A randomized controlled trial of warfarin anti-coagulation efficacy and safety of clinical pharmacist-participated anticoagulation management for patients with atrial fibrillation after percutaneous balloon mitral valvuloplasty

Abstract

Objective To explore the warfarin anti-coagulation effect and safety of clinical pharmacist-participated anticoagulation management service (AMS) on patients with atrial fibrillation after percutaneous balloon mitral valvuloplasty(PBMV). Methods The patients who underwent PBMV were divided into trial group and control group by random number table. The patients in the trial group received the clinical pharmacist-participated AMS. The clinical pharmacist provided adjusted warfarin dosage suggestion to clinician and warfarin anticoagulant education to the patients and their family members. The patients in the control group received warfarin following the visiting doctor's advice. Anticoagulant effect indicators included international normalized ratio (INR) compliance rate, effective anticoagulation rate, anticoagulant deficiency rate and excessive anticoagulation rate. Safety evaluation indicators were embolism and bleeding events during the anticoagulant therapy. Results A total of 131 patients were enrolled in the study. The trial group comprised 68 and the control group 63 patients, respectively. The differences in the patients' age, sex composition, body weight, smoking and drinking habits, degree of mitral stenosis, combined disease, baseline INR, and preliminary warfarin dosage after PBMV were not significant between the 2 groups (all P>0.05). The INR compliance rate in the trial group and the control group were 53.3% (217/407) and 41.8% (155/371), respectively (P=0.001); effective anticoagulation rates were 55.9% (38/68) and 33.3% (21/63), respectively (P=0.016); anticoagulant deficiency rate were 19.9% (81/407) and 27.8% (103/371), respectively (P=0.003); and the excessive anticoagulation rates were 7.9%(32/407) and 14.0%(52/371), respectively (P=0.006). There were 6 and 9 patients developed minor bleeding events and each was one slight embolism in the trial group and the control group, respectively. The incidence rate of adverse reactions in the trial group (10.3%) was lower than that in the control group (15.9%), but the difference was not significant. Conclusion The clinical pharmacist-participated AMS may increase the INR compliance rate and the effective anticoagulation rate, decrease the anticoagulant deficiency rate and the excessive anticoagulation rate, and help to increase the effectiveness and safety of warfarin treatment in the patients with atrial fibrillation after PBMV. Key words: Anticoagulants; Mitral valve annuloplasty; Atrial fibrillation; Randomized controlled trial; Pharmacists