Percutaneous coronary intervention in calcified stenoses: a protocol for a systematic review with meta-analysis, trial sequential analysis and network meta-analysis
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Published on: September 22, 2023
Andreas Torp Kristensen1, Janus C Jakobsen2,3, Niels Thue Olsen4
1Department of Cardiology, Copenhagen University Hospital, Herlev and Gentofte, Denmark andreas.torp.kristensen@regionh.dk.
Insights
This systematic review examines percutaneous coronary intervention for severely calcified lesions, aiming to improve treatment strategies for complex coronary artery disease. Evidence is limited, highlighting the need for better interventions in this high-risk patient group.
Area of Science:
- Cardiology
- Interventional Cardiology
- Clinical Trials
Background:
- Severely calcified coronary stenoses pose significant challenges for percutaneous coronary interventions.
- These calcifications complicate lesion preparation, stent deployment, and expansion, increasing risks.
- Patients with complex calcified lesions often have comorbidities and are underrepresented in clinical trials.
Purpose of the Study:
- To systematically review randomized controlled trials on percutaneous coronary intervention for calcified coronary artery disease.
- To evaluate various lesion preparation, stenting, and post-dilatation techniques.
- To identify optimal treatment strategies for patients with severe coronary calcifications.
Main Methods:
- Systematic review of randomized controlled trials.
- Comprehensive search of major biomedical databases (e.g., Cochrane, MEDLINE, Embase) up to October 2022.
- Coprimary outcomes include all-cause mortality and serious adverse events; potential for meta-analysis, trial sequential analysis, and network meta-analysis.
Main Results:
- This section is to be populated upon study completion.
Conclusions:
- This section is to be populated upon study completion.
Introduction:
Severely calcified coronary stenoses are difficult to treat with percutaneous coronary interventions. The presence of severe calcifications complicates lesion preparation, advancement of stents and achievement of full stent expansion. Intervention in these lesions is associated with an increased risk of complications and procedural failure compared with treatment of less calcified lesions. Due to the high burden of comorbidity, patients with severely calcified lesions are often excluded from interventional trials, and there is little evidence on how to treat these patients.
Methods And Analysis:
We will conduct a systematic review of randomised trials enrolling patients with calcified coronary artery disease undergoing percutaneous coronary intervention. We will investigate any percutaneous treatment option including any lesion preparation, stenting or postdilatation technique. We will search The Cochrane Central Register of Controlled Trials, Medical Literature Analysis and Retrieval System Online, Latin American and Caribbean Health Sciences Literature, Science Citation Index Expanded, and Excerpta Medica database for studies from inception to 31 October 2022. The coprimary outcome is all-cause mortality and serious adverse events. If appropriate, we will conduct meta-analysis, trial sequential analysis and network meta-analysis.
Ethics And Dissemination:
No ethics approval is required for this study. The results will be published in a peer-reviewed journal in this field.
Prospero Registration Number:
CRD42021226034.
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