Drug-Eluting Stenting Followed by Cilostazol Treatment Reduces Late Restenosis in Patients With Diabetes Mellitus. The DECLARE-DIABETES Trial (A Randomized Comparison of Triple Antiplatelet Therapy With Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation in Diabetic Patients)

Seung Whan Lee, Seong Wook Park, Young Hak Kim, Sung Cheol Yun, Duk Woo Park, Cheol Whan Lee, Myeong Ki Hong, Hyun Sook Kim, Jae Ki Ko, Jae Hyeong Park, Jae Hwan Lee, Si Wan Choi, In Whan Seong, Yoon Haeng Cho, Nae Hee Lee, June Hong Kim, Kook Jin Chun, Seung Jung Park

Research output: Contribution to journalArticle

169 Citations (Scopus)

Abstract

Objectives: We sought to evaluate the impact of cilostazol on neointimal hyperplasia after drug-eluting stent (DES) implantation in patients with diabetes mellitus (DM). Background: Although cilostazol has reduced the extent of neointimal hyperplasia and restenosis in patients after bare-metal stent implantation, it is not known whether this effect occurs after DES implantation in diabetic patients. Methods: This randomized, multicenter, prospective study compared triple antiplatelet therapy (aspirin, clopidogrel, and cilostazol, triple group, n = 200) and dual antiplatelet therapy (aspirin and clopidogrel, standard group, n = 200) for 6 months in patients with DM receiving DES. The primary end point was in-stent late loss at 6 months. Results: The 2 groups had similar baseline clinical and angiographic characteristics. The in-stent (0.25 ± 0.53 mm vs. 0.38 ± 0.54 mm, p = 0.025) and in-segment (0.42 ± 0.50 mm vs. 0.53 ± 0.49 mm, p = 0.031) late loss were significantly lower in the triple versus standard group, as were 6-month in-segment restenosis (8.0% vs. 15.6%, p = 0.033) and 9-month target lesion revascularization (TLR) (2.5% vs. 7.0%, p = 0.034). At 9 months, major adverse cardiac events, including death, myocardial infarction, and TLR, tended to be lower in the triple than in the standard group (3.0% vs. 7.0%, p = 0.066). Multivariate analysis showed that sirolimus-eluting stents and the use of cilostazol were strong predictors of reduced restenosis or TLR. Conclusions: Triple antiplatelet therapy after DES implantation decreased angiographic restenosis and extent of late loss, resulting in a reduced risk of 9-month TLR compared with dual antiplatelet therapy in diabetic patients.

Original languageEnglish
Pages (from-to)1181-1187
Number of pages7
JournalJournal of the American College of Cardiology
Volume51
Issue number12
DOIs
Publication statusPublished - 2008 Mar 25

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Drug-Eluting Stents
clopidogrel
Diabetes Mellitus
Stents
Pharmaceutical Preparations
Aspirin
Hyperplasia
Therapeutics
Sirolimus
Multicenter Studies
Multivariate Analysis
Metals
Myocardial Infarction
cilostazol
Prospective Studies

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Lee, Seung Whan ; Park, Seong Wook ; Kim, Young Hak ; Yun, Sung Cheol ; Park, Duk Woo ; Lee, Cheol Whan ; Hong, Myeong Ki ; Kim, Hyun Sook ; Ko, Jae Ki ; Park, Jae Hyeong ; Lee, Jae Hwan ; Choi, Si Wan ; Seong, In Whan ; Cho, Yoon Haeng ; Lee, Nae Hee ; Kim, June Hong ; Chun, Kook Jin ; Park, Seung Jung. / Drug-Eluting Stenting Followed by Cilostazol Treatment Reduces Late Restenosis in Patients With Diabetes Mellitus. The DECLARE-DIABETES Trial (A Randomized Comparison of Triple Antiplatelet Therapy With Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation in Diabetic Patients). In: Journal of the American College of Cardiology. 2008 ; Vol. 51, No. 12. pp. 1181-1187.
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title = "Drug-Eluting Stenting Followed by Cilostazol Treatment Reduces Late Restenosis in Patients With Diabetes Mellitus. The DECLARE-DIABETES Trial (A Randomized Comparison of Triple Antiplatelet Therapy With Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation in Diabetic Patients)",
abstract = "Objectives: We sought to evaluate the impact of cilostazol on neointimal hyperplasia after drug-eluting stent (DES) implantation in patients with diabetes mellitus (DM). Background: Although cilostazol has reduced the extent of neointimal hyperplasia and restenosis in patients after bare-metal stent implantation, it is not known whether this effect occurs after DES implantation in diabetic patients. Methods: This randomized, multicenter, prospective study compared triple antiplatelet therapy (aspirin, clopidogrel, and cilostazol, triple group, n = 200) and dual antiplatelet therapy (aspirin and clopidogrel, standard group, n = 200) for 6 months in patients with DM receiving DES. The primary end point was in-stent late loss at 6 months. Results: The 2 groups had similar baseline clinical and angiographic characteristics. The in-stent (0.25 ± 0.53 mm vs. 0.38 ± 0.54 mm, p = 0.025) and in-segment (0.42 ± 0.50 mm vs. 0.53 ± 0.49 mm, p = 0.031) late loss were significantly lower in the triple versus standard group, as were 6-month in-segment restenosis (8.0{\%} vs. 15.6{\%}, p = 0.033) and 9-month target lesion revascularization (TLR) (2.5{\%} vs. 7.0{\%}, p = 0.034). At 9 months, major adverse cardiac events, including death, myocardial infarction, and TLR, tended to be lower in the triple than in the standard group (3.0{\%} vs. 7.0{\%}, p = 0.066). Multivariate analysis showed that sirolimus-eluting stents and the use of cilostazol were strong predictors of reduced restenosis or TLR. Conclusions: Triple antiplatelet therapy after DES implantation decreased angiographic restenosis and extent of late loss, resulting in a reduced risk of 9-month TLR compared with dual antiplatelet therapy in diabetic patients.",
author = "Lee, {Seung Whan} and Park, {Seong Wook} and Kim, {Young Hak} and Yun, {Sung Cheol} and Park, {Duk Woo} and Lee, {Cheol Whan} and Hong, {Myeong Ki} and Kim, {Hyun Sook} and Ko, {Jae Ki} and Park, {Jae Hyeong} and Lee, {Jae Hwan} and Choi, {Si Wan} and Seong, {In Whan} and Cho, {Yoon Haeng} and Lee, {Nae Hee} and Kim, {June Hong} and Chun, {Kook Jin} and Park, {Seung Jung}",
year = "2008",
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doi = "10.1016/j.jacc.2007.11.049",
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Drug-Eluting Stenting Followed by Cilostazol Treatment Reduces Late Restenosis in Patients With Diabetes Mellitus. The DECLARE-DIABETES Trial (A Randomized Comparison of Triple Antiplatelet Therapy With Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation in Diabetic Patients). / Lee, Seung Whan; Park, Seong Wook; Kim, Young Hak; Yun, Sung Cheol; Park, Duk Woo; Lee, Cheol Whan; Hong, Myeong Ki; Kim, Hyun Sook; Ko, Jae Ki; Park, Jae Hyeong; Lee, Jae Hwan; Choi, Si Wan; Seong, In Whan; Cho, Yoon Haeng; Lee, Nae Hee; Kim, June Hong; Chun, Kook Jin; Park, Seung Jung.

In: Journal of the American College of Cardiology, Vol. 51, No. 12, 25.03.2008, p. 1181-1187.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Drug-Eluting Stenting Followed by Cilostazol Treatment Reduces Late Restenosis in Patients With Diabetes Mellitus. The DECLARE-DIABETES Trial (A Randomized Comparison of Triple Antiplatelet Therapy With Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation in Diabetic Patients)

AU - Lee, Seung Whan

AU - Park, Seong Wook

AU - Kim, Young Hak

AU - Yun, Sung Cheol

AU - Park, Duk Woo

AU - Lee, Cheol Whan

AU - Hong, Myeong Ki

AU - Kim, Hyun Sook

AU - Ko, Jae Ki

AU - Park, Jae Hyeong

AU - Lee, Jae Hwan

AU - Choi, Si Wan

AU - Seong, In Whan

AU - Cho, Yoon Haeng

AU - Lee, Nae Hee

AU - Kim, June Hong

AU - Chun, Kook Jin

AU - Park, Seung Jung

PY - 2008/3/25

Y1 - 2008/3/25

N2 - Objectives: We sought to evaluate the impact of cilostazol on neointimal hyperplasia after drug-eluting stent (DES) implantation in patients with diabetes mellitus (DM). Background: Although cilostazol has reduced the extent of neointimal hyperplasia and restenosis in patients after bare-metal stent implantation, it is not known whether this effect occurs after DES implantation in diabetic patients. Methods: This randomized, multicenter, prospective study compared triple antiplatelet therapy (aspirin, clopidogrel, and cilostazol, triple group, n = 200) and dual antiplatelet therapy (aspirin and clopidogrel, standard group, n = 200) for 6 months in patients with DM receiving DES. The primary end point was in-stent late loss at 6 months. Results: The 2 groups had similar baseline clinical and angiographic characteristics. The in-stent (0.25 ± 0.53 mm vs. 0.38 ± 0.54 mm, p = 0.025) and in-segment (0.42 ± 0.50 mm vs. 0.53 ± 0.49 mm, p = 0.031) late loss were significantly lower in the triple versus standard group, as were 6-month in-segment restenosis (8.0% vs. 15.6%, p = 0.033) and 9-month target lesion revascularization (TLR) (2.5% vs. 7.0%, p = 0.034). At 9 months, major adverse cardiac events, including death, myocardial infarction, and TLR, tended to be lower in the triple than in the standard group (3.0% vs. 7.0%, p = 0.066). Multivariate analysis showed that sirolimus-eluting stents and the use of cilostazol were strong predictors of reduced restenosis or TLR. Conclusions: Triple antiplatelet therapy after DES implantation decreased angiographic restenosis and extent of late loss, resulting in a reduced risk of 9-month TLR compared with dual antiplatelet therapy in diabetic patients.

AB - Objectives: We sought to evaluate the impact of cilostazol on neointimal hyperplasia after drug-eluting stent (DES) implantation in patients with diabetes mellitus (DM). Background: Although cilostazol has reduced the extent of neointimal hyperplasia and restenosis in patients after bare-metal stent implantation, it is not known whether this effect occurs after DES implantation in diabetic patients. Methods: This randomized, multicenter, prospective study compared triple antiplatelet therapy (aspirin, clopidogrel, and cilostazol, triple group, n = 200) and dual antiplatelet therapy (aspirin and clopidogrel, standard group, n = 200) for 6 months in patients with DM receiving DES. The primary end point was in-stent late loss at 6 months. Results: The 2 groups had similar baseline clinical and angiographic characteristics. The in-stent (0.25 ± 0.53 mm vs. 0.38 ± 0.54 mm, p = 0.025) and in-segment (0.42 ± 0.50 mm vs. 0.53 ± 0.49 mm, p = 0.031) late loss were significantly lower in the triple versus standard group, as were 6-month in-segment restenosis (8.0% vs. 15.6%, p = 0.033) and 9-month target lesion revascularization (TLR) (2.5% vs. 7.0%, p = 0.034). At 9 months, major adverse cardiac events, including death, myocardial infarction, and TLR, tended to be lower in the triple than in the standard group (3.0% vs. 7.0%, p = 0.066). Multivariate analysis showed that sirolimus-eluting stents and the use of cilostazol were strong predictors of reduced restenosis or TLR. Conclusions: Triple antiplatelet therapy after DES implantation decreased angiographic restenosis and extent of late loss, resulting in a reduced risk of 9-month TLR compared with dual antiplatelet therapy in diabetic patients.

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