Does intravascular ultrasound provide clinical benefits for bare-metal stenting?

Electronic search: PubMed, EMBASE and Web of Knowledge databases with the terms Myocardial Ischemia, Ischemic Heart Disease, Acute Coronary Syndrome, Angina, Coronary Disease, Coronary Artery Disease, Coronary Occlusion, Coronary Thrombosis, and Myocardial Infarction in association with the terms Interventional Ultraso*, Intravascular Ultraso*, Intracoronary Ultraso*, IVUS and ICUS.

The electronic search was limited neither by publication date nor by language.

Manual search: potential articles cited in previous meta-analyses, in review articles and those considered to be relevant by the reviewers.

We will include only randomized controlled trials that compared IVUS-guided PCI with angiography-guided PCI, with clinical endpoints and, in which, at least six months of clinical follow-up were included.

Coronary artery disease.

Percutaneous coronary intervention.

Inclusion criteria: randomized controlled trials that compared intravascular ultrasound-guided PCI with angiography-guided PCI, with clinical endpoints and, at least, six months of clinical follow-up.

Exclusion criteria: studies that do not meet the inclusion criteria.

As a diagnostic tool, intravascular ultrasound (IVUS) helps in the assessment of coronary lesions classified as moderate based on angiography, especially those located in the left main coronary artery, and in the assessment of long lesions, small artery lesions, bifurcations and in-stent restenosis. As an ancillary technique in percutaneous coronary intervention (PCI), IVUS is useful in the evaluation of the target lesion and during stent implantation. In theory, its use should reduce the risk of major adverse cardiovascular events (MACE) because of lower restenosis and stent thrombosis rates. But IVUS clinical benefit is still controversial, a meta-analysis to assess the role of IVUS in PCI with bare-metal stenting was performed. . The clinical endpoints considered were death, nonfatal MI and the combined endpoint of MACE (death, nonfatal MI, or repeat revascularization). For repeat revascularization, a report of any new coronary revascularization (surgical or percutaneous), regardless of the lesion and vessel treated was considered. Surrogate outcomes, such as angiographic outcomes, were not taken into account because these can show a “positive” result with no effect (or harmful effect) on clinical outcomes.

A group of percutaneous coronary interventions guided only by angiography.

Primary outcomes

Death, nonfatal MI and the combined endpoint of MACE (death, nonfatal MI, or repeat revascularization).

Secondary outcomes

None

The titles and abstracts from the articles retrieved by the search strategy will be independently evaluated by two reviewers (LCP, LLJ). All articles in which IVUS is mentioned will be selected. These articles will be fully read, and those that meet the criteria will be included. Disagreements will be solved by consensus. If consensus is not achieved, a third reviewer (ALR) will define the question.

Publication bias evaluation will be performed by Duval and Tweedie’s Trim and Fill Test. The Egger's Test will also be performed to analyze the impact of several factors on the size of the treatment effect. The small study effect will also be evaluated by the cumulative analysis (from largest to smallest sample size) and by the One Study Removed method. The heterogeneity between studies will be estimated by the I-squared statistic and by qualitative study analysis.

After the systematic review, an intention to treat meta-analysis will be carried out, pooling the results using a random-effects model, with standardised mean differences for continuous outcomes and risk ratios for binary outcomes, and calculate 95% confidence intervals and two sided P values for each outcome.

The heterogeneity between studies will be estimated by the I-squared statistic.

We will conduct sensitivity analyses based on study quality. We will also assess evidence of publication bias.

The Egger's Test will also be performed to analyze the impact of several factors on the size of the treatment effect. The small study effect will be evaluated by the cumulative analysis (from largest to smallest sample size) and by the One Study Removed method.

None planned.

Lucas Lodi-Junqueira

Rua Assuncao, 535 / Apto 501 - Bairro Sion - CEP: 30320-020 - Belo Horizonte, MG - BRASIL

lucaslodi@yahoo.com.br

Universidade Federal de Minas Gerais

Dr Lucas Lodi-Junqueira, Hospital das Clínicas da Universidade Federal de Minas Gerais
Professor Marcos Roberto de Sousa, Hospital das Clínicas da Universidade Federal de Minas Gerais
Dr Leonardo da Paixão, Hospital das Clínicas da Universidade Federal de Minas Gerais
Dr Silvana Kelles, Hospital das Clínicas da Universidade Federal de Minas Gerais
Professor Carlos Amaral, Hospital das Clínicas da Universidade Federal de Minas Gerais
Professor Antonio Ribeiro, Hospital das Clínicas da Universidade Federal de Minas Gerais

01 April 2011

31 August 2012

Funded by the National Council for Scientific and Technological Development (CNPq).

None known

English

Brazil

Subject indexing assigned by CRD

Coronary Artery Disease; Coronary Vessels; Humans; Stents; Ultrasonography, Interventional

06 August 2012

07 March 2013

Lodi-Junqueira et al. Systematic Reviews 2012, 1:42

http://www.systematicreviewsjournal.com/content/1/1/42