Bivalirudin during percutaneous coronary intervention in acute coronary syndromes
Marc Laine1,2,3, Gilles Lemesle4, Thibaut Dabry1,2,3
1a Department of Cardiology , Intensive care unit, Aix-Marseille Université, Assistance Publique-Hôpitaux de Marseille, Hôpital Nord , Marseille , France.
Insights
Unfractionated heparin (UFH) remains superior to bivalirudin for preventing complications in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI). Clinical trials show UFH offers unmatched anticoagulation efficacy, challenging bivalirudin
Area of Science:
- Cardiology
- Pharmacology
- Interventional Cardiology
Background:
- Anticoagulant therapy is crucial for acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI).
- Unfractionated heparin (UFH) has limitations including unpredictable efficacy and risk of bleeding.
- Bivalirudin, a direct thrombin inhibitor, was proposed as an alternative with potential for better outcomes.
Purpose of the Study:
- To review randomized clinical trials comparing bivalirudin and UFH in ACS patients undergoing PCI over two decades.
- To evaluate the efficacy and safety of bivalirudin versus UFH in this patient population.
Main Methods:
- Systematic review and meta-analysis of randomized clinical trials.
- Comparison of bleeding events, stent thrombosis, and overall clinical outcomes between bivalirudin and UFH groups.
- Analysis of trial data considering changes in concomitant therapies like glycoprotein inhibitors (GPI).
Main Results:
- Early trials suggested reduced bleeding with bivalirudin, particularly when combined with GPI.
- Recent studies question bleeding reduction as GPI use declined.
- Concerns regarding increased stent thrombosis risk with bivalirudin emerged.
- Bivalirudin's guideline recommendations have been downgraded.
Conclusions:
- The purported bleeding reduction with bivalirudin is questionable.
- The risk of stent thrombosis with bivalirudin is a significant concern.
- Unfractionated heparin (UFH) provides superior and unparalleled anticoagulation for ACS patients undergoing PCI.
Introduction:
Anticoagulant therapy is critical to prevent ischemic recurrences and complications in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI). Unfractionated heparin (UFH), an injectable anticoagulant has several limitations: lack of predictability of its biological efficacy, platelets activation, heparin-induced thrombopenia and bleedings. Bivalirudin, a synthetic direct thrombin inhibitor has biological properties that promised better clinical outcome in ACS patients undergoing PCI.
Areas Covered:
The present review aimed to summarize two decades of randomized clinical trials that compared bivalirudin to UFH in ACS patients treated with PCI. Early trials highlighted a reduction of bleedings with bivalirudin compared to UFH in combination with glycoprotein inhibitors (GPI). Recent studies questioned this reduction given that GPI are less and less used during PCI. Further, trials raised concerns about the risk of stent thrombosis in patients treated with bivalirudin. In light of this data, bivalirudin has been downgraded in international guidelines and appears as a second line anticoagulant agent after UFH.
Expert Opinion:
The highly questioned reduction of bleedings under bivalirudin and the potential risk of stent thrombosis are unwarranted. Based on clinical trials, UFH has no equivalent in terms of anticoagulation in ACS patients undergoing PCI.
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