Ultrasound guidance: technique and results of aggressive ultrasound-guided PTCA. The UPSIZE Pilot Trial.

Abstract

Stenting results in a larger lumen than conventional balloon angioplasty. This is the major determinant of a good acute and long-term result. In this non-randomised, single centre trial, intravascular ultrasound was used preinterventionally to guide the choice of the balloon size. The aim was to achieve a maximum lumen area with balloon angioplasty only. We included 346 patients with 360 lesions. The diameter of the external elastic lamina by intravascular ultrasound was 4.67 mm. A mean balloon size of 4.0 mm was chosen. The initial luminal gain was 1.82 mm, the lumen area post intervention was 6.6 mm(2). Dissections occurred frequently but the incidence of major adverse events was not increased. At one year follow-up, the overall event free survival was 81%. Target lesion revascularisation was performed in 34 patients (10%). An angiographic follow-up was available for 261 patients (76%). Restenosis (> 50% diameter Stenosis) was found in 21%. The results show, that ultrasound guidance of balloon angioplasty provides a means to achieve a large initial luminal gain without the routine use of stents. The acute and long-term results suggest that the approach is safe and efficient. The data compare favorably with similar studies using advanced intravascular diagnostic tools to guide the angioplasty procedure.