Bivalirudin Versus Heparin Plus a Glycoprotein IIb/IIIa Inhibitor in Patients With Non–ST-Segment Elevation Myocardial Infarction Undergoing Percutaneous Coronary Intervention After Clopidogrel Pretreatment

Ndrepepa, Gjin; Neumann, Franz‐Josef; Deliargyris, Efthymios N.; Mehran, Roxana; Mehilli, Julinda; Ferenc, Mirosław; Schulz, Stefanie; Schömig, Albert; Kastrati, Adnan; Stone, Gregg W.

doi:10.1161/circinterventions.112.972869

Cited by 31 publications

(14 citation statements)

References 29 publications

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“…Compared with our analysis, only the post hoc results of the ACUITY trial showed a decrease in major bleeding with bivalirudin use in diabetes patients undergoing PCI, whereas the post hoc results of both HORIZONS‐AMI and REPLACE‐2 as well as the NAPLES trial showed no differences in major bleeding events between these two treatment arms. In a patient‐level pooled data from the ACUITY and ISAR‐REACT 4 trials, major bleeding was decreased with bivalirudin use in NSTEMI patients with diabetes who were pretreated with clopidogrel . Similar to our analysis, minor bleeding was lower with bivalirudin use in all studies that reported it.…”

Section: Discussionsupporting

confidence: 82%

“…The higher risk of complications faced by diabetes patients who develop ACS and undergo PCI highlights the importance of evaluating such a strategy in this specific patient population. Moreover, outcomes in diabetes patients in previously published meta‐analyses and patient‐level pooled data of randomized trials comparing bivalirudin with heparin and GPI in PCI have been limited . Given the scarcity of data published on this topic, we sought to perform a pooled analysis to evaluate the use of bivalirudin compared with heparin and GPI in diabetes patients undergoing PCI and report both 30‐day and 1‐year clinical outcomes.…”

Section: Introductionmentioning

confidence: 99%

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Short‐ and long‐term outcomes in diabetes patients undergoing percutaneous coronary intervention with bivalirudin compared with heparin and glycoprotein IIb/IIIA inhibitors: A meta‐analysis of randomized trials

Nairooz

Sardar

Amin

et al. 2015

Cathet Cardio Intervent

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Background: Diabetes patients undergoing percutaneous coronary intervention (PCI) have more complications than nondiabetes patients, including increased long-term mortality. Use of bivalirudin versus heparin and glycoprotein IIb/IIIa inhibitors (GPI) in diabetes patients undergoing PCI and its effect on long-term mortality were evaluated in few randomized trials, but with conflicting results. Methods: We searched the literature for randomized controlled trials that compared heparin and GPI therapy with bivalirudin in diabetes patients undergoing PCI. The incidence of major adverse cardiovascular events (MACE), death from any cause, myocardial infarction (MI), urgent revascularization, major and minor bleeding (at 30 days), as well as all-cause mortality at 1 year were included, and meta-analysis was performed. Results: A total of 5,137 patients with diabetes were included in four randomized trials. At 30 days, bivalirudin, compared with heparin and GPI, caused less major bleeding (odds ratio (OR), 0.68; 95% confidence interval (CI), 0.52-0.89; P 5 0.005) and less minor bleeding (OR, 0.48; 95% CI, 0.41-0.57; P < 0.00001) and similar rates of MACE (OR, 0.87; 95% CI, 0.70-1.08; P 5 0.21), MI (OR, 0.87; 95% CI, 0.68-1.10; P 5 0.25), and urgent revascularization (OR, 1.12; 95% CI, 0.76-1.65; P 5 0.57). Death from any cause at 30 day was numerically lower with bivalirudin use but not statistically significant (OR, 0.72; 95% CI, 0.46-1.13; P 5 0.15). Mortality at 1 year was significantly lower in diabetes patients treated with bivalirudin compared with heparin and GPI (OR, 0.72; 95% CI, 0.52-0.99; P 5 0.04). A secondary analysis suggests that the major bleeding benefit with bivalirudin may be driven by mandated use Catheterization and Cardiovascular Interventions 86: 364-375 (2015) of GPI in heparin arm. Conclusion: Among patients with diabetes undergoing PCI, bivalirudin caused less major and minor bleeding compared with heparin and GPI, with similar rates of MACE, death, MI, and urgent revascularization at 30 days, but significantly lower mortality rates at 1 year. V C 2015 Wiley Periodicals, Inc.

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Section: Discussionsupporting

confidence: 82%

Section: Introductionmentioning

confidence: 99%

Short‐ and long‐term outcomes in diabetes patients undergoing percutaneous coronary intervention with bivalirudin compared with heparin and glycoprotein IIb/IIIA inhibitors: A meta‐analysis of randomized trials

Nairooz

Sardar

Amin

et al. 2015

Cathet Cardio Intervent

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“…Bivalirudin has consistently shown to reduce the bleeding risk of patients with coronary artery disease undergoing PCI compared with heparin and glycoprotein IIb/IIIa inhibitors, particularly those presenting with an ACS. [97][98][99] A recent meta-analysis has confirmed the safety benefit of bivalirudin over unfractionated heparin alone. 100 However, there are no studies exploring whether such benefit is enhanced, similar, or blunted in patients who are orally anticoagulated.…”

Section: Intraprocedural Anticoagulationmentioning

confidence: 98%

Management of Antiplatelet and Anticoagulant Therapy in Patients With Atrial Fibrillation in the Setting of Acute Coronary Syndromes or Percutaneous Coronary Interventions

Capodanno

Angiolillo

2014

Circ: Cardiovascular Interventions

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A trial fibrillation (AF), the most common cardiac arrhythmia, occurs in 1% to 2% of the general population, with a prevalence varying from 0.5% in subjects 40 to 50 years old to 5% to 15% in the elderly who are >80 years old. [1][2][3] Stroke is the most feared complication of AF, resulting in death or disabling symptoms in a vast proportion of cases. 4 In the Framingham study, the age-adjusted incidence of stroke was 5-fold higher in subjects with AF, and the attributable risk raised from 1.5% at 50 to 59 years to 23.5% at 80 to 89 years. 5Chronic oral anticoagulation (OAC) therapy is the mainstay of stroke prevention in patients with AF at high risk for cardioembolic sequelae; ≈70% to 80% of all patients with AF have an indication for OAC, and coronary artery disease coexists in 20% to 30% of them. 6,7 With an estimated prevalence of AF in 1% to 2% of the population, it may be projected that ≈1 to 2 million patients on OAC in both the United States and Europe are candidates for coronary revascularization, often in the form of percutaneous coronary interventions (PCI). Patients undergoing PCI, as well as those who present with an acute coronary syndrome (ACS), also require dual antiplatelet therapy (DAPT), usually aspirin in combination with a platelet adenosine diphosphate P2Y 12 receptor antagonist, with the goal of reducing the risk of ischemic recurrences, including stent thrombosis. 8 However, the efficacy and safety of combining OAC with DAPT (triple antithrombotic therapy) in these patients is a topic of debate. In fact, although this combination can potentially prevent both thromboembolism and atherothrombotic events, it is also associated with an increased risk of severe bleeding. In a large nationwide registry of 40 812 patients hospitalized with myocardial infarction (MI), the risk of subsequent hospitalizations for bleeding increased with the number of antithrombotic drugs used, being 1.8-fold in patients on vitamin K antagonists (VKAs) and aspirin, 3.5-fold in patients on VKAs and clopidogrel, and 4-fold in patients on triple therapy, with numbers needed to harm of 45.4, 15.2, and 12.5, respectively. 9 On this background, treatment with OAC and antiplatelet agents requires careful consideration of the risks and benefits associated with each drug and their combination.On one hand, the challenge of balancing the risk of thromboembolism (ie, stroke) and atherothrombotic events (ie, stent thrombosis) and, on the other, the risk of bleeding demand for a timely review of the literature on using various combinations of OAC and antiplatelet therapies in patients with coexisting AF and coronary artery disease. This is also underscored by the recent availability of newer antithrombotic agents, including oral anticoagulants (ie, dabigatran, rivaroxaban, apixaban) and antiplatelets (ie, prasugrel, ticagrelor). This article reviews the evidence supporting antithrombotic agents for AF and ACS/PCI, and describes contemporary antithrombotic regimens and practical recommendations for patients with both condition...

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“…The direct-acting thrombin inhibitor bivalirudin is recommended as an alternative to UFH (plus GPIIb/IIIa inhibitors) during PCI (Class I, LOE A). Based on the results of clinical trials comparing these two agents and related meta-analysis (75)(76)(77), bivalirudin increased the risk of ischaemic events, while it decreased the risk of bleeding. However, available data is conflicting and further studies are urgently needed to compare UFH versus bivalirudin in a contemporary setting that includes a preferred radial access for PCI and that excludes the use of GPIIb/IIIa inhibitors in any of the study arms.…”

Section: The Presentmentioning

confidence: 99%

Antithrombotic therapy for acute coronary syndrome: Past, present and future

Sibbing

Angiolillo²,

Huber³

2017

Thromb Haemost

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SummaryPlaque erosions and ruptures are the histopathological hallmarks of arterial thrombus formation in the coronary arteries. The clinical condition associated with this process is usually referred to as acute coronary syndrome (ACS). Importantly, both blood platelets and the coagulation cascade are key players for initiation, amplification and perpetuation of ACS. There has been great progress in ACS treatment in recent decades, both at the technical level of (percutaneous) revascularisation and at the level of antithrombotic treatment. Numerous trials have led to significant advancements in the development of effective anticoagulant and antiplatelet drugs. The large number of randomised controlled clinical trials (RCTs) and the huge number of patients enrolled in these RCTs, with mega trials including >10,000 patients, is unique in the history of medical research and also reflects the exceptional efforts associated with these huge research activities. The crucial issue, however, with respect to optimising treatment, relates to finding the delicate balance between the reduction of thrombotic events by effective drug treatment and the induction of bleeding that is linked to the use of potent or multiple antithrombotic agents. Interestingly, there is a gap in modern days between current guideline recommendations favouring potent platelet inhibition in ACS and the utilization of the respective drugs in clinical practice. In this review, we will summarise and discuss the past, present and future antithrombotic treatment for ACS patients with a focus on the development of optimised antiplatelet treatment strategies and their utilisation in the real world.

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Bivalirudin Versus Heparin Plus a Glycoprotein IIb/IIIa Inhibitor in Patients With Non–ST-Segment Elevation Myocardial Infarction Undergoing Percutaneous Coronary Intervention After Clopidogrel Pretreatment

Cited by 31 publications

References 29 publications

Short‐ and long‐term outcomes in diabetes patients undergoing percutaneous coronary intervention with bivalirudin compared with heparin and glycoprotein IIb/IIIA inhibitors: A meta‐analysis of randomized trials

Short‐ and long‐term outcomes in diabetes patients undergoing percutaneous coronary intervention with bivalirudin compared with heparin and glycoprotein IIb/IIIA inhibitors: A meta‐analysis of randomized trials

Management of Antiplatelet and Anticoagulant Therapy in Patients With Atrial Fibrillation in the Setting of Acute Coronary Syndromes or Percutaneous Coronary Interventions

Antithrombotic therapy for acute coronary syndrome: Past, present and future

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