a trend toward lower MACE in favor of the Endeavor DES.
E-III five-year outcomes confirm the phenomena of late catch-up in TLR with the Cypher DES: From years 1–5 of follow up, the data show a TLR increase of 86% with the Cypher DES compared to 21% with the Endeavor stent. The difference in TLR rates after the first year of patient follow up in E-III drives similar overall TLR rates at five years. Additionally, MACE increased in the Cypher patients by 173% compared to 74 % in the Endeavor patients, the company reports.
David Kandzari, co-principal investigator of E-III and E-IV of Medtronic, said: “The consistency of results across these well conducted clinical trials is remarkable. The Endeavor stent has demonstrated a very compelling safety and efficacy profile wherein there is a very low likelihood that patients treated with the Endeavor stent will experience late stent clotting or the need for a repeat procedure beyond the first year of follow up.”