Comparison of outcomes (early and six- month) of direct stenting with conventional stenting (a meta-analysis of ten randomized trials)

doi:10.1016/S0002-9149(03)00009-2

The American Journal of Cardiology

Volume 91, Issue 7, 1 April 2003, Pages 790-796

https://doi.org/10.1016/S0002-9149(03)00009-2 Get rights and content

Abstract

Although direct stenting (DS) is increasingly used in clinical practice instead of stent implantation after predilatation (conventional stenting [CS]), its impact has not been scientifically proved. We therefore performed, using Mantel-Haenszel analysis, a meta-analysis of the published randomized studies comparing DS with CS. Furthermore, all the key procedural data were systematically sought out and pooled. Ten trials (2,650 coronary lesions, 2,576 patients) were identified and entered 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 postintervention period, DS was associated with a trend toward 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), respectively. 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 equipment use, and may enhance the early results of coronary interventions while warranting similar late clinical outcomes.

Section snippets

Search strategy and data abstraction

Studies published within June 2002 comparing DS with CS were identified by Medline (http://www.ncbi.nlm.nih.gov) entering the words “stent” and “randomized” and “dilatation” or “conventional” or “direct.” No restriction according to the language was done.

Identified studies and data extraction

Ten 1:1 randomized studies comparing DS with CS were identified1, 2, 3, 4, 5, 6, 7, 8, 9, 10 and were all included in the present analysis. The following characteristics were systematically sought out in each study and abstracted: clinical

Study characteristics

The characteristics of the randomized studies included in the analysis are listed in Table 1. All but 3 trials1, 8, 10 recruited patients in > 1 center. Most included both patients with stable or unstable coronary disease (Sabatier et al10 enrolled only patients with acute coronary syndromes, whereas the Benefit Evaluation of Direct Coronary Stenting (BET) Study4 enrolled only stable patients), excluding those with acute MI. Such patients, however, constituted the study population of the trial

Discussion

We pooled data of 10 randomized trials comparing DS with CS, including approximately 2,600 patients and 2,700 lesions. DS was found to be a safe approach; its use was not associated with any specific complication while providing identical acute success rates. Furthermore, it did not carry an increased need for postdilatation (the postprocedural minimal lumen diameter and the residual stenosis were identical in both groups, whereas the rate of postdilatation widely varied across the studies

Acknowledgements

We thank Dr. Paolo Burzotta for invaluable assistance with the statistical analyses.

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Regular paperComparison of outcomes (early and six- month) of direct stenting with conventional stenting (a meta-analysis of ten randomized trials)

Abstract

Section snippets

Search strategy and data abstraction

Identified studies and data extraction

Study characteristics

Discussion

Acknowledgements

Am J Cardiol

Am J Cardiol

J Am Coll Cardiol

Am Heart J

Am Heart J

Am Heart J

A randomized study of direct coronary stent delivery compared with stenting after predilatationthe NIR Future Trial

Cathet Cardiovasc Intervent

Regular paper
Comparison of outcomes (early and six- month) of direct stenting with conventional stenting (a meta-analysis of ten randomized trials)