Comparison of Outcomes (Early and Six- Month) of Direct Stenting With Conventional Stenting (a Meta-Analysis of Ten Randomized Trials) Francesco Burzotta, MD, Carlo Trani, MD, Francesco Prati, MD, Martial Hamon, MD, Mario Attilio Mazzari, MD, Rocco Mongiardo, MD, Remi Sabatier, MD, Alessandro Boccanelli, MD, Giovanni Schiavoni, MD, and Filippo Crea, MD Although direct stenting (DS) is increasingly used in clin- ical practice instead of stent implantation after predila- tation (conventional stenting [CS]), its impact has not been scientifically proved. We therefore performed, us- ing Mantel-Haenszel analysis, a meta-analysis of the published randomized studies comparing DS with CS. Furthermore, all the key procedural data were system- atically sought out and pooled. Ten trials (2,650 coro- nary lesions, 2,576 patients) were identified and en- tered into the analysis. Adopted angiographic exclusion criteria were homogenous. DS, compared with CS, was found to have a similar success rate (98.7% vs 98.9%) and no specific complications. Across the studies, the mean rate of crossover to predilatation in the DS arm was 5.9%. Overall, DS was associated with a 17% procedural time (95% confidence interval [CI] 14% to 20%), a 18% fluoroscopic time (95% CI 15% to 21%), a 11% contrast volume (95% CI 9% to14%), and a 22% cost reduction (95% CI 16% to 28%). In the early postin- tervention period, DS was associated with a trend to- ward reduction of each of the major adverse events (MACEs) and with a significant reduction of myocardial infarction (MI)  death (odds ratio [OR] 0.57, 95% CI 0.35 to 0.95). However, at 6 months, the OR (95% CI) for death, MI, target lesion revascularization, and MACEs were 0.47 (0.19 to 1.27), 0.72 (0.45 to 1.25), 1.07 (0.77 to 1.46), and 0.82 (0.63 to 1.08), respec- tively. In the subgroup of studies providing quantitative angiographic data, all the parameters were found to be similar between the CS and DS groups. In conclusion, the present meta-analysis shows that DS compared with CS, in selected coronary lesions, is safe, optimizes equip- ment use, and may enhance the early results of coronary interventions while warranting similar late clinical outcomes. 2003 by Excerpta Medica, Inc. (Am J Cardiol 2003;91:790 –796) D espite the relevant number of stenting procedures performed every day, the best technique for stent implantation has not been clearly established. The conventional technique for stent implantation (CS) consists of predilatation of the target lesion with a balloon catheter to allow correct positioning, followed by deployment of the stent. However, modern tech- nology has changed the stent’s characteristics, and current stent implantation without predilatation, the so-called direct stenting (DS) technique, has become standard practice for many interventional cardiolo- gists. The DS technique may offer some potential economic advantages (reduction of equipment usage and procedural time) as well as a modification of the approach to coronary lesion dilatation, reducing vessel trauma and plaque embolization. We performed a meta-analysis to assess whether DS reduces equip- ment usage and ameliorates clinical and angiographic findings. METHODS Search strategy and data abstraction: Studies pub- lished within June 2002 comparing DS with CS were identified by Medline (http://www.ncbi.nlm.nih.gov) entering the words “stent” and “randomized” and “di- latation” or “conventional” or “direct.” No restriction according to the language was done. Identified studies and data extraction: Ten 1:1 ran- domized studies comparing DS with CS were identi- fied 1–10 and were all included in the present analysis. The following characteristics were systematically sought out in each study and abstracted: clinical en- rollment criteria, angiographic exclusion criteria, number of subjects enrolled, number of lesions treated, arterial approach used, vessels approached, lesion characteristics, type, number, and length of the used stents, and the crossover rate. The following procedural data according to the 2 interventional tech- niques (DS and CS) were sought out and abstracted from the individual studies: rate of angiographic suc- cess, fluoroscopic time, procedural time, contrast me- dium usage, number of balloon catheters, and esti- mated cost of the procedure. For each study, the observed in-hospital (or up to 30 days) rate of death, nonfatal myocardial infarction (MI) (including the cases of subacute stent thrombo- sis), death + MI, target lesion revascularization, and From the Institute of Cardiology, Catholic University, Rome, Italy; Department of Cardiology, S. Giovanni Hospital, Rome, Italy; and Department of Cardiology, University, Hospital of Caen, Caen, France. Manuscript received October 2, 2002; revised manuscript received and accepted December 9, 2002. Address for reprints: Francesco Burzotta, MD, Via Prati Fiscali 158, 00141 Rome, Italy. E-mail: f.burzotta@eudoramail.com. 790 ©2003 by Excerpta Medica, Inc. All rights reserved. 0002-9149/03/$–see front matter The American Journal of Cardiology Vol. 91 April 1, 2003 doi:10.1016/S0002-9149(03)00009-2