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Results of the randomized, placebo-controlled clopidogrel and acetylsalicylic acid in bypass surgery for peripheral arterial disease (CASPAR) trial

Jill JF Belch, John Dormandy, the CASPAR Trial Writing Committee and Frank Vermassen UGent (2010) JOURNAL OF VASCULAR SURGERY. 52(4). p.825-833
abstract
Objective: Dual antiplatelet therapy with clopidogrel plus acetylsalicylic acid (ASA) is superior to ASA alone in patients with acute coronary syndromes and in those undergoing percutaneous coronary intervention. We sought to determine whether clopidogrel plus ASA conferred benefit on limb outcomes over ASA alone in patients undergoing below-knee bypass grafting. Methods: Patients undergoing unilateral, below-knee bypass graft for atherosclerotic peripheral arterial disease (PAD) were enrolled 2 to 4 days after surgery and were randomly assigned to clopidogrel 75 mg/day plus ASA 75 to 100 mg/day or placebo plus ASA 75 to 100 mg/day for 6 to 24 months. The primary efficacy endpoint was a composite of index-graft occlusion or revascularization, above-ankle amputation of the affected limb, or death. The primary safety endpoint was severe bleeding (Global Utilization of Streptokinase and Tissue plasminogen activator for Occluded coronary arteries [GUSTO] classification). Results: In the overall population, the primary endpoint occurred in 149 of 425 patients in the clopidogrel group vs 151 of 426 patients in the placebo (plus ASA) group (hazard ratio [FIR], 0.98; 95% confidence interval [CI], 0.78-1.23). In a prespecified subgroup analysis, the primary endpoint was significantly reduced by clopidogrel in prosthetic graft patients (HR, 0.65; 95% CI, 0.45-0.95; P = .025) but not in venous graft patients (HR, 1.25; 95% CI, 0.94-1.67, not significant [NS]). A significant statistical interaction between treatment effect and graft type was observed (P(interaction) =.008). Although total bleeds were more frequent with clopidogrel, there was no significant difference between the rates of severe bleeding in the clopidogrel and placebo (plus ASA) groups (2.1% vs 1.2%). Conclusion: The combination of clopidogrel plus ASA did not improve limb or systemic outcomes in the overall population of PAD patients requiring below-knee bypass grafting. Subgroup analysis suggests that clopidogrel plus ASA confers benefit in patients receiving prosthetic grafts without significantly increasing major bleeding risk.
Please use this url to cite or link to this publication:
author
organization
year
type
journalArticle (original)
publication status
published
subject
keyword
RISK, MANAGEMENT, PREVENTION, ASPIRIN, LOWER-EXTREMITY, ISCHEMIC EVENTS, ORAL ANTICOAGULANTS, ANTIPLATELET THERAPY, ACUTE MYOCARDIAL-INFARCTION, DRUG-ELUTING STENTS
journal title
JOURNAL OF VASCULAR SURGERY
J. Vasc. Surg.
volume
52
issue
4
pages
825 - 833
Web of Science type
Article
Web of Science id
000282660300001
JCR category
SURGERY
JCR impact factor
3.851 (2010)
JCR rank
10/186 (2010)
JCR quartile
1 (2010)
ISSN
0741-5214
DOI
10.1016/j.jvs.2010.04.027
language
English
UGent publication?
yes
classification
A1
additional info
correction (author name) was published in J. Vasc. Surg. (2011) 53(2), 564
copyright statement
I have transferred the copyright for this publication to the publisher
id
1256486
handle
http://hdl.handle.net/1854/LU-1256486
date created
2011-06-07 14:35:31
date last changed
2016-12-19 15:46:35
@article{1256486,
  abstract     = {Objective: Dual antiplatelet therapy with clopidogrel plus acetylsalicylic acid (ASA) is superior to ASA alone in patients with acute coronary syndromes and in those undergoing percutaneous coronary intervention. We sought to determine whether clopidogrel plus ASA conferred benefit on limb outcomes over ASA alone in patients undergoing below-knee bypass grafting. 
Methods: Patients undergoing unilateral, below-knee bypass graft for atherosclerotic peripheral arterial disease (PAD) were enrolled 2 to 4 days after surgery and were randomly assigned to clopidogrel 75 mg/day plus ASA 75 to 100 mg/day or placebo plus ASA 75 to 100 mg/day for 6 to 24 months. The primary efficacy endpoint was a composite of index-graft occlusion or revascularization, above-ankle amputation of the affected limb, or death. The primary safety endpoint was severe bleeding (Global Utilization of Streptokinase and Tissue plasminogen activator for Occluded coronary arteries [GUSTO] classification). 
Results: In the overall population, the primary endpoint occurred in 149 of 425 patients in the clopidogrel group vs 151 of 426 patients in the placebo (plus ASA) group (hazard ratio [FIR], 0.98; 95\% confidence interval [CI], 0.78-1.23). In a prespecified subgroup analysis, the primary endpoint was significantly reduced by clopidogrel in prosthetic graft patients (HR, 0.65; 95\% CI, 0.45-0.95; P = .025) but not in venous graft patients (HR, 1.25; 95\% CI, 0.94-1.67, not significant [NS]). A significant statistical interaction between treatment effect and graft type was observed (P(interaction) =.008). Although total bleeds were more frequent with clopidogrel, there was no significant difference between the rates of severe bleeding in the clopidogrel and placebo (plus ASA) groups (2.1\% vs 1.2\%). 
Conclusion: The combination of clopidogrel plus ASA did not improve limb or systemic outcomes in the overall population of PAD patients requiring below-knee bypass grafting. Subgroup analysis suggests that clopidogrel plus ASA confers benefit in patients receiving prosthetic grafts without significantly increasing major bleeding risk.},
  author       = {Belch, Jill JF and Dormandy, John and CASPAR Trial Writing Committee, the and Vermassen, Frank},
  issn         = {0741-5214},
  journal      = {JOURNAL OF VASCULAR SURGERY},
  keyword      = {RISK,MANAGEMENT,PREVENTION,ASPIRIN,LOWER-EXTREMITY,ISCHEMIC EVENTS,ORAL ANTICOAGULANTS,ANTIPLATELET THERAPY,ACUTE MYOCARDIAL-INFARCTION,DRUG-ELUTING STENTS},
  language     = {eng},
  number       = {4},
  pages        = {825--833},
  title        = {Results of the randomized, placebo-controlled clopidogrel and acetylsalicylic acid in bypass surgery for peripheral arterial disease (CASPAR) trial},
  url          = {http://dx.doi.org/10.1016/j.jvs.2010.04.027},
  volume       = {52},
  year         = {2010},
}

Chicago
Belch, Jill JF, John Dormandy, the CASPAR Trial Writing Committee, and Frank Vermassen. 2010. “Results of the Randomized, Placebo-controlled Clopidogrel and Acetylsalicylic Acid in Bypass Surgery for Peripheral Arterial Disease (CASPAR) Trial.” Journal of Vascular Surgery 52 (4): 825–833.
APA
Belch, J. J., Dormandy, J., CASPAR Trial Writing Committee, the, & Vermassen, F. (2010). Results of the randomized, placebo-controlled clopidogrel and acetylsalicylic acid in bypass surgery for peripheral arterial disease (CASPAR) trial. JOURNAL OF VASCULAR SURGERY, 52(4), 825–833.
Vancouver
1.
Belch JJ, Dormandy J, CASPAR Trial Writing Committee the, Vermassen F. Results of the randomized, placebo-controlled clopidogrel and acetylsalicylic acid in bypass surgery for peripheral arterial disease (CASPAR) trial. JOURNAL OF VASCULAR SURGERY. 2010;52(4):825–33.
MLA
Belch, Jill JF, John Dormandy, the CASPAR Trial Writing Committee, et al. “Results of the Randomized, Placebo-controlled Clopidogrel and Acetylsalicylic Acid in Bypass Surgery for Peripheral Arterial Disease (CASPAR) Trial.” JOURNAL OF VASCULAR SURGERY 52.4 (2010): 825–833. Print.