Introduction: The advantage of primary percutaneous coronary intervention (pPCI) in the management of ST-elevation myocardial infarction (STEMI) over thrombolytic therapy has been demonstrated. However, an optimal medical treatment of STEMI patients admitted to regional hospitals without catheterisation facilities has not yet been established. Delay in initiation of pPCI resulting from transportation to the catheterisation laboratory may diminish the benefits of such therapy in comparison with thrombolysis administered in a regional hospital. Early initiation of therapy with platelet glycoprotein IIb/IIIa receptor inhibitor, which provides protection for the transportation, may be a reasonable solution to maintain the advantage of pPCI over thrombolysis alone in STEMI patients.
Methods: The studied group comprised patients with STEMI (infarct duration time <12 hours, typical clinical and electrocardiographic criteria of MI) who were randomly assigned in 13 regional hospitals located 20 to 150 km from invasive centre to one of two subgroups, either to thrombolysis in the community hospital or to transport after thrombolysis initiation with platelet GP IIb/IIIa receptor inhibitor (tirofiban; 10 mg/kg in intravenous bolus in the emergency room of the community hospital followed by continuous intravenous infusion of 0.1 mg/kg/min during transport as well as coronary procedure) in order to receive pPCI. All patients with cardiogenic shock on admission were routinely treated with PCI and were excluded from the study.
Results: 341 patients were included in the study (169 were randomised to receive thrombolytic therapy and 172--transport with intention to perform PCI). Mean time between onset of MI and randomisation was similar in the transport and thrombolysis groups, (139+/-133 min. vs 143+/-117 min., respectively, p=0.94). Mean infusion time of tirofiban to the beginning of PCI in the transport group was 121+/-36 min. Anterior MI was present in 42.6% of patients in the PCI group and in 41.5% in the thrombolytic group (p=0.085). Mean time from randomisation to pPCI was 158+/-60 min., and to thrombolysis initiation in 44+/-43 min. (p <0.0001). None of the patients died during transfer. In a 30-day follow-up we noted (pPCI vs thrombolytic group, respectively): mortality 3.49% vs 8.88% (p=0.04); reinfarction 1.16% vs 5.92% (p=0.02), stroke 0.58% vs 1.18% (p=0.55). In-hospital stay was significantly shorter in the transport group (9+/-3 days vs 14+/-7 days, p <0.0001). During hospitalisation, 17 (10.05%) patients initially assigned to thrombolysis alone had to be transferred to the catheterisation laboratory to undergo PCI (rescue PCI or PCI for postinfarction angina). Combined end-point (death/reinfarction/stroke) was reached more frequently in the thrombolytic group (15.98% vs 5.23%, p=0.001).
Conclusions: A strategy of invasive therapy involving transport with GP IIb/IIIa receptor inhibitor and pPCI in STEMI patients admitted to hospital without catheterisation facilities was found to be more effective than thrombolytic therapy alone employed in the regional hospitals.