Multicenter randomized trial evaluating the efficacy of cilostazol on ischemic vascular complications after drug-eluting stent implantation for coronary heart disease

Results of the CILON-T (influence of cilostazol-based triple antiplatelet therapy on ischemic complication after drug-eluting stent implantation) trial

Jung Won Suh, Seung Pyo Lee, Kyung Woo Park, Hae Young Lee, Hyun Jae Kang, Bon Kwon Koo, Young Seok Cho, Tae Jin Youn, In Ho Chae, Dong Ju Choi, Seung-Woon Rha, Jang Ho Bae, Taek Geun Kwon, Jang Whan Bae, Myeong Chan Cho, Hyo Soo Kim

Research output: Contribution to journalArticle

153 Citations (Scopus)

Abstract

Objectives We aimed to test whether cilostazol has beneficial effects in the real-world patients treated with intracoronary drug-eluting stents (DES). Background The addition of cilostazol on the conventional dual antiplatelet therapy has been reported to reduce platelet reactivity and to improve clinical outcomes after percutaneous coronary intervention in previous studies. Methods In a randomized multicenter trial, we enrolled 960 patients who received DES. They were randomized to receive either dual antiplatelet therapy (DAT) (aspirin and clopidogrel) or triple antiplatelet therapy (TAT) (aspirin, clopidogrel, and cilostazol) for 6 months. Primary end point was the composite of cardiac death, nonfatal myocardial infarction, ischemic stroke, or target lesion revascularization (TLR). Secondary end points were P2Y12 reaction unit (PRU) measured with the VerifyNow P2Y12 assay (Accumetrics, San Diego, California) at discharge and at 6 months after the index procedure. All-cause death, stent thrombosis, and each component of the primary end point at 6 months were other secondary end points. Analysis was done on an intention-to-treat basis. Results At 6 months' follow-up, there was no difference in the primary end point between the 2 groups (8.5% in TAT vs. 9.2% in DAT, p = 0.74). In secondary end point analysis, the TAT group achieved lower PRU levels than the DAT group both at discharge (206.6 ± 90.3 PRU vs. 232.2 ± 80.3 PRU, p < 0.001) and at 6 months (210.7 ± 87.9 PRU vs. 255.7 ± 73.7 PRU, p < 0.001). In the Cox proportional hazards analysis, lesion length (<28 mm, hazard ratio [HR]: 2.10, 95% confidence interval [CI]: 1.25 to 3.52), and PRU level at discharge (every increase in tertile, HR: 1.61, 95% CI: 1.16 to 2.25) were predictors of the primary end point, but not the use of cilostazol (HR: 0.90, 95% CI: 0.54 to 1.52). Conclusions Despite the greater reduction of platelet reactivity by addition of cilostazol to conventional DAT, TAT did not show superiority in reducing the composite of adverse cardiovascular outcomes after DES implantation. (The Efficacy of CILostazol ON Ischemic Complications After DES Implantation [CILON-T]; NCT00776828)

Original languageEnglish
Pages (from-to)280-289
Number of pages10
JournalJournal of the American College of Cardiology
Volume57
Issue number3
DOIs
Publication statusPublished - 2011 Jan 18

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Drug-Eluting Stents
Multicenter Studies
Coronary Disease
Blood Vessels
clopidogrel
Confidence Intervals
Group Psychotherapy
Therapeutics
Aspirin
Blood Platelets
Percutaneous Coronary Intervention
cilostazol
Stents
Cause of Death
Thrombosis
Stroke
Myocardial Infarction

Keywords

  • cilostazol
  • DES
  • platelet reactivity

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Multicenter randomized trial evaluating the efficacy of cilostazol on ischemic vascular complications after drug-eluting stent implantation for coronary heart disease : Results of the CILON-T (influence of cilostazol-based triple antiplatelet therapy on ischemic complication after drug-eluting stent implantation) trial. / Suh, Jung Won; Lee, Seung Pyo; Park, Kyung Woo; Lee, Hae Young; Kang, Hyun Jae; Koo, Bon Kwon; Cho, Young Seok; Youn, Tae Jin; Chae, In Ho; Choi, Dong Ju; Rha, Seung-Woon; Bae, Jang Ho; Kwon, Taek Geun; Bae, Jang Whan; Cho, Myeong Chan; Kim, Hyo Soo.

In: Journal of the American College of Cardiology, Vol. 57, No. 3, 18.01.2011, p. 280-289.

Research output: Contribution to journalArticle

Suh, Jung Won ; Lee, Seung Pyo ; Park, Kyung Woo ; Lee, Hae Young ; Kang, Hyun Jae ; Koo, Bon Kwon ; Cho, Young Seok ; Youn, Tae Jin ; Chae, In Ho ; Choi, Dong Ju ; Rha, Seung-Woon ; Bae, Jang Ho ; Kwon, Taek Geun ; Bae, Jang Whan ; Cho, Myeong Chan ; Kim, Hyo Soo. / Multicenter randomized trial evaluating the efficacy of cilostazol on ischemic vascular complications after drug-eluting stent implantation for coronary heart disease : Results of the CILON-T (influence of cilostazol-based triple antiplatelet therapy on ischemic complication after drug-eluting stent implantation) trial. In: Journal of the American College of Cardiology. 2011 ; Vol. 57, No. 3. pp. 280-289.
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abstract = "Objectives We aimed to test whether cilostazol has beneficial effects in the real-world patients treated with intracoronary drug-eluting stents (DES). Background The addition of cilostazol on the conventional dual antiplatelet therapy has been reported to reduce platelet reactivity and to improve clinical outcomes after percutaneous coronary intervention in previous studies. Methods In a randomized multicenter trial, we enrolled 960 patients who received DES. They were randomized to receive either dual antiplatelet therapy (DAT) (aspirin and clopidogrel) or triple antiplatelet therapy (TAT) (aspirin, clopidogrel, and cilostazol) for 6 months. Primary end point was the composite of cardiac death, nonfatal myocardial infarction, ischemic stroke, or target lesion revascularization (TLR). Secondary end points were P2Y12 reaction unit (PRU) measured with the VerifyNow P2Y12 assay (Accumetrics, San Diego, California) at discharge and at 6 months after the index procedure. All-cause death, stent thrombosis, and each component of the primary end point at 6 months were other secondary end points. Analysis was done on an intention-to-treat basis. Results At 6 months' follow-up, there was no difference in the primary end point between the 2 groups (8.5{\%} in TAT vs. 9.2{\%} in DAT, p = 0.74). In secondary end point analysis, the TAT group achieved lower PRU levels than the DAT group both at discharge (206.6 ± 90.3 PRU vs. 232.2 ± 80.3 PRU, p < 0.001) and at 6 months (210.7 ± 87.9 PRU vs. 255.7 ± 73.7 PRU, p < 0.001). In the Cox proportional hazards analysis, lesion length (<28 mm, hazard ratio [HR]: 2.10, 95{\%} confidence interval [CI]: 1.25 to 3.52), and PRU level at discharge (every increase in tertile, HR: 1.61, 95{\%} CI: 1.16 to 2.25) were predictors of the primary end point, but not the use of cilostazol (HR: 0.90, 95{\%} CI: 0.54 to 1.52). Conclusions Despite the greater reduction of platelet reactivity by addition of cilostazol to conventional DAT, TAT did not show superiority in reducing the composite of adverse cardiovascular outcomes after DES implantation. (The Efficacy of CILostazol ON Ischemic Complications After DES Implantation [CILON-T]; NCT00776828)",
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T1 - Multicenter randomized trial evaluating the efficacy of cilostazol on ischemic vascular complications after drug-eluting stent implantation for coronary heart disease

T2 - Results of the CILON-T (influence of cilostazol-based triple antiplatelet therapy on ischemic complication after drug-eluting stent implantation) trial

AU - Suh, Jung Won

AU - Lee, Seung Pyo

AU - Park, Kyung Woo

AU - Lee, Hae Young

AU - Kang, Hyun Jae

AU - Koo, Bon Kwon

AU - Cho, Young Seok

AU - Youn, Tae Jin

AU - Chae, In Ho

AU - Choi, Dong Ju

AU - Rha, Seung-Woon

AU - Bae, Jang Ho

AU - Kwon, Taek Geun

AU - Bae, Jang Whan

AU - Cho, Myeong Chan

AU - Kim, Hyo Soo

PY - 2011/1/18

Y1 - 2011/1/18

N2 - Objectives We aimed to test whether cilostazol has beneficial effects in the real-world patients treated with intracoronary drug-eluting stents (DES). Background The addition of cilostazol on the conventional dual antiplatelet therapy has been reported to reduce platelet reactivity and to improve clinical outcomes after percutaneous coronary intervention in previous studies. Methods In a randomized multicenter trial, we enrolled 960 patients who received DES. They were randomized to receive either dual antiplatelet therapy (DAT) (aspirin and clopidogrel) or triple antiplatelet therapy (TAT) (aspirin, clopidogrel, and cilostazol) for 6 months. Primary end point was the composite of cardiac death, nonfatal myocardial infarction, ischemic stroke, or target lesion revascularization (TLR). Secondary end points were P2Y12 reaction unit (PRU) measured with the VerifyNow P2Y12 assay (Accumetrics, San Diego, California) at discharge and at 6 months after the index procedure. All-cause death, stent thrombosis, and each component of the primary end point at 6 months were other secondary end points. Analysis was done on an intention-to-treat basis. Results At 6 months' follow-up, there was no difference in the primary end point between the 2 groups (8.5% in TAT vs. 9.2% in DAT, p = 0.74). In secondary end point analysis, the TAT group achieved lower PRU levels than the DAT group both at discharge (206.6 ± 90.3 PRU vs. 232.2 ± 80.3 PRU, p < 0.001) and at 6 months (210.7 ± 87.9 PRU vs. 255.7 ± 73.7 PRU, p < 0.001). In the Cox proportional hazards analysis, lesion length (<28 mm, hazard ratio [HR]: 2.10, 95% confidence interval [CI]: 1.25 to 3.52), and PRU level at discharge (every increase in tertile, HR: 1.61, 95% CI: 1.16 to 2.25) were predictors of the primary end point, but not the use of cilostazol (HR: 0.90, 95% CI: 0.54 to 1.52). Conclusions Despite the greater reduction of platelet reactivity by addition of cilostazol to conventional DAT, TAT did not show superiority in reducing the composite of adverse cardiovascular outcomes after DES implantation. (The Efficacy of CILostazol ON Ischemic Complications After DES Implantation [CILON-T]; NCT00776828)

AB - Objectives We aimed to test whether cilostazol has beneficial effects in the real-world patients treated with intracoronary drug-eluting stents (DES). Background The addition of cilostazol on the conventional dual antiplatelet therapy has been reported to reduce platelet reactivity and to improve clinical outcomes after percutaneous coronary intervention in previous studies. Methods In a randomized multicenter trial, we enrolled 960 patients who received DES. They were randomized to receive either dual antiplatelet therapy (DAT) (aspirin and clopidogrel) or triple antiplatelet therapy (TAT) (aspirin, clopidogrel, and cilostazol) for 6 months. Primary end point was the composite of cardiac death, nonfatal myocardial infarction, ischemic stroke, or target lesion revascularization (TLR). Secondary end points were P2Y12 reaction unit (PRU) measured with the VerifyNow P2Y12 assay (Accumetrics, San Diego, California) at discharge and at 6 months after the index procedure. All-cause death, stent thrombosis, and each component of the primary end point at 6 months were other secondary end points. Analysis was done on an intention-to-treat basis. Results At 6 months' follow-up, there was no difference in the primary end point between the 2 groups (8.5% in TAT vs. 9.2% in DAT, p = 0.74). In secondary end point analysis, the TAT group achieved lower PRU levels than the DAT group both at discharge (206.6 ± 90.3 PRU vs. 232.2 ± 80.3 PRU, p < 0.001) and at 6 months (210.7 ± 87.9 PRU vs. 255.7 ± 73.7 PRU, p < 0.001). In the Cox proportional hazards analysis, lesion length (<28 mm, hazard ratio [HR]: 2.10, 95% confidence interval [CI]: 1.25 to 3.52), and PRU level at discharge (every increase in tertile, HR: 1.61, 95% CI: 1.16 to 2.25) were predictors of the primary end point, but not the use of cilostazol (HR: 0.90, 95% CI: 0.54 to 1.52). Conclusions Despite the greater reduction of platelet reactivity by addition of cilostazol to conventional DAT, TAT did not show superiority in reducing the composite of adverse cardiovascular outcomes after DES implantation. (The Efficacy of CILostazol ON Ischemic Complications After DES Implantation [CILON-T]; NCT00776828)

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KW - DES

KW - platelet reactivity

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