Document Detail

Evaluation of prolonged antithrombotic pretreatment ("cooling-off" strategy) before intervention in patients with unstable coronary syndromes: a randomized controlled trial.
MedLine Citation:
PMID:  14506118     Owner:  NLM     Status:  MEDLINE    
CONTEXT: In unstable coronary syndromes, catheter intervention is frequently preceded by antithrombotic treatment to reduce periprocedural risk; however, evidence from clinical trials to support antithrombotic pretreatment is sparse.
OBJECTIVE: To test the hypothesis that prolonged antithrombotic pretreatment improves the outcome of catheter intervention in patients with acute unstable coronary syndromes compared with early intervention.
DESIGN, SETTING, AND PATIENTS: Randomized controlled trial conducted from February 27, 2000, to April 8, 2002, and including patients admitted to 2 German tertiary care centers with symptoms of unstable angina plus either ST-segment depression or elevation of cardiac troponin T levels.
INTERVENTIONS: Patients were randomly allocated to antithrombotic pretreatment for 3 to 5 days or to early intervention after pretreatment for less than 6 hours. In both groups, antithrombotic pretreatment consisted of intravenous unfractionated heparin (60-U/kg bolus followed by infusion adjusted to maintain partial thromboplastin time of 60 to 85 seconds), aspirin (500-mg intravenous bolus followed by 100-mg twice-daily oral dose), oral clopidogrel (600-mg loading dose followed by 75-mg twice-daily dose), and intravenous tirofiban (10- microg/kg bolus followed by continuous infusion of 0.10 microg/kg per min).
MAIN OUTCOME MEASURE: Composite 30-day incidence of large nonfatal myocardial infarction or death from any cause.
RESULTS: Of the 410 patients enrolled, 207 were allocated to receive prolonged antithrombotic pretreatment and 203 to receive early intervention. Elevated levels of cardiac troponin T were present in 274 patients (67%), while 268 (65%) had ST-segment depression. The antithrombotic pretreatment and the early intervention groups were well matched with respect to major baseline characteristics and definitive treatment (catheter revascularization: 133 [64.3%] vs 143 [70.4%], respectively; coronary artery bypass graft surgery: 16 [7.7%] vs 16 [7.9%]). The primary end point was reached in 11.6% (3 deaths, 21 infarctions) of the group receiving prolonged antithrombotic pretreatment and in 5.9% (no deaths, 12 infarctions) of the group receiving early intervention (relative risk, 1.96 [95% confidence interval, 1.01-3.82]; P =.04). This outcome was attributable to events occurring before catheterization; after catheterization, both groups incurred 11 events each (P =.92).
CONCLUSION: In patients with unstable coronary syndromes, deferral of intervention for prolonged antithrombotic pretreatment does not improve the outcome compared with immediate intervention accompanied by intense antiplatelet treatment.
Franz-Josef Neumann; Adnan Kastrati; Gisela Pogatsa-Murray; Julinda Mehilli; Hildegard Bollwein; Hans-Peter Bestehorn; Claus Schmitt; Melchior Seyfarth; Josef Dirschinger; Albert Schömig
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Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  JAMA     Volume:  290     ISSN:  1538-3598     ISO Abbreviation:  JAMA     Publication Date:  2003 Sep 
Date Detail:
Created Date:  2003-09-24     Completed Date:  2003-09-29     Revised Date:  2014-09-17    
Medline Journal Info:
Nlm Unique ID:  7501160     Medline TA:  JAMA     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1593-9     Citation Subset:  AIM; IM    
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MeSH Terms
Angina Pectoris / therapy*
Aspirin / administration & dosage
Fibrinolytic Agents / administration & dosage*
Heparin / administration & dosage
Middle Aged
Myocardial Revascularization / methods*
Platelet Aggregation Inhibitors / administration & dosage*
Preoperative Care
Ticlopidine / administration & dosage,  analogs & derivatives
Treatment Outcome
Troponin T / blood
Tyrosine / administration & dosage,  analogs & derivatives
Reg. No./Substance:
0/Fibrinolytic Agents; 0/Platelet Aggregation Inhibitors; 0/Troponin T; 144494-65-5/tirofiban; 42HK56048U/Tyrosine; 9005-49-6/Heparin; A74586SNO7/clopidogrel; OM90ZUW7M1/Ticlopidine; R16CO5Y76E/Aspirin
Comment In:
ACP J Club. 2004 Mar-Apr;140(2):30   [PMID:  15122851 ]
Curr Cardiol Rep. 2004 Jul;6(4):271   [PMID:  15182602 ]
JAMA. 2004 Feb 11;291(6):691; author reply 691-2   [PMID:  14871906 ]

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