AFFECT: a prospective, open-label, multicenter trial to evaluate the feasibility and safety of a short-term treatment with subcutaneous certoparin in patients with persistent non-valvular atrial fibrillation
- Ulrich TebbeAffiliated withKlinikum Lippe GmbH, Fachbereich Herz-Kreislauf Email author
- , Ralph OeckinghausAffiliated withKlinikum Lippe GmbH, Fachbereich Herz-Kreislauf
- , Karl-Friedrich AppelAffiliated withAmbulantes Herzzentrum Kassel
- , Hubertus HeuerAffiliated withSt.-Johannes Hospital Dortmund
- , Hendrik HaakeAffiliated withKrankenhaus St. Franziskus, Mönchengladbach
- , Egbert EggersAffiliated withKreiskrankenhaus Torgau
- , Karlheinz SeidelAffiliated withHerzzentrum Ludwigshafen
- , Jan AdamsAffiliated withNovartis Pharma GmbH
- , Job HarenbergAffiliated withMedizinische Klinik, Universitätsklinikum Mannheim
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Patients with persistent atrial fibrillation (AF) scheduled for electrical cardioversion need immediate anticoagulation. Unfractionated heparin (UFH) is often used for early anticoagulation in these patients before oral anticoagulation becomes effective. However, dose adjustment is required to achieve a two- to three-fold prolongation of the activated partial thromboplastin. Low molecular weight heparins, given in body weight-adjusted or independent fixed dosage, require less laboratory monitoring and are also effective within hours of first dosing. They seem to be an attractive alternative to UFH. Previous evidence has shown that these drugs are safe and effective in this indication.
Patients and methods
In this prospective, open-label, multicenter pilot study, 203 patients were enrolled with persistent non-valvular AF scheduled for electrical cardioversion. Patients received a fixed dose of 8000 U anti-Xa certoparin twice daily starting immediately after enrolment and before cardioversion was performed. Patients with AF > 48 h underwent transoesophageal echocardiography (TEE) before cardioversion to exclude intra-atrial thrombi. After cardioversion, overlapping oral anticoagulation was started. Treatment with certoparin was stopped only after two consecutive days with INR values >2.
The objective was to document the feasibility and safety of a short-term treatment with a fixed, body weight-independent certoparin regimen (2 × 8000 U anti-Xa).
Out of 203 patients enrolled, 200 received at least one dose of certoparin and were included in the analysis (safety population). Median treatment duration with certoparin was 7 days. Bleedings were observed in 8 patients (4.0%) and were classified as major (1.5%) or minor (2.5%). Cerebral ischemia was reported for 1 patient (0.5%). One patient showed mild thrombocytopenia (0.5%). There were no reports of venous thromboembolism or death during the treatment period.
Certoparin administered at 8000 U anti-Xa twice daily independent of body weight was safe and appeared to be effective in patients with non-valvular AF undergoing electrical cardioversion. Its ease of use and the possibility of treatment on an outpatient basis make it an attractive option for early anticoagulation in AF.
Keywordscardioversion transoesophageal echocardiography atrial fibrillation anticoagulation low molecular weight heparin certoparin
- AFFECT: a prospective, open-label, multicenter trial to evaluate the feasibility and safety of a short-term treatment with subcutaneous certoparin in patients with persistent non-valvular atrial fibrillation
Clinical Research in Cardiology
Volume 97, Issue 6 , pp 389-396
- Cover Date
- Print ISSN
- Online ISSN
- D. Steinkopff-Verlag
- Additional Links
- transoesophageal echocardiography
- atrial fibrillation
- low molecular weight heparin
- Industry Sectors
- Author Affiliations
- 1. Klinikum Lippe GmbH, Fachbereich Herz-Kreislauf, Röntgenstrasse 18, 32756, Detmold, Germany
- 2. Ambulantes Herzzentrum Kassel, Kassel, Germany
- 3. St.-Johannes Hospital Dortmund, Dortmund, Germany
- 4. Krankenhaus St. Franziskus, Mönchengladbach, Mönchengladbach, Germany
- 5. Kreiskrankenhaus Torgau, Torgau, Germany
- 6. Herzzentrum Ludwigshafen, Ludwigshafen, Germany
- 7. Novartis Pharma GmbH, Nuremberg, Germany
- 8. Medizinische Klinik, Universitätsklinikum Mannheim, Mannheim, Germany