Direct versus predilatation drug-eluting stenting: a randomized clinical trial.
BACKGROUND
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.


METHODS
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.


RESULTS
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).


CONCLUSIONS
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.
Katritsis
Demosthenes G
DG
Athens Euroclinic, 9 Athanassiadou Street, Athens 11521, Greece. dkatritsis@euroclinic.gr
Korovesis
Socrates
S
Karvouni
Evangelia
E
Giazitzoglou
Eleftherios
E
Theodorou
Spyridoula
S
Kourlaba
Georgia
G
Panagiotakos
Demosthenes
D
Voridis
Eutychios
E
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation* / Q000379:methods*; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000453:epidemiology; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D016503:Drug Delivery Systems / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011336:Probability; D011446:Prospective Studies; D018570:Risk Assessment; D020123:Sirolimus / Q000627:therapeutic use*; D018709:Statistics, Nonparametric; D015607:Stents; D015996:Survival Rate; D016896:Treatment Outcome; D014654:Vascular Patency
D020123:Sirolimus