Early stenting vs conservative treatment after thrombolysis in acute myocardial infarction: results of a randomized trial

Thrombolysis (T) in acute myocardial infarction (AMI) is limited by TIMI III-flow rates of 60% and reocclusion of the infarct related artery in 5 to 10%. Prior studies showed no benefit of PTCA following T in AMI. Recent studies have demonstrated superiority of primary stenting versus PTCA alone in AMI.

We are conducting a multicenter, randomized, prospective, controlled trial to compare the strategy of early coronary stenting (group A) with conservative treatment (group B) following T within 12 hours after onset of AMI. Patients of group A are transferred to the interventional center within 6 hours after T for coronary angiography including stenting of the infarct related artery. Group B has elective coronary angiography after 2 weeks. Primary endpoint is a combined endpoint of death, reinfarction, and target lesion revascularization.

So far (November 2000) 176 pts have been randomized. There are no significant differences regarding sex, age, infarct localization, risk factors, ck-elevation and cardiogenic shock. Mean follow-up time is 158 ± 97 days.

Results

Table 1

Bleeding complications occurred in 11% of pts in group I vs 8% in group II (ns).

Conclusion

Early stenting after T in AMI is safe. This preliminary data indicate a clinical benefit by this approach compared to conservative treatment after T in AMI.