Daiichi Sankyo Europe GmbH has announced snapshot results from the PREvention oF thromboembolic events - European Registry in Venous ThromboEmbolism (PREFER in VTE), including initial baseline analysis of the management and use of Novel Oral Anticoagulants (NOACs) across Europe.2,3

Closing the current gap in understanding regarding the management of patients with VTE across Europe, the baseline data reveals that although NOACs are used frequently throughout Europe for the treatment of VTE, usage varies greatly from country to country and is associated with variable patient characteristics.2 Germany, Austria and Switzerland are leading the way in uptake of NOAC use with 46.7% of patients compared with 8% in Spain and 3.2% in Italy, 2 where the blood thinners have recently been made available.

At the time of analysis patient enrolment was still ongoing, with the preliminary results evaluating 1,843 VTE patients (62.8% with Deep Vein Thrombosis [DVT] and 37.2% suffering from Pulmonary Embolism [PE])3 showing that NOAC use in DVT and PE patients is in the same ballpark (DVT 23.9% vs. PE 18.4%).2 Initial baseline analysis highlighted that NOACs are currently used more frequently in younger patients; 26.8% in those aged < 65 years, compared with 19.8% in those aged 65 to 74 and 14.3% in those > 75 years,2 with the mean age of the evaluable patient population currently being 61.6 years of age.3

Within a clinical trial setting, current data supports NOAC efficacy and safety including a significantly reduced risk of bleeding events compared to standard of care heparin/warfarin treatment,4 yet the PREFER in VTE baseline data shows limited use of NOACs in practice with patients registered at a lower weight (≤60 kg vs >60kg; 13.4% vs 23.3%), with renal impairment (22.7% vs 11.1% in patients with CRCL levels >60 ml/min vs. ≤60ml/min), diabetes (22.9% vs 13.5% in patients without/with diabetes) and those at risk of bleeding (HAS-BLED low 27.1%, medium 17.8%, high 12.5%).2

PREFER in VTE is a registry investigating the management and use of NOACs in the treatment and management of VTE2 and has been designed with a unique patient focus gathering comprehensive data on the quality of life and treatment satisfaction of patients with VTE.5 It collates real-life data from VTE patients across 388 recruiting hospitals and specialised centres in Austria, France, Germany, Italy, Spain, Switzerland, and the UK.2,3

Commenting on the importance of this registry, Dr. Alexander T. Cohen Consultant Vascular Physician, Department of Haematology, Guys and St Thomas' Hospitals and King's College London, , Co-Chairman of the PREFER Study said: "PREFER in VTE is the first registry of its kind that will provide detailed insight into the patient's perspective. Relying on patient interviews and diaries rather than focusing purely on a doctor's assessment of VTE, will give us important patient data outside of a clinical trial setting. The ability to assess current management of VTE in practice and monitor its development over a 12 month period will help establish whether current treatment developments are translating into optimal management in practice, and support ongoing developments to give patients the best possible outcomes."

In Europe there are over one million VTE events annually,1,3 causing more than double the number of deaths among Europeans than breast cancer, prostate cancer, HIV/AIDS and road traffic accidents combined each year.1 Despite this, there is a paucity of data regarding current, real-life case-mix and management of the disease.3,6

Discussing the need for real-life insights, Professor Giancarlo Agnelli , Professor of Internal Medicine at the University of Perugia, Director of the Department of Internal and Cardiovascular Medicine and Stroke-Unit at the University Hospital in Perugia, commented: "We are delighted to announce the baseline data from PREFER in VTE. The registry enables us to assess genuine outcomes for patients with deep vein thrombosis or pulmonary embolism and for the first time will demonstrate the true impact of VTE on patient quality of life in Europe. It's important that we have registries such as this to provide us with data outside of a clinical setting for variable patient populations including those at higher risk. As such, these insights need to be considered in therapeutic pathways moving forward."

PREFER in VTE will go on to provide detailed insights into the characteristics and management of patients with VTE. Exploring geographic variations in the management of VTE patients will provide demographic data, along with key insights into risk factors, management of diagnosis and treatment modalities within this patient population.

Dr. Juan Carlos Jaramillo, Head of Market Access and Medical, Daiichi Sankyo Europe GmbH, said: "By focusing on patients perspectives, real life approach, PREFER in VTE will give a detailed snapshot highlighting current management of this disease and insight into further improving patient care." Daiichi Sankyo, a global leader in cardiovascular medicine, is sponsor of this registry and is dedicated to support advancement in cardiovascular medicine and related indications such as VTE.

About PREFER in VTE

The PREFER in VTE registry is a multicentre, prospective observational disease registry, with a one-year follow up, enrolling patients with VTE, in particular deep vein thrombosis (DVT) and/or pulmonary embolism (PE).2,3

PREFER in VTE is the first registry of its kind to collate comprehensive data on the management of patients with VTE with key insight into patient satisfaction and quality of life.2,3 In addition to the clinical outcomes, PREFER in VTE has been set up to capture real life data regarding quality of life, patient satisfaction and the economic burden of VTE treatment across Europe.5

All patients taking part in the study are at least 18 years of age and have all been diagnosed with acute initial or recurrent VTE. The observation criteria for PREFER in VTE include:5

  • Site and physician characteristics
  • Patient characteristics (including basic characteristics such as demography and medical history)
  • Patient pathways (including referral details between primary and secondary care)
  • Drug utilisation (including drug type, dosage and where applicable INR levels)
  • Health related quality of life (including standardised tests and anecdotal feedback)
  • Healthcare resource use (including diagnosis measures, number of medical appointments and productivity loss).

Baseline visits are conducted by investigators and standardised patient telephone follow-up calls will be performed at 1, 3, 6 and 12 months.2