The Italian START-Register on Anticoagulation with Focus on Atrial Fibrillation

PLoS One. 2015 May 22;10(5):e0124719. doi: 10.1371/journal.pone.0124719. eCollection 2015.

Abstract

START-Register--Survey on anTicoagulated pAtients RegisTer--is an independent, inception-cohort, observational, collaborative database aimed at recording prospectively the clinical history of adult patients starting anticoagulant treatment for any reason and using whatever drug. In this article we present the START-Register and give cross section baseline data focusing on non valvular atrial fibrillation (NVAF). Participants are asked to insert prospectively consecutive patients recorded as electronic file on the web-site of the registry. Required data are: demographic and clinical characteristics of patients, associated risk factors for stroke and bleeding, laboratory routine data, clinical indication for treatment, expected therapeutic range (in cases of treatment with vitamin K antagonists -VKAs). The follow-up is carried out to record: quality of treatment (for patients on VKAs), bleeding complications, thrombotic events, and the onset of any type of associated disease. To date 5252 patients have been enrolled; 97.6% were on VKAs because direct oral anticoagulants (DOAC) have been available in Italy only recently. The median age was 74 years [interquartile range (IQR) 64-80]; males 53.7%. This analysis is focused on the 3209 (61.1%) NVAF patients. Mean CHADS2 score was 2.1 ± 1.1, CHADSVASc score was 3.1 ± 1.3;median age was 76 years (IQR 70-81); 168 patients (5.3%) had severe renal failure [Creatinine clearance (CrCl) <30 ml/min]. Moderate renal failure (CrCl 30-59 ml/min) was found in 1265 patients (39.5%). The analysis of the START-Register data shows that two-third of patients who started chronic anticoagulant treatment had NVAF, one-third of them was > 80 years with high prevalence of renal failure.

Trial registration: ClinicalTrials.gov NCT02219984.

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Anticoagulants / adverse effects*
  • Atrial Fibrillation / chemically induced*
  • Cohort Studies
  • Creatinine / metabolism
  • Female
  • Hemorrhage / chemically induced
  • Humans
  • Italy
  • Male
  • Middle Aged
  • Registries / statistics & numerical data
  • Renal Insufficiency / chemically induced
  • Risk Factors
  • Stroke / chemically induced

Substances

  • Anticoagulants
  • Creatinine

Associated data

  • ClinicalTrials.gov/NCT02219984

Grants and funding

The authors have no support or funding to report.