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

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

Outline of This CME Activity

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.

Agency for Healthcare Research and Quality (AHRQ) Comparative Effectiveness Review Development

Sobieraj DM, White CM, Kluger J, et al. Comparative Effectiveness Review No. 42. Available at www.effectivehealthcare.ahrq.gov/thrombusacs.cfm.

The strength of evidence was classified into four broad categories:

Rating the Strength of Evidence From the CER


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.

Background: Coronary Heart Disease

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.

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.

Background: Percutaneous Coronary Intervention

Silber S, Albertsson P, Aviles FF, et al. Eur Heart J 2005;26:804-47. PMID: 15769784.

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

Background: The “No-Reflow Phenomenon” After PCI

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.

Thrombolysis in Myocardial Infarction Flow Grading System Defined

Thrombolysis in Myocardial Infarction Flow Grading System

Grade 0

Complete occlusion of the infarct-related artery

Grade 1

Some penetration of contrast material beyond the point of obstruction but without perfusion of the distal coronary bed

Grade 2

Perfusion of the entire infarct vessel into the distal bed but with delayed flow when compared with a normal artery

Grade 3

Full perfusion of the infarct vessel with normal flow

Chesebro JH, Knatterud G, Roberts R, et al. Circulation 1987;76:142-54. PMID: 3109764.

Myocardial Blush Grades Defined

Myocardial Blush GradesGrade 0(MBG-0)

Failure of dye to enter the microvasculature. Either minimal or no ground glass appearance (“blush”) or opacification of the myocardium in the distribution of the culprit artery indicating lack of tissue-level perfusion.

Grade 1(MBG-1)

Dye slowly enters but fails to exit the microvasculature. There is the ground glass appearance (“blush”) or opacification of the myocardium in the distribution of the culprit lesion that fails to clear from the microvasculature, and dye staining is present on the next injection (approximately 30 seconds between injections).

Grade 2(MBG-2)

Delayed entry and exit of dye from the microvasculature. There is the ground glass appearance (“blush”) or opacification of the myocardium in the distribution of the culprit lesion that is strongly persistent at the end of the washout phase (i.e., dye is strongly persistent after three cardiac cycles of the washout phase and either does not or only minimally diminishes in intensity during washout).

Grade 3(MBG-3)

Normal entry and exit of dye from the microvasculature. There is the ground glass appearance (“blush”) or opacification of the myocardium in the distribution of the culprit lesion that clears normally and is either gone or only mildly/moderately persistent at the end of the washout phase (i.e., dye is gone or is mildly/moderately persistent after three cardiac cycles of the washout phase and noticeably diminishes in intensity during the washout phase), similar to that in an uninvolved artery. Blush that is of only mild intensity throughout the washout phase but fades minimally is also classified as grade 3.

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

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

Adjunctive Devices That Remove Thrombi and Protect Against Distal Embolization During PCI

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.

Explanation of Thrombectomy DevicesIncluded in the CER

Catheter Aspiration Thrombectomy

Mechanical Thrombectomy

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

Explanation of Proximal Balloon Embolic Protection Devices Included in the CER

Occlusion balloon is advanced over a guidewire distal to the thrombus


Thrombotic debris is trapped by the balloon and aspirated

Explanation of Distal Balloon Embolic Protection Devices Included in the CER

Filter is advanced over a guidewire distal to the thrombus


Thrombotic debris is aspirated or trapped by the filter and removed

Explanation of Distal Filter Embolic Protection Devices Included in the CER

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.

Current Practice for Patients Undergoing PCI

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.

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.

CER on Adjunctive Devices for Patients With ACS Undergoing PCI of 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

CER Outcomes of Interest for Studies on Adjunctive Devices for Patients With ACS Undergoing PCI on Native Vessels


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)


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.

Adjunctive Catheter Aspiration Thrombectomy: Devices Included in the CER

Device Name Manufacturer

FDA-Approved Indication(s)

DiverTM Invatec No longer available for sale in United States

DiverTM CE Invatec No longer available for sale in United States

Export® Medtronic Removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial system, and to subselectively infuse/deliver diagnostic or therapeutic agents with or without vessel occlusion

ProntoTM VascularSolutions

Removal of emboli and thrombi from vessels in the arterial or deep venous system and to infuse diagnostic or therapeutic agents

RescueTM Boston Scientific

No longer available for sale in United States

Thrombobuster® Kaneka Medix No FDA-approved indication

TransVascularAspirationCatheter® (TVAC)

Nipro No FDA-approved indication


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

Outcome No. of

Studies

Conclusion RR (95% CI)a Strength of Evidence

Mortality 10 No effect 0.69 (0.47 to 1.02)

Low

Myocardial infarction

10 No effect 0.61 (0.36 to 1.04)

Low

Target revascularization

9 No effect 0.79 (0.61 to 1.02)

Low

MACE 13 Decreased risk by 27%(NNT = 33)

0.73 (0.61 to 0.88)

High


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

Outcome No. of

Studies

Conclusion NNT

RR (95% CI) a Strength of Evidence

ST-segmentresolution

16 Increased by 51% 5 1.51 (1.32 to 1.73)

Moderate

Ejection fraction

12 No effect Moderate

Achieving MBG-3

13 Increased likelihood by 61%

5 1.61 (1.41 to 1.84)

Moderate

Achieving TIMI-3 blood flow


17 1.08 (1.04 to 1.12)

Moderate

Distal embolization

11 Decreased risk by 44% 12 0.56 (0.39 to 0.79)

High

No reflow 8 Decreased risk by 48% 15 0.52 (0.35 to 0.76)

High


Adjunctive Catheter Aspiration Thrombectomy Versus PCI Alone in Patients With STEMI: Adverse Events


NNH = number needed to harm

Outcome No. of

Studies

Conclusion RR (95% CI) a Strength of Evidence

Coronary dissection

5 Decreased risk by 70%; (NNT=50)

0.30 (0.12 to 0.75)

High

Procedure time

9 No effect High


Adjunctive Catheter Aspiration Thrombectomy Versus PCI Alone in Patients With Mixed ACS: All Outcomes

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.

Outcome No. of Studies

Conclusion RR (95% CI)

a

Strength of Evidence

Achievement of MBG-3

1 Increased likelihood by 4.45-fold (NNT=3)

4.45 (1.51 to 13.88)

Low


MBG-3 = myocardial blush grade 3; NNT = number needed to treat


Comparative Effectiveness of Adjunctive Mechanical

Thrombectomy Devices Versus PCI Alone in

Patients With ACSMechanical Thrombectomy Devices in Patients With

STEMI

and

Mechanical Thrombectomy Devices in Other ACS Populations


Adjunctive Mechanical Thrombectomy Devices Included in the CER

Device Name

Manufacturer


AngioJet® MEDRADInterventional/Possis

Removal of thrombus in the treatment of patients with symptomatic coronary artery or saphenous vein graft lesions in vessels ≥2 mm in diameter prior to balloon angioplasty or stent placement

X-Sizer® ev3 Removal of thrombus in synthetic hemodialysis access grafts


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



INTERMEDIATE HEALTH OUTCOMES


5 No effect 1.16 (0.99 to 1.36)

Low

Ejection fraction 2 No effect Moderate

Achieving MBG-3 4 No effect 1.07 (0.80 to 1.43)

Low


5 No effect 0.98 (0.92 to 1.04)

Moderate

Distal embolization

3 No effect 0.44 (0.17 to 1.12)

Moderate

No reflow 3 No effect 0.50 (0.17 to 1.48)

ADVERSE EVENTS

Prolonged procedure time

3 Increased average procedure time by 9–16 minutes

High


Adjunctive Mechanical Thrombectomy Devices Versus PCI Alone in Patients With Mixed ACS: All Outcomes and Adverse Events

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.

Outcome No. of

Studies



1 Increased likelihood by 58%(NNT = 3)

1.58 (1.05 to 2.57)

Moderatea 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


Comparative Effectiveness of Adjunctive Embolic Protection Devices Versus PCI Alone in

Patients With ACSDistal Filter Embolic Protection Devices,

Distal Balloon Embolic Protection Devices,

and

Proximal Balloon Embolic Protection Devices in Patients With ACS


Adjunctive Distal Filter Embolic Protection Devices Included in the CER

Device Name

Manufacturer


FilterWire EXTM Boston Scientific Use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/ debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures in coronary saphenous vein bypass grafts with reference vessel diameters of 3.5 to 5.5 mm

FilterWire EZTM Boston Scientific Use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/ debris) while performing angioplasty and stenting procedures in coronary saphenous vein bypass grafts and carotid arteries

SpideRXTM ev3 No longer available for sale in the United States

AngioGuardTM Cordis No longer available for sale in the United States

AngioGuardTM XP Cordis Use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/ debris) while performing angioplasty and stenting procedures in carotid arteries

Filtrap Nipro No FDA-approved indication


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.



FINAL HEALTH OUTCOMES

Target revascularization

2 Increased risk by 61%(NNH = 25)

1.61 (1.03 to 2.54) Low

MACE 5 No effect 1.34 (0.97 to 1.86) Moderate



5 No effect 1.05 (0.97 to 1.15) Moderate

Ejection fraction 2 No effect Low

Achieving MBG-3 2 No effect 0.97 (0.81 to 1.15) Moderate


5 No effect 1.00 (0.90 to 1.11) Lowa 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


Adjunctive Distal Balloon Embolic Protection Devices Included in the CER

Device Name

Manufacturer


PercuSurge GuardWire®

Medtronic Not/no longer available for sale in the United States

PercuSurgeGuardWireTM Plus

Medtronic Use to contain and aspirate embolic material (thrombus/ debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures


Adjunctive Distal Balloon Embolic Protection Devices Versus PCI Alone in Patients With STEMI: Final and Intermediate Health Outcomes


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.

Outcome No. of

Studies

Conclusion RR (95% CI) a Strength of

Evidence


4 No effect 1.08 (0.91 to 1.29)

Moderate

Ejection fraction 6 No effect Moderate

Achieving MBG-3 6 Increased likelihood by 39%; (NNT = 7)

1.39 (1.15 to 1.69)

High


8 Increased likelihood by 11%; (NNT = 13)

1.11 (1.03 to 1.19)

Low

Distal embolization 4 No effect Moderate


Adjunctive Distal Balloon Embolic Protection Devices Versus PCI Alone in Patients With STEMI: Adverse Events


Outcome No. of

Studies


Coronary perforation

1 No effect 5.11 (0.53 to infinity)

Low


3 Increased median procedure time by 14 minutes

Moderate

Side branch occlusion

2 No effect 0.93 (0.61 to 1.42)

Moderate


Adjunctive Distal Balloon Embolic Protection Devices Versus PCI Alone in Patients With Mixed ACS: All Outcomes and Adverse Events


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.


Conclusion NNT RR (95% CI) a Strength of

Evidence




3 1.58 (1.10 to 2.46)

Moderate

Achieving MBG-3

2 Increased likelihood by 3-fold

2 3.22 (1.03 to 10.10)

Moderate

No reflow 1 Decreased likelihood by 64%

2 0.36 (0.20 to 0.59)

High

ADVERSE EVENTS


1 Prolonged by a mean of 7 minutes

Moderate


Adjunctive Proximal Balloon Embolic Protection Devices Included in the CER

Device Name Manufacturer


ProxisTM St. Jude Medical

Use as a proximal embolic protection system to prevent distal release of and to aspirate embolic material (thrombus/debris) in saphenous vein coronary bypass graft(s) during percutaneous transluminal coronary angioplasty and/or stenting procedures and to control the flow of fluids in the coronary and peripheral vasculatureSobieraj DM, White CM, Kluger J, et al. Comparative Effectiveness Review No. 42.

Available at www.effectivehealthcare.ahrq.gov/thrombusacs.cfm.

Adjunctive Proximal Balloon Embolic Protection Devices Versus PCI Alone in Patients With STEMI: All Outcomes and Adverse Events


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.

Outcome No. of

Studies

Conclusion RR (95% CI) a

Strength of Evidence


1 Prolonged the median time by 14 minutes

Moderate


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.

Overall Conclusions


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.

Gaps in Knowledge


Date post:	02-Jan-2016
Category:	Documents
Upload:	preston-house
View:	41 times
Download:	2 times

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

Documents