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Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet]. York (UK): Centre for Reviews and Dissemination (UK); 1995-.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet].

Stent-supported angioplasty versus endarterectomy for carotid artery stenosis: evidence from current randomized trials

R Zahn, M Hochadel, A Grau, and J Senges.

Review published: 2005.

CRD summary

The authors concluded that carotid angioplasty (CAS) and carotid endarterectomy (CEA) are equally effective concerning short- and medium-term results, but CAS is associated with fewer minor complications. Limitations in the review methodology and the presented evidence suggest that these results should be treated with caution. However, the authors acknowledged that the results of ongoing large randomised controlled trials are required before recommending the use of CAS.

Authors' objectives

To assess the effect of carotid angioplasty (CAS) compared with carotid endarterectomy (CEA) in patients with symptomatic or asymptomatic high-grade carotid stenosis.

Searching

MEDLINE was searched from inception to December 2004; the keywords were reported. Textbooks were also searched and researchers in the field were contacted.

Study selection

Study designs of evaluations included in the review

Randomised controlled trials (RCTs) were eligible for inclusion.

Specific interventions included in the review

Studies that evaluated CAS compared with CEA were eligible for inclusion. The cut-off points for diagnosis of stenosis varied between studies.

Participants included in the review

Studies of patients with symptomatic or asymptomatic carotid stenosis were eligible for inclusion. Most of the participants in the included studies had symptomatic stenosis (range: 0 to 100%). No further population details were reported.

Outcomes assessed in the review

No inclusion criteria for the outcomes were specified. The primary outcome was all-cause mortality and death due to stroke combined, during the first 30 days and during subsequent follow-up. The secondary outcomes reported were myocardial infarction, cranial nerve palsy, haematoma requiring surgery or extended hospital stay, and restenosis.

How were decisions on the relevance of primary studies made?

Two reviewers independently selected the studies.

Assessment of study quality

The authors did not state that they assessed validity.

Data extraction

Two reviewers independently extracted the data. Data extracted by one reviewer were cross-checked by the other. Data were extracted to allow the calculation of an odds ratio (OR) with 95% confidence interval (CI) for each outcome of interest, using an intention-to-treat format where possible.

Methods of synthesis

How were the studies combined?

Pooled ORs and 95% CIs were calculated using a fixed-effect meta-analysis (Peto). Separate analyses were performed on acute- (within 30 days) and medium-term outcomes (1 to 2 years).

How were differences between studies investigated?

Heterogeneity was assessed using the Breslow-Day test. Forest plots and a L'Abbe plot were provided for visual inspection of heterogeneity. Possible explanations for differences between the studies were also discussed. The authors reported that there were insufficient data to allow a separate analysis of symptomatic versus asymptomatic patients. Some study details were also tabulated.

Results of the review

Six RCTs (n=1,263) were included in the review. Two of these RCTs had been stopped early (n=236). The authors identified four ongoing RCTs.

Thirty-day death or stroke.

There was no statistically significant difference in combined deaths or stroke rate within 30 days between CAS and CEA (8% versus 6.1%, OR 1.36, 95% CI: 0.88, 2.11; P=0.17; 5 RCTs). There was evidence of statistically significant heterogeneity (P=0.009). Following the exclusion of the smallest study, which had a particularly high death or stroke rate after CAS and was stopped early, statistically significant heterogeneity was no longer observed (P=0.18) and there was no statistically significant difference between CAS and CEA (OR 1.19, 95% CI: 0.76, 1.85; P=0.45).

Follow-up death or stroke.

There was no statistically significant difference in combined deaths or stroke rate at follow-up between CAS and CES (12.1% versus 12.2%, OR 0.99, 95% CI: 0.70, 1.42; P=0.98). There was evidence of statistically significant heterogeneity (P=0.02).

Secondary outcomes.

The rate of cranial nerve palsy and 30-day myocardial infarction were significantly greater after CEA than CAS (P<0.0001 and P=0.02, respectively).

Authors' conclusions

CAS and CEA are equally effective concerning short- and medium-term results, but CAS is associated with lower minor complications than CEA. However, there was statistically significant heterogeneity between the studies and the results of ongoing large RCTs are required.

CRD commentary

The review question was clear in terms of the participants, intervention and study design, but there were no inclusion criteria relating to the outcomes. The authors undertook a limited search and it was unclear whether any language restrictions were applied, thus there is a potential for both language and publication bias. However, the authors did make attempts to locate unpublished studies. Methods were employed to reduce the potential for error and bias during the study selection and data extraction processes. An assessment of study quality was not reported, and insufficient study details were presented to make a judgment upon their quality.

Appropriate measures of effect were calculated and limitations in the reporting of the outcomes were noted. The results were presented visually and the source of the heterogeneity was identified. The lack of a quality assessment and the possibility that relevant studies might have been overlooked, combined with limitations in the evidence presented, suggested that the results should be treated with caution. The authors' comment on the need to await the results of ongoing studies appears appropriate.

Implications of the review for practice and research

Practice: The authors stated that the results of ongoing large RCTs should be awaited before the use of CAS in a broader perspective can be advised.

Research: The authors did not state any implications for further research.

Bibliographic details

Zahn R, Hochadel M, Grau A, Senges J. Stent-supported angioplasty versus endarterectomy for carotid artery stenosis: evidence from current randomized trials. Zeitschrift fur Kardiologie 2005; 94(12): 836-843. [PubMed: 16382386]

Indexing Status

Subject indexing assigned by NLM

MeSH

Angioplasty, Balloon /statistics & numerical data; Blood Vessel Prosthesis /statistics & numerical data; Carotid Stenosis /mortality /surgery; Endarterectomy, Carotid /statistics & numerical data; Evidence-Based Medicine; Humans; Incidence; Prognosis; Randomized Controlled Trials as Topic /statistics & numerical data; Risk Assessment /methods; Risk Factors; Stents /statistics & numerical data; Survival Analysis; Survival Rate; Treatment Outcome

AccessionNumber

12006000501

Database entry date

28/02/2007

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.

CRD has determined that this article meets the DARE scientific quality criteria for a systematic review.

Copyright © 2014 University of York.

PMID: 16382386

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