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Prepared for: Agency for Healthcare Research and Quality (AHRQ) ahrq

Adjunctive Devices for Patients With Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention. Prepared for: Agency for Healthcare Research and Quality (AHRQ) www.ahrq.gov. Outline of This CME Activity. The comparative effectiveness review (CER) process Background

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Prepared for: Agency for Healthcare Research and Quality (AHRQ) ahrq

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  1. Adjunctive Devices for Patients With Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention Prepared for: Agency for Healthcare Research and Quality (AHRQ) www.ahrq.gov

  2. Outline of This CME Activity • The comparative effectiveness review (CER) process • Background • Questions addressed in the CER for patients with acute coronary syndrome (ACS)who are undergoing percutaneous coronary intervention (PCI)of native vessels: • The comparative effects of adjunctive devices on intermediate outcomes (e.g., ST-segment resolution, myocardial blush grade 3 [MBG-3], thrombolysis in myocardial infarction flow grade 3 [TIMI-3], ejection fraction, distal embolization and no reflow) and terminal outcomes (mortality, myocardial infarction [MI], stroke, target revascularization, major adverse cardiovascular events [MACEs], and health-related quality of life). • The rate and type of adverse events (e.g., coronary dissection, coronary perforation, prolonged procedure time) and how they differ between device types when compared with PCI alone. • Results • Conclusions

  3. Agency for Healthcare Research and Quality (AHRQ) Comparative Effectiveness Review Development • Topics are nominated through a public process, which includes submissions from health care professionals, professional organizations, the private sector, policymakers, the public, and others. • A systematic review of all relevant clinical studies is conducted by independent researchers, funded by AHRQ, to synthesize the evidence in a report summarizing what is known and not known about the select clinical issue. The research questions and the results of the report are subject to expert input, peer review, and public comment. • The results of these reviews are summarized into Clinician Research Summaries and Consumer Research Summaries for use in decisionmaking and in discussions with patients. The Clinician Research Summary and full report are available at www.effectivehealthcare.ahrq.gov/thrombusacs.cfm. No Consumer Research Summary was prepared for the current topic. Sobieraj DM, White CM, Kluger J, et al. Comparative Effectiveness Review No. 42. Available at www.effectivehealthcare.ahrq.gov/thrombusacs.cfm.

  4. Rating the Strength of Evidence From the CER • The strength of evidence was classified into four broad categories: Sobieraj DM, White CM, Kluger J, et al. Comparative Effectiveness Review No. 42. Available at www.effectivehealthcare.ahrq.gov/thrombusacs.cfm.

  5. Background: Coronary Heart Disease • Coronary heart disease (CHD) is a leading cause of morbidity and mortality in the United States. • More than 650,000 deaths were attributed to CHD in 2003. • Treatment costs for CHD represent the largest health care expenditure for a single disease in the United States. • Acute coronary syndromes (ACSs) account for more than 1.5 million hospital admissions annually in the United States alone. • ACSs include the clinical entities of: • Unstable angina (UA) • Non–ST-segment elevation MI (NSTEMI) • ST-segment elevation MI (STEMI) • Approximately 1 million of hospital admissions are classified as UA/NSTEMI, and approximately 500,000 are STEMI. Smith SC Jr, Feldman TE, Hirshfeld JW, et al. J Am Coll Cardiol 2006;47:1-121. PMID 16386656. Silber S, Albertsson P, Aviles FF, et al. Eur Heart J 2005;26:804-47. PMID: 15769784.

  6. Background: Percutaneous Coronary Intervention • Percutaneous coronary intervention (PCI) has revolutionized the management of angina and MI. • Often, coronary bypass surgery is not needed as a result. • PCI permits a more rapid return to normal activities. • In the United States, 664,000 procedures were performed in 652,000 patients in 2003. • Coronary stents and adjunctive pharmacologic agents have improved the effect of PCI. Silber S, Albertsson P, Aviles FF, et al. Eur Heart J 2005;26:804-47. PMID: 15769784.

  7. Background: The “No-Reflow Phenomenon” After PCI • Dislodgement of atherothrombotic material from coronary lesions during PCI can result in distal embolization that leads to what is commonly referred to as the “no-reflow phenomenon.” • Characterized by inadequate flow at the cardiac tissue level despite patent coronary vessels is often defined as: • A thrombolysis in MI (TIMI) flow grade ≤2 despite vessel patency and the absence of dissection, spasm, or distal macroembolus • An MBG of 0 or 1 • Or a contrast perfusion defect observed upon myocardial contrast echocardiography • Patients with no-reflow experience a higher rate of adverse outcomes including: • Larger infarcts • More significant left ventricular systolic dysfunction • Increased risk of MACEs • Death Mehta RH, Harhai KJ, Cox D, et al. J Am Coll Cardiol 2003;42:1739. PMID: 14642681; Silber S, Albertsson P, Aviles FF, et al. Eur Heart J 2005;26:804-47. PMID: 15769784; Smith SC Jr, Feldman TE, Hirshfeld JW, et al. J Am Coll Cardiol 2006;47:e1-121. PMID: 16386656.

  8. Thrombolysis in Myocardial Infarction Flow Grading System Defined Chesebro JH, Knatterud G, Roberts R, et al. Circulation1987;76:142-54. PMID: 3109764.

  9. Myocardial Blush Grades Defined van 't Hof AW, Liem A, Suryapranata H, et al. Circulation 1998;97:2302-6. PMID: 9639373.

  10. Adjunctive Devices That Remove Thrombi and Protect Against Distal Embolization During PCI • Adjunctive devices have been developed in an attempt to improve clinical outcomes by removing thrombi and to protect against distal embolization during PCI. • Classes of devices include: • Catheter aspiration thrombectomy devices • Mechanical thrombectomy devices • Embolic protection devices Chevalier B, et al. EuroIntervention 2008;4:222-8. PMID: 19110787; Ciszewski M, et al. Circulation 2008;118:S764. PMID: 21234920; Dudek D, De Feyter PJ. Polish-Italian-Hungarian Randomized Thrombectomy Trial (PHIRATE trial). Available at www.escardio.org/CONGRESSES/ESC2008/CONGRESS-REPORTS/Pages/779-980-dudek-defeyter.aspx; Haeck JD, et al. JACC Cardiovasc Interv 2009;2:934-43. PMID: 19850252; Ikari Y, et al. JACC Cardiovasc Interv 2008;1:424-31. PMID: 19463340; Liistro F, et al. 2009;2:376-83. PMID: 20031746; Lipiecki J, et al. Am Heart J 2009;157:583.e1-7. PMID: 19249433; Mamas MA, et al. EuroIntervention 2008;4:115-23. PMID: 19112733; Migliorini A, et al. J Am Coll Cardiol 2010;56:1298-306. PMID: 20691553; Sardella G, et al. J Am Coll Cardiol 2009;53:309-15. PMID: 19161878; Silber S, et al. Eur Heart J 2005;26:804-47. PMID: 15769784; Smith SC Jr, et al. J Am Coll Cardiol 2006;47:e1-121. PMID: 16386656; Tahk SJ, et al. Int J Cardiol 2008;123:162-8. PMID: 17490759; U.S. Food and Drug Administration. Medical Devices. Available at www.fda.gov/MedicalDevices/default.htm.

  11. Explanation of Thrombectomy DevicesIncluded in the CER Catheter Aspiration Thrombectomy Mechanical Thrombectomy

  12. Explanation of Proximal Balloon Embolic Protection Devices Included in the CER • Occlusion balloon is advanced over a guidewire proximal to the thrombus • Angioplasty or stenting procedures take place • Thrombotic debris is trapped by the balloon and aspirated

  13. Explanation of Distal Balloon Embolic Protection Devices Included in the CER • Occlusion balloon is advanced over a guidewire distal to the thrombus • Angioplasty or stenting procedures take place • Thrombotic debris is trapped by the balloon and aspirated

  14. Explanation of Distal Filter Embolic Protection Devices Included in the CER • Filter is advanced over a guidewire distal to the thrombus • Angioplasty or stenting procedures take place • Thrombotic debris is aspirated or trapped by the filter and removed

  15. Current Practice for Patients Undergoing PCI • Distal embolic protection devices are recommended for use in patients undergoing PCI of saphenous vein grafts due to previously demonstrated ability to reduce MACE. • However, use of embolic protection devices in STEMI has been less well supported, mainly because of underpowered clinical trials that evaluated intermediate markers. • Larger randomized controlled trials (RCTs) of patients with STEMI have evaluated MACE as an end point and followed patients beyond hospital discharge (typically 3 to 12 months) but have given conflicting results. • The comparative effectiveness and the risk differences between these devices in patients with ACS undergoing PCI for native coronary arteries are not well established and need to be systematically evaluated. Antoniucci D, et al. Am J Cardiol 2004;93:1033-5. PMID: 15081450; Chevalier B, et al. EuroIntervention 2008;4:222-8. PMID: 19110787; Ciszewski M, et al. Circulation 2008;4:222-8. PMID: 21234920; Gartlehner G, et al. J Clin Epidemiol 2006;59:1040-8. PMID: 16980143; Lefevre T, et al. J Am Coll Cardiol 2005;46:246-52. PMID: 16022950; Liistro F, et al. 2009;2:376-83. PMID: 20031746; Lipiecki J, et al. Am Heart J 2009;157:583.e1-7. PMID: 19249433; Mamas MA, et al. EuroIntervention 2008;4:115-23. PMID: 19112733; Migliorini A, et al. J Am Coll Cardiol 2010;56:1298-306. PMID: 20691553; Napodano M, et al. J Am Coll Cardiol 2003;42:1395-402. PMID: 14563581; Sardella G, et al. J Am Coll Cardiol 2009;53:309-15. PMID: 19161878; Smith SC Jr, et al. J Am Coll Cardiol 2006;47:e1-121. PMID: 16386656.

  16. CER on Adjunctive Devices for Patients With ACS Undergoing PCI of Native Vessels • A systematic review of 175 clinical studies published between January 1996 and March 2011 sought to determine the effectiveness, benefits, and adverse effects of adjunctive devices to remove thrombi or protect against embolization in patients with ACSs undergoing PCI of native vessels when compared with PCI alone. • This CME activity is provided to assist in decisionmaking and should not be construed to represent clinical recommendations or guidelines. The full report is available at www.effectivehealthcare.ahrq.gov/thrombusacs.cfm. Sobieraj DM, White CM, Kluger J, et al. Comparative Effectiveness Review No. 42. Available at www.effectivehealthcare.ahrq.gov/thrombusacs.cfm.

  17. CER Outcomes of Interest for Studies on Adjunctive Devices for Patients With ACS Undergoing PCI on Native Vessels • Final health outcomes • Mortality • MI • Stroke • Target revascularization • MACE(including reinfarction, target revascularization, and stroke) • Health-related quality of life • Intermediate health outcomes • ST-segment resolution • MBG-3 • Thrombolysis in myocardial infarction 3 flow (TIMI-3) • Ejection fraction • Distal embolization • Safety • Coronary dissection • Coronary perforation • Prolonged procedure time Sobieraj DM, White CM, Kluger J, et al. Comparative Effectiveness Review No. 42. Available at www.effectivehealthcare.ahrq.gov/thrombusacs.cfm.

  18. Breakdown of Unique Trials Included in the CER • Quantitative analysis (meta-analysis; n = 43) • STEMI (n = 37) • Catheter aspiration (n = 17) • Mechanical thrombectomy (n = 5) • Distal filter embolic protection (n = 5) • Distal balloon embolic protection (n = 9) • Proximal balloon embolic protection (n = 1) • Mixed ACS (n = 6) • Catheter aspiration (n = 2) • Distal balloon embolic protection (n = 3) • Distal filter embolic protection (n = 1) • Qualitative analysis (not in meta-analysis; n = 38) • Mixed ACS (n = 3) • NSTEMI/UA (n = 2) • STEMI (n = 5) • Observational study (n = 9) • Systematic reviews and meta-analyses (n = 18) • Pooled analysis (n = 1) Sobieraj DM, White CM, Kluger J, et al. Comparative Effectiveness Review No. 42. Available at www.effectivehealthcare.ahrq.gov/thrombusacs.cfm.

  19. Comparative Effectiveness of Adjunctive Catheter Aspiration Thrombectomy Devices Versus PCI Alone in Patients With ACS Catheter Aspiration Devices in Patients With STEMI and Catheter Aspiration Devices in Other ACS Populations Sobieraj DM, White CM, Kluger J, et al. Comparative Effectiveness Review No. 42. Available at www.effectivehealthcare.ahrq.gov/thrombusacs.cfm.

  20. Adjunctive Catheter Aspiration Thrombectomy: Devices Included in the CER Sobieraj DM, White CM, Kluger J, et al. Comparative Effectiveness Review No. 42. Available at www.effectivehealthcare.ahrq.gov/thrombusacs.cfm.

  21. Adjunctive Catheter Aspiration Thrombectomy Versus PCI Alone in Patients With STEMI: Final Health Outcomes a Data amenable to meta-analysis were pooled as relative risks (RRs) with accompanying 95 percent confidence intervals (95% CIs) using a random-effects model. MACE = major adverse cardiovascular events; NNT = number needed to treat Sobieraj DM, White CM, Kluger J, et al. Comparative Effectiveness Review No. 42. Available at www.effectivehealthcare.ahrq.gov/thrombusacs.cfm.

  22. Adjunctive Catheter Aspiration Thrombectomy Versus PCI Alone in Patients With STEMI: Intermediate Health Outcomes a Data amenable to meta-analysis were pooled as relative risks (RRs) with accompanying 95 percent confidence intervals (95% CIs) by using a random-effects model. MBG-3 = myocardial blush grade 3; NNT = number needed to treat; TIMI-3 = thrombolysis in myocardial infarction grade 3 Sobieraj DM, White CM, Kluger J, et al. Comparative Effectiveness Review No. 42. Available at www.effectivehealthcare.ahrq.gov/thrombusacs.cfm.

  23. Adjunctive Catheter Aspiration Thrombectomy Versus PCI Alone in Patients With STEMI: Adverse Events a Data amenable to meta-analysis were pooled as relative risks (RRs) with accompanying 95 percent confidence intervals (95% CIs) by using a random-effects model. NNH = number needed to harm Sobieraj DM, White CM, Kluger J, et al. Comparative Effectiveness Review No. 42. Available at www.effectivehealthcare.ahrq.gov/thrombusacs.cfm.

  24. Adjunctive Catheter Aspiration Thrombectomy Versus PCI Alone in Patients With Mixed ACS: All Outcomes a Data amenable to meta-analysis were pooled as relative risks (RRs) with accompanying 95 percent confidence intervals (95% CIs) by using a random-effects model. MBG-3 = myocardial blush grade 3; NNT = number needed to treat • Mixed ACS patients consisted of STEMI, NSTEMI, or UA patients. • There was insufficient evidence on catheter aspiration devices with respect to all final health outcomes and additional intermediate outcomes. • There were no available studies that evaluated adverse events for this device in this population. Sobieraj DM, White CM, Kluger J, et al. Comparative Effectiveness Review No. 42. Available at www.effectivehealthcare.ahrq.gov/thrombusacs.cfm.

  25. Comparative Effectiveness of Adjunctive Mechanical Thrombectomy Devices Versus PCI Alone in Patients With ACS Mechanical Thrombectomy Devices in Patients With STEMI and Mechanical Thrombectomy Devices in Other ACS Populations Sobieraj DM, White CM, Kluger J, et al. Comparative Effectiveness Review No. 42. Available at www.effectivehealthcare.ahrq.gov/thrombusacs.cfm.

  26. Adjunctive Mechanical Thrombectomy Devices Included in the CER Sobieraj DM, White CM, Kluger J, et al. Comparative Effectiveness Review No. 42. Available at www.effectivehealthcare.ahrq.gov/thrombusacs.cfm.

  27. Adjunctive Mechanical Thrombectomy Devices Versus PCI Alone in Patients With STEMI: All Health Outcomes and Adverse Events a Data amenable to meta-analysis were pooled as relative risks (RRs) with accompanying 95 percent confidence intervals (95% CI) by using a random-effects model. MBG-3 = myocardial blush grade 3; TIMI-3 = thrombolysis in myocardial infarction grade 3 Sobieraj DM, White CM, Kluger J, et al. Comparative Effectiveness Review No. 42. Available at www.effectivehealthcare.ahrq.gov/thrombusacs.cfm.

  28. Adjunctive Mechanical Thrombectomy Devices Versus PCI Alone in Patients With Mixed ACS: All Outcomes and Adverse Events a Data amenable to meta-analysis were pooled as relative risks (RRs) with accompanying 95 percent confidence intervals (95% CIs) by using a random-effects model. NNT = number needed to treat • There was insufficient evidence supporting mechanical thrombectomy devices with respect to all final health outcomes and additional intermediate outcomes in this population. • There were no available studies that evaluated adverse events for this device in this population. Sobieraj DM, White CM, Kluger J, et al. Comparative Effectiveness Review No. 42. Available at www.effectivehealthcare.ahrq.gov/thrombusacs.cfm.

  29. Comparative Effectiveness of Adjunctive Embolic Protection Devices Versus PCI Alone in Patients With ACS Distal Filter Embolic Protection Devices, Distal Balloon Embolic Protection Devices, and Proximal Balloon Embolic Protection Devices in Patients With ACS Sobieraj DM, White CM, Kluger J, et al. Comparative Effectiveness Review No. 42. Available at www.effectivehealthcare.ahrq.gov/thrombusacs.cfm.

  30. Adjunctive Distal Filter Embolic Protection Devices Included in the CER Sobieraj DM, White CM, Kluger J, et al. Comparative Effectiveness Review No. 42. Available at www.effectivehealthcare.ahrq.gov/thrombusacs.cfm.

  31. Adjunctive Distal Filter Embolic Protection Devices Versus PCI Alone in Patients With STEMI: All Outcomes • There were limited or no data for the use of adjunctive distal filter embolic protection devices for all other outcomes and adverse events for patients with STEMI and for other ACS populations. a Data amenable to meta-analysis were pooled as relative risks (RRs) with accompanying 95 percent confidence intervals (95% CIs) by using a random-effects model. MBG-3 = myocardial blush grade 3; NNH = number needed to harm; TIMI-3 = thrombolysis in myocardial infarction grade 3 Sobieraj DM, White CM, Kluger J, et al. Comparative Effectiveness Review No. 42. Available at www.effectivehealthcare.ahrq.gov/thrombusacs.cfm.

  32. Adjunctive Distal Balloon Embolic Protection Devices Included in the CER Sobieraj DM, White CM, Kluger J, et al. Comparative Effectiveness Review No. 42. Available at www.effectivehealthcare.ahrq.gov/thrombusacs.cfm.

  33. Adjunctive Distal Balloon Embolic Protection Devices Versus PCI Alone in Patients With STEMI: Final and Intermediate Health Outcomes a Data amenable to meta-analysis were pooled as relative risks (RRs) with accompanying 95 percent confidence intervals (95% CIs) by using a random-effects model. MBG-3 myocardial blush grade 3; NNT = number needed to treat; TIMI-3 = thrombolysis in myocardial infarction grade 3 • There were limited or no data for the use of adjunctive distal balloon embolic protection devices for all final health outcomes and other intermediate outcomes in this population. Sobieraj DM, White CM, Kluger J, et al. Comparative Effectiveness Review No. 42. Available at www.effectivehealthcare.ahrq.gov/thrombusacs.cfm.

  34. Adjunctive Distal Balloon Embolic Protection Devices Versus PCI Alone in Patients With STEMI: Adverse Events a Data amenable to meta-analysis were pooled as relative risks (RRs) with accompanying 95 percent confidence intervals (95% CIs) by using a random-effects model. Sobieraj DM, White CM, Kluger J, et al. Comparative Effectiveness Review No. 42. Available at www.effectivehealthcare.ahrq.gov/thrombusacs.cfm.

  35. Adjunctive Distal Balloon Embolic Protection Devices Versus PCI Alone in Patients With Mixed ACS: All Outcomes and Adverse Events a Data amenable to meta-analysis were pooled as relative risks (RRs) with accompanying 95 percent confidence intervals (95% CIs) by using a random-effects model. MBG-3 = myocardial blush grade 3; NNT = number needed to treat • There were limited or no data for the use of adjunctive distal balloon embolic protection devices for all other outcomes and adverse events in patients with mixed ACS. Sobieraj DM, White CM, Kluger J, et al. Comparative Effectiveness Review No. 42. Available at www.effectivehealthcare.ahrq.gov/thrombusacs.cfm.

  36. Adjunctive Proximal Balloon Embolic Protection Devices Included in the CER Sobieraj DM, White CM, Kluger J, et al. Comparative Effectiveness Review No. 42. Available at www.effectivehealthcare.ahrq.gov/thrombusacs.cfm.

  37. Adjunctive Proximal Balloon Embolic Protection Devices Versus PCI Alone in Patients With STEMI: All Outcomes and Adverse Events a Data amenable to meta-analysis were pooled as relative risks (RRs) with accompanying 95 percent confidence intervals (95% CIs) by using a random-effects model. • There were limited or no data for the use of adjunctive proximal balloon embolic protection devices for all other outcomes and adverse events in patients with STEMI or in other ACS populations. Sobieraj DM, White CM, Kluger J, et al. Comparative Effectiveness Review No. 42. Available at www.effectivehealthcare.ahrq.gov/thrombusacs.cfm.

  38. Overall Conclusions • In patients with STEMI undergoing primary PCI: • Catheter aspiration thrombectomy reduces the occurrence of major adverse cardiovascular events, distal embolization, and no reflow. • Catheter aspiration thrombectomy improves ST-segment elevation resolution and coronary flow. • Evidence does not support benefits from mechanical thrombectomy or embolic protection devices, which appear to prolong procedure time. • Current evidence is too limited to permit conclusions about the comparative benefits and harms of these devices with respect to final health outcomes and adverse events. Sobieraj DM, White CM, Kluger J, et al. Comparative Effectiveness Review No. 42. Available at www.effectivehealthcare.ahrq.gov/thrombusacs.cfm.

  39. Gaps in Knowledge • Direct comparative RCTs are needed that compare one thrombectomy or embolic protection device with another and evaluate final health outcomes. • Studies examining final health outcomes and using longer followup data are needed to fully determine the impact of adjunctive thrombectomy and embolic protection devices in patients with ACS who are undergoing PCI. Sobieraj DM, White CM, Kluger J, et al. Comparative Effectiveness Review No. 42. Available at www.effectivehealthcare.ahrq.gov/thrombusacs.cfm.

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