Aims To assess the safety of direct coronary stenting, its influence on costs, duration of the procedure, radiation exposure, clinical outcome and angiographic restenosis.
Methods and Results We randomized 416 patients (446 lesions) to direct stent implant or stent implant following balloon pre-dilation. Patients >75 years old, heavily calcified lesions, bifurcations, total occlusions, left main lesions and very tortuous vessels were excluded. Direct stenting was successful in 217/224 lesions (96·8%). No single loss or embolization of the stent occurred. All stents in the group with pre-dilation were effectively deployed. The immediate post-procedure angiographic results were similar with both techniques. Fluoroscopy and procedural time were significantly lower in direct stenting (6·4±0·3 and 21±0·9min) than in pre-dilated stenting (9·1±0·4 and 27·5±1·1min) (P>0·001). Major adverse cardiac events during hospitalization were one in direct and four in pre-dilated stenting (P=0·05) but there were no significant differences at follow-ups at 1, 6 and 12 months between the two groups. Angiographic revaluation at 6 months was performed in 94% of the cases. Restenosis rate was 16·5% in direct stenting and 14·3% in pre-dilated stenting (P=ns).
Conclusions Direct stenting is as safe as pre-dilated stenting in selected coronary lesions. Acute angiographic results are similar but procedural costs, duration of the procedure and radiation exposure are lower in direct stenting. Overall success rate, mid-term clinical outcome and restenosis are similar with both techniques.