Randomized comparison of primary stenting and provisional balloon angioplasty guided by flow velocity measurement

Background-Coronary stenting improves outcomes compared with balloon angiop lasty, but it is costly and may have other disadvantages. Limiting stent us e to patients with a suboptimal result after angioplasty (provisional angio plasty) may be as effective and less expensive. Methods and Results-To analyze the cost-effectiveness of provisional angiop lasty, patients scheduled for single-vessel angioplasty were first randomiz ed to receive primary stenting (97 patients) or balloon angioplasty guided by Doppler flow velocity and angiography (523 patients). Patients in the la tter group were further randomized after optimization to either additional stenting or termination of the procedure to further investigate what is "op timal." An optimal result was defined as a flow reserve >2.5 and a diameter stenosis <36%. Bailout stenting was needed in 129 patients (35%) who were randomized to balloon angioplasty, and an optimal result was obtained in 18 4 of the 523 patients (35%). There was no significant difference in event-f ree survival at 1 year between primary stenting (86.6%) and provisional ang ioplasty (85.6%). Costs after I year were significantly higher for provisio nal angioplasty (EUR 6573 versus EUR 5885; P=0.014). Results after the seco nd randomization showed that stenting was also more effective after optimal balloon angioplasty (1-year event free survival, 93.5% versus 84.1%; P=0.0 66). Conclusions-After 1 year of follow-up, provisional angioplasty was more exp ensive and without clinical benefit. The beneficial value of stenting is no t limited to patients with a suboptimal result after balloon angioplasty.