Direct versus predilatation drug-eluting stenting: a randomized clinical trial
Katritsis, D.G.; Korovesis, S.; Karvouni, E.; Giazitzoglou, E.; Theodorou, S.; Kourlaba, G.; Panagiotakos, D.; Voridis, E.
Journal of Invasive Cardiology 18(10): 475-479
2006
ISSN/ISBN: 1557-2501 PMID: 17235419 Document Number: 605182
Direct stenting without balloon predilatation has been shown to be feasible and safe with drug-eluting stents, but no randomized comparisons between the two strategies exist. This study was designed to compare direct stenting with balloon predilatation followed by stent placement using only drug-eluting stents. One hundred and sixty-six consecutive coronary lesions in 95 consenting patients (mean age 59 +/- 11 years; 12 women) were randomly assigned to direct stenting (n = 88), or balloon predilatation followed by stenting (n = 78), using sirolimus- or paclitaxel-eluting stents. All procedures were uneventful. Crossover to balloon predilatation was necessary in 6 (7%) lesions randomized to direct stenting. During a 12-month follow up period, ischemia-driven angiography was performed in 13 patients. By intention to treat analysis, target lesion revascularization was required in 4 lesions, all of which were randomized to the predilatation group (p = 0.04). Direct stenting was feasible in up to 93% of attempted lesions. A strategy of direct stenting resulted in a significantly lower rate of target lesion revascularization over a 12-month follow-up period compared to balloon predilatation followed by stenting.