Randomized comparison of direct and provisional stenting in de novo coronary artery lesions: the RADICAL study

Although preliminary reports have demonstrated excellent primary success and improved economics with direct stenting, a clinically relevant reduction of restenosis rate has not been documented yet.

Aims of the study were the comparison of restenosis rate (primary endpoint), procedural success, fluoroscopy time, amount of contrast dye and clinical outcome (secondary endpoints).

Between January and December 1999, 250 patients were randomly assigned either to direct stent implantation without predilatation (DS; 125 patients) or provisional stenting (PB; 125 patients) and followed for 7.9+/-2.7 (6-9) months. Angiographic follow-up was available in 92.0% of patients. Procedural success rate was 92.8% in DS and 100% in PB (n.s.), while radiation exposure was lower (4.7+/-4.3 versus 5.1+/-1.8 min; p<0.0001) with DS. Conversely, the amount of contrast dye (131+/-62 versus 139+/-36 ml; n.s.) was not different between DS and PB. Direct stenting leads to a 25.0% reduction in binary restenosis rate (15.7% in DS versus 20.9% in PB), indicating an advantageous trend, missing however the level of statistical significance. Similarly, there was a trend to fewer major cardiac events with DS (DS 16.8%, PB 21.6%).

We conclude that direct stenting is at least as safe and efficacious as balloon dilatation followed by provisional stent implantation, but failed to reduce restenosis rate or improve outcome within 6 months. Larger prospective randomized trials are required to assess the potential of direct stenting to reduce restenosis rate and improve clinical outcome in subgroups of patients.