Randomized comparison of direct stenting with predilatation followed by stenting on vessel trauma and restenosis.

Background: Direct stenting may reduce trauma to the vessel wall, thereby having a positive impact on acute and long-term results. This study evaluated acute vessel trauma and acute and follow-up angiographic and intravascular ultrasound (IVUS) results after direct stenting in comparison to conventional stenting.

Methods: Two hundred forty-nine patients were randomly assigned to direct stenting (n = 124) or stenting after predilatation (n = 125) and were followed up by angiography at 6 +/- 2 months. Intracoronary serum endothelin (ET-1) levels were determined distal to the lesion before and after coronary intervention to define vessel trauma, and IVUS was performed before and after intervention and at follow-up to determine induced changes in vessel morphology and intimal hyperplasia in a subgroup of 40 patients.

Results: Feasibility of direct stenting was 91%, with 9% requiring crossover to predilatation. There were no differences between the 2 groups in immediate clinical, angiographic, and intravascular ultrasound results. Intracoronary ET-1 levels increased significantly after intervention, without differences between the 2 groups (increase in ET-1 level, 0.79 +/- 1.06 vs 0.96 +/- 1.22 fmol/L, P =.206). At 6-month follow-up, angiographic late loss (0.76 +/- 0.86 vs 0.69 +/- 1.09 mm, P =.788) and restenosis rate (21% vs 20%, P = 1.000) were similar for direct stenting versus conventional stenting, respectively. IVUS demonstrated comparable intimal hyperplasia areas for direct versus conventional stenting (2.0 +/- 1.5 mm(2) vs 2.2 +/- 1.6 mm(2), respectively, P =.243).

Conclusions: Direct stenting is highly feasible and results in similar vessel trauma and change in vessel morphology and acute lumen dimensions compared with stenting after predilatation. Similar acute angiographic and IVUS results persist at 6-month follow-up.