Bleeding complications of oral anticoagulant treatment: an inception-cohort, prospective collaborative study (ISCOAT)

SummaryThe paper reports on rate and type of thrombotic events occurring during the observational, prospective, inception-cohort, multicenter ISCOAT study. 2,745 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 2,011 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.1.1.16-3.07; 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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Oral anticoagulant treatment in patients with mechanical heart valves: how to reduce the risk of thromboembolic and bleeding complications

Journal of Internal Medicine ◽

10.1046/j.1365-2796.1999.00460.x ◽

1999 ◽

Vol 245 (4) ◽

pp. 369-374 ◽

Cited By ~ 26

Author(s):

S. C. Cannegieter ◽

M. Torn ◽

F. R. Rosendaal

Keyword(s):

Oral Anticoagulant ◽

Heart Valves ◽

Mechanical Heart Valves ◽

Bleeding Complications ◽

Anticoagulant Treatment ◽

Oral Anticoagulant Treatment

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Bleeding Complications in Atrial Fibrillation Patients on Anticoagulant Therapy

Revista de Chimie ◽

10.37358/rc.19.5.7173 ◽

2019 ◽

Vol 70 (5) ◽

pp. 1582-1585 ◽

Cited By ~ 1

Author(s):

Ionela Silivastru (Cozlea) ◽

Gabriela Keresztesi ◽

Arthur Atilla Keresztesi ◽

Daniel Laurentiu Cozlea ◽

Carmen Caldararu ◽

...

Keyword(s):

Atrial Fibrillation ◽

Gastrointestinal Bleeding ◽

Vitamin K ◽

Oral Anticoagulant ◽

Bleeding Event ◽

Bleeding Complications ◽

Anticoagulant Treatment ◽

Bleeding Events ◽

Oral Anticoagulant Treatment ◽

Significant Difference

The risk of bleeding in atrial fibrillation patients on direct oral anticoagulant treatment increases with age; particularly dabigatran is associated with a higher risk of gastrointestinal bleeding in elderly patients, low body mass ([48 kg) and women due to the induced dyspepsia. We aimed to evaluate the safety of direct oral anticoagulants (DOAC) dabigatran, rivaroxaban and apixaban by comparing each agent with a widely used vitamin K antagonist (VKA)-acenocoumarol in terms of bleeding event rates. A retrospective study regarding bleeding events in atrial fibrillation patients treated with oral anticoagulation (OAC) was performed. Haematuria, epistaxis and haemoptysis were considered minor events and intracranial bleeding, gastrointestinal bleeding (superior or inferior), blood transfusion after haemorrhagic events linked to OAC treatment were considered to be major events. A number of 219 atrial fibrillation patients were included using electronic medical records: 118 patients treated with DOAC s (82 using dabigatran, 28 on rivaroxaban regimen and 8 cases treated with apixaban) and 101 cases had vitamin K antagonists treatment (acenocumarol). A total of 75 bleeding events were encountered (70 minor and 5 major). A higher number of events were encountered in patients treated with DOAC s, but with no statistically significant difference compared to acenocumarol. The associated risk factors did not play a decisive role in bleeding events in the two treatment groups. No statistical significant difference was noted between the occurrence of haemorrhagic events and the class of oral anticoagulant treatment used (DOAC vs. VKA).

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Oral Anticoagulant Treatment with and without Aspirin

Thrombosis and Haemostasis ◽

10.1055/s-0038-1642729 ◽

1995 ◽

Vol 74 (01) ◽

pp. 506-510 ◽

Cited By ~ 11

Author(s):

Raul Altman ◽

Jorge Rouvier ◽

Enrique Gurfinkel

Keyword(s):

Oral Anticoagulant ◽

Anticoagulant Treatment ◽

Oral Anticoagulant Treatment

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A Comparison of a Moderate with Moderate-high Intensity Oral Anticoagulant Treatment in Patients with Mechanical Heart Valve Prostheses

Thrombosis and Haemostasis ◽

10.1055/s-0038-1656064 ◽

1997 ◽

Vol 77 (05) ◽

pp. 0839-0844 ◽

Cited By ~ 34

Author(s):

Vittorio Pengo ◽

Fabio Barbero ◽

Alberto Banzato ◽

Elisabetta Garelli ◽

Franco Noventa ◽

...

Keyword(s):

Heart Valve ◽

High Intensity ◽

Oral Anticoagulant ◽

Oral Anticoagulants ◽

Mechanical Heart Valve ◽

Moderate Intensity ◽

Minor Bleeding ◽

Anticoagulant Treatment ◽

Oral Anticoagulant Treatment ◽

Valve Prostheses

SummaryBackground. The long-term administration of oral anticoagulants to patients with mechanical heart valve prostheses is generally accepted. However, the appropriate intensity of oral anticoagulant treatment in these patients is still controversial.Methods and Results. From March 1991 to March 1994, patients referred to the Padova Thrombosis Center who had undergone mechanical heart valve substitution at least 6 months earlier were randomly assigned to receive oral anticoagulants at moderate intensity (target INR = 3) or moderate-high intensity (target INR = 4). Principal end points were major bleeding, thromboembolism and vascular death. Minor bleeding was a secondary end-point.A total of 104 patients were assigned to the target 3 group and 101 to the target 4 group; they were followed for from 1.5 years to up 4.5 years (mean, 3 years). Principal end-points occurred in 13 patients in the target 3 group (4 per 100 patient-years) and in 20 patients in the target 4 group (6.9 per 100 patient-years). Major hemorrhagic events occurred in 15 patients, 4 in the target 3 group (1.2 per 100 patient-years) and 11 in the target 4 group (3.8 per 100 patient-years) (p = 0.019). The 12 recorded episodes of thromboembolism, 4 of which consisted of a visual deficit, were all transient ischemic attacks, 6 in the target 3 group (1.8 per 100 patient-years) and 6 in the target 4 group (2.1 per 100 patient- years). There were 3 vascular deaths in each group (0.9 and 1 per 100 patient-years for target 3 and target 4 groups, respectively). Minor bleeding episodes occurred 85 times (26 per 100 patient-years) in the target 3 group and 123 times (43 per 100 patient-years) in the target 4 group (p = 0.001).Conclusions. Mechanical heart valve patients on anticoagulant treatment who had been operated on at least 6 months earlier experienced fewer bleeding complications when maintained on a moderate intensity regimen (target INR = 3) than those on a moderate-high intensity regimen (target INR = 4). The number of thromboembolic events and vascular deaths did not differ between the two groups.

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