Dual Antiplatelet Therapy With Cilostazol for Secondary Prevention in Lacunar Stroke: Subanalysis of the CSPS.com Trial

Author:

Nishiyama Yasuhiro1ORCID,Kimura Kazumi1ORCID,Otsuka Toshiaki2,Toyoda Kazunori3ORCID,Uchiyama Shinichiro4ORCID,Hoshino Haruhiko5ORCID,Sakai Nobuyuki6ORCID,Okada Yasushi7ORCID,Origasa Hideki8ORCID,Naritomi Hiroaki9ORCID,Houkin Kiyohiro10,Yamaguchi Keiji11ORCID,Minematsu Kazuo12,Matsumoto Masayasu13ORCID,Tominaga Teiji14ORCID,Tomimoto Hidekazu15,Terayama Yasuo16,Yasuda Satoshi17,Yamaguchi Takenori3ORCID,

Affiliation:

1. Department of Neurology (Y.N., K.K.), Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.

2. Department of Hygiene and Public Health (T.O.), Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.

3. Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan (K.T., T.Y.).

4. Clinical Research Center for Medicine, International University of Health and Welfare, Center for Brain and Cerebral Vessels, Sanno Medical Center, Tokyo, Japan (S.U.).

5. Department of Neurology, Tokyo Saiseikai Central Hospital, Japan (H.H.).

6. Department of Neurosurgery, Kobe City Medical Centre General Hospital, Japan (N.S.).

7. Clinical Research Institute and Department of Cerebrovascular Medicine and Neurology, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan (Y.O.).

8. The Institute of Statistical Mathematics, Tokyo, Japan (H.O.).

9. Department of Neurology, Senri Chuo Hospital, Toyonaka, Japan (H.N.).

10. Hokkaido University Graduate School of Medicine, Sapporo, Japan (K.H.).

11. Department of Neurology, Ichinomiya Nishi Hospital, Japan (K.Y.).

12. Headquarters of the Medical Corporation ISEIKAI, Osaka, Japan (K.M.).

13. Department of Neurology, Ikeda City Medical Center, Osaka, Japan (M.M.).

14. Department of Neurosurgery (T.T.), Tohoku University Graduate School of Medicine, Sendai, Japan.

15. Department of Neurology, Graduate School of Medicine, Mie University, Tsu, Japan (H.T.).

16. Neurological Institute, Shonan Keiiku Hospital, Fujisawa, Japan (Y.T.).

17. Department of Cardiovascular Medicine (S.Y.), Tohoku University Graduate School of Medicine, Sendai, Japan.

Abstract

Background: The effectiveness of long-term dual antiplatelet therapy (DAPT) to prevent recurrent strokes in patients with lacunar stroke remains unclarified. Therefore, this study aimed to compare and to elucidate the safety and effectiveness of DAPT and single antiplatelet therapy (SAPT) in preventing recurrence in chronic lacunar stroke. Methods: CSPS.com (Cilostazol Stroke Prevention Study for Antiplatelet Combination) was a prospective, multicenter, randomized controlled trial. In this prespecified subanalysis, 925 patients (mean age, 69.5 years; 69.4% men) with lacunar stroke were selected from 1884 patients with high-risk noncardioembolic stroke, enrolled in the CSPS.com trial after 8 to 180 days following stroke. Patients were randomly assigned to receive either SAPT or DAPT using cilostazol and were followed for 0.5 to 3.5 years. The primary efficacy outcome was the first recurrence of ischemic stroke. The safety outcomes were severe or life-threatening bleeding. Results: The DAPT group receiving cilostazol and either aspirin or clopidogrel and SAPT group receiving aspirin or clopidogrel alone comprised 464 (50.2%) and 461 (49.8%) patients, respectively. Ischemic stroke occurred in 12 of 464 patients (1.84 per 100 patient-years) in the DAPT group and 31 of 461 patients (4.42 per 100 patient-years) in the SAPT group, during follow-up. After adjusting for multiple potential confounding factors, ischemic stroke risk was significantly lower in the DAPT group than in the SAPT group (hazard ratio, 0.43 [95% CI, 0.22–0.84]). The rate of severe or life-threatening hemorrhage did not differ significantly between the groups (2 patients [0.31 per 100 patient-years] versus 6 patients [0.86 per 100 patient-years] in the DAPT and SAPT groups, respectively; hazard ratio, 0.36 [95% CI, 0.07–1.81]). Conclusions: In patients with lacunar stroke, DAPT using cilostazol had significant benefits in reducing recurrent ischemic stroke incidence compared with SAPT without increasing the risk of severe or life-threatening bleeding. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01995370. URL: https://www.umin.ac.jp/ctr ; Unique identifier: UMIN000012180.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Advanced and Specialized Nursing,Cardiology and Cardiovascular Medicine,Neurology (clinical)

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