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Adjunctive Devices for Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention
Comparative Effectiveness Reviews, No. 42
Investigators: Diana M Sobieraj, PharmD, C Michael White, PharmD, FCP, FCCP, Jeffrey Kluger, MD, FACC, Vanita Tongbram, MBBS, MPH, Jennifer Colby, PharmD, Wendy T Chen, PharmD, Sagar S Makanji, PharmD, Soyon Lee, PharmD, Ajibade Ashaye, MD, MPH, Robert Quercia, MS, Jeffrey Mather, MS, Sharon Giovenale, MS, and Craig I Coleman, PharmD.
Author Information and AffiliationsStructured Abstract
Objectives:
This is a Comparative Effectiveness Review examining the benefits to harms of adjunctive devices to remove thrombi or protect against embolization in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) of native vessels.
Data sources:
MEDLINE®, Cochrane Database, and abstracts from major cardiology meetings were searched from 1996 through March 2011, as were www.clinicaltrials.gov and references from identified citations.
Review methods:
Randomized controlled trials (RCTs), controlled observational studies enrolling ≥500 patients, and systematic reviews were eligible for inclusion. Data amenable to meta-analysis were pooled as relative risks (RRs) with accompanying 95-percent confidence intervals using a random-effects model.
Results:
A total of 175 articles were included. Three direct comparative RCTs were identified comparing catheter aspiration with distal balloon protection devices or other catheter aspiration devices; they showed no significant differences for evaluated outcomes. The data comparing adjunctive devices with standard PCI (control) are predominantly in patients with ST-segment elevation myocardial infarction (STEMI).
In RCTs conducted in STEMI patients, catheter aspiration devices decreased the risk of a major adverse cardiovascular event (MACE) [RR 0.73 (0.61-0.88)] versus control. Catheter aspiration devices increased the achievement of ST-segment resolution [RR 1.51 (1.32-1.73)], myocardial blush grade of 3 (MBG-3) [RR 1.61 (1.41-1.84)], and thrombolysis in myocardial infarction (TIMI) 3 flow [RR 1.08 (1.04-1.12)], while reducing distal embolization [RR 0.56 (0.39-0.79)], no reflow [RR 0.52 (0.35-0.76)], and coronary dissection [RR 0.30 (0.12-0.75)] versus control. Other final health and intermediate outcomes were not significantly impacted by catheter aspiration devices versus control. In a majority of trials, the use of catheter aspiration devices increased procedural time upon qualitative assessment.
Distal filter embolic protection devices increased the risk of target revascularization [RR 1.61 (1.03-2.54)], although the use of mechanical thrombectomy or embolic protection devices did not significantly impact other final health outcomes or harms in RCTs. Qualitative assessment indicated that procedure time was increased versus control. Distal balloon or any embolic protection device increased the achievement of MBG-3 [RR 1.39 (1.15-1.69) and RR 1.20 (1.02-1.40), respectively] and TIMI-3 flow [RR 1.11 (1.03-1.19) and RR 1.06 (1.01-1.12), respectively] but did not significantly impact other intermediate outcomes versus control. Mechanical thrombectomy, distal filter, or proximal balloon embolic protection devices did not significantly impact any of the intermediate outcomes evaluated versus control. The associations between predetermined factors and outcomes in people receiving adjunctive devices were generally insufficient.
Conclusions:
For most devices, there are few RCTs evaluating final health outcomes over a long period of followup, and furthermore the data outside of STEMI are scarce. Due to insufficient data, the safety of these devices is unclear.
Contents
- Preface
- Acknowledgments
- Key Informants
- Peer Reviewers
- Executive Summary
- Introduction
- Methods
- Input From Stakeholders
- Searching for the Evidence: Literature Search Strategies for Identifying Relevant Studies to Answer the Key Questions
- Criteria for Inclusion and Exclusion of Studies in the Review
- Data Extraction and Data Management
- Assessment of Methodological Quality of Individual Studies
- Data Synthesis
- Grading the Evidence for Each Key Question
- Applicability of Evidence
- Results
- Results of Literature Search
- Key Question 1 In patients with ACS who are undergoing PCI of native vessels, what are the comparative effects of adjunctive devices from different classes (e.g., catheter aspiration, mechanical thrombectomy, distal balloon embolic protection, distal filter embolic protection, proximal balloon embolic protection, embolic protection devices combined) on intermediate outcomes (e.g., ST-segment resolution, MBG-3, TIMI-3 blood flow, ejection fraction, distal embolization and no reflow) and terminal outcomes (mortality, myocardial infarction, stroke, target revascularization, MACE, and health-related quality-of-life)?
- Key Question 2 In patients with ACS who are undergoing PCI of native vessels, how does the rate and type of adverse events (e.g., coronary dissection, coronary perforation, prolonged procedure time) differ between device types when compared to PCI alone?
- Key Question 3 In ACS patients undergoing PCI of native vessels, which patient characteristics (e.g., gender, age, ethnicity, diabetes, smoker, ejection fraction, primary or rescue PCI, use of glycoprotein IIb/IIIa inhibitors, ischemia time, presence of thrombus-containing lesion, infarct-related artery and prePCI TIMI flow, use of direct stenting) affect outcomes?
- Strength of Evidence and Applicability
- Discussion
- Future Research
- References and Included Studies
- Acronyms/Abbreviations
- Appendixes
- Appendix A Exact Search Strategy
- Appendix B Data Extraction Form
- Appendix C Characteristics and Quality Assessment of Included Trials, Studies and Systematic Reviews With Meta-analyses
- Appendix D Excluded Studies From Full-text Review
- Appendix E Baseline and Procedural Characteristics of Included Trials and Studies
- Appendix F Additional Evidence Tables and Reference List
- Appendix G Strength of Evidence for Outcomes
- Appendix H Applicability of Individual Studies and of the Body of Evidence
- Appendix I Forest Plots for Results of Final Health Outcomes Analyzed at Individual Time Points
- Appendix J Glossary
Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services1, Contract No. 290-2007-10067-I. Prepared by: University of Connecticut/Hartford Hospital Evidence-based Practice Center, Hartford, CT
Suggested citation:
Sobieraj DM, White CM, Kluger J, Tongbram V, Colby J, Chen WT, Makanji SS, Lee S, Ashaye A, Quercia R, Mather J, Giovenale S, Coleman CI. Adjunctive Devices for Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention. Comparative Effectiveness Review No. 42. (Prepared by the University of Connecticut/Hartford Hospital Evidence-based Practice Center under Contract No. 290-2007-10067-I.) AHRQ Publication No. 11(12)-EHC089-EF. Rockville, MD: Agency for Healthcare Research and Quality. December 2011. www.effectivehealthcare.ahrq.gov/reports/final.cfm.
This report is based on research conducted by the University of Connecticut/Hartford Hospital Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2007-10067-I). The findings and conclusions in this document are those of the authors, who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.
The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers—make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients.
This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.
None of the investigators has any affiliations or financial involvement that conflicts with the material presented in this report.
- 1
540 Gaither Road, Rockville, MD 20850; www
.ahrq.gov
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