Objective: To evaluate the impact of routine stenting, compared with balloon angioplasty, in unselected patients presenting with ST segment elevation myocardial infarction (STEMI).
Design: Randomised trial.
Setting: Tertiary referral centre.
Participants: All patients presenting with STEMI randomly assigned to stenting or balloon angioplasty. No exclusion criteria were applied.
Main outcome measure: The primary end point was combined death or reinfarction at one year's follow up.
Results: 1683 consecutive patients with STEMI were randomly assigned before angiography to stenting (n = 849) or balloon angioplasty (n = 834). A total of 785 patients (92.5%) in the stent group and 763 patients (91.5%) in the balloon group actually underwent primary angioplasty. The groups were comparable in terms of postprocedural TIMI (thrombolysis in myocardial infarction) flow, myocardial blush grade, and distal embolisation. No difference was observed in clinical outcome at both intention to treat (14% v 12.5%, not significant) and actual treatment analyses (12.4% v 11.3%, not significant).
Conclusions: Compared with balloon angioplasty, routine stenting does not seem to reduce death and reinfarction in a large cohort of unselected patients with STEMI.