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Impact of intravascular ultrasound-guided stenting on long-term clinical outcome: a meta-analysis of available studies comparing intravascular ultrasound-guided and angiographically guided stenting |
Casella G, Klauss V, Ottani F, Uwe S, Sangiorgio P, Bracchetti D |
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CRD summary This review assessed differences in effects, at 6 months, of implanting coronary stents using either ultrasound (IVUS)-guided or angiographically guided techniques. For the primary outcome of death or nonfatal myocardial infarction, there was no difference. However, there was a reduction in restenosis and target vessel revascularisation with IVUS-guided stenting. Despite some problems in the methodology of the review, the conclusions appear reasonable.
Authors' objectives To compare the clinical efficacy of intracoronary ultrasound (IVUS)-guided with angiographically guided coronary stenting, using meta-analysis, in order to improve the level of available evidence.
Searching MEDLINE was searched for English language publications up to December 2001; the search terms were given. The references of identified studies and reviews were checked.
Study selection Study designs of evaluations included in the reviewThe only inclusion criteria stated regarding study design was a minimum of 6 months of follow-up. The included studies were randomised controlled trials (RCTs), multicentre and single-centre registries and 'non-randomised' studies.
Specific interventions included in the reviewThe inclusion criteria specified direct comparisons of IVUS-guided versus angiographically guided coronary stent implantation. The authors stated that various stents were used in the included studies.
Participants included in the reviewNo inclusion criteria for the participants were specified, except that they were undergoing coronary stent implantation. With the exception of some details on vessel disease (de novo native vessel or restenosis), there was no information on the included participants.
Outcomes assessed in the reviewThe primary outcome of interest was a composite of death and nonfatal myocardial infarction (MI) at 6 months. The secondary outcome was a composite of major adverse cardiac events (MACE), as defined in the individual studies, most commonly death, nonfatal MI and target vessel revascularisation (TVR). Other secondary outcomes were individual end points (death, MI, TVR, re-percutaneous transluminal coronary angioplasty, or coronary artery bypass surgery), as well as binary restenosis angiography, and main angiographic parameters. All outcomes were assessed at 6 months.
How were decisions on the relevance of primary studies made?Three authors reviewed the papers for inclusion, and any disagreements were resolved by consensus.
Assessment of study quality The authors stated that the paper had to give a clear description of the methods used. No further information was given. The authors did not state how the papers were assessed for validity, or how many reviewers performed the validity assessment.
Data extraction The authors did not state how the data were extracted for the review, or how many reviewers performed the data extraction. They did, however, refer to these methods being discussed in another published paper (see Other Publications of Related Interest). The data extracted included numbers (and percentages) of individual outcome events. Odds ratios (OR) and 95% confidence intervals (CIs) were calculated for each outcome in each study.
Methods of synthesis How were the studies combined?The studies were combined using the Mantel-Haenszel fixed-effect model. The results were reported as an OR with 95% CIs. Z-values were calculated, with a P-value of less than 0.05 taken to be statistically significant.
How were differences between studies investigated?Heterogeneity was examined using the Q statistic. The studies were also grouped and analysed according to study type (RCT and registry).
Results of the review Nine studies (3,184 participants) were included: 5 RCTS (1,883 participants) and 4 registries or non-RCTs (1,301 participants). The primary outcome analyses were based on 8 studies (2,972 participants).
Stents were implanted in only 49% of cases in 4 of the RCTS. There was no statistical heterogeneity for the primary end point analysis, although there was evidence of heterogeneity for individual and angiographic outcomes.
There was no difference in death and nonfatal MI between the two strategies (OR 1.13, 95% CI: 0.79, 1.61, P=0.5).
There was a reduction in MACE with IVUS-guided stenting in comparison with angiographically guided stenting (OR 0.79, 95% CI: 0.64, 0.98, P=0.03), and also a reduction in TVR in favour of IVUS-guided stenting (OR 0.62, 95% CI: 0.49, 0.78, P=0.00003). However, there was no difference for death, nonfatal MI or coronary artery bypass graft surgery.
An angiographic analysis of binary restenosis showed a reduction with IVUS-guided compared with angiographically guided stenting (OR 0.75, 95% CI: 0.60, 0.94, P=0.01).
When pooling data from RCTs only, there was no difference in death or MI between the two groups (OR 1.02, 95% CI: 0.65, 1.57, P=0.5). There was a reduction in TVR with IVUS-guiding (OR 0.67, 95% CI: 0.51, 0.89, P=0.005), and some trend towards a reduction in binary restenosis (OR 0.81, 95% CI: 0.62, 1.06, P=0.1) and MACE (OR 0.82, 95% CI: 0.64, 1.04, P=0.1). These effects were smaller in the RCTs than in the registry studies.
Authors' conclusions Using IVUS-guided stent implantation had no differential effect on long-term death or nonfatal MI in comparison with angiographically guided stenting. However, there was a reduction in angiographic restenosis and TVR at 6 months with IVUS-guided stenting.
CRD commentary The inclusion criteria were only partially stated as the authors did not state what types of studies they sought. The database search was limited to MEDLINE and to studies in English. It is possible that studies were missed and this could have introduced bias into the results of the review. There was no mention of any quality assessment of the included studies, and two of the studies were reported only as abstracts; the results from poorer quality studies may be less reliable. Little detail was given on the types of participants. The authors stated that there were wide differences in the clinical risk profile of participants, but the lack of detail about the participants themselves (e.g. age, gender, severity of disease, concomitant diseases, etc.) means that it may be difficult to generalise from the results of the review.
Data from RCTs and observational studies were pooled and this may not have been appropriate; when the authors presented the results for RCTs separately, the effects appeared less favourable for IVUS-guided stenting in comparison with the pooled results. Bearing these comments in mind, the authors' conclusions are supported by the evidence presented.
Implications of the review for practice and research Practice: The authors suggested that IVUS-guided stenting could be useful for treating lesions at high risk of restenosis, although they stated that there was limited evidence for this.
Research: The authors did not state any implications for research.
Bibliographic details Casella G, Klauss V, Ottani F, Uwe S, Sangiorgio P, Bracchetti D. Impact of intravascular ultrasound-guided stenting on long-term clinical outcome: a meta-analysis of available studies comparing intravascular ultrasound-guided and angiographically guided stenting. Catheterization and Cardiovascular Interventions 2003; 59(3): 314-321 Other publications of related interest Ottani F, Galvani M, Nicolini FA, Ferrini D, Pozzati A, Di Pasquale G, et al. Elevated cardiac troponin levels predict the risk of adverse outcome in patients with acute coronary syndromes. Am Heart J 2000;140:917-27
Indexing Status Subject indexing assigned by NLM MeSH Angioplasty, Balloon, Coronary /instrumentation /methods; Coronary Angiography /methods; Coronary Stenosis /mortality /radiography /therapy /ultrasonography; Female; Humans; Male; Odds Ratio; Probability; Prognosis; Randomized Controlled Trials as Topic; Registries; Risk Assessment; Sensitivity and Specificity; Severity of Illness Index; Stents; Survival Rate; Treatment Outcome; Ultrasonography, Interventional /methods AccessionNumber 12003001513 Date bibliographic record published 31/08/2005 Date abstract record published 31/08/2005 Record Status This is a critical abstract of a systematic review that meets the criteria for inclusion on DARE. Each critical abstract contains a brief summary of the review methods, results and conclusions followed by a detailed critical assessment on the reliability of the review and the conclusions drawn. |
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