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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

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Abstract

Background

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.

Objectives

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).

Results

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.

Conclusion

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.

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Acknowledgments

The study was sponsored by Novartis Pharma GmbH, Nürnberg, Germany. We thank the patients participated in the study and all investigators who conducted the trial mentioned in Appendix.

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Authors and Affiliations

  1. Klinikum Lippe GmbH, Fachbereich Herz-Kreislauf, Röntgenstrasse 18, 32756, Detmold, Germany

    Ulrich Tebbe & Ralph Oeckinghaus

  2. Ambulantes Herzzentrum Kassel, Kassel, Germany

    Karl-Friedrich Appel

  3. St.-Johannes Hospital Dortmund, Dortmund, Germany

    Hubertus Heuer

  4. Krankenhaus St. Franziskus, Mönchengladbach, Mönchengladbach, Germany

    Hendrik Haake

  5. Kreiskrankenhaus Torgau, Torgau, Germany

    Egbert Eggers

  6. Herzzentrum Ludwigshafen, Ludwigshafen, Germany

    Karlheinz Seidel

  7. Novartis Pharma GmbH, Nuremberg, Germany

    Jan Adams

  8. Medizinische Klinik, Universitätsklinikum Mannheim, Mannheim, Germany

    Job Harenberg

Authors
  1. Ulrich Tebbe
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  2. Ralph Oeckinghaus
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  3. Karl-Friedrich Appel
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  4. Hubertus Heuer
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  5. Hendrik Haake
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  6. Egbert Eggers
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  7. Karlheinz Seidel
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  8. Jan Adams
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  9. Job Harenberg
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Corresponding author

Correspondence to Ulrich Tebbe.

Appendix

Appendix

List of participating centers (in order of recruitment, in brackets number of patients recruited): Ralph Oeckinghaus, Klinikum Lippe (35 patients); Karl-Friedrich Appel, Ambulantes Herzzentrum Kassel (17), Hubertus Heuer, St.-Johannes Hospital Dortmund (16); Jürgen vom Dahl, Krankenhaus St.Franziskus Mönchengladbach (15); Egbert Eggers, Kreiskrankenhaus Torgau (15), Karlheinz Seidl, Herzzentrum Ludwigshafen (14); Jürgen Krülls-Münch, Carl-Thiem-Klinikum Cottbus (11); Ralf Degenhardt, Institut für klinische Forschung Rotenburg/Fulda (9); Ralf Berger, St.-Markus-Krankenhaus Frankfurt (7); Michael Sternkopf, Kreiskrankenhaus Bürgerhospital Friedberg (7); Stefan Schuster, St.-Antonius-Hospital Kleve (5); Peter Schwimmbeck, Klinikum Leverkusen (5); Achim Rotter, Privatklinik Dr. Schindlbeck Herrsching (4); Christoph Geller, Zentralklinik Bad Berka (4); Heinz-Peter Remmlinger, DRK-Krankenhaus Clementinenhaus Hannover (4); Norbert Kaag, Diakoniekrankenhaus Rotenburg (4); Klaus Hauer, Robert-Bosch-Krankenhaus Stuttgart (3); Wolf Dörffel, Humaine Klinikum Bad Saarow-Pieskow (3); Jörg Kreuzer, St.-Vincenz-Krankenhaus Limburg (3); Peter Schuster, St.-Marien-Krankenhaus Siegen (2); Tanja Rosolski, Klinikum Wismar (2); Jörg Neuzner, Klinikum Kassel (2); Verena Stangl, Charité Berlin (2); Holger Sigusch, Heinrich-Braun-Krankenhaus Zwickau (2); Wolfgang Kasper, St.-Josefs-Hospital Wiesbaden (2); Horst Nebelsieck, Kreiskrankenhaus Böblingen (1); Olaf Göing, Krankenhaus Lichtenberg Berlin (1); Luciano Pizzulli, Gemeinschaftskrankenhaus Bonn (1); Hermann Klein, Städtische Krankenanstalten Idar-Oberstein (1); Claudius Teupe, Krankenhaus Sachsenhausen Frankfurt a. Main (1); Wolfgang Habscheid, Paracelsus Krankenhaus Ruit (1); Thorsten Lewalter, Universitätsklinikum Bonn (1).

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Tebbe, U., Oeckinghaus, R., Appel, KF. et al. 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. Clin Res Cardiol 97, 389–396 (2008). https://doi.org/10.1007/s00392-008-0644-y

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  • DOI: https://doi.org/10.1007/s00392-008-0644-y

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