Efficacy of Xience/promus versus Cypher in rEducing Late Loss after stENTing (EXCELLENT) trial: Study design and rationale of a Korean multicenter prospective randomized trial

Kyung Woo Park, Junghan Yoon, Jung Sun Kim, Joo Yong Hahn, Young Seok Cho, In Ho Chae, Hyeon Cheol Gwon, Taehoon Ahn, Byung Hee Oh, Jeong Euy Park, Won Heum Shim, Eak Kyun Shin, Yangsoo Jang, Hyo Soo Kim

Research output: Contribution to journalArticle

27 Citations (Scopus)

Abstract

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.

Original languageEnglish
JournalAmerican Heart Journal
Volume157
Issue number5
DOIs
Publication statusPublished - 2009 Jan 1

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Stents
Drug-Eluting Stents
Sirolimus
Safety
Therapeutics
Percutaneous Coronary Intervention
Paclitaxel
Everolimus
Polymers

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Park, Kyung Woo ; Yoon, Junghan ; Kim, Jung Sun ; Hahn, Joo Yong ; Cho, Young Seok ; Chae, In Ho ; Gwon, Hyeon Cheol ; Ahn, Taehoon ; Oh, Byung Hee ; Park, Jeong Euy ; Shim, Won Heum ; Shin, Eak Kyun ; Jang, Yangsoo ; Kim, Hyo Soo. / Efficacy of Xience/promus versus Cypher in rEducing Late Loss after stENTing (EXCELLENT) trial : Study design and rationale of a Korean multicenter prospective randomized trial. In: American Heart Journal. 2009 ; Vol. 157, No. 5.
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abstract = "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.",
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Efficacy of Xience/promus versus Cypher in rEducing Late Loss after stENTing (EXCELLENT) trial : Study design and rationale of a Korean multicenter prospective randomized trial. / Park, Kyung Woo; Yoon, Junghan; Kim, Jung Sun; Hahn, Joo Yong; Cho, Young Seok; Chae, In Ho; Gwon, Hyeon Cheol; Ahn, Taehoon; Oh, Byung Hee; Park, Jeong Euy; Shim, Won Heum; Shin, Eak Kyun; Jang, Yangsoo; Kim, Hyo Soo.

In: American Heart Journal, Vol. 157, No. 5, 01.01.2009.

Research output: Contribution to journalArticle

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T1 - Efficacy of Xience/promus versus Cypher in rEducing Late Loss after stENTing (EXCELLENT) trial

T2 - Study design and rationale of a Korean multicenter prospective randomized trial

AU - Park, Kyung Woo

AU - Yoon, Junghan

AU - Kim, Jung Sun

AU - Hahn, Joo Yong

AU - Cho, Young Seok

AU - Chae, In Ho

AU - Gwon, Hyeon Cheol

AU - Ahn, Taehoon

AU - Oh, Byung Hee

AU - Park, Jeong Euy

AU - Shim, Won Heum

AU - Shin, Eak Kyun

AU - Jang, Yangsoo

AU - Kim, Hyo Soo

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Y1 - 2009/1/1

N2 - 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.

AB - 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.

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