Results From the Multicenter CROSSCUT Study
Results From the Multicenter CROSSCUT Study
Stenting without predilatation has become possible due to the availability of a new generation of flexible, low-profile, securely crimped, balloon-expandable stents. This study compared the feasibility, efficacy and cost-effectiveness of direct stenting (DS) to the standard predilatation technique (PS) using the premounted Crossflex LC stent (Cordis Corporation, Miami Lakes, Florida). The study is a randomized prospective multicenter evaluation including 271 patients (140 patients in the DS group and 131 patients in the PS group) with 1 or 2 de novo or restenotic lesions located in native coronary arteries.
Procedural success was 98.9% and 98.7% in the DS and PS groups, respectively (p = NS); crossover to PS was required in 22/166 lesions (13.2%) enrolled in the DS group because of inability to cross the target lesion without predilatation. Nonsignificant reductions in procedural time (-10.5%), fluoroscopy time (-4.7%) and amount of contrast (-3.8%) were observed in the DS group in comparison to the PS group. The number of balloons used (-76.6%) and the global cost of the procedure (-18.8%) were significantly lower in the DS group (p < 0.01 for both comparisons). After 6 months, no differences were observed in the restenosis rate between the two groups (22.0% for DS group versus 18.1% for PS group; p = NS) and in the incidence of major adverse clinical events (5.0% for DSgroup versus 3.0% for PS group; p = NS).
Direct stenting is safe and feasible for the treatment of lesions in native coronary arteries and obtains a significant reduction in procedural cost, mainly due to the lower number of balloons used. Clinical and angiographic results at 6 months are comparable to those obtained after a conventional predilatation-stenting strategy.
In the last decade, coronary stenting has evolved from a bailout procedure following balloon angioplasty into an elective strategy for the treatment of all lesions located in vessels with an angiographic reference diameter larger than 3.0 mm. The standard procedure for stent implantation includes balloon predilatation to facilitate positioning of the stent delivery system at the target lesion; more recently, however, the strategy of stenting without predilatation has become possible due to the availability of new generations of flexible stents, securely crimped on low-profile balloons. This technique, called "direct stenting" (DS), has the potential advantage of reducing costs and radiation exposure. Moreover, preliminary observations suggest that DS may reduce the incidence of restenosis by lowering the endothelial trauma in comparison to dilatation followed by stenting. This study addressed the feasibility, efficacy and cost effectiveness of this strategy using the Crossflex LC stent.
Stenting without predilatation has become possible due to the availability of a new generation of flexible, low-profile, securely crimped, balloon-expandable stents. This study compared the feasibility, efficacy and cost-effectiveness of direct stenting (DS) to the standard predilatation technique (PS) using the premounted Crossflex LC stent (Cordis Corporation, Miami Lakes, Florida). The study is a randomized prospective multicenter evaluation including 271 patients (140 patients in the DS group and 131 patients in the PS group) with 1 or 2 de novo or restenotic lesions located in native coronary arteries.
Procedural success was 98.9% and 98.7% in the DS and PS groups, respectively (p = NS); crossover to PS was required in 22/166 lesions (13.2%) enrolled in the DS group because of inability to cross the target lesion without predilatation. Nonsignificant reductions in procedural time (-10.5%), fluoroscopy time (-4.7%) and amount of contrast (-3.8%) were observed in the DS group in comparison to the PS group. The number of balloons used (-76.6%) and the global cost of the procedure (-18.8%) were significantly lower in the DS group (p < 0.01 for both comparisons). After 6 months, no differences were observed in the restenosis rate between the two groups (22.0% for DS group versus 18.1% for PS group; p = NS) and in the incidence of major adverse clinical events (5.0% for DSgroup versus 3.0% for PS group; p = NS).
Direct stenting is safe and feasible for the treatment of lesions in native coronary arteries and obtains a significant reduction in procedural cost, mainly due to the lower number of balloons used. Clinical and angiographic results at 6 months are comparable to those obtained after a conventional predilatation-stenting strategy.
In the last decade, coronary stenting has evolved from a bailout procedure following balloon angioplasty into an elective strategy for the treatment of all lesions located in vessels with an angiographic reference diameter larger than 3.0 mm. The standard procedure for stent implantation includes balloon predilatation to facilitate positioning of the stent delivery system at the target lesion; more recently, however, the strategy of stenting without predilatation has become possible due to the availability of new generations of flexible stents, securely crimped on low-profile balloons. This technique, called "direct stenting" (DS), has the potential advantage of reducing costs and radiation exposure. Moreover, preliminary observations suggest that DS may reduce the incidence of restenosis by lowering the endothelial trauma in comparison to dilatation followed by stenting. This study addressed the feasibility, efficacy and cost effectiveness of this strategy using the Crossflex LC stent.