Radial vs femoral approach with StarClose clip placement for primary percutaneous coronary intervention in patients with ST-elevation myocardial infarction. RADIAMI II: a prospective, randomised, single centre trial

Abstract

Background: Compared to the transfemoral approach (TFA), the transradial approach (TRA) for primary percutaneous coronary intervention (PCI) is associated with less risk of access site complications, greater patient comfort and faster mobilisation. Using vascular closure devices during TFA can offer similar advantages.

Aim: To compare the results of TRA and TFA using a StarClose device for primary PCI in patients with ST-elevation myocardial infarction (STEMI).

Methods: Patients were randomised to PCI using TRA (n = 49) or PCI using TFA and StarClose (n = 59).

Results: Door-to-balloon inflation time was 67.4 ± 17.1 vs 57.5 ± 17.5 min (p = 0.009) in the TRA and TFA groups respectively. Procedural success rate was 100% and 98.3%, respectively (NS). There were no significant differences in the incidence of major adverse cardiac events (MACE) or bleeding complications between the groups: 2.1% and 8.2% in the TRA group vs 1.7% and 10.2% in the TFA group (NS). Time to resume an upright position and time to full mobility was comparable in both groups.

Conclusions: The TRA for PCI in patients with STEMI is related to a significantly longer door to balloon time compared to the TFA. This had no influence on the incidence of MACE. The duration and efficacy of PCI were comparable in both groups. Using StarClose after PCI performed via the TFA resulted in an incidence of access site and bleeding complications comparable to that found when using TRA.