Background: The everolimus-eluting stent (EES) is a newly developed drug-eluting stent using the MULTILINK VISION stent platform combined with the drug everolimus contained in a polymer coating. Recently reported randomized trials have shown the noninferiority and subsequent superiority of the EES compared with the paclitaxel-eluting stent regarding in-stent late loss (LL) at 180 days. However, there have been no studies comparing head to head the EES with the sirolimus-eluting stent (SES), which has shown the least amount of LL among the previously released drug-eluting stent (DES). In addition, adjunctive antiplatelet therapy is a critical factor in optimizing long-term DES safety. Despite the recommendation of the American Heart Association/American College of Cardiology to maintain 12 months of dual antiplatelet therapy, there have been no prospective randomized trials comparing the efficacy and safety of different durations. Study Design: In the Efficacy of Xience/promus versus Cypher in rEducing Late Loss after stENTing (EXCELLENT) trial, approximately 1,400 patients are being prospectively and randomly assigned in a 2 × 2 factorial design according to the type of stent (EES vs SES) and the duration of dual antiplatelet therapy (6 vs 12 months). The primary end point is in-segment LL at 9 months for comparison of type of stent, and the coprimary end point is target vessel failure at 12 months for comparison of dual antiplatelet therapy duration. Summary: The EXCELLENT trial is the largest study yet performed to directly compare the efficacy and safety of the EES versus the SES. In addition, this study will also address the issue of a 6- versus 12-month duration of dual antiplatelet therapy for post-percutaneous coronary intervention management.
Bibliographical noteFunding Information:
This is a prospective, randomized, open-label, 2 × 2 factorial designed multicenter trial to test whether EES is noninferior to SES in preventing LL and to test whether a 6-month duration of DAT is noninferior to a 12-month duration of DAT in preventing the occurrence of TVF. In total, approximately 1,400 patients will be enrolled at 17 centers in Korea. After enrollment and index PCI procedure, clinical follow-up will occur at 1, 3, 9, 12 months and yearly up to 5 years after intervention. The investigator may conduct follow-up as telephone contacts or office visits. An angiographic follow-up will be required at 9 months to determine late luminal loss. The trial algorithm is shown in Figure 1 . This study is an investigator-initiated clinical trial with grant support from 3 sources: the Ministry of Health, Welfare, and Family Affairs of the Republic of Korea; Boston Scientific Korea (Seoul, Korea); and Abbott Korea Ltd (Seoul, Korea). Other than providing financial support, the companies were not involved with the protocol development or the study process, including site selection, management, and data collection and analysis. The authors are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of the paper and its final contents. The protocol of the trial has been registered at www.clinicaltrials.gov ( NCT00698607 ).
All Science Journal Classification (ASJC) codes
- Cardiology and Cardiovascular Medicine