Presentation: Presented with progressive dyspnea on exertion and cresendo angina CCS Class III,...

Presentation:

Presented with progressive dyspnea on exertion and cresendo

angina CCS Class III, presented on 10/14/2011 and cath

revealed mild pulm HTn, minimal AS, II V CAD (RCA and

calcified LAD/D1/D2 bifurcation) and LVEF 25%. Pt

underwent DES (Promus 3.0/15mm) PCI of RCA. Still

continues to have Class II angina and mild DOE

Prior History:

Hyperlipidemia, Hypertension, Diet controlled DM,

Medications: All once daily dosage

ASA 81mg, Carvedilol CR 10mg, Amlodipine 5mg, Simvastatin 40mg

Lisinopril 10mg, Spironolactone 25mg, added Clopidogrel 75mg

November 15th 2011 Case #15: BS, 72 yr F

Cardiac Cath 10/14/2011: Syntax score 21

2 Vessel CAD with LVEF 25%

Left Main: No obstruction

LAD: 80% proximal and 50% mid calcified bifurcation

lesions with 70% lesions in D1 and D2

LCx: mild diffuse disease

RCA: 95% prox lesion with large distal vessel

Subsequent Course:- Pt underwent DES (Promus 3/15mm) of RCA on 10/14/2011;

since then still continues to have exertional symptoms

Plan Today:

- PCI of LAD/D1/D2 calcified bifurcation lesion with Impella assist

Case# 15: cont…

Appropriateness Criteria for Coronary Revascularization

• Impella use in pts with aortic valve disease

Technical Pearls and Issues With the Case by Dr Kini

• Inability to fully dilate lesion or full stent expansion vessel due to calcification

• Bifurcation lesion intervention with a plan to

‘keep artery open’ (KAO of SBr) at end of PCI

Issues Involving The Case

• Hemodynamic support in high risk PCI

• On-treatment platelet reactivity (OTR) & outcomes

Percutaneous LV Assist Devices

IABPPTVA:

TandemHeartIMPELLA:

Recovers 2.5

IABP and infarct size in patients with acute anterior MI infarction without shock: CRISP AMI Randomized Trial

Inclusion Criteria• Anterior STEMI 2 mm in 2 contiguous leads or at least 4 mm in the anterior leads• Planned Primary PCI within 6 hr

Anterior STEMI

Without Shock

IABP prior to PCI Standard of Care Primary PCI alone

At least 12 hours of IABP post PCI Routine Post PCI care

Cardiac MRI performed day 3-5 post PCI

Primary Endpoint: Infarct Size on CMR1. All Patients with CMR data2. Patients with Prox LAD occlusion TIMI 0/1 flow

Clinical Events – 6 months

Randomize

Open Label

(n ~ 300 )

Patel et al. JAMA 2011;306:1329

All IABP+PCI PCI Alone P

(N=337) (N=161) (N=176) Value

Primary endpoint

Infarct size (% LV), modified ITT all patients with CMR data 0.060

N 275 133 142

Mean 39.8 42.1 37.5

Median 38.8 42.8 36.2

Infarct size (%LV), modified ITT patients prox. LAD and TIMI flow 0/1 0.110

N 192 93 99

Mean 44.4 46.7 42.3

Median 42.1 45.1 38.6



IABP+PCI

(N=161)

PCI Alone

(N=176)

P

Value

Death, % 1.9* 4.0* 0.26*

Stroke, % 1.9 0.6 0.35

Major bleed per GUSTO 1 definition or transfusion, % 3.1 1.7 0.49

Vascular complications, (n) % 7 (4.3) 2 (1.1) 0.09

Major limb ischemia requiring operative intervention (n) 0 0

Distal embolization (n) 0 0

Major dissection (n) 2 0

Pseudoaneurysm or AV fistula (n) 3 2

Hematoma > 5 cm (n) 3 0

30-day Clinical Events

* From KM curves and log-rank test.Patel et al. JAMA 2011;306:1329


1.9

6.3

55.2

10.9

12

0

5

10

15

(%)

Death Death/recurrent MI/ Death/Shock/

new or worsening CHF new or worsening CHF

IABP+PCI (N=161)

PCI Alone (N=176)

P = 0.12

P = 0.15

P = 0.03


IABP and infarct size in patients with acute anterior MI infarction without shock: CRISP AMI- 6 Month F/U

PROTECT II Trial Design

IMPELLA 2.5 +PCI

IABP + PCI

Primary Endpoint = 30-day Composite MAE* rate

1:1R

Patients Requiring Prophylactic Hemodynamic Support During Non-Emergent High Risk PCI on

Unprotected LM/Last Patent Conduit and LVEF≤35% OR3 Vessel Disease and LVEF≤30%

Follow-up of the Composite MAE* rate at 90 days *Major Adverse Events (MAE) : Death, MI (>3xULN CK-MB or Troponin) , Stroke/TIA, Repeat Revasc, Cardiac or Vascular Operation of Vasc. Operation for limb ischemia, Acute Renal Dysfunction, Increase in Aortic insufficiency, Severe Hypotension, CPR/VT, Angio Failure

PROTECT II: Procedural Differences

Procedural Characteristics IABPIABP(N=223)(N=223)

ImpellaImpella(N=224)(N=224)

p-valuep-value

Use of Heparin 82.4% 93.5% <.001

GP IIb/IIIa Inhibitors 26.1% 13.5% 0.001

Total Contrast Media (cc) 241±114 267±142 0.037

Rotational Atherectomy (RA) 9.5% 14.9% 0.088

Median # of RA Passes/lesion (IQ range) 1 (1-2) 3 (2-5) 0.001

Median # of RA passes/pt (IQ range) 2.0 (2.0-4.0) 5.0 (3.5-8.5) 0.004

Median RA time/lesion (IQ range sec) 40 (20-47) 60 (40-97) 0.005

RA of Left Main Artery 3.1% 8.0% 0.024

% of SVG Treatment or RA use 17.5% 25.4% 0.041

Total Support Time (hour) 8.2±21.1 1.9±2.7 <.001

Discharge from Cath Lab on device 37.7% 5.7% <.001

PROTECT II MAE Outcome

IABP

IMPELLA

MAE= Major Adverse Event Rate

40.4%

49.5%

35.7%

41.4%

30 day MAE 90 day MAE

Intent to Treat (N=447)

p=0.312

N=224N=223

p=0.087

N=222N=220

42.7%

51.4%

34.9%

40.8%

30 day MAE 90 day MAE

p=0.100

N=215N=211

↓ 21% MAE

p=0.029

N=213N=210

Per Protocol (N=426)

Per Protocol= Patients that met all incl./ excl. criteria.

PROTECT II MACCEPer Protocol Population, n=426

Log rank test, p=0.04

Death, Stroke, MI,

Repeat revasc.IABP

IMPELLA

Primary Endpoint Components

Death

MI (>3x ULN)

Stroke/TIA

Repeat Revasc

Vascular Complication

Acute Renal Dysfun

Severe Hypotension

CPR / VT

Aortic Insufficiency

Angio Failure

11.7%

18.3%

1.4%

6.1%

2.3%

9.9%

10.8%

12.2%

0.0%

3.8%

9.0%

16.7%

2.4%

12.4%

3.8%

11.4%

12.9%

10.5%

0.0%

1.9%

IMPELLA IABP

PROTECT II 90-day Outcome (PP)

* Designates statistically significant difference (p<0.05). All other differences are non-significant

51.4%

34.3%

40.8%

28.2%

Composite MAE MACCE

p=0.029

p=0.175

* (p=0.026)

N=210N=213 N=210N=213

Per Protocol (PP)= Patients that met all incl./ excl. criteria.

(p=0.365)

(p=0.656)

(p=0.463)

(p=0.384)

(p=0.601)

(p=0.512)

(p=0.575)

(p=0.252)

PROTECT II 90-day Outcome (PP)PROTECT II 90-day Outcome (PP)HRPCI w/o Atherectomy (N=371, 88%)HRPCI w/o Atherectomy (N=371, 88%)

DeathDeath

MI (>3x ULN)MI (>3x ULN)

Stroke/TIAStroke/TIA

Repeat RevascularizationRepeat Revascularization

Vascular ComplicationVascular Complication

Acute Renal DysfunctionAcute Renal Dysfunction

Severe HypotensionSevere Hypotension

CPR / VTCPR / VT

Aortic InsufficiencyAortic Insufficiency

Angio FailureAngio Failure

11.6%11.6%

14.9%14.9%

1.1%1.1%

6.6%6.6%

2.8%2.8%

7.7%7.7%

9.4%9.4%

12.7%12.7%

0.0%0.0%

4.4%4.4%

8.9%8.9%

17.4%17.4%

2.6%2.6%

10.5%10.5%

3.7%3.7%

11.6%11.6%

12.1%12.1%

10.0%10.0%

0.0%0.0%

2.1%2.1%

CompositeComposite

IMPELLAIMPELLA IABPIABP

12.5%12.5%

37.5%37.5%

3.1%3.1%

3.1%3.1%

0.0%0.0%

21.9%21.9%

18.8%18.8%

9.4%9.4%

0.0%0.0%

0.0%0.0%

10.0%10.0%

10.0%10.0%

0.0%0.0%

30.0%30.0%

5.0%5.0%

10.0%10.0%

20.0%20.0%

15.0%15.0%

0.0%0.0%

0.0%0.0%

HRPCI with Atherectomy (N=52, 12%)HRPCI with Atherectomy (N=52, 12%)

35.9%35.9% 51.1%51.1% (p=0.003)(p=0.003)

IMPELLAIMPELLA IABPIABP

68.8%68.8% 55.0%55.0% (p=0.316)(p=0.316)

(p=0.006)(p=0.006)

(p=0.03)(p=0.03)

(p=0.399)(p=0.399)

(p=0.522)(p=0.522)

(p=0.280)(p=0.280)

(p=0.181)(p=0.181)

(p=0.616)(p=0.616)

(p=0.211)(p=0.211)

(p=0.400)(p=0.400)

(p=0.411)(p=0.411)

(p=0.208)(p=0.208)

(p=0.784)(p=0.784)

(p=0.425)(p=0.425)

(p=0.202)(p=0.202)

(p=0.271)(p=0.271)

(p=0.911)(p=0.911)

(p=0.537)(p=0.537)

PROTECT II: Critical Look at 90 day Outcomes

Repeat Revascularization (PP)

(90 day Per Protocol, N=425)

O’Neill et al, TCT 2011

IABP IMPELLA

$173,402

IABP

Impella

$172,583

Protect II Economic Study: Total Hospital Charges Per Patient at 90 Days (N=427)

PROTECT II: Critical Look at 90 day OutcomesCost-Effectiveness of Impella vs. IABP


PROTECT II: Critical Look at 90 day Outcomes


Comparative Cost-Effectiveness Studies

• Class I: 5.2.3 Cardiogenic Shock: Recommendation: “A hemodynamic support device is recommended for patients with cardiogenic shock after STEMI who do not quickly stabilize with pharmacological therapy (384,424–427). (Level of Evidence: B).” This classification includes the statement: “Refractory cardiogenic shock unresponsive to revascularization may necessitate institution of more intensive cardiac support with a ventricular assist device or other hemodynamic support devices to allow for myocardial recovery or subsequent cardiac transplantation in suitable patients.”

• Class II b: 5.6 Percutaneous Hemodynamic Support Devices: Recommendation: “Elective insertion of an appropriate hemodynamic support device as an adjunct to PCI may be reasonable in carefully selected high-risk patients (Level of Evidence: C).”

ACCF/AHA/SCAI 2011 Guidelines for Percutaneous Coronary Intervention Incorporates IMPELLA Support

LVEF + Lesion Complexity: LV Support during High-Risk PCI

LVEF >35% LVEF 20-35% LVEF <20%

Simple PCI

Complex PCI

No support

IABP

Impella/PTVA

Simple or Complex:Inoperable

cases

IABP

Impella

Simple PCI

Complex PCI: High Syntax score

>32/STS >5Extensive revasc.

Issues Involving The Case

• Hemodynamic support in high risk PCI

• On-treatment platelet reactivity (OTR) & outcomes

Price et al., Circulation 2011;124:1132

%

6240

48.4

25.8

010203040506070

Standard Dose Clopidogrel (N=1013) High Dose Clopidogrel (N= 1011)

Platelet Reactivity & PCI: Update from GRAVITAS Trial Impact of On-treatment Reactivity (OTR) at 30 days

1.4

2.3

0

1

2

3P =0.20

%

< 230 > 230

< 230 PRU < 208 PRU

P <0.01 P <0.001

P =0.02

1

2.7

0

1

2

3

4

5

< 208 >208

%

Primary endpoints

ADAPT–DESAssessment of Dual AntiPlatelet Therapy with Drug-Eluting

Stents

A large Scale, Prospective, Multicenter Registry Examining the Relationship Between Platelet Responsiveness and

Stent Thrombosis After DES Implantation

Gregg W. Stone, MD

Columbia University Medical Center New York- Presbyterian Hospital

Cardiovascular Research Foundation

ADAPT–DES

Stone et al, TCT 2011

PCI with >1 non-investigational DES Successful and uncomplicated

(IVUS/VH substudy;Up to 3000 pts. enrolled)

Clinical FU at 30 days, 1 year and 2 yearsAngio core lab assessment all STs w/1:2 matching controls

Up to 11,000 pts. prospectively enrolled No clinical or anatomic exclusion criteria

11 sites in US and Germany

Assessment of Dual Antiplatelet Drug Eluting Stents

Assess platelet function after adequate DAPT loading and GPI washout: Accumetrics Verify Now Aspirin, Verify Now P2Y12, and Verify Now IIb/IIIa assays

++

++

++

+

+ +

+


Conclusions and Implications of Platelet OTR

• Data suggests that agents which more effectively inhibit ADP-induced platelet activation should reduce 30-day stent thrombosis when applied to large patient populations (underlying the positive findings of TRITION-TIMI 38 and PLAT0)

• However, the modest sensitivity and specificity of platelet function testing, coupled with the low prevalence of events, implies that testing of platelet ADP antagonist responsiveness is unlikely to provide useful information to guide clinical decision-making in most indidual patients for the prevention of stent thrombosis at 30 days; New PRU cutoff is <208 which predicts outcomes post PCI

Take Home Messages:High Risk PCI with Support and Platelet

Reactivity

Impella assist device use has shown to be safe and beneficial in high risk complex PCI achieving extensive and full revascularization

Platelet reactivity testing on treatment may be indicated in pts with ACS and new PRU cutoff is <208

Presentation: Presented with progressive dyspnea on exertion and cresendo angina CCS Class III,...

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