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Updated: Aug 9, 2026

Interventional Diagnostic Procedure: A Practical Guide for the Assessment of Coronary Vascular Function
Published on: March 15, 2022
[Direct thrombin inhibitors in coronary angioplasty. Value of bivalirudin ]
P Coste1, J N Labèque, L Leroux
1Unité de soins cardiaques intensifs et plateau de cardiologie interventionnelle, Hôpital cardiologique du Haut-Lévêque, Pessac.
Insights
Bivalirudin, a direct thrombin inhibitor, is a safe and effective alternative to unfractionated heparin (NFH) during angioplasty, reducing bleeding complications and mortality, especially in high-risk patients.
Area of Science:
- Cardiology
- Pharmacology
- Interventional Cardiology
Background:
- Coronary angioplasty requires antithrombin agents to prevent myocardial infarction.
- Bivalirudin is a synthetic direct thrombin inhibitor validated for angioplasty.
- Bivalirudin offers comparable efficacy to NFH/LMWH with fewer bleeding complications.
Purpose of the Study:
- To evaluate the efficacy and safety of bivalirudin compared to NFH in patients undergoing angioplasty.
- To assess the impact of bivalirudin on bleeding complications and mortality.
- To explore the role of bivalirudin in acute coronary syndromes.
Main Methods:
- REPLACE-2 trial compared bivalirudin (with optional anti-GPIIb/IIIa agents) to NFH (with systematic anti-GPIIb/IIIa agents).
- Assessed serious adverse events at 30 days, including death, infarctus, and bleeding.
- One-year follow-up evaluated mortality, particularly in high-risk subgroups.
Main Results:
- Bivalirudin showed non-inferior clinical efficacy to NFH.
- Serious adverse events were lower in the bivalirudin group (9.2% vs. 10.2%).
- One-year mortality was reduced with bivalirudin (1.9% vs. 2.5%), especially in elderly, diabetic, or renal failure patients.
Conclusions:
- Bivalirudin is a safe and effective alternative to NFH in angioplasty, with a favorable bleeding profile.
- Direct thrombin inhibitors like bivalirudin play a crucial role in improving angioplasty safety.
- Ongoing trials (ACUITY) will further elucidate the role of direct antithrombin agents in acute coronary syndromes.
Abstract:
During coronary angioplasty, the association of platelet inhibitors and antithrombin agents is required to prevent myocardial infarction. Bivalirudine, a synthetic direct thrombin inhibitor, has been widely validated in this context and has shown its efficacy and safety in several comparative studies. It is officially recommended as a replacement of NFH and LMWH associated or not with anti-GPIIb/IIIa agents because at comparable efficacy it causes fewer bleeding complications. In acute coronary syndromes without ST elevation, anti GPIIb/IIIa agents reduce angioplasty-related complications and mortality, especially in high risk patients in salvage situations. In the REPLACE-2 trial the clinical efficacy of bivalirudine (associated only when necessary with anti-GPIIb/IIIa agents) was no less than that of NFH associated systematically with anti-GPIIb/IIIa agents at the time of intervention. The incidents of serious adverse events at 30 days (death, infarctus, emergency revascularisation, major bleeding) in the bivalirudine group was 9.2% versus 10.2% in the NFH group. In a retrospective analysis, these results did not seem to be influenced by the prior administration of clopidogrel. Finally, the one year follow-up results showed a lower mortality in patients treated with bivalirudine (1.9% versus 2.5%), essentially in the high risk sub-groups such as the elderly, the diabetic or the renal failure patients. Clinical trials are underway (ACUITY) to study the interaction of anti GPIIb/IIIa agents with bivalirudine in the first hours of acute coronary syndromes and should confirm a major role of direct anti-thrombin drugs in the safety of angioplasty.
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