title: 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.
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.
  
  
  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.
  
  
  OBJECTIVE
  The objective was to document the feasibility and safety of a short-term treatment with a fixed, body weight-independent certoparin regimen (2 x 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Klinikum Lippe GmbH, Fachbereich Herz-Kreislauf, Röntgenstrasse 18, 32756 Detmold, Germany. ulrich.tebbe@klinikum-lippe.de
authors.forename: Ulrich
authors.initials: U
authors.lastname: Tebbe
authors.forename: Ralph
authors.initials: R
authors.lastname: Oeckinghaus
authors.forename: Karl-Friedrich
authors.initials: KF
authors.lastname: Appel
authors.forename: Hubertus
authors.initials: H
authors.lastname: Heuer
authors.forename: Hendrik
authors.initials: H
authors.lastname: Haake
authors.forename: Egbert
authors.initials: E
authors.lastname: Eggers
authors.forename: Karlheinz
authors.initials: K
authors.lastname: Seidel
authors.forename: Jan
authors.initials: J
authors.lastname: Adams
authors.forename: Job
authors.initials: J
authors.lastname: Harenberg
mesh_terms: D000368:Aged; D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects; D001281:Atrial Fibrillation / Q000209:etiology / Q000628:therapy*; D002985:Clinical Protocols; D004334:Drug Administration Schedule; D017548:Echocardiography, Transesophageal; D004554:Electric Countershock; D005260:Female; D006495:Heparin, Low-Molecular-Weight / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D010865:Pilot Projects; D011446:Prospective Studies
chemical_list: D000925:Anticoagulants; D006495:Heparin, Low-Molecular-Weight; C403769:certoparin