Effects of aspirin or picotamide, an antithromboxane agent, in combination with low-intensity oral anticoagulation in patients with acute myocardial infarction: a controlled randomized pilot trial.
OBJECTIVE
Combined treatment with antiplatelet drugs and oral anticoagulants seems more effective than monotherapy in the reduction of thrombotic episodes in patients with ischemic heart diseases. We compared the safety and efficacy of two different antiplatelet drugs, aspirin (asa) and picotamide (pico)--a dual antithromboxane agent--in combination with low-intensity oral anticoagulation with warfarin or acenocoumarol in acute myocardial infarction (AMI).


METHODS
Primary endpoint of the study was to compare the incidence of major events (death, reinfarction, postinfarction angina and heart failure) in AMI patients undergoing thrombolytic therapy. In a controlled randomized parallel group pilot study, 101 patients with AMI were enrolled and treated with asa 160 mg/die plus low-intensity oral anticoagulation (target INR: 1.5-2.5) (n = 51) or pico 300 mg/tid plus low-intensity oral anticoagulation (n = 50). Secondary endpoint of the study was to compare the cumulative incidence of major events plus major hemorrhagic episodes defined as macroscopic hematuria, nose bleeding and melena.


RESULTS
The two groups were well matched regarding the main demographic and clinical variables. AMI location was anterior in 22 and 20 patients in the pico and asa group respectively, inferoposterior in 27 (pico) and 29 (asa) patients. At the end of the six-month period, major events were observed in 20 patients in the pico group and in 31 patients in the asa group (p < 0.05). The cumulative incidence of major clinical events plus major hemorrhagic episodes was significantly lower in the pico group in comparison with the asa group (28 vs 48; p < 0.001).


CONCLUSIONS
The results of this pilot study suggest that combination therapy with picotamide and low-intensity oral anticoagulation could be a safe and effective alternative to aspirin in patient with AMI. This hypothesis should be confirmed by controlled randomized trial with an adequate sample size.
Vetrano
A
A
Cardiology Department, Caserta General Hospital.
Milani
M
M
Corsini
G
G
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects; D001241:Aspirin / Q000008:administration & dosage* / Q000009:adverse effects; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy*; D010795:Phthalic Acids / Q000008:administration & dosage* / Q000009:adverse effects; D010865:Pilot Projects; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D016037:Single-Blind Method; D013931:Thromboxanes / Q000037:antagonists & inhibitors*
D000925:Anticoagulants; D010795:Phthalic Acids; D010975:Platelet Aggregation Inhibitors; D013931:Thromboxanes; C011581:picotamide; D001241:Aspirin