To Örebro University

Background: The safety and efficacy of the Promus Element stent have been recently demonstrated in a selected population from one randomized trial. The aim of this study was to describe the initial clinical experience with the everolimus eluting platinum chromium stent (Promus Element) in unselected patients from a real life nationwide registry.

Methods: The Promus Element DES was compared to all other DES implanted in Sweden (with more than 500 implants) from November 2009 to March 2011. The results were assessed using Cox regression.

Results: A total of 13,577 stents (Promus Element, n = 2724, Cypher, n = 782; Endeavor, n = 747; Taxus Liberte, n = 1393, Xience V/Promus, n = 4832, Resolute, n = 1566, Xience Prime, n = 4832) were implanted at 8375 procedures. At one year the restenosis rate in the Promus Element was not significantly different from the overall DES group (2.8% vs. 2.7%, adjusted HR: 1.17, 95% CI: 0.75-1.75). A significantly lower restenosis rate was observed in the Promus Element when compared with Endeavor (2.8% vs. 5.8%; adjusted HR: 0.44; 95% CI: 0.26-0.74). The stent thrombosis (ST) rate at one year was not significantly different in the Promus Element as compared with the overall DES group (0.2% vs. 0.5% adjusted HR: 0.59; 95% CI: 025-1.40). ST rate was significantly lower as compared with Endeavor stent (0.2% vs. 0.8%; HR: 0.24; 95% CI: 0.08-0.67).

Conclusions: In a large unselected population the Promus Element stent appears to be safe and effective with a low risk of restenosis and ST. (C) 2011 Elsevier Ireland Ltd. All rights reserved.