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Oral anticoagulant therapy for heart disease: results in actual cardiology practice
Insights
Oral anticoagulation success and complication rates in routine cardiology practice mirror those from controlled trials. This study confirms similar outcomes in real-world patient care, ensuring effective treatment for cardiovascular conditions.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Oral anticoagulation is crucial for managing cardiovascular diseases.
- Recommendations for anticoagulation therapy are primarily based on large, controlled clinical trials.
- Real-world effectiveness and safety in routine practice require validation.
Purpose of the Study:
- To compare the success and complication rates of oral anticoagulation in routine cardiology practice with those reported in major clinical trials.
- To assess the generalizability of trial findings to everyday patient care.
Main Methods:
- An observational, prospective cohort study followed 1078 patients at an anticoagulant clinic for 804 patient-years.
- Data on bleeding and thromboembolic events were collected via telephone and medical record review.
- International Normalized Ratios (INRs) were monitored against target ranges.
Main Results:
- Bleeding events occurred at 13.9 per 100 patient-years, with 1.9% being major hemorrhages.
- Thromboembolic events occurred at 2.7 per 100 patient-years, with 1.2% being major.
- International Normalized Ratios (INRs) were within the target range 62.3% of the time.
Conclusions:
- The success and complication rates observed in routine cardiology practice are comparable to those from large, controlled trials.
- Findings suggest that established anticoagulation protocols are effective and safe in real-world clinical settings.
Objective:
To determine whether the success and complication rates of oral anticoagulation obtained in large, well controlled trials, upon which recommendations are based, are comparable with routine cardiology practice.
Design:
An observational, prospective cohort study collected data on all patients followed at an anticoagulant clinic over one calendar year.
Patients:
One thousand and seventy-eight patients anticoagulated for cardiovascular indications, mainly atrial fibrillation, prosthetic valves and ventricular dysfunction, were followed for 804 patient-years of treatment. No patient was lost to follow-up.
Interventions:
Telephone conversations and regular verification of medical files were used to record and classify all bleeding and thromboembolic events according to severity. International normalized ratios (INR) were compared with target ranges.
Results:
One hundred and twelve bleeding events, ie, 13.9/100 patient-years (% p-y), were recorded, of which 61 required medical attention. Major hemorrhages, defined as those requiring treatment or hospital observation for more than 24 h, occurred in 15 instances (1.9% p-y). Among these, 9 (1.1% p-y) were classified as life threatening, with four being fatal (0,5% p-y). Twenty-two thromboembolic events (2.7% p-y) occurred, of which 10 were major (1.2% p-y), leaving three patients (0.4% p-y) with long term sequelae and causing two deaths (0.25% p-y). INRs were within target range 62.3% of the time, with 2.2% of values recorded above 5 and 0.3% above 10.
Conclusion:
The low failure and complication rates obtained in large, controlled trials are similar to those observed in actual cardiology practice.