Regular Article
The MASTER registry on venous thromboembolism: Description of the study cohort

https://doi.org/10.1016/j.thromres.2007.06.009Get rights and content

Abstract

Introduction

Information on the epidemiology and long-term clinical outcome of venous thromboembolism (VTE) is mainly based on data from clinical trials and thus may be not representative of the full spectrum of VTE patients. The aim of this multicenter registry (MASTER) was to prospectively collect data on the epidemiology and long-term clinical outcome of VTE in an unselected cohort of patients.

Materials and methods

In symptomatic patients with objectively confirmed acute VTE, information about clinical presentation, diagnostic methods, temporary and permanent risk factors, pre-event prophylaxis and treatment were captured by an electronic data network at the time of the index event. A 24-month follow-up is currently ongoing.

Results

From January 2002 to October 2004, 2119 patients were included in the MASTER registry in 25 Italian centers. At entry, the mean patient age was 59.3±18.1 years (range 18–99 years). 1541 patients (72.7%) were affected by deep vein thrombosis, 206 patients (9.7%) by pulmonary embolism and 372 patients (17.5%) by both deep vein thrombosis and pulmonary embolism. 676 patients (31.9%) received home-treatment. 899 patients (42.4%) had one or more temporary risk factors. 381 patients (18.0%) had a known cancer at the time of the index event and in 50 patients (2.4%) a new cancer was discovered at the time of the index event. 311 patients (14.7%) had a previous VTE.

Conclusions

Following a real world approach, our registry describes the clinical presentation, risk factors, diagnosis and treatment procedures in a large cohort of unselected patients with VTE.

Introduction

Venous thromboembolism (VTE) is a common disease with two cardinal clinical presentations, deep vein thrombosis (DVT) and pulmonary embolism. These two presentations are closely linked; asymptomatic pulmonary embolism can be found in about 40% of patients with symptomatic DVT and about 70% of patients with symptomatic pulmonary embolism have a DVT of the lower limbs.

The estimated yearly incidence of symptomatic VTE ranges between 0.5 to 1.6×1000 [1], [2], [3]. This is probably an underestimation of the overall true incidence, as many VTE events are asymptomatic. VTE is the third most frequent disease among the cardiovascular diseases, following myocardial infarction and ischemic stroke.

Information on the epidemiology and long-term clinical outcome of VTE is mainly based on the data from clinical trials and thus may be not representative of the full spectrum of VTE patients. MASTER (Multicenter Advanced Study for a ThromboEmbolism Registry) is a multicenter, Italian registry recruiting consecutive VTE patients in both primary and secondary care thrombosis centers. Study centers were identified among emergency departments, internal medicine or vascular surgery or angiology units. The primary aim of the MASTER registry is to prospectively collect data on the epidemiology and long-term clinical outcome of VTE from a large unselected cohort of patients. More specifically, the purposes of MASTER are: 1) to describe the clinical and demographic characteristics of unselected patients with VTE; 2) to provide an analysis of baseline characteristics, risk factors, diagnostic and treatment procedures in these patients; 3) to prospectively collect data on the main clinical outcomes during long-term follow-up.

In this paper we describe the design of the study and we report information on baseline characteristics, clinical presentations, risk factors, diagnostic and treatment procedures of VTE in the patients enrolled in the MASTER registry.

Section snippets

Patients

The MASTER registry included consecutive patients, aged 18 years or older, with an acute symptomatic, objectively confirmed VTE (deep vein thrombosis, pulmonary embolism or both), managed both in-hospital and as out-patients. Twenty-five Italian centers participated in the registry.

Exclusion criteria were life expectancy shorter than three months, the anticipated inability to participate to the scheduled follow up visits or consent refusal. The study protocol was approved by the Ethical

Baseline patient characteristics

A total of 2119 consecutive patients were enrolled in the registry; 1056 males and 1063 females. One thousand five hundred and forty-one patients had a DVT of the limbs (1437 of the lower limbs, 124 of the upper limbs). 206 patients had a pulmonary embolism alone and 372 patients had both DVT and pulmonary embolism. The mean age at the time of the VTE event was 59.3±18.1 years (range 18–99), with no difference between patients with DVT and patients with pulmonary embolism (59.0±18 and 58.2±20,

Discussion

MASTER is a registry on consecutive patients with VTE, designed to assess demography, risk factors, management and the long term clinical outcome of the disease in an unselected population. Given its structure and design, MASTER is likely to provide information that is more generalizable than that achieved from interventional studies carried out in selected populations. For instance, 10.5% of the patients enrolled in the MASTER registry were older than 80 years. Patients of this age had a

Acknowledgments

The MASTER investigators are grateful to Sanofi-Aventis Pharmaceuticals-Italy for supporting this registry with an educational grant and Comunica & Comunica group for the administrative and logistic support. We express our particular gratitude to Valeria Cantone and Alfredo Spreafico and to Albino Ventura.

References (15)

There are more references available in the full text version of this article.

Cited by (82)

  • Percutaneous thrombectomy of filter-associated inferior vena cava occlusion

    2022, Annals of Vascular Surgery - Brief Reports and Innovations
View all citing articles on Scopus
1

The members of MASTER group are: Coordinating Center: G. Agnelli, M. Verso, R. Rossi (Perugia). Investigator Centers: W. Ageno: Dipartimento di Medicina Clinica, Università degli studi dell'Insubria, Ospedale di Circolo(Varese); M. Bellisi: Chirurgia Vascolare, Policlinico Paolo Giaccone (Palermo); M. Bianchi: Medicina Generale, Ospedale Valduce(Como); V. Brancaccio: Unità Emostasi -Trombosi, Divisione di Ematologia, Azienda Ospedaliera Cardarelli (Napoli); C. Caponi: Divisione di Medicina Interna e Cardiovascolare, Azienda Ospedaliera S. Maria della Misericordia(Perugia); A. Ciampa: U.O.S.S. “Centro Emostasi”, AORN “S. G. Moscati” (Avellino); C. Cimminiello: Ambulatorio di diagnostica vascolare non invasiva U.O.C. Medicina 2, Azienda Ospedaliera “Ospedale Civile” (Vimercate-Milano); A. Dragani: Dipartimento di Ematologia, Servizio delle malattie emorragiche e trombotiche, Ospedale Civile dello Spirito Santo (Pescara); S. Grifoni: DEA, Ospedale Careggi (Firenze); D. Imberti: Centro Trombosi, Medicina Interna-Area Critica, Ospedale di Piacenza (Piacenza); A. M. Impagliatelli: Dipartimento Cardiovascolare U.O.S. Angiologia, IRCCS Casa del Sollievo e della Sofferenza (S.Giovanni Rotondo-Foggia); G. Iovane: Reparto di Chirurgia d'Urgenza, Day-Surgery, Angiologia-ambulatorio di diagnostica e terapia vascolare, Azienda Ospedaliera Bianchi Melacrino Morelli (Reggio Calabria); R. Margheriti: U.O.C. Medicina Generale, Ospedale G. B. Grassi (Roma); M. Moia: Centro Emofilia e Trombosi Bianchi Bonomi, Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena di Milano (Milano); S. Musumeci: Clinica Chirurgica, Sezione di Patologia Vascolare, Ospedale di Vittorio Emanuele II(Catania); G. Palareti: U.O. Angiologia e Malattie della Coagulazione “Marino Golinelli” (Bologna); M. Pini: Medicina II, Ospedale di Fidenza (Fidenza-PR); P.A. Pittaluga: Medicina Generale II, Ospedale di Galliera (Genova); V. Prisco: U.O. Angiologia Medica, ASL SA/2 c/o Ospedale di Mercato San Severino (Salerno); S. Rupoli: Clinica ematologia, Azienda Ospedaliero-Universitaria, Ospedali Riuniti (Ancona); G. Scannapieco: S.C. Qualità, Piani e Programmi, Azienda ULSS 9(Treviso); S.S. Signorelli: U.O. Angiologia Medica, Dipartimento di Medicina Interna e Patologie Sistemiche, Ospedale Garibaldi (Catania); M. Silingardi: U.O. I° Medicina Interna, Centro Emostasi e Trombosi, Azienda Ospedaliera S. Maria Nuova (Reggio Emilia); S. Siragusa: U.O. di Ematologia con trapianto, Policlinico Universitario (Palermo); V. Virgilio: S. C. di Chirurgia Vascolare, Ospedale Garibaldi-Nesima(Catania).

View full text