Abstract:Background Current guidelines for patients with moderate-or high-risk acute coronary syndromes recommend an early invasive approach with concomitant antithrombotic therapy, including aspirin, clopidogrel, unfractionated or low-molecular-weight heparin, and glycoprotein IIb/IIIa inhibitors. We evaluated the role of thrombin-specific anticoagulation with bivalirudin in such patients. Methods We assigned 13,819 patients with acute coronary syndromes to one of three antithrombotic regimens: unfractionated heparin … Show more
“…The ACUITY and HORIZONS AMI trials were excluded because these open label trials included a bivalirudin-based strategy. 42,43 Lastly, several trials used a higher dose of unfractionated heparin in the control arm than the GPI arm. This difference might have diminished the relative efficacy of GPIs and masked any increased tendency toward bleeding.…”
Background: Early studies of glycoprotein IIb/IIIa inhibitors (GPIs) demonstrated benefit during percutaneous coronary intervention for acute coronary syndromes (ACS). Since their introduction, the magnitude of benefit of GPIs has become unclear. Hypothesis: We hypothesized that adding a GPI to unfractionated heparin in ACS patients treated with stents and thienopyridines is beneficial. Methods: We searched the MEDLINE, Cochrane, and clinicaltrials.gov databases for randomized clinical trials that studied the use of GPIs during ACS. We required that patients be randomly assigned to unfractionated heparin plus a GPI versus unfractionated heparin plus placebo (or control). Additional inclusion criteria included the use of coronary stents and periprocedural thienopyridines. Outcomes were assessed at 30 days. Random effects DerSimonian-Laird summary risk ratios (RR) and 95% confidence intervals (CIs) were constructed. Results: Sixteen studies with 7611 patients were included. Myocardial infarction was 3.1% with GPI versus 4.4% with control (RR = 0.74; 95% CI, 0.59-0.94, P = 0.014); revascularization, 1.7% versus 2.7% (RR = 0.64; 95% CI, 0.46-0.89, P = 0.008); major bleeding, 2.5% versus 2.1% (RR = 1.21; 95% CI, 0.89-1.63, P = 0.22); minor bleeding, 5.5% versus 4.1% (RR = 1.37; 95% CI, 1.06-1.78, P = 0.016); and mortality, 2.2% versus 2.9% (RR = 0.79; 95% CI, 0.59-1.06, P = 0.12), respectively. Conclusions: Among ACS patients treated with stents and thienopyridines, GPIs were associated with reduced myocardial infarction and revascularization. Minor, but not major bleeding was increased with GPIs. Mortality was similar between the groups.
“…The ACUITY and HORIZONS AMI trials were excluded because these open label trials included a bivalirudin-based strategy. 42,43 Lastly, several trials used a higher dose of unfractionated heparin in the control arm than the GPI arm. This difference might have diminished the relative efficacy of GPIs and masked any increased tendency toward bleeding.…”
Background: Early studies of glycoprotein IIb/IIIa inhibitors (GPIs) demonstrated benefit during percutaneous coronary intervention for acute coronary syndromes (ACS). Since their introduction, the magnitude of benefit of GPIs has become unclear. Hypothesis: We hypothesized that adding a GPI to unfractionated heparin in ACS patients treated with stents and thienopyridines is beneficial. Methods: We searched the MEDLINE, Cochrane, and clinicaltrials.gov databases for randomized clinical trials that studied the use of GPIs during ACS. We required that patients be randomly assigned to unfractionated heparin plus a GPI versus unfractionated heparin plus placebo (or control). Additional inclusion criteria included the use of coronary stents and periprocedural thienopyridines. Outcomes were assessed at 30 days. Random effects DerSimonian-Laird summary risk ratios (RR) and 95% confidence intervals (CIs) were constructed. Results: Sixteen studies with 7611 patients were included. Myocardial infarction was 3.1% with GPI versus 4.4% with control (RR = 0.74; 95% CI, 0.59-0.94, P = 0.014); revascularization, 1.7% versus 2.7% (RR = 0.64; 95% CI, 0.46-0.89, P = 0.008); major bleeding, 2.5% versus 2.1% (RR = 1.21; 95% CI, 0.89-1.63, P = 0.22); minor bleeding, 5.5% versus 4.1% (RR = 1.37; 95% CI, 1.06-1.78, P = 0.016); and mortality, 2.2% versus 2.9% (RR = 0.79; 95% CI, 0.59-1.06, P = 0.12), respectively. Conclusions: Among ACS patients treated with stents and thienopyridines, GPIs were associated with reduced myocardial infarction and revascularization. Minor, but not major bleeding was increased with GPIs. Mortality was similar between the groups.
“…In a combined analysis of the PURSUIT and Platelet IIb/IIIa Antagonism for the Reduction of Acute coronary syndrome events in a Global Organization Network (PARAGON) trials (41), 30-day and six-month mortality relate to the severity of bleeding as measured by the GUSTO scale (Figure 1). In the recent ACUITY trial (42), major bleeding occurred in 5.9% of patients, and was associated with more deaths than in those who had no major bleeding (5.4% versus 0.8%), myocardial infarction (17.1% versus 5.5%) and the need for unplanned revascularization (9.3% versus 3.0%).…”
Section: Impact Of Bleeding On Prognosis Of Patients With Acsmentioning
confidence: 99%
“…This was an acceptable hazard, provided that the bleeding risk was small and that the treatment reduced ischemic outcomes. Recent studies (1,2) with newer antithrombotic agents have failed to show incremental benefits, but indicate that the same benefits can be achieved as the previous standard of care with a lower risk of bleeding. In addition, it is now recognized that both bleeding and the need for blood transfusions are associated with a major risk for recurrent ischemic coronary events and death, independent of the immediate consequence of blood loss.…”
“…Of these, only bivalirudin is approved for use in ACS patients undergoing PCI; 21 the other agents are approved only for patients at risk for or who develop heparin-induced thrombocytopenia. 22,23 In two large trials, bivalirudin was associated with significantly less bleeding vs. combination UFH plus GP IIb/IIIa inhibitor or enoxaparin plus GP IIb/IIIa inhibitor in ACS patients 24 and vs. UFH plus planned GP IIb/IIIa inhibition in patients undergoing PCI. 25,26 The rates of transfusion also were significantly lower in bivalirudin-treated patients in these trials.…”
Section: Introductionmentioning
confidence: 99%
“…25,26 The rates of transfusion also were significantly lower in bivalirudin-treated patients in these trials. 24,25 In both of these trials, the use of heparin or enoxaparin rather than bivalirudin was an independent predictor of major bleeding, which, in turn, was an independent predictor of the 30-day 5 and 1-year mortality. 10 Thus, the use of agents associated with lower bleeding risk is likely to improve outcomes in patients with ACS and those undergoing PCI.…”
SummaryThis supplement reviews the findings of a roundtable discussion of experts focusing on the prevention, effects, and management of bleeding events among patients with acute coronary syndromes (ACS) and those undergoing percutaneous coronary intervention (PCI).
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