Background: Prospective, randomized, double-blind study (POLENOX) proved that administration of low molecular weight heparin (LMWH)--enoxaparin for elective percutaneous coronary interventions (PCI) is as safe and as effective like unfractionated heparin (UFH). The aim of the present study was to determine safety and efficacy of the other LMWH--dalteparin for elective PCI.
Methods: 100 patients planned for elective PCI were enrolled to the study. PCI were performed after i.v. dalteparin administration; 120 U/kg (up to 10 000 U). Importantly, all patients were pretreated with aspirin (75-325 mg per day) and ticlopidine (250 mg bid) prior to the procedure. During hospitalization rate of ischemic cardiac events and haemorrhagic complications were assessed. Serial CK and CK-MB were obtained 0, 8, 16, 24 hours after PCI. The results were compared with data from POLENOX study. Group 1 was treated with dalteparin, group 2 with UFH and group 3 with enoxaparin.
Results: Rate of death, myocardial infarction (CK-MB elevation > x 5 normal level) and repeated revascularization in groups was similar. In group 1 (0%; 2%; 1%) in group 2 (0.5%; 2%; 0%) in group 3 (0%, 2%, 0%) respectively. In group 1 CPK elevation (> 3 x normal) after PCI was more frequent (9%) in comparison with group 2 (3.5%) and group 3 (5%), but without statistical significance (p=0.14). Major bleeding complications were not observed in treated groups. Minor bleeding complications were more frequent in group 1 (9%) and 3 (8.5%) than in group 2 (2%), p< 0.001.
Conclusions: The use of dalteparin during PCI in patients with aspirin and ticlopidine pre-treatment is safe. However, more frequent benign local bleeding complications and mild CK-MB elevations may be expected.