Is There a Role for Aspiration in STEMI? David A. Cox, MD FSCAI FACC Lehigh Valley Health Network Director, Cardiovascular Research Institute Associate Director of Cardiac Catheterization Laboratory Allentown, PA CRT 2017

Disclosures Advisory Board: Abbott Vascular Medtronic,Inc. Boston Scientific Speaker: Medicure

Thanks to all of you…

Happy CardioVascular Professionals Week!

Now what?

Mechanical Aspiration

Mechanical Aspiration

Manual Aspiration

Gotta Help to Remove!

You know….Removing Clot Decrease DISTAL EMBOLI Lessen NO-REFLOW Decrease STENT THROMBOSIS

But….

Lots of papers in this area

Not all clinical trials are correct

AngioJet Rheolytic Thrombectomy 18

“Don’t bring a knife to a gunfight”

Sully: US Air Flt 1549

Angiojet: First Class Rx

Thrombectomy 2011 I IIa IIb III Aspiration thrombectomy is reasonable for patients undergoing primary PCI. B 22

Why Angiojet Rarely Used? Set up more complex Heart Block, hypotension Deaths in AiMI often related to procedural complications Manual Aspiration…must be better

Aspiration Thrombectomy 2013 IIa IIb III B Manual aspiration thrombectomy is reasonable for patients undergoing primary PCI.

Manual Thrombectomy

Tale of 3 Trials TAPAS TASTE TOTAL

TAPAS: 1,071 pts with STEMI undergoing PCI randomized in the ER to aspiration (Export) vs. control Myocardial Blush (1 EP) ST-segment Resolution P<0.001 P<0.001 Thrombus aspiration Conventional PCI Thrombus aspiration Conventional PCI Svilaas T et al. NEJM 2008;358;-557-67

TAPAS: 1,071 pts with STEMI undergoing primary PCI randomized in the ER to manual aspiration (Export) vs. control 30 days 4.0% vs. 2.1% P=0.07 Time (days) Mortality (%) Conventional PCI Thrombus-Aspiration 100 200 300 400 2 4 6 8 10 12 1 year 7.6% vs. 4.0% P=0.04 Vlaar et al. Lancet 2008;371:1915-20

Ole Fröbert, MD, PhD - on behalf of the TASTE investigators UCR Uppsala Clinical Research Center Thrombus Aspiration in ST- Elevation myocardial infarction in Scandinavia (TASTE trial): Results and Methodology of a Registry based Randomized Clinical Trial (RRCT) Ole Fröbert, MD, PhD - on behalf of the TASTE investigators Departement of Cardiology Örebro University Hospital Sweden

TASTE and previous studies

All-cause mortality at 30 days HR 0.94 (0.72 - 1.22), P=0.63 Per protocol analysis based on actual treatment: HR 0.88 (0.66 - 1.17), P=0.38 Fröbert, O. et al. N Engl J Med 2013; 369:1587-97

TASTE vs. TAPAS

TASTE 12 mo: NO BENEFIT

TOTAL Recruitment from 87 sites in 20 countries Europe 5617 North America 3863 Asia Pacific 865 South America 387 10,732 patients randomized between August 2010 and July 2014

Primary Outcome (CV death, MI, Shock or CHF) at 1 year

Primary Outcome (CV death, MI, Shock or CHF) at 1 year

Primary Outcome at 1 year Thrombectomy (N=5033) (%) PCI alone (N=5030) (%) HR 95% CI p CV death, MI, shock or class IV heart failure 395 (7.8) 394 (7.8) 1.00 (0.87 – 1.15) 0.99 CV death 179 (3.6) 192 (3.8) 0.93 (0.76 – 1.14) 0.48 Recurrent MI 125 (2.5) 118 (2.3) 1.05 (0.82 -1.36) 0.68 Cardiogenic Shock 95 (1.9) 105 (2.1) 0.90 (0.68 – 1.19) 0.47 Class IV heart failure 106 (2.1) 96 (1.9) 1.01 (0.83 – 1.45) 0.50

Safety Outcomes at 1 year   Thrombectomy (N=5033) (%) PCI alone (N=5030) (%) HR 95% CI p Stroke at 1 year 60 (1.2) 36 (0.7) 1.66 (1.10 – 2.51) 0.015 Stroke or TIA at 1 year 73 (1.4) 44 (0.9) 1.6 5 (1.14 – 2.40) 0.008 Landmark Analyses Stroke 180 days to 1 year 7 (0.1) 10 (0.2) 0.7 0 (0.27 – 1.83) 0.46

Site Primary PCI Volume: Tertile 1 2450 8.1 8.4 Tertile 2 2139 8.4 7.8 Thrombectomy (%) PCI Alone (%) P (INTERACTION) OVERALL 10064 7.8 7.8 TIMI Thrombus Grade: ≥3 8983 8.0 8.2 <3 1073 6.0 4.9 0.407 TIMI Thrombus Grade: ≥4 7919 8.4 8.5 <4 2137 5.8 5.5 0.759 Symptom Onset: <6 hrs 8416 7.6 7.4 6-12 hrs 1645 9.3 10.2 0.480 Initial TIMI Flow: 0-1 7453 8.3 8.6 2-3 2517 6.8 5.7 0.195 Site Primary PCI Volume: Tertile 1 2450 8.1 8.4 Tertile 2 2139 8.4 7.8 Tertile 3 5475 7.5 7.6 0.823 MI Type: Anterior 4017 9.7 10.1 Non-Anterior 6039 6.7 6.3 0.509 Age: ≤65 yrs 6662 5.5 5.1 >65 yrs 3401 12.6 13.1 0.375 Favours Thrombectomy Favours PCI Alone 0.5 1.0 2.0

2015 ACC/AHA/SCAI Focused Update on Primary PCI for Patients with STEMI: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention and the 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction Developed in Collaboration with the American College of Emergency Physicians © American College of Cardiology Foundation, American Heart Association, and Society for Cardiovascular Angiography and Interventions

Aspiration Thrombectomy COR LOE Recommendations IIb C-LD The usefulness of selective and bailout aspiration thrombectomy in patients undergoing primary PCI is not well established.1 III: No Benefit A Routine aspiration thrombectomy before primary PCI is not useful.2 1. Modified recommendation from 2013 guideline (Class changed from IIa to IIb for selective and bailout aspiration thrombectomy before PCI) 2. New recommendation

Routine Aspiration in ALL STEMI’s

Don’t believe everything you hear….

Use what works for you! Selective Thrombectomy