New anticoagulant faces the challenge of bleeding in PCI

Contemporary regimens for antithrombotic use during PCI have been successful at preventing ischaemic events, but often result in increased bleeding.


Angiox ™ (bivalirudin), however, enables significant reductions in post-PCI haemorrhagic complications while maintaining levels of efficacy in preventing ischaemic events.


Bleeding complications cause significant pain and discomfort to the patient and can delay a patient's return to complete mobility. Research has shown that bleeding complications are among the most costly aspects of percutaneous coronary intervention (PCI). The incremental costs of hospitalisation due to bleeding after PCI in the US are estimated to average between $8,000 to $10,000 per patient, primarily due to increased length of stay and the use of additional resources. Data from the REPLACE-2 trial, a large 6000 patients randomised trial of Angiox™ (bivalirudin) in PCI, showed that minor bleeding events cost an average of $396 per patient.


"Bleeding after PCI is a common complication in patients. Retrospective research of nearly 11,000 patients has demonstrated that major bleeding occurs in 5.4% and minor bleeding in 12.7% of patients undergoing PCI. However, the frequency of bleeding events and their impact on patient well being, clinical outcomes and hospital resources is underestimated as a result of varying methods used to detect and measure blood loss following PCI," says Professor Martin T. Rothman from the London Chest Hospital.


Patients with bleeding complications have more recurrent events and an increased risk of all major cardiac events, including myocardial infarction, left ventricular dysfunction, arrhythmia, and stroke. Major bleeding complications have also shown to result in higher 1-year mortality rates and are an independent predictor of in-hospital mortality.ii



"In order to reduce the incidence of bleeding complications, the choice of anticoagulant therapy needs careful consideration. Clinical trials of patients undergoing PCI have shown that the thrombin-specific anticoagulant Angiox™ (bivalirudin) provides effective anticoagulation and protection from ischaemic events, while significantly reducing bleeding events compared with the standard treatment options," adds Director of the Coronary Laboratory at Falu Lasarett in Sweden, Iwar Sj?gren.


In the 'Guidelines for Percutaneous Coronary Interventions', published by the European Society of Cardiology (ESC) earlier this year, bivalirudin (Angiox™) is suggested as a replacement for heparins. In the recommendations for GP IIb/IIIa inhibitors and bivalirudin as adjunctive medications for PCI, bivalirudin is indicated as a replacement for UFH or LMWH (plus/minus GP IIb/IIIa inhibitors) to reduce bleeding complications.


"Until now, reducing the occurrence of ischaemic events has been the primary goal of anticoagulation therapy in PCI. But newer therapeutic options such as Angiox™ (bivalirudin) have made it possible to address the clinical challenge of reducing both ischaemic events and bleeding complications to the benefit of patient well being, clinical outcomes and hospital resources," concludes Professor Rothman.


About Angiox™ (bivalirudin)


Angiox™ is a thrombin-specific anticoagulant indicated for use in patients undergoing percutaneous coronary intervention (PCI). In clinical trials, Angiox™ has demonstrated reductions in both ischaemic and bleeding complications. These reductions are evident even in high-risk patients.


Angiox™ was developed by The Medicines Company and launched in the US in 2001 (US trade name Angiomax®). Nycomed entered into a collaboration with The Medicines Company in March 2002 to be the exclusive distributor of Angiox™ in 33 countries in Europe and in Russia/CIS.


Angiox™ was approved by the European Commission in September 2004 and has subsequently been launched in most of Europe with the remaining countries expecting to launch throughout 2005.


About Nycomed


Nycomed is a pharmaceutical company dedicated to meeting needs in Europe. The company provides hospital products throughout the region and general practitioner and pharmacy medicines in selected markets.


New products are sourced through licensing agreements with research companies. Here Nycomed provides late-stage clinical development, registration and marketing.


Headquartered in Roskilde, Denmark, the company employs about 3,000 people throughout Europe and Russia/CIS. Nycomed is privately owned and had a 2004 revenue of ? 644.6 million.


For more information visit nycomed


Milkovich G and Gibson G (2003) in Am J Health Syst Pharm 60 (Suppl 3): S15-S21. Cohen DJ et al (2004) in J Am Coll Cardiol 44: 1792-1800

Kinnaird et al in Am J Cardiol 2003; 92: 930-935