Effect Of Bivalirudin Research Articles

Exploring the Difference in Post-procedural Stroke Rates Between Patients with Aortic Stenosis Who Undergo Transcatheter Aortic Valve Replacement Versus Surgical Aortic Valve Replacement.

Transcatheter aortic valve replacement (TAVR) is a newer alternative to surgical aortic valve replacement (SAVR) for patients with severe aortic stenosis. Clinical trials have investigated TAVR's safety and effectiveness. Cerebral embolization is a common complication leading to stroke after TAVR and SAVR; different cerebral protection methods have been studied to prevent this.This paper evaluates the rate of post-procedural stroke rates between TAVR and SAVR and investigates the effect of cerebral protective methods on the stroke risk post-TAVR.Publications on TAVR and SAVR were found using specific criteria on PubMed. The Placement of Aortic Transcatheter Valves 1 (PARTNER 1) and PARTNER 2, the Nordic Aortic Valve Intervention (NOTION), and Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) trials compared the incidence of complications between TAVR and SAVR. The Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation (ADVANCED), CoreValve (Medtronic, Minneapolis, MN), Neurologic Complications of Unprotected Transcatheter Aortic Valve Implantation (Neuro-TAVI), Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of LotusTM Valve System (Boston Scientific, Marlborough, MA) - Randomized Clinical Evaluation (REPRISE II), and The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (STC/ACC TVT) registry studies further explored the risk of stroke in TAVR. The Effect of Bivalirudin on Aortic Valve Intervention Outcomes (BRAVO)-3 MRI, a prospective randomized evaluation of the TriGuardTM HDH (Keystone Heart, Tampa, FL) Embolic Deflection Device During Transcatheter Aortic Valve Replacement (DEFLECT III), Claret Embolic Protection and Transcatheter Aortic Valve Implantation (CLEAN-TAVI), and Cerebral Protection in Transcatheter Aortic Valve Replacement (SENTINEL) trials investigated cerebral protection methods post-TAVR for stroke prevention.In the PARTNER 1 trial, the stroke rate was greater in the TAVR group than in the SAVR group at one year (8.3% vs. 4.3%, P=0.04); the PARTNER 2 trial showed a lower risk of stroke at two years (6.2% and 6.4%, respectively). The NOTION and SURTAVI trials showed no significant difference in stroke rate between TAVR and SAVR at one year (13.1% vs 16.3%, respectively; p = 0.43). An increase in stroke rate after TAVR was found in the ADVANCED trial (5.6% at 31 days - two years) and CoreValve trial (4.3% in the late phase). The Neuro-TAVI trial showed ischemia after TAVR in 20% of patients at discharge. In the STC/ACC TVT Registry, the rate of post-procedure disabling stroke was 1.7% at 30 days. Finally, the BRAVO-3 MRI study showed no advantages between bivalirudin or unfractionated heparin in preventing cerebral lesion formation (65.5% vs 58.1%, respectively; p = 0.55). The DEFLECT III, CLEAN-TAVI, and SENTINEL trials assessed the safety and efficacy of transcatheter cerebral embolic protection devices (CEPDs); their results ranged from 50% improvement (CLEAN-TAVI) to none (DEFLECT III, SENTINEL), therefore, showing non-inferiority of cerebral embolic protection devices for TAVR patients.The clinical trials studied in this paper showed a similar incidence of stroke in both groups, with the majority of TAVR patients developing cerebral lesions. With the addition of cerebral embolic protective devices, this incidence has decreased.

GW28-e1171 The effect of Intra-coronary Bivalirudin injection during primary PCI on coronary blood flow and clinical events in patients with acute ST segment elevation myocardial infarction: A Pilot Study

The aim of the study was to explore the effect of bivalirudin by intracoronary injection during primary PCI on coronary blood flow and 30 days clinical events in patients with acute ST segment elevation myocardial infarction. This was a prospective, randomized controlled pilot trial. A total of 84

Cerebral Embolism During Transcatheter Aortic Valve Replacement: The BRAVO-3 MRI Study

BackgroundCerebral embolization is a frequent complication after transcatheter aortic valve replacement (TAVR). We hypothesized that cerebral embolization may be reduced by anticoagulation with bivalirudin during TAVR. ObjectivesThis study sought to determine the proportion of patients with new cerebral embolus after TAVR and to investigate whether parenteral procedural anticoagulation strategies affect cerebral embolization. MethodsThe BRAVO (Effect of Bivalirudin on Aortic Valve Intervention Outcomes)-3 randomized trial compared bivalirudin with unfractionated heparin in patients undergoing transfemoral TAVR. A prospective cerebral magnetic resonance imaging (MRI) substudy was conducted in 4 sites; 60 patients were imaged with brain MRI after TAVR. Primary endpoint was proportion of patients with new cerebral emboli on MRI. Secondary endpoints included quantitative MRI analyses of cerebral lesions and neurological outcomes at 48 h and 30 days. ResultsPatients were randomized to bivalirudin (n = 29) versus heparin (n = 31). The proportion of patients with new cerebral emboli on MRI did not differ between bivalirudin and heparin groups (65.5% vs. 58.1%; p = 0.55). Groups were similar for median number of emboli per patient (1 [interquartile range (IQR): 0 to 3] vs. 1 [IQR: 0 to 1]; p = 0.08), total volume of emboli (45 [IQR: 0 to 175] mm3 vs. 33 [IQR: 0 to 133] mm3; p = 0.86), or proportion of patients with a clinical neurological deficit at 48 h or 30 days. All patients who presented clinically with stroke had evidence of new emboli on MRI. ConclusionsThis study documented cerebral embolization in nearly two-thirds of patients during contemporary TAVR. There were no significant differences in cerebral embolization for bivalirudin versus heparin anticoagulation during TAVR. (Open-Label, Randomized Trial in Patients Undergoing TAVR to Determine Safety and Efficacy of Bivalrudin vs. UFH [BRAVO-2/3]; NCT01651780)

Abstract 15709: Bivalirudin is Associated With Decreased Cardiovascular Outcomes and Bleeding as Compared to Heparin During PCI: A Meta- Analysis

Background: Anticoagulant therapy is needed for safe and effective Percutaneous Coronary Intervention (PCI). Bivalirudin is widely used as an anticoagulant during PCI in acute coronary syndromes. Prior analysis had shown significant decrease in bleeding with similar rates of death with Bivalirudin compared to Heparin. Recent studies have shown mixed results. We performed this meta-analysis to compare the effect of bivalirudin versus heparin on major bleeding and deaths after PCI. Methods: We performed a systematic literature search for studies comparing bivalirudin versus heparin on major bleeding and deaths after PCI. Studies providing data on the outcome of major bleeding and deaths were included. Statistical heterogeneity across the various trials was tested using the Cochran’s Q statistic and I2 was computed to quantify heterogeneity. A two-sided alpha error of less than 0.05 was considered to be statistically significant (p < 0.05). Results: Total of 22 eligible studies was included for major bleeding events and total 24 eligible studies were included for death events. The studies for major bleeding events were heterogeneous while studies for death events were homogenous; hence random and fixed effect model was used respectively to calculate combined relative risk (RR). Meta-analysis revealed that the use of bivalirudin compared to heparin is associated with statistically significant lower rates of major bleeding (RR, 0.612; CI, 0.504 to 0.742; p = 0.000) and death (RR, 0.709; CI, 0.606 to 0.830; p = 0.000). Conclusion: Our analysis concluded that bivalirudin compared to heparin is associated with lower rates of major bleeding and death during PCI.

The effect of bivalirudin and closure device on bleeding outcomes after percutaneous coronary interventions.

IntroductionStudies have demonstrated bivalirudin efficacy in some patients at increased risk of bleeding. The aim of this study was to determine the extent to which bleeding reduction is achieved among all patients using bivalirudin as compared with a heparin with or without 2B3A inhibitor strategy.MethodsThis is a real-world, large-scale retrospective study utilising the American College of Cardiology (ACC) data from a 37-hospital Ascension Health System. The registry represents routine clinical practice between 1 June 2009 and 30 June 2012. End points included major bleeding, major adverse cardiac events and death. Multivariate regression analysis modelled on predictors of end points.ResultsThis study included 58 862 PCI procedures. Major bleeding rates were lowest for bivalirudin plus closure device overall (OR=0.53, CI 0.21 to 0.84, p=0.001). The use of a device for access closure contributed to the greatest declines in major bleeding. Compared with heparin with device, bivalirudin with device had a significantly lower rate of bleeding (OR=0.37, CI 0.18 to 0.74, p=0.005). The use of device had a greater effect on decreasing bleeding among patients receiving bivalirudin compared with heparin, especially among women (p=0.001). After adjustment for 2B3A use, this advantage was no longer significant in ST segment elevation myocardial infarction patients (OR=1.8, CI 0.5 to 6.0, p=0.34).ConclusionsAll risk groups in this real world database representing current clinical practice benefited from the use of bivalirudin and device closure with lower risk groups benefiting the most. This robust analysis of real-world clinical data supports a combined treatment strategy of bivalirudin and closure device.

Effect of bivalirudin on aortic valve intervention outcomes study: a two-centre registry study comparing bivalirudin and unfractionated heparin in balloon aortic valvuloplasty

We sought to assess if bivalirudin use during balloon aortic valvuloplasty (BAV) would affect clinical outcomes compared with heparin. We compared the outcomes of consecutive patients who underwent elective or urgent BAV with intraprocedural use of bivalirudin or heparin at two high-volume centres. All in-hospital events post BAV were adjudicated by an independent, blinded clinical events committee. Of 427 patients, 223 patients (52.2%) received bivalirudin and 204 (47.8%) received heparin. Compared with patients who received heparin, patients who received bivalirudin had significantly less major bleeding (4.9% vs. 13.2%, p=0.003). Net adverse clinical events (NACE, major bleeding or major adverse cardiovascular events [MACE]) were also reduced (11.2% vs. 20.1%, p=0.01). There was no significant difference in the rates of MACE (mortality, myocardial infarction or stroke, 6.7% vs. 11.3%, p=0.1), or vascular complications (major, 2.7% vs. 2.0%; minor, 4.5% vs. 4.9%; p=0.83). After multivariate analysis controlling for vascular preclosure, the use of bivalirudin remained independently associated with reduced major bleeding (OR 0.37; 95% CI: 0.16 to 0.84; p=0.02) while the association was attenuated in propensity-adjusted analysis (OR 0.44, 95% CI: 0.18 to 1.07, p=0.08). In this registry of patients with severe aortic stenosis, bivalirudin as compared to heparin resulted in improved in-hospital outcomes post BAV in terms of reduced major bleeding, similar MACE and reduced NACE. If verified in a randomised study and extended to the transcatheter aortic valve implantation (TAVI) population, these results might indicate a potential benefit for patients undergoing such procedures.

The effect of bivalirudin on costs and outcomes of treatment of ST-segment elevation myocardial infarction

Bivalirudin is commonly used during percutaneous coronary intervention (PCI) rather than unfractionated heparin. The higher cost of bivalirudin may be offset if it reduces costly bleeding complications and/or length of stay. We sought to assess the effect of using bivalirudin on the costs of care among patients with ST-segment elevation myocardial infarction (STEMI) undergoing PCI. We analyzed data from 64,872 patients treated in 1 of 278 hospitals. The effect of overall hospital use of bivalirudin on clinical and economic outcomes was assessed using multivariable regression, based on average hospital use of treatments. The use of bivalirudin among patients with STEMI treated with PCI varied widely across hospitals, with a median of 6.9% (interquartile range 2.3%-18.6%). After controlling for patient and hospital characteristics, use of bivalirudin rather than heparin and a glycoprotein IIb/IIIa inhibitor reduced bleeding (odds ratio 0.47, P < .001), length of stay (-0.47 days, P < .03), and hospital costs (-14%, P < .04). Use of bivalirudin among patients with STEMI treated with PCI appears to reduce bleeding and overall costs.

Bivalirudin Is a Dual Inhibitor of Thrombin and Collagen-Dependent Platelet Activation in Patients Undergoing Percutaneous Coronary Intervention

Bivalirudin, a direct thrombin inhibitor, is a widely used adjunctive therapy in patients undergoing percutaneous intervention (PCI). Thrombin is a highly potent agonist of platelets and activates the protease-activated receptors, PAR1 and PAR4, but it is not known whether bivalirudin exerts antiplatelet effects in PCI patients. We tested the hypothesis that bivalirudin acts as an antiplatelet agent in PCI patients by preventing activation of PARs on the platelet surface. The effect of bivalirudin on platelet function and systemic thrombin levels was assessed in patients undergoing elective PCI. Mean plasma levels of bivalirudin were 2.7±0.5 μmol/L during PCI, which correlated with marked inhibition of thrombin-induced platelet aggregation and significantly inhibited cleavage of PAR1. Unexpectedly, bivalirudin also significantly inhibited collagen-platelet aggregation during PCI. Collagen induced a conversion of the platelet surface to a procoagulant state in a thrombin-dependent manner that was blocked by bivalirudin. Consistent with this result, bivalirudin reduced systemic thrombin levels by >50% during PCI. Termination of the bivalirudin infusion resulted in rapid clearance of the drug with a half-life of 29.3 minutes. Bivalirudin effectively suppresses thrombin-dependent platelet activation via inhibition of PAR1 cleavage and inhibits collagen-induced platelet procoagulant activity as well as systemic thrombin levels in patients undergoing PCI.

TCT-355: Effect of Bivalirudin on Clinical Outcomes among STEMI Patients in an Observational Dataset

TCT-355: Effect of Bivalirudin on Clinical Outcomes among STEMI Patients in an Observational Dataset

Effect of bivalirudin on length of stay in the recovery area after percutaneous coronary intervention compared with heparin alone, heparin + abciximab, or heparin + eptifibatide

Three hundred nine patients were followed during their recovery area stay after percutaneous coronary intervention. Recovery area times for patients who received bivalirudin during percutaneous coronary intervention showed an average reduction in total recovery area length of stay of 36 minutes (p <0.0001) compared with patients who received heparin alone. This reduction was also seen when compared with the heparin + abciximab group (46-minute reduction, p = 0.0007), and the heparin + eptifibatide group (35-minute reduction, p = 0.0005). Patients who received bivalirudin took significantly less time for the activated clotting time (ACT) to normalize despite significantly higher average ACTs and significantly fewer subtherapeutic ACTs.

The effect of bivalirudin in combination with ticlopidine on laboratory coagulation parameters and the incidence of clinically significant bleeding in patients undergoing percutaneous transluminal coronary angioplasty (PTCA) and stenting

The effect of bivalirudin in combination with ticlopidine on laboratory coagulation parameters and the incidence of clinically significant bleeding in patients undergoing percutaneous transluminal coronary angioplasty (PTCA) and stenting