Bivalirudin or Heparin in Patients Undergoing Invasive Management of Acute Coronary Syndromes

Gargiulo, Giuseppe; Carrara, Greta; Frigoli, Enrico; Vranckx, Pascal; Leonardi, Sergio; Ciociano, Nestor; Campo, Gianluca; Varbella, Ferdinando; Calabrò, Paolo; Garducci, Stefano; Iannone, Alessandro; Briguori, Carlo; Andò, Giuseppe; Limbruno, Ugo; Garbo, Roberto; Sganzerla, Paolo; Russo, Filippo; Lupi, Alessandro; Cortese, Bernardo; Ausiello, Arturo; Ierna, Salvatore; Esposito, Giovanni; Zavalloni, Dennis; Santarelli, Andrea; Sardella, Gennaro; Tresoldi, Simone; Cesare, Nicoletta De; Sciahbasi, Alessandro; Zingarelli, Antonio; Tosi, Paolo; Hof, Arnoud van ’t; Ömerovic, Elmir; Brugaletta, Salvatore; Windecker, Stephan; Valgimigli, Marco

doi:10.1016/j.jacc.2018.01.033

Cited by 35 publications

(25 citation statements)

References 12 publications

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“…Although the role of anticoagulants in the secondary prevention of recurrent ischemic events after acute coronary syndrome (ACS) and during percutaneous coronary intervention (PCI) in stable coronary artery disease (CAD) is well established [5][6][7][8], the possible increase in ischemic coronary events with anticoagulants in different clinical settings is a matter of concern [2,6,9,10]. In this context, enoxaparin, a low molecular weight heparin (LMWH) with predominant anti-Xa mechanism, was shown to be safe in other studies, without pro-aggregatory effects [4,5,11,12].…”

Section: Introductionmentioning

confidence: 99%

Influence of Direct Thrombin Inhibitor and Low Molecular Weight Heparin on Platelet Function in Patients with Coronary Artery Disease: A Prospective Interventional Trial

et al. 2019

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Introduction: The interaction between anticoagulants and platelet function is complex. Previous publications showed mixed results regarding the role of heparins in platelet aggregation. On the other hand, the direct thrombin inhibitor (DTI) dabigatran might enhance the risk of myocardial infarction in patients with atrial fibrillation, which could be related to increased platelet aggregability. Methods: This was a prospective, interventional study of patients with chronic coronary artery disease (CAD) taking low-dose aspirin. The objective of the current study was to compare the effects of dabigatran versus enoxaparin on platelet aggregability. Subjects initially were on orally administered dabigatran for 5 days followed by subcutaneously administered enoxaparin after a 30-day washout period. Platelet function was assessed at baseline and after each intervention by multiple electrode aggregometry (MEA-ASPI) (primary endpoint), serum thromboxane B2 (TXB2), VerifyNow Aspirin TM , and coagulation tests (secondary endpoints). Results: Compared to baseline MEA-ASPI values, dabigatran increased platelet aggregation while enoxaparin decreased platelet aggregation (? 5 U ± 24.1 vs-6 U ± 22.2, respectively, p = 0.012). The TXB2 assay showed the same pattern (? 2 pg/ml for dabigatran vs-13 pg/ml for enoxaparin, p = 0.011). None of the additional tests showed significant differences between the groups. Individually, compared to baseline TXB2 results, enoxaparin significantly decreased platelet activation [33 (16.5-95) pg/ mL vs 20 (10-52) pg/mL, respectively, p = 0.026], but no significant differences were observed with dabigatran. Conclusions: DTI and anti-Xa drugs exert opposite effects on platelet function. A significant decrease in platelet activation through COX1 (also known as prostaglandin G/H synthase 1) was observed with enoxaparin, but no significant differences in platelet function were observed with dabigatran. Trial Registration: ClinicalTrials.gov identifier, NCT02389582.

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Section: Introductionmentioning

confidence: 99%

Influence of Direct Thrombin Inhibitor and Low Molecular Weight Heparin on Platelet Function in Patients with Coronary Artery Disease: A Prospective Interventional Trial

et al. 2019

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“…10 Similar findings were observed in the MATRIX antithrombin study, regardless of the concurrent therapy with GPIs or access site. 7 Collectively, these trials have consistently shown reduced bleeding events with bivalirudin, despite the differences in their design including variable use of P2Y 12 inhibitors and GPIs, and In conclusion, in patients undergoing TRI, bivalirudin was associated with reduced short-term NACE compared with heparin. There were no significant differences between groups with regard to other short-and long-term ischemic and bleeding events.…”

Section: Discussionmentioning

confidence: 94%

“…4 However, the added ischemic benefit from GPIs was offset by increased bleeding-a risk that has been linked with mortality. [5][6][7] In contrast to heparin, bivalirudin is a short-lived direct thrombin inhibitor with an intrinsic antiplatelet activity and more stable pharmacokinetic and pharmacodynamic properties which has been associated with reduced bleeding, primarily in trials utilizing femoral artery access. 8 However, the efficacy and safety outcomes of bivalirudin administration in patients undergoing transradial artery coronary interventions (TRI) are conflicting.…”

Section: Introductionmentioning

confidence: 99%

Meta‐analysis of bivalirudin versus heparin in transradial coronary interventions

Kheiri

Rao

Simpson

et al. 2020

Cathet Cardio Intervent

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Objectives: We sought to evaluate the efficacy and safety of bivalirudin versus heparin in patients with coronary artery disease undergoing transradial artery coronary intervention (TRI). Background: Bivalirudin and radial artery access are independently associated with improved cardiovascular outcomes. However, data supporting a strategy of combining both to achieve additive improvements in cardiovascular outcomes provide conflicting results. Methods: A systematic search was performed to identify randomized controlled trials (RCTs) of bivalirudin, in which vascular access sites were reported. The primary outcome was net adverse clinical events (NACE) at 30 days. Secondary outcomes were long-term NACE, short-, and long-term major adverse cardiovascular events, all-cause mortality, myocardial infarction, unplanned revascularization, stent thrombosis, and major bleeding. Results: We identified 10 RCTs, including 16,328 patients who underwent TRI (mean age 64.6 ± 15.7 years, 72.5% male). Bivalirudin use was associated with decreased 30-day NACE compared with heparin (6.3 vs. 7.4%; risk ratio [RR] = 0.87; 95% confidence interval [CI] = 0.76-0.99; p = .04; number needed to treat = 91). No significant interactions were observed based on clinical presentation, administration of P2Y 12 inhibitors, or glycoprotein IIb/IIIa-receptor inhibitors (GPI) use. There were no significant differences between groups in any prespecified secondary outcomes. There was, however, a significant reduction of major bleeding in the bivalirudin group compared with heparin when used in combination with routine GPI (RR = 0.41; 95% CI = 0.19-0.90; p = .03). Conclusions: Among patients undergoing TRI, use of bivalirudin was associated with significantly reduced 30-day NACE compared with heparin. There was no significant difference in long term NACE, ischemic, or bleeding events compared with heparin.

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“…1 Both unfractionated heparin (UFH) and bivalirudin are used as antithrombin strategies during PPCI. [2][3][4][5][6][7] Remaining thrombus within the stented infarct-related artery has been consistently observed with optical coherence tomography (OCT) at the end of PPCI. 8,9 This residual thrombosis of stent struts may promote further thrombus growth and represent a risk factor for acute stent thrombosis.…”

Section: Introductionmentioning

confidence: 87%

“…Patients presenting with acute ST‐elevation myocardial infarction (STEMI) receive primary percutaneous coronary intervention (PPCI) as the treatment of choice 1 . Both unfractionated heparin (UFH) and bivalirudin are used as antithrombin strategies during PPCI 2–7 …”

Section: Introductionmentioning

confidence: 99%

Assessment of residual thrombus burden in patients with ST‐segment elevation myocardial infarction undergoing bivalirudin versus unfractionated heparin infusion: The MATRIX (minimizing adverse hemorrhagic events by transradial access site and angioX) OCT study

García‐García

Adamo

Soud

et al. 2019

Cathet Cardio Intervent

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Background: Residual stent strut thrombosis after primary percutaneous coronary intervention (PCI), negatively affects myocardial perfusion, may increase stent thrombosis risk, and it is associated with neointima hyperplasia at follow-up. Objectives: To study the effectiveness of any bivalirudin infusion versus unfractionated heparin (UFH) infusion in reducing residual stent strut thrombosis in patients with ST-elevation myocardial infarction (STEMI). Methods: Multi-vessel STEMI patients undergoing primary PCI and requiring staged intervention were selected among those randomly allocated to two different bivalirudin infusion regimens in the MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and angioX) Treatment-Duration study. Those receiving heparin only were enrolled into a registry arm. Optical coherence tomography (OCT) of the infarct-related artery was performed at the end of primary PCI and 3-5 days thereafter during a staged intervention. The primary endpoint was the change in minimum flow area (ΔMinFA) defined as (stent area + incomplete stent apposition [ISA] area) − (intraluminal defect + tissue prolapsed area) between the index and staged PCI.

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Bivalirudin or Heparin in Patients Undergoing Invasive Management of Acute Coronary Syndromes

Cited by 35 publications

References 12 publications

Influence of Direct Thrombin Inhibitor and Low Molecular Weight Heparin on Platelet Function in Patients with Coronary Artery Disease: A Prospective Interventional Trial

Influence of Direct Thrombin Inhibitor and Low Molecular Weight Heparin on Platelet Function in Patients with Coronary Artery Disease: A Prospective Interventional Trial

Meta‐analysis of bivalirudin versus heparin in transradial coronary interventions

Assessment of residual thrombus burden in patients with ST‐segment elevation myocardial infarction undergoing bivalirudin versus unfractionated heparin infusion: The MATRIX (minimizing adverse hemorrhagic events by transradial access site and angioX) OCT study

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