RESUMO
Patients with diffuse in-stent restenoses (ISRs) are at high risk for recurrent restenosis after percutaneous transluminal balloon angioplasty (PTCA). Percutaneous transluminal rotational ablation (PTCR) has proved effective in removing neointimal burden in ISRs. This study compares the acute and long-term results of PTCA and PTCR for the treatment of diffuse ISR in a randomized, multicenter investigation. The primary end point was the comparison of the minimum luminal diameter (MLD) between both groups at 6-month follow-up. Patients with symptomatic, diffuse, or high-grade ISRs were included; 146 patients were randomized to PTCA and 152 patients to PTCR. Diameter stenosis was reduced from 80 +/- 12% to 29 +/- 10% and from 80 +/- 11% to 28 +/- 12%, respectively, and MLD increased from 0.55 +/- 0.3 to 1.9 +/- 0.3 mm in the PTCA group and from 0.54 +/- 0.3 mm to 1.9 +/- 0.4 mm in the PTCR group. Spasm in the treated vessel and an intermittent slow flow phenomenon occurred more often after rotational ablation (17.7% vs 8.6%, p = 0.001; 5.3% vs 0%, p = 0.007). Minimum stenosis diameter at 6-month follow-up was smaller in the PTCR group than in the PTCA group (1.0 +/- 0.6 vs 1.2 +/- 0.6 mm, p = 0.008) and the restenosis rate was higher (64.9% vs 51.2%, p = 0.027). Procedural factors did not influence long-term outcome. In the PTCR group, the restenosis rate increased with decreasing vessel size, whereas this was not seen in the PTCA group. The lesion length and the baseline diameter stenosis were found to be predictive of restenosis with both treatment strategies; however, a residual diameter stenosis of <30% predicted absence of a restenosis only in the PTCR group. Thus, PTCA and PTCR of diffuse ISRs yield comparable acute angiographic results. The recurrence of a restenosis is higher after PTCR than after PTCA.