A multicentre randomised clinical endpoint study of parma 5 computer‐assisted oral anticoagulant dosage

Abstract

SummaryTo meet growing demand for oral anticoagulation worldwide there has been increased dependence on computer-assistance in dosage although the safety and effectiveness of any of the individual computer-assisted dosage programs has not previously been established. This randomised multicentre clinical end-point study assessed a new version of the parma 5 program. It compared parma 5 safety and effectiveness with manual dosage by experienced medical staff at 19 centres with a known interest in oral anticoagulation. Target recruitment was 8000 patient-years, randomised to medical staff or parma-5 assisted dosage. Safety and effectiveness of the parma 5 program was compared with manual dosage. A total of 10 421 patients were recruited (15 369 patient-years) in the 5-year study. International normalised ratio (INR) tests numbered 167 791 with manual and 160 078 with parma 5 dosage. With parma 5 there was overall a non-significant reduction in clinical events but in the 2542 patients with deep vein thrombosis/pulmonary embolism, clinical events were significantly reduced (P = 0AE005). Success in achieving 'time in target INR range' was also significantly greater with parma 5 compared with the dosage by experienced medical staff. This study demonstrated the safety and effectiveness of parma 5-assisted dosage.

Gut‐Derived Serum Lipopolysaccharide is Associated With Enhanced Risk of Major Adverse Cardiovascular Events in Atrial Fibrillation: Effect of Adherence to Mediterranean Diet

“…17 International normalized ratio values were maintained in an intended range between 2.0 to 3.0, and time in therapeutic range was calculated to assess the quality of anticoagulation. 18 Exclusion criteria were prosthetic heart valves or the presence of any severe valvulopathies, severe cognitive impairment, chronic infections (human immunodeficiency virus infection, hepatitis C virus, hepatitis B virus), or autoimmune systemic disease. Subjects were also excluded from the study if they had active cancer or liver insufficiency (eg, cirrhosis).…”

Evaluation of European Concerted Action on Anticoagulation Lyophilized Plasmas for INR Derivation Using the PT/INR Line

“…[8][9][10] All participants used an automated method for PT determination with a range of locally used commercial thromboplastins. The ISIs of the local PT systems were determined by ISI calibrations according to the US Food and Drug Administration-approved method using 20 ECAA artificially depleted lyophilized abnormal plasmas and 7 lyophilized normal plasmas.…”

“…The main aims of the present study were therefore to investigate the following: (1) the use of calibrant plasma sets varying in number (3)(4)(5)(6)(7)(8)(9)(10) to derive the PT/INR Line; (2) the use of different calibrant sets with varying INR values; (3) whether sets of calibrant plasmas specifically selected from clusters to provide a spread of INR values across and outside the therapeutic 2.0 to 4.5 interval gave better results than randomly selected plasmas regardless of their INR values; and (4) whether there was additional value from the inclusion of a normal plasma in the set.…”

Incidence of Myocardial Infarction and Vascular Death in Elderly Patients With Atrial Fibrillation Taking Anticoagulants

“…International normalized ratio values were maintained in an intended range of between 2.0 and 3.0, and the time in therapeutic range was calculated to assess the quality of anticoagulation. 8 Exclusion criteria were prosthetic heart valves or the presence of any severe valvulopathies, severe cognitive impairment, chronic infections (HIV infection, hepatitis C virus, hepatitis B virus), or systemic autoimmune diseases. Subjects were also excluded from the study if they had active cancer or liver insuffi ciency (eg, cirrhosis).…”