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Impact of sodium-hydrogen exchange inhibition by cariporide on death or myocardial infarction in high-risk CABG surgery patients: Results of the CABG surgery cohort of the GUARDIAN study

Boyce, SW; Bartels, C; Bolli, R; Chaitman, B; Chen, JC; Chi, E; Jessel, A; Kereiakes, D; Knight, J and Thulin, Lars LU , et al. (2003) In Journal of Thoracic and Cardiovascular Surgery 126(2). p.420-427
Abstract
Objectives: To evaluate the effects of cariporide on all-cause mortality or myocardial infarction at 36 days in patients at risk,of myocardial necrosis after coronary artery bypass graft surgery. Methods: In the coronary artery bypass graft cohort of the GUARD During Ischemia Against Necrosis trial, patients greater than or equal to 18 years who required urgent coronary artery bypass graft, repeat coronary artery bypass graft, or had a history of unstable angina and 2 :2 risk factors (age >65 years, female gender, diabetes mellitus, ejection fraction <35%, or left main or 3-vessel disease) were randomized to placebo (n = 743) or cariporide 20 mg (n = 736), 80 mg (n = 705), or 120 mg (n = 734). A 1-hour intravenous infusion was... (More)
Objectives: To evaluate the effects of cariporide on all-cause mortality or myocardial infarction at 36 days in patients at risk,of myocardial necrosis after coronary artery bypass graft surgery. Methods: In the coronary artery bypass graft cohort of the GUARD During Ischemia Against Necrosis trial, patients greater than or equal to 18 years who required urgent coronary artery bypass graft, repeat coronary artery bypass graft, or had a history of unstable angina and 2 :2 risk factors (age >65 years, female gender, diabetes mellitus, ejection fraction <35%, or left main or 3-vessel disease) were randomized to placebo (n = 743) or cariporide 20 mg (n = 736), 80 mg (n = 705), or 120 mg (n = 734). A 1-hour intravenous infusion was initiated shortly before surgery and administered every 8 hours for 2 to 7 days. Patients were followed up for 6 months. A nonparametric covariance analysis was used to calculate the primary efficacy endpoint. Results: Baseline characteristics were similar between treatment groups. The cariporide 20- and 80-mg groups had event rates similar to placebo. The endpoint of all-cause mortality or myocardial infarction at day 36 was significant with cariporide 120 mg versus placebo (event rate 12.2% vs 16.2%; P = .027). The risk reduction was evident on postoperative day 1 (3.3% vs 6.5%; P = .005) and was maintained at 6 months (event rate 15.0% vs 18.6%; P = .033). Cariporide was well tolerated, and most adverse events were mild and transient in this high-risk population. Conclusions: Clinical benefit with cariporide 120 mg was observed early after treatment initiation and continued for 6 months postsurgery, suggesting that sodium-hydrogen exchange inhibition with cariporide is cardioprotective in patients undergoing high-risk coronary artery bypass graft surgery. (Less)
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Contribution to journal
publication status
published
subject
in
Journal of Thoracic and Cardiovascular Surgery
volume
126
issue
2
pages
420 - 427
publisher
Mosby
external identifiers
  • wos:000184991800021
  • pmid:12928639
  • scopus:0042856663
ISSN
1097-685X
DOI
10.1016/S0022-5223(03)00209-5
language
English
LU publication?
yes
id
cfb47ee6-3e18-4250-b561-3ac6a379214e (old id 302187)
alternative location
http://jtcs.ctsnetjournals.org/cgi/content/abstract/126/2/420
date added to LUP
2007-08-27 09:09:35
date last changed
2018-10-03 11:40:32
@article{cfb47ee6-3e18-4250-b561-3ac6a379214e,
  abstract     = {Objectives: To evaluate the effects of cariporide on all-cause mortality or myocardial infarction at 36 days in patients at risk,of myocardial necrosis after coronary artery bypass graft surgery. Methods: In the coronary artery bypass graft cohort of the GUARD During Ischemia Against Necrosis trial, patients greater than or equal to 18 years who required urgent coronary artery bypass graft, repeat coronary artery bypass graft, or had a history of unstable angina and 2 :2 risk factors (age &gt;65 years, female gender, diabetes mellitus, ejection fraction &lt;35%, or left main or 3-vessel disease) were randomized to placebo (n = 743) or cariporide 20 mg (n = 736), 80 mg (n = 705), or 120 mg (n = 734). A 1-hour intravenous infusion was initiated shortly before surgery and administered every 8 hours for 2 to 7 days. Patients were followed up for 6 months. A nonparametric covariance analysis was used to calculate the primary efficacy endpoint. Results: Baseline characteristics were similar between treatment groups. The cariporide 20- and 80-mg groups had event rates similar to placebo. The endpoint of all-cause mortality or myocardial infarction at day 36 was significant with cariporide 120 mg versus placebo (event rate 12.2% vs 16.2%; P = .027). The risk reduction was evident on postoperative day 1 (3.3% vs 6.5%; P = .005) and was maintained at 6 months (event rate 15.0% vs 18.6%; P = .033). Cariporide was well tolerated, and most adverse events were mild and transient in this high-risk population. Conclusions: Clinical benefit with cariporide 120 mg was observed early after treatment initiation and continued for 6 months postsurgery, suggesting that sodium-hydrogen exchange inhibition with cariporide is cardioprotective in patients undergoing high-risk coronary artery bypass graft surgery.},
  author       = {Boyce, SW and Bartels, C and Bolli, R and Chaitman, B and Chen, JC and Chi, E and Jessel, A and Kereiakes, D and Knight, J and Thulin, Lars and Theroux, P},
  issn         = {1097-685X},
  language     = {eng},
  number       = {2},
  pages        = {420--427},
  publisher    = {Mosby},
  series       = {Journal of Thoracic and Cardiovascular Surgery},
  title        = {Impact of sodium-hydrogen exchange inhibition by cariporide on death or myocardial infarction in high-risk CABG surgery patients: Results of the CABG surgery cohort of the GUARDIAN study},
  url          = {http://dx.doi.org/10.1016/S0022-5223(03)00209-5},
  volume       = {126},
  year         = {2003},
}