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Results of CRYSTAL AMI: A Pilot Trial Before INFUSE AMI, the Concept and Evolution in Thrombus Management . Saihari Sadanandan, MD, FACC, FASE, Dip. CBNC, FSCAI Associate Professor of Clinical Medicine Director, Vascular Interventions Division of Cardiology

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slide1

Results of CRYSTAL AMI: A Pilot Trial Before INFUSE AMI, the Concept and Evolution in Thrombus Management

Saihari Sadanandan, MD, FACC, FASE, Dip. CBNC, FSCAIAssociate Professor of Clinical MedicineDirector, Vascular InterventionsDivision of Cardiology

IU- HealthIndiana UniversityIndianapolis

slide2

Disclosure - I

Speaker Bureau – Sanofi Aventis

Bristol Myers Squibb

Daichi Sankyo/Lilly

Educational Grant from Atrium Medical

towards IRB fees to collect data on the case

Studies

CRYSTAL – AMI slide courtesy – R. Dave, MD

slide6

5 year outcomes of No-reflow during Primary PCI for STEMI

  • N = 1406
  • Pts with STEMI undergoing PCI
  • No reflow defined as TIMI <3 flow or
  • TMPG 0-1 after successful PCI
  • Occurred in 30% of pts
  • 7-14 day infarct size 15% vs. 8% p<0.001
  • 5-year mortality 18.2% vs. 9.5%, p < 0.001

Ndrepepa G, et al.. J Am Coll Cardiol. 2010;55:2383-2389.

slide7

Distal embolization and small distal

vessel cutoff is neither infrequent nor

benign!!!!

  • Occurs in about 15% of patients undergoing PCI for STEMI
  • Associated with larger infarct size, lower LVEF and
  • increased long term Mortality

(Eur H J 2002:23-1112-17

slide8

Distal embolization during Primary PCI for STEMI

(Eur H J 2002:23-1112-17)

(Eur H J 2002:23-1112-17

timi myocardial perfusion tmp grades
TIMI Myocardial Perfusion (TMP) Grades

TMP Grade 3

TMP Grade 2

TMP Grade 1

TMP Grade 0

Normal ground-glass

appearance of blush.

Dye mildly persistent

at end of washout.

No or minimal blush.

Dye strongly persistent

at end of washout.

Gone by next injection.

Stain present.

Blush persists

on next injection.

6.2%

5.1%

4.4%

P=0.05

Mortality (%)

2.0%

n=434

n=79

n=46

n=203

Adapted from Gibson CM, et al. Circulation. 2000;101:125-130.

slide11

Final Blush Score (patients with final TIMI 3 flow)

100

95

3

90

Cumulative Survival(%)

2

85

Blush 1-Year Mortality

0/1

3

6.8%

80

P=0.004

2

13.2%

0/1

18.3%

75

0

2

4

6

8

10

12

Myocardial Perfusion After Primary PCI is the Strongest Predictor of Mortality independently from IRA reopening

meta analysis of various devices mortality
Meta-Analysis of Various Devices—Mortality

P = 0.050

P = 0.018

P = 0.69

Mortality, %

Catheter thrombus aspiration

Embolic

protection

Mechanical thrombectomy

Bavry AA, Kumbhani D, Bhatt DL. Eur Heart J. 2008;29:2989-3001.

tapas one year outcome myocardial blush grade and death
TAPAS one year outcome: Myocardial blush grade and death

Death/reinfarction P= 0.001

Myocardial blush grade

Svilaas T et al. NEJM 2008;358-557 - FZ 2008-9

FZ 2008-12

slide16

MORTALITY

7.4%

8%

6%

5.0%

4.8%

4%

3.3%

2%

Thrombectomy±IIb/IIIa inhibitors

P=0.02

IIb/IIIa inhib -

Thrombectomy -

IIb/IIIa inhib +

Thrombectomy -

IIb/IIIa inhib –

Thrombectomy +

IIb/IIIa inhib +

Thrombectomy +

summary of current limitations in stemi pci
Summary of Current Limitations in STEMI PCI
  • No optimal method of thrombus management
  • Once embolization occurs in primary PCI , it is a challenging scenario
  • Higher MACE, Infarct size with poor MBG
  • Aspiration catheters are good, but not uniformly effective.
  • There may be a synergistic effect between thrombectomy and GP-IIBIIIA receptor inhibitors
slide18

How can we improve on this further iN STEMI PCI?Combine the Mechanical approach with Pharmacology -(Intracoronary drug)MINIMIZE BLEEDING & Maximize dethrombosis

slide19

Meta Analysis of IC Versus IV Abciximab administration of peer reviewed studies (N=2,301) 997 STEMI, 1304 NSTEMI

Hansen et al. Journal of Invasive Cardiology Vol 22; 6. June 2010. 278-282.

slide21

Localized Drug Delivery via ClearWayfor Pharmacological Thrombectomy and Prevention of Distal Embolization

slide22

During inflation, drug is being infused through the microporous balloon pores while blood flow is occluded, maximizing drug availability without substantial dilution by the systemic circulation.

Containment of the treatment zone provides extended residence time to help local drug bioavailability, concentration and dose

Occlusion

Containment

Controlled infusion at 1-4 ATM throughout the entire length of the targeted treatment zone provides increased residence time and uptake

Infusion

slide23

IC vs. Clearway Abciximab: The Coctail Study

Tamburino, Capodanno, et al. J Cardiovasc Med 2009

slide24

Pre ReoPro through ClearWay

Post ReoPro through Clearway

slide25

Coctail study: Change in Thrombus score

P=0.002

N= 20

N =21

Tamburino, Capodanno, et al. J Cardiovasc Med 2009

slide26

Coctail study: Final TIMI MBG

P=0.24

N 21

N 20

Tamburino, Capodanno, et al. J Cardiovasc Med 2009

crystal ami study design single center prospectively randomized
CRYSTAL AMI: Study DesignSingle center, prospectively randomized

STEMI within 6 hours, Heparin, 600mg Clopidogrel (n=50)

R

1:1

IV Abciximab

ClearWay™ IC Abciximab

PCI as per standard of care, Evaluate

MBG, TIMI flow, ST Resolution, LV Function at Discharge

30 day follow up, Echo, Resting Sestamibi

timi flow comparison n 48
TIMI Flow Comparison (N=48)

96%

TIMI Flow

(n = 25)

(n = 23)

primary endpoint timi myocardial blush grade mbg 2 n 48
Primary Endpoint: TIMI Myocardial Blush Grade (MBG) >2 (N=48)

92% of IC versus 86% of IV patients

MBG

(n = 25)

(n = 23)

mbg 3 and st resolution rates comparison
In Tapas, MBG 3 was only achieved in 45% of patients in extraction arm (identical to IV Abciximab group), but was directly linked to 5 times increase in mortality. IC Abciximab Administration through ClearWay™ has resulted in 72% of patients leaving the lab with a blush score of 3.MBG 3 and ST Resolution Rates comparison

80%

70%

72%

52%

(n = 25)

(n = 23)

conclusions
Conclusions
  • Our understanding of evaluation of surrogate markers which directly correlates to Mortality and Myocardial preservation has improved significantly
  • Improving myocardial preservation also has profound economic impacts: low cost of care, better QOL, less need for ICD
  • Localized superselective drug delivery (GP 2b3a inhibitors and vasodilators) with ClearWay as a stand alone device or when combined with Aspiration devices significantly improves MBG
  • Series of data already promising, INFUSE AMI is underway…