42799
document
Intravenous platelet blockade with cangrelor during PCI . BACKGROUND Intravenous cangrelor , a rapid-acting , reversible adenosine diphosphate ( ADP ) receptor antagonist , might reduce ischemic events during percutaneous coronary intervention ( PCI ) . METHODS In this double-blind , placebo-controlled study , we randomly assigned 5362 patients who had not been treated with clopidogrel to receive either cangrelor or placebo at the time of PCI , followed by 600 mg of clopidogrel . The primary end point was a composite of death , myocardial infarction , or ischemia-driven revascularization at 48 hours . Enrollment was stopped when an interim analysis concluded that the trial would be unlikely to show superiority for the primary end point . RESULTS The primary end point occurred in 185 of 2654 patients receiving cangrelor ( 7.0 % ) and in 210 of 2641 patients receiving placebo ( 8.0 % ) ( odds ratio in the cangrelor group , 0.87 ; 95 % confidence interval [ CI ] , 0.71 to 1.07 ; P=0.17 ) ( modified intention-to-treat population adjusted for missing data ) . In the cangrelor group , as compared with the placebo group , two prespecified secondary end points were significantly reduced at 48 hours : the rate of stent thrombosis , from 0.6 % to 0.2 % ( odds ratio , 0.31 ; 95 % CI , 0.11 to 0.85 ; P=0.02 ) , and the rate of death from any cause , from 0.7 % to 0.2 % ( odds ratio , 0.33 ; 95 % CI , 0.13 to 0.83 ; P=0.02 ) . There was no significant difference in the rate of blood transfusion ( 1.0 % in the cangrelor group and 0.6 % in the placebo group , P=0.13 ) , though major bleeding on one scale was increased in the cangrelor group , from 3.5 % to 5.5 % ( P < 0.001 ) , because of more groin hematomas . CONCLUSIONS The use of periprocedural cangrelor during PCI was not superior to placebo in reducing the primary end point . The prespecified secondary end points of stent thrombosis and death were lower in the cangrelor group , with no significant increase in the rate of transfusion . Further study of intravenous ADP blockade with cangrelor may be warranted . ( ClinicalTrials.gov number , NCT00385138 . )
42800
Intervention_Pharmacological
cangrelor
42801
Intervention_Pharmacological
cangrelor
42802
Intervention_Pharmacological
cangrelor
42803
Intervention_Control
placebo
42804
Intervention_Pharmacological
clopidogrel
42805
Intervention_Pharmacological
cangrelor
42806
Intervention_Control
placebo
42807
Intervention_Pharmacological
cangrelor
42808
Intervention_Pharmacological
cangrelor
42809
Intervention_Control
placebo
42810
Intervention_Pharmacological
cangrelor
42811
Intervention_Pharmacological
cangrelor
42812
Intervention_Pharmacological
ADP blockade with cangrelor
42813
Outcome_Mortality
composite of death
42814
Outcome_Physical
myocardial infarction , or ischemia-driven revascularization at 48 hours
42815
Outcome_Physical
primary end point
42816
Outcome_Physical
rate of stent thrombosis
42817
Outcome_Mortality
rate of death from any cause
42818
Outcome_Physical
rate of blood transfusion
42819
Outcome_Physical
major bleeding
42820
Outcome_Physical
groin hematomas .
42821
Participant_Sample-size
5362
42822
Participant_Sample-size
2654
42823
Participant_Sample-size
2641