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. 2025 Jun 23;23(1):71.
doi: 10.1186/s12959-025-00749-1.

Α 6-month, multicenter, observational study investigating the treatment of venous thromboembolism in Greece (VICTORIA study)

Paraskevi Savvari  1 , Ioannis Skiadas  1 , Evgenia Mavrokefalou  2 , Stavros Kakkos  3 , Ioulia Antoniou  4 , Georgios A Pitoulias  5 , Effrosyni Dima  6 , Emmanouil Ferdoutsis  7 , Georgios Ntaios  8 , Athanasios Giannoukas  9 , Ourania Kotsiou  10 , Flora Zagouri  11 , Georgios Tsoukalas  12 , Konstantinos Kostikas  13 , Dimitrios Staramos  14 , Haralampos Milionis  15 , Konstantinos Filis  16 , Christos Savopoulos  17 , Ioannis Kakisis  18 , Vasileios Tzilalis  19 , Nikolaos Koulouris  20 , Theophanis Papas  21 , Ioanna Skrapari  22 , Damianos Menegas  1 ; VICTORIA Study Group
Collaborators, Affiliations

Α 6-month, multicenter, observational study investigating the treatment of venous thromboembolism in Greece (VICTORIA study)

Paraskevi Savvari et al. Thromb J. .

Abstract

Background: Real-world data are needed to inform clinical practice with regards to anticoagulation treatment for persons with venous thromboembolism (VTE).

Objectives: To identify the type and duration of antithrombotic treatment in persons with VTE. Anticoagulation dosage and persistence/adherence were among the secondary objectives.

Methods: A multicenter, observational, prospective study conducted in Greek adults with VTE with two on-site visits -baseline and at three months- and a telephone follow-up at 6 months.

Results: A total of 600 eligible persons were enrolled. The index event was 'PE only' in 50%, 'DVT only' in 40%, and 'DVT+PE' in 10%. Risk factors were categorized as temporary major (21%), temporary minor (37%), and persistent (43%), with active cancer present in 18% of patients. All VTE patients received anticoagulants: 73% received oral anticoagulants (72% DOACs, 1% VKAs) and 70% received parenteral anticoagulants. Treatment was oral only in 30%, parenteral only in 27%, and both in 43%. The most common DOAC was apixaban (47%). Extended anticoagulation (>6 months) was administered to 41% with only 9% (18/198) of those on DOACs receiving a reduced dose. Persistent risk factors predicted extended anticoagulation, while diabetes, COVID-19, and temporary minor risk factors did not. Adherence/persistence rates were similar between DOAC and non-DOAC-treated patients.

Conclusion: VTE was mainly treated with a combination of parenteral and oral anticoagulants. DOACs, primarily apixaban, were the most common oral treatments. Forty percent of patients received extended anticoagulation, mostly at standard dosages. Adherence and persistence rates were high for both DOAC and non-DOAC treatments.

Keywords: Anticoagulant; Deep vein thrombosis; Duration of anticoagulation; Pulmonary embolism.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: All participants signed an informed consent document. The final protocol, any amendments, and informed consent documentation were reviewed and approved by an Institutional Review Board for each site participating in the study. The study was conducted in accordance with legal and regulatory requirements and followed generally accepted research practices described in the Guidelines for Good Pharmacoepidemiology Practices issued by the International Society for Pharmacoepidemiology. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests. Supported by Pfizer Hellas SA. PS, IS, IA and DM are employees of Pfizer and may hold stock or stock options. EM, SK, GP, EF, GN, OK, GT, KF, CS, KI, VT, NK, IS, IK, GM, KN, DC, DS, CK, KM, IV, CK, PT and SFN declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. ED reports receiving support from Boehringer and MSD for attending meetings and travels. AG reports receiving consulting fees from Bayer, Servier, Medtronic and Gore. FZ reports participating as principal investigator at Alexandra General Hospital where payments were made to institute and receiving consulting fees, receiving honoraria for lectures and support for attending meetings and travel from AstraZeneca, Daiichi, Eli-Lilly, Merck, Pfizer, Genesis-Pharma, Novartis, MSD, Roche and Gilead. KK reports receiving grants from AstraZeneca, Boehringer Ingelheim, Chiesi, Elpen, GlaxoSmithKline, Menarini and Novartis, consulting fees from AstraZeneca, Boehringer Ingelheim, Chiesi, Elpen, GlaxoSmithKline, Guidotti, Menarini, Pfizer and Sanofi, payment for lectures, presentations, manuscript writing from Alector Pharmaceuticals, AstraZeneca, Boehringer Ingelheim, Chiesi, Elpen, Gilead, GlaxoSmithKline, Guidotti, Menarini, Pfizer and Sanofi, participating on a safety data monitoring board or advisory board of Chiesi and being a board member of GOLD Assembly. DS being a board member of Hellenic Angiological Society. HM reports participating at clinical trials of Pfizer, receiving consulting fees from Sanofi and Novartis, honoraria for lectures from Amgen, AstraZeneca, Novartis, Pfizer and Sanofi, support for attending international congresses with travel, accommodation and meeting expenses from Novartis, Sanofi and Vianex and being a board member of Hellenic Society of Atherosclerosis and Hellenic Stroke Organization. TP receiving honoraria for lectures from Pfizer, support for attending international congresses with travel, accommodation and meeting expenses from Pfizer and being general secretary of Hellenic Phlebology Society. FM reports receiving support from Pfizer and Bayer for attending meetings and travels. Disclosure forms provided by the authors are available with the full text of this article at supplementary. No other potential conflict of interest relevant to this article was reported.

Figures

Fig. 1
Fig. 1
Patient disposition in the study and care setting. a16 patients (DVT only: 2; PE only: 12; DVT + PE: 2) did not attend the 3-month visit but continued study participation. Abbreviations: DVT, Deep Vein Thrombosis; FU, Follow-Up; IC, Informed Consent; IE, Index (VTE) Event; IQR, Interquartile Range; N, number of patients with available data; nhosp., number of hospitalized patients; PE, Pulmonary Embolism; tr., treatment; VTE, Venous Thromboembolism
Fig. 2
Fig. 2
Pharmacologic VTE treatment throughout the study observation period. aTwo patients (IE: PE only) also received antiplatelet therapy; bOne patient (IE: PE only) also received systemic thrombolytic therapy; cNine patients (DVT only: 4; PE only: 4; DVT + PE: 1) received ≥ 2 DOACs; dNine patients (DVT only:1; PE only:7; DVT + PE:1) received both LMWH and fondaparinux; either 5 or 2.5 mg BID; f10-20 mg QD and for one patient (IE: PE only) 20 mg BID. Abbreviations: AC, Anticoagulation; BID, twice a day; DOAC, Direct Oral Anticoagulant; DVT, Deep Vein Thrombosis; IE, Index (VTE) Event; LMWH, Low Molecular Weight Heparins; N, number of patients with available data; PE, Pulmonary Embolism; QD, once a day; VTE, Venous Thromboembolism
Fig. 3
Fig. 3
Rate of extended AC beyond 6 months. aDenominators represent number of patients receiving the indicated initial AC and with available data on extended AC; bDenominators represent number of patients receiving extended AC; cNumerators indicate reduced dosing schedule (2.5 mg BID for apixaban and 10 mg QD for rivaroxaban); dabigatran was administered as standard dosing schedule of 150 mg BID in both cases of extended dabigatran (not shown); ePresence of any persistent factor, including active cancer. The modeled probability was use of extended AC beyond months: 'Yes'vs'No’. The following variables were entered in the initial step of the stepwise procedure: Age at IE confirmation (categorical with cut-off 65 years), Gender (Male vs Female), Type of IE (DVT only vs PE ± DVT), Initial presentation of IE (Symptomatic vs asymptomatic), Haemodynamic instability at IE initial presentation (Yes vs No), Temporary major risk factors (Yes vs No), Temporary minor risk factors within 2 months before IE (Yes vs No), Any persistent risk factor (Yes vs No), Diabetes (Yes vs No), Varicose veins (Yes vs No), COVID-19 (Yes vs No), Obesity (Yes vs No), Cigarette smoking (Ever vs Never), Arterial hypertension (Yes vs No). Physician's specialty (Internists vs other) was found to be a confounder in a separate analysis (data not shown); thus; it was forced in the final model (i.e., after the stepwise procedure). Abbreviations: AC, Anticoagulation; AIC, Akaike’s Information Criterion; CI, Confidence Interval; DOAC, Direct Oral Anticoagulant; DVT, Deep Vein Thrombosis; IE, Index (VTE) Event; N, number of patients with available data; OR, Odds Ratio; PE, Pulmonary Embolism
Fig. 4
Fig. 4
Adherence and persistence to antithrombotic treatment. The modeled probability was poor adherence and/or non-persistence to antithrombotic treatment throughout study participation'yes'versus'no’. The following variables were entered in the initial step of the stepwise procedure: Age at baseline (continuous), Gender (Male vs Female), Type of IE (DVT only vs PE ± DVT), Initial presentation of IE (Symptomatic vs asymptomatic), Temporary major risk factors (Yes vs No), Temporary minor risk factors within 2 months before IE (Yes vs No), Persistent risk factors at the time of IE (Yes vs No), Obesity (Yes vs No), Diabetes (Yes vs No), Varicose veins (Yes vs No), COVID-19 (Yes vs No), Cigarette smoking (Ever vs Never), Obesity (Yes vs No), Cigarette smoking (Ever vs Never), Arterial hypertension (Yes vs No), DOAC only (DOAC only vs Other), Hospitalized at the IE (Yes vs No). Abbreviations: AC, Anticoagulation; CI, Confidence Interval; DOAC, Direct Oral Anticoagulant; DVT, Deep Vein Thrombosis; IE, Index (VTE) Event; N, number of patients with available data; OR, Odds Ratio; PE, Pulmonary Embolism
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