Complex Coronary Cases

Supported by:

• Abbott Vascular

• Boston Scientific Corporation

• Medtronic, Inc.

• Astrazeneca

DisclosuresSamin K. Sharma, MBBS, FACC

Speaker’s Bureau – Boston Scientific Corporation, Abbott, The Medicines Company, Daiichi Sankyo, Inc. and Lilly USA, LLC

Annapoorna S. Kini, MBBS, FACC

Nothing to disclose

Sameer Mehta, MBBS, FACC

Consulting Fees – The Medicines Company

American College of Cardiology Foundation staff involved with this case have nothing to disclose

Presentation:

Presented on 2/8/2013 with cresendo CCS class III angina & exertional dyspnea. Pt had stress MPI revealing severe anterior and lateral ischemia. Echo in past revealed severe MR and minimal LV dysfunction; surgical repair recommended but declined. Cath revealed 3 V CAD and LVEF 55%. SYNTAX score 25. Cardiac surgery recommended but again declined after Heart-Team discussion. Pt underwent Xience Xpedition DES to LCx-HL and

prox LAD and did well. Pt Still has residual class II angina.

Prior History:

Hyperlipidemia, Hypertension, H/o CVA

Medications: All once daily dosage

Aspirin 81mg, Clopidogrel 75mg, Metoprolol XL 100mg, Diltiazem CD 180mg, Rosuvastatin 20mg

March 19th 2013 Case #9: CS, 73 yr M

Cardiac Cath 2/8/2013: Left Dominance

3 Vessel CAD with LVEF 56%

Left Main: Mild diffuse disease

LAD: 80-90% lesion in prox, total D1 fills via collaterals

LCx: 90% distal LCx with 80% OM1 bifurcation lesion

Ramus Intermedius: 95% lesion, moderate size

PCI: Underwent Xience Xpedition DES (3/23mm) to pLAD and

Xience Xpedition DES (2.5/28mm) to Ramus Intermedius

Plan Today:

- PCI of bifurcation lesion of circumflex (SYNTAX score 16)

Case# 9: cont… SYNTAX score 25

Appropriateness Criteria for Coronary Revascularization

Issues Involving The Case

• Two DES for bifurcation lesions

• Newer devices for calcified lesions

Issues Involving The Case

• Two DES for bifurcation lesions

• Newer devices for calcified lesions

Coronary Artery Bifurcation Lesion Interventional Techniques

Interventional Bifurcation Techniques

One Stent Technique (OST)

OST with SBR Dilatation (SBT)

Kissing Stent Technique (SKS)

‘T’ Stent Technique (TST)

Culotte Stent Technique (CUT)

Crush Stent Technique (CrST)

0

5

10

15

20

25 MACE

TLR

%

1SColombo et al.

SES stents(n=85)

13.6

Clinical Outcomes in Trials Comparing One-DES (1S) vs. Two-DES (2S) Strategy in Treating Coronary

Bifurcations

1S 1S 1S 1S 1S 1S2S 2S 2S 2S 2S 2S 2SPan et al.

SES stents(n=91)

Steigen et al.NORDIC Trial

(n=413)

Ferenc et al.T-stenting

(n=202)

Colombo et al.CACTUS trial

(n=85)

Hildick et al.BBC ONE

(n=500)

Sharma et al.PRECISE-SKS

(n=100)

4.5

9.5

2.9

10.98.9

11.912.9

19

2.1

12.8

4.5

11.4

1.9

3.4

15

1.0

5.8 5.6

15.8

5.6

8.0

7.2

15.2

4.0

8.0

12.0

18.0

0

1

2

3

4

5

1S group2S group

%

1SColombo et al.

SES stents(n=85)

Clinical Outcomes in Trials Comparing One-DES (1S) vs. Two-DES (2S) Strategy in Treating Coronary Bifurcations

1S 1S 1S 1S 1S 1S2S 2S 2S 2S 2S 2S 2SPan et al.

SES stents(n=91)

Steigen et al.NORDIC Trial

(n=413)

Ferenc et al.T-stenting

(n=202)

Colombo et al.CACTUS trial

(n=85)

Hildick et al.BBC ONE

(n=500)

Sharma et al.PRECISE-SKS

(n=100)

Incidence of Reported Stent Thrombosis

0 0.40 00

3.5

0.5

1.1

1.7

0

2.0

3.03.0

2.0

DKCRUSH Technique for Bifurcation Lesions

Chen S et al. J Interven Cardiol 2009;22:127

3.1st Kissing balloon inflation

5.Final Kissing balloon inflation

1.SBr stenting

2.Balloon crush

4.MV stent and crush

Conventional (n= 185)

DK Crush (n=185)

9.7

Angiographic Restenosis

%

A Randomized Clinical Study Comparing Double Kissing Crush With Provisional Stenting for Treatment of Coronary

Bifurcation Lesions: DK Crush II Study

Main Vessel TVR

p=0.036

3.8

p<0.001

4.9

22.2p=0.017

14.6

6.5

17.3

MACE ST

p=0.07

10.3

0.5

p=0.37

2.2

Chen S et al, JACC 2011;57:914

Side Vessel

DK-CRUSH III Study Flowchart of Study Design

Chen et al., JACC 2013 In Press

DK-CRUSH III Study

Chen et al., JACC 2013 In Press

TVR-Free Survival Rate at 12 M MACE-Free Survival Rate at 12 M

DK-CRUSH III Study: Clinical F/U at 12 Months

Chen et al., JACC 2013 In Press

%

p=0.001

p=1.00

p=0.38

p=0.03

p=0.62

Culotte Group (N = 209)

DK Group (N = 210)

DK-CRUSH III Study

Chen et al., JACC 2013 In Press

Forest Plots of 1-Year MACE Rate in Pre-Specifies Subgroups

Sirker et al., JACC Cardiovasc Interv 2013;6:139

BBC One Study: 9-Month Post-PCI Scores on SAQ for Simple and Complex Groups

Sirker et al., JACC Cardiovasc Interv 2013;6:139

BBC One Study: Direction of Change in Individual Patients’ Scores on SAQ

Issues Involving The Case

• Two DES for bifurcation lesions

• Newer devices for calcified lesions

Facts about Calcified Lesions1. Angiography underestimates the presence, extent and axial

depth of calcium

2. Calcium significantly increases procedural complications

3. Most studies have excluded calcified lesions

4. While rotational atherectomy (RA) allows for greater stent expansion, studies have reported increased late loss and restenosis, likely due to platelet activation and thermal injury from the device

5. Thus, at the present time, RA is mainly reserved for undilatable or extremely calcified lesions.

Mintz et al., Circ 1995;01:1959, Lofberg et al., Cardiovasc Interv Radiol 1998;19:317, Davies et al., J Am Coll Surg 2005;201:275, Gallino et al., Circ 1984;70:619, Becquemin et al., J Endovasc Surg, 1995;2:42, Zdanowski et al., Int Angio 1999;18:251, Vroegindeweij et al., Cardiovasc Interv Radiol 1997;20:420

Généreux, TCT 2012

Impact of Severity of Coronary Calcification on 1-Year Outcomes After PCI in NSTEMI/STEMI:

Insight from an angiographic pooled analysis from ACUITY and HORIZONS Trials

Frequency of Moderate/Severe Calcification in ACS Population

n = 6,855 patients

Généreux, TCT 2012

Moderate/Severe

None/Mild

1-Year Ischemic Outcomes: ACS Population (N= 6855 patients)

%

Généreux, TCT 2012

p=0.0002

p=0.001

p=0.22

p=0.007

p=0.002

p=0.001None/Mild

Moderate/Severe

Device Selection for Various Coronary Lesions Type

*

Compliant or

Non-compliant Balloon

All Comers/Fibrotic Undilatable/Mild-Mod Calcified Heavily Calcified

AngioSculpt

Balloon AtherotomyCutting Balloon (Flextome)

Longitudinalmicrotomes

- Security & performance are engineered to:• Reduce vessel wall expansion• Maximize plaque compression• Relief hoop stress

- Better results with lower inflation pressure

compared to plain old balloon angioplasty

AngioSculpt balloon

Indications:-Mild calcified -Inelastic/chronic-Ostial-ISR

Post-procedure Stent Luminal Area ≥5.0 mm2

Costa et al., Am J Cardiol 2007;100:812

%

p=<0.001

Stent Expansion by Plaque Morphology

Pre-dilatation with AngioSculpt

Pre-dilatation with POBA

Direct Stent

Soft 87 75 74

Calcific 90 75 72

Fibrotic 87 82 77

Mixed 87 77 76

% Optimal Stent Expansion

Costa et al., Am J Cardiol 2007;100:812

ROTAXUS240 patients with calcified lesions enrolled between August 2006 and

March 2010 at 3 clinical sites in Germany

1:1 randomization

Rotoblator + PES(n=120)

PTCA + PES(n=120)

Clinical follow-up at 9 months in 96.2%

(n=227)

Angio follow-up at 9 months in 80.5%

(n=190)

IVUS not used

Mean age 71DM 28%

MVD 74%

Ostial 18%Bifurc 48%B2/C 90%

Richert, TCT 2011*Primary endpoint: In-stent late loss

- 2 patients died in-hospital- 6 patients withdrew consent- 5 patients lost at follow-up

ROTAXUS: 9-month Follow-up

%

Richert, TCT 2011

* Defined as death, MI and TVR

p=0.78 p=0.79

p=0.73

p=0.84

p=0.46

p=1.0

ROTA + PES (n=123)

PTCA + PES (n=132)

ORBITAL ATHERECTOMY: Unique Mechanism of Action

Differential Orbital Sanding

Crown will only sand the hard

components of plaque

Soft components (plaque/tissue) flex away from crown

Orbital Mechanism• Increased speed = Increased centrifugal force• Greater centrifugal force = Larger orbital diameter

CF=Mass X Rotational speed2

Radius of the orbit

Orbital Atherectomy Technology for Calcified Coronary Arteries

• Easy setup and use• Control of device in operating field• .012” OAS guide wire• Compatible with 6 French guiding catheters

ORBITAL Atherectomy: Unique Mechanism of Action

• Orbiting Crown Enables

• Continous flow of blood and saline• Minimizes thermal injury• Potentially decreases no-reflow and

periprocedural cardiac enzyme elevation• One crown treats different vessel

diameters based on orbiting speed

The Differences Between Sanding and Drilling

Orbital Rotational

Mechanism of Action

Direction

Bi-directional Uni-directional

ORBIT I Trial• First-in-man study using orbital atherectomy in coronary arteries • Designed to demonstrate safety and performance in calcified coronary

lesions• Prospective, single-arm• 2 centers OUS• 50 subjects with >90⁰ of calcium via IVUS

• Compared to ORBIT II• Shorter lesions• Less B2/C lesions

MACE Rate30 days1 6 months1 2 years2 3 years2

6% 8% 15% 18.2%

Cardiac Death 0% 2% 6% 9.1%

Q-wave MI 0% 0% 0% 0%

Non Q-wave MI 6% 6% 9% 9.1%

TLR 2% 2% 3% 3%

1. Parikh et al., Catheter Cardiovasc Interv 2012, March 52. Parikh et al., JACC Cardiovasc Interv 2013;6:Suppl 5

Chambers, ACC 2013

ORBIT II Study Design• To evaluate safety and efficacy of coronary OAS to prepare de

novo severely calcified coronary lesions for enabling stent placement

• Prospective• Multi-center trial• Single arm – FDA recommendation as there are no FDA-

approved percutaneous treatments for patients with severely calcified lesions.

443 patients enrolled in 49 US sites

30 days follow-up

Complete in 97.7 % (N=430/443)

Chambers, TCT 2012

ORBIT II Study Design

Primary Safety Endpoint: 30-Day MACE

Cardiac death

MI defined as CK-MB level > 3 times upper limit of lab normal (ULN) value

• With or without abnormal Q-wave

Target vessel revascularization (TVR)

Primary Efficacy Endpoint: Procedural Success

Success in facilitating stent delivery with a final residual stenosis of <50% and without in-hospital MACE

Chambers, TCT 2012

The ORBIT II Trial: An Historic Coronary Study

Unique Study Design to Evaluate Higher Risk CAD Patients

EF < 35%INCLUDED

DIALYSISPATIENTSINCLUDED

SEVERELY CALCIFIED ARTERIES

ORBIT IIStudy

Chambers, ACC 2013

The ORBIT II Trial: Primary Safety Endpoint

30 Day MACE Rate Components:

MI (CK-MB >3x ULN): 9.7% Non Q-wave 8.8%

Q-wave 0.9% TVR/TLR: 1.4%

TVR 0.7% TLR 0.7%

Cardiac death: 0.2%

80% 85% 90% 95% 100%

Freedom from 30 Day MACE = 89.8%Performance Goal = 83%

95% CI = 87.0%, 92.7%

Chambers, ACC 2013

The ORBIT II Trial: Primary Efficacy Endpoint

Procedural Success Components:

Successful Stent Delivery: 97.7% Less than 50% residual stenosis: 98.6%

In-hospital MACE: 9.5% MI (CK-MB >3x ULN)/TVR/TLR: 9.3%

Non- Q-wave 8.6% Q-wave 0.7%

TVR 0.7% Cardiac death: 0.2%

80% 85% 90% 95% 100%

Procedural Success = 89.1%Performance Goal = 82%

95% CI = 85.8%, 91.8%

Chambers, ACC 2013

The ORBIT II Trial: 30 Day Results (N=443) Patients with Severely Calcified Coronary Lesions Underwent

Diamondback 360⁰ Orbital Atherectomy at 49 States

Primary Efficacy Endpoint of Procedural Success

%

Primary Safety Endpoint of Freedom from MACE

Successful <50% In-hospital MI TVR Cardiac stent residual MACE death delivery stenosis

%

Take Home Message:Two stent strategy and devices for calcified

lesions Appropriately done 2 stent treatment strategy is emerging as the superior strategy over 1 stent in large coronary bifurcation lesions. Hence no longer the issue should 1 or 2 DES; rather we should identify lesions which will need 2 DES and plan accordingly (rather then bailout strategy)

Orbital atherectomy system in heavily calcified coronary lesions appears very promising and once available, has a chance for wider acceptance because of effectiveness and simple setup and easy learning curve.

DK-Crush technique has shown to be superior to other stent strategy for bifurcation lesions except :

A. Lower restenosis

B. Lower TVR

C. Lower MACE

D. Lower stent thrombosis

Question # 1

Orbital atherectomy trials have shown 9-12M MACE rate of:

A. 6-10%

B. 11-15%

C. 16-20%

D. 21-25%

E. >25%

Question # 2

Statement about mechanism of Orbital atherectomy is true:

A. Lumen gain is proportional to the size of the burr

B. Lumen gain is proportional to burr movement

C. Lumen gain is proportional to the burr speed

Question # 3

DK-Crush technique has shown to be superior to other stent strategy for bifurcation lesions except :

A. Lower restenosis

B. Lower TVR

C. Lower MACE

D. Lower stent thrombosis

Question # 1

The correct answer is D. While DK Crush trials have shown lower MACE and restenosis, thee has been no

difference in the incidence of stent thrombosis.

Orbital atherectomy trials have shown 9-12M MACE rate of:

A. 6-10%

B. 11-15%

C. 16-20%

D. 21-25%

E. >25%

Question # 2

The correct answer is A. Both ORBIT I and II trials showed MACE rate of <10% at 1 year follow-up. All was

largely due to small non-Q wave MI.

Statement about mechanism of Orbital atherectomy is true:

A. Lumen gain is proportional to the size of the burr

B. Lumen gain is proportional to burr movement

C. Lumen gain is proportional to the burr speed

Question # 3

The correct answer is C. Lumen gain after Orbital atherectomy is dependent on the burr speed; faster it is,

more arc it covers and larger is the lumen gain.