Thrombotic events during oral anticoagulant treatment: Results of the inception-cohort, prospective, collaborative ISCOAT study

Gualtiero Palareti, Cesare Manotti, Armando D'Angelo, Vittorio Pengo, Nicoletta Erba, Marco Moia, Nicola Ciavarella, Gianluigi Devoto, Mauro Berrettini, Nicoletta Leali, Mario Poggi, Cristina Legnani, Serena Musolesi, Sergio Coccheri

Research output: Contribution to journalArticle

Abstract

The paper reports on rate and type of thrombotic events occurring during the observational, prospective, inception-cohort, multicenter ISCOAT study. 2745 unselected, daily practice patients, consecutively referring to 34 Italian anticoagulation clinics to monitor the oral anticoagulant treatment, were included in the study from beginning of their first anticoagulant course. During a total follow-up of 2011 patient-years of treatment 70 thrombotic events (3.5 per 100 patient years) were recorded in 67 patients: 20 fatal (1%), 39 major (1.9%) and 11 minor (0.6%). 34/70 events occurred within the first 90 days of treatment (relative risk - at multivariate analysis - of ≤ 90 days vs. > 90 = 20.6, C.I. 12.7-33.5; p <0.0001). The risk was higher in patients aged ≤ 70 y (1.62, C.I. 1.0-2.61; p <0.05), and when indication for anticoagulant treatment was peripheral/cerebral arterial disease (1.84, C.I. 1.01-3.36; p <0.05). The frequency of thrombotic events was 17.5% when international normalised ratio (INR) levels were <1.5, decreasing to 2.3% for INRs within the 2-2.99 category (relative risk of INRs <2.0 vs. ≤ 2 = 1.88, C.I. 1.16-3.07; p <0.05). The recorded rate of thrombotic events was lower than that reported in the few available studies. A greater risk should be expected during the first 90 days of treatment, when anticoagulation levels are <2.0 INR, in patients > 70 years and in those with cerebrovascular/peripheral arterial disease.

Original languageEnglish
Pages (from-to)1438-1443
Number of pages6
JournalThrombosis and Haemostasis
Volume78
Issue number6
Publication statusPublished - Dec 1997

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Anticoagulants
Peripheral Arterial Disease
Therapeutics
Multicenter Studies
Multivariate Analysis

ASJC Scopus subject areas

  • Hematology

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Thrombotic events during oral anticoagulant treatment : Results of the inception-cohort, prospective, collaborative ISCOAT study. / Palareti, Gualtiero; Manotti, Cesare; D'Angelo, Armando; Pengo, Vittorio; Erba, Nicoletta; Moia, Marco; Ciavarella, Nicola; Devoto, Gianluigi; Berrettini, Mauro; Leali, Nicoletta; Poggi, Mario; Legnani, Cristina; Musolesi, Serena; Coccheri, Sergio.

In: Thrombosis and Haemostasis, Vol. 78, No. 6, 12.1997, p. 1438-1443.

Research output: Contribution to journalArticle

Palareti, G, Manotti, C, D'Angelo, A, Pengo, V, Erba, N, Moia, M, Ciavarella, N, Devoto, G, Berrettini, M, Leali, N, Poggi, M, Legnani, C, Musolesi, S & Coccheri, S 1997, 'Thrombotic events during oral anticoagulant treatment: Results of the inception-cohort, prospective, collaborative ISCOAT study', Thrombosis and Haemostasis, vol. 78, no. 6, pp. 1438-1443.
Palareti, Gualtiero ; Manotti, Cesare ; D'Angelo, Armando ; Pengo, Vittorio ; Erba, Nicoletta ; Moia, Marco ; Ciavarella, Nicola ; Devoto, Gianluigi ; Berrettini, Mauro ; Leali, Nicoletta ; Poggi, Mario ; Legnani, Cristina ; Musolesi, Serena ; Coccheri, Sergio. / Thrombotic events during oral anticoagulant treatment : Results of the inception-cohort, prospective, collaborative ISCOAT study. In: Thrombosis and Haemostasis. 1997 ; Vol. 78, No. 6. pp. 1438-1443.
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AU - Palareti, Gualtiero

AU - Manotti, Cesare

AU - D'Angelo, Armando

AU - Pengo, Vittorio

AU - Erba, Nicoletta

AU - Moia, Marco

AU - Ciavarella, Nicola

AU - Devoto, Gianluigi

AU - Berrettini, Mauro

AU - Leali, Nicoletta

AU - Poggi, Mario

AU - Legnani, Cristina

AU - Musolesi, Serena

AU - Coccheri, Sergio

PY - 1997/12

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N2 - The paper reports on rate and type of thrombotic events occurring during the observational, prospective, inception-cohort, multicenter ISCOAT study. 2745 unselected, daily practice patients, consecutively referring to 34 Italian anticoagulation clinics to monitor the oral anticoagulant treatment, were included in the study from beginning of their first anticoagulant course. During a total follow-up of 2011 patient-years of treatment 70 thrombotic events (3.5 per 100 patient years) were recorded in 67 patients: 20 fatal (1%), 39 major (1.9%) and 11 minor (0.6%). 34/70 events occurred within the first 90 days of treatment (relative risk - at multivariate analysis - of ≤ 90 days vs. > 90 = 20.6, C.I. 12.7-33.5; p <0.0001). The risk was higher in patients aged ≤ 70 y (1.62, C.I. 1.0-2.61; p <0.05), and when indication for anticoagulant treatment was peripheral/cerebral arterial disease (1.84, C.I. 1.01-3.36; p <0.05). The frequency of thrombotic events was 17.5% when international normalised ratio (INR) levels were <1.5, decreasing to 2.3% for INRs within the 2-2.99 category (relative risk of INRs <2.0 vs. ≤ 2 = 1.88, C.I. 1.16-3.07; p <0.05). The recorded rate of thrombotic events was lower than that reported in the few available studies. A greater risk should be expected during the first 90 days of treatment, when anticoagulation levels are <2.0 INR, in patients > 70 years and in those with cerebrovascular/peripheral arterial disease.

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