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      Heparin Versus Bivalirudin in Acute Myocardial Infarction: Unfractionated Heparin Monotherapy Elevated to Primary Treatment in Contemporary Percutaneous Coronary Intervention

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          Abstract

          Bivalirudin, a direct thrombin inhibitor, was developed as an antithrombin agent for patients undergoing percutaneous coronary interventions (PCI) with the hypothesis that it would reduce bleeding complications without compromising the rate of ischemic events compared to heparin plus GP IIb/IIIa inhibitors. Although the cumulative evidence makes a strong argument for the use of bivalirudin rather than heparin plus systematic GP IIb/IIIa inhibitors for the great majority of patients with acute myocardial infarction (AMI) undergoing PCI, the benefit observed with bivalirudin was achieved because of the major bleeding complications with the use of heparin plus GP IIb/IIIa inhibitors. When bivalirudin was compared with unfractionated heparin alone there was no benefit in ischemic complications with a decrease in major bleeding. However, in a recent large randomized controlled trial comparing bivalirudin with unfractionated heparin alone in AMI patients undergoing primary PCI, bivalirudin did not reduce bleeding complications and was associated with higher rates of stent thrombosis, myocardial reinfarction, and repeat revascularization compared with heparin. Moreover, a very recent meta-analysis shed more insights on the utilization of bivalirudin versus heparin regimens during PCI. Findings from this meta-analysis suggest that routine use of bivalirudin offers little advantage over heparin among PCI patients. In a detailed analysis of some randomized trials and observational studies with bivalirudin in AMI patients done by myself and published almost five years ago in this journal, I rendered some reflections on the future widespread use of bivalirudin. “In the setting of PCI in AMI patients, and in the absence of GP IIb/IIIa inhibitors, bivalirudin did not offer any beneficial effect in the incidence of the composite end points when compared with heparin alone. For now, in real world practice, one would probably choose a well known cheaper drug that has already passed the test of time, heparin. There may be reinforcement in the sole utilization of heparin confining GP IIb/IIIa inhibitors and other intravenous antithrombotics to bailout therapy for periprocedural PCI complications in AMI patients”. Therefore, instead of being the beginning of a new era with bivalirudin, it sure is a welcome back to an old friend, heparin. Indeed, after more than two decades, it is always good to welcome back an old friend, unfractionated heparin, as monotherapy and preferred anticoagulant regimen for contemporary PCI in AMI patients.

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          Most cited references34

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          Adverse impact of bleeding on prognosis in patients with acute coronary syndromes.

          The use of multiple antithrombotic drugs and aggressive invasive strategies has increased the risk of major bleeding in acute coronary syndrome (ACS) patients. It is not known to what extent bleeding determines clinical outcome. Using Cox proportional-hazards modeling, we examined the association between bleeding and death or ischemic events in 34,146 patients with ACS enrolled in the Organization to Assess Ischemic Syndromes and the Clopidogrel in Unstable Angina to Prevent Recurrent Events studies. Patients with major bleeding were older, more often had diabetes or a history of stroke, had a lower blood pressure and higher serum creatinine, more often had ST-segment changes on the presenting ECG, and had a 5-fold-higher incidence of death during the first 30 days (12.8% versus 2.5%; P < 0.0001) and a 1.5-fold-higher incidence of death between 30 days and 6 months (4.6% versus 2.9%; P = 0.002). Major bleeding was independently associated with an increased hazard of death during the first 30 days (hazard ratio, 5.37; 95% CI, 3.97 to 7.26; P < 0.0001), but the hazard was much weaker after 30 days (hazard ratio, 1.54; 95% CI, 1.01 to 2.36; P = 0.047). The association was consistent across subgroups according to cointerventions during hospitalization, and there was an increasing risk of death with increasing severity of bleeding (minor less than major less than life-threatening; P for trend = 0.0009). A similar association was evident between major bleeding and ischemic events, including myocardial infarction and stroke. In ACS patients without persistent ST-segment elevation, there is a strong, consistent, temporal, and dose-related association between bleeding and death. These data should lead to greater awareness of the prognostic importance of bleeding in ACS and should prompt evaluation of strategies to reduce bleeding and thereby improve clinical outcomes.
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            Bivalirudin during primary PCI in acute myocardial infarction.

            Treatment with the direct thrombin inhibitor bivalirudin, as compared with heparin plus glycoprotein IIb/IIIa inhibitors, results in similar suppression of ischemia while reducing hemorrhagic complications in patients with stable angina and non-ST-segment elevation acute coronary syndromes who are undergoing percutaneous coronary intervention (PCI). The safety and efficacy of bivalirudin in high-risk patients are unknown. We randomly assigned 3602 patients with ST-segment elevation myocardial infarction who presented within 12 hours after the onset of symptoms and who were undergoing primary PCI to treatment with heparin plus a glycoprotein IIb/IIIa inhibitor or to treatment with bivalirudin alone. The two primary end points of the study were major bleeding and combined adverse clinical events, defined as the combination of major bleeding or major adverse cardiovascular events, including death, reinfarction, target-vessel revascularization for ischemia, and stroke (hereinafter referred to as net adverse clinical events) within 30 days. Anticoagulation with bivalirudin alone, as compared with heparin plus glycoprotein IIb/IIIa inhibitors, resulted in a reduced 30-day rate of net adverse clinical events (9.2% vs. 12.1%; relative risk, 0.76; 95% confidence interval [CI] 0.63 to 0.92; P=0.005), owing to a lower rate of major bleeding (4.9% vs. 8.3%; relative risk, 0.60; 95% CI, 0.46 to 0.77; P<0.001). There was an increased risk of acute stent thrombosis within 24 hours in the bivalirudin group, but no significant increase was present by 30 days. Treatment with bivalirudin alone, as compared with heparin plus glycoprotein IIb/IIIa inhibitors, resulted in significantly lower 30-day rates of death from cardiac causes (1.8% vs. 2.9%; relative risk, 0.62; 95% CI, 0.40 to 0.95; P=0.03) and death from all causes (2.1% vs. 3.1%; relative risk, 0.66; 95% CI, 0.44 to 1.00; P=0.047). In patients with ST-segment elevation myocardial infarction who are undergoing primary PCI, anticoagulation with bivalirudin alone, as compared with heparin plus glycoprotein IIb/IIIa inhibitors, results in significantly reduced 30-day rates of major bleeding and net adverse clinical events. (ClinicalTrials.gov number, NCT00433966 [ClinicalTrials.gov].). Copyright 2008 Massachusetts Medical Society.
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              Impact of major bleeding on 30-day mortality and clinical outcomes in patients with acute coronary syndromes: an analysis from the ACUITY Trial.

              The purpose of this study was to determine the predictors of major bleeding and the impact of major bleeding on outcomes, including mortality, in acute coronary syndromes (ACS). Whether major bleeding independently predicts mortality in patients with ACS undergoing an early invasive strategy is undefined. Patients (n = 13,819) with moderate- and high-risk ACS were randomized to heparin (unfractionated or enoxaparin) plus glycoprotein IIb/IIIa inhibition (GPI), bivalirudin plus GPI, or bivalirudin monotherapy (plus provisional GPI). Logistic regression was used to determine predictors of 30-day major bleeding and mortality. Major bleeding rates in patients treated with heparin plus GPI were higher versus bivalirudin monotherapy (5.7% vs. 3.0%, p /=1 mm, and treatment with heparin plus GPI versus bivalirudin monotherapy. Patients with major bleeding had higher 30-day rates of mortality (7.3% vs. 1.2%, p < 0.0001), composite ischemia (23.1% vs. 6.8%, p < 0.0001), and stent thrombosis (3.4% vs. 0.6%, p < 0.0001) versus those without major bleeding. Major bleeding was an independent predictor of 30-day mortality (odds ratio 7.55, 95% confidence interval 4.68 to 12.18, p < 0.0001). Major bleeding is a powerful independent predictor of 30-day mortality in patients with ACS managed invasively. Several factors independently predict major bleeding, including treatment with heparin plus GPI compared with bivalirudin monotherapy. Knowledge of these findings might be useful to reduce bleeding risk and improve outcomes in ACS.
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                Author and article information

                Journal
                Open Cardiovasc Med J
                Open Cardiovasc Med J
                TOCMJ
                The Open Cardiovascular Medicine Journal
                Bentham Open
                1874-1924
                30 June 2016
                2016
                : 10
                : 122-129
                Affiliations
                Department of Cardiology, Clínic Hospital, Asunción National University, Cardiovascular Institute, Sanatorio Migone-Battilana, Asunción, Paraguay
                Author notes
                Address correspondence to this author at the Conacyt Investigator Level II, Department of Cardiology, Asunción National University, Trejo y Sanabria 1657, Sajonia, Asunción, Paraguay; Tel: 595-21-421423; Fax: 595-21-421423; E-mail: osmarcenturion@ 123456hotmail.com
                Article
                TOCMJ-10-122
                10.2174/1874192401610010122
                5002443
                b23b4a1d-3add-4a54-aab0-e8ca15e04adf
                © Osmar Antonio Centurión; Licensee Bentham Open.

                This is an open access article licensed under the terms of the Creative Commons Attribution-Non-Commercial 4.0 International Public License (CC BY-NC 4.0) ( https://creativecommons.org/licenses/by-nc/4.0/legalcode), which permits unrestricted, non-commercial use, distribution and reproduction in any medium, provided the work is properly cited.

                History
                : 22 February 2015
                : 20 March 2015
                : 22 April 2015
                Categories
                Article

                Cardiovascular Medicine
                acute myocardial infarction,bivalirudin,percutaneous coronary intervention,unfractionated heparin

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