Supported by:
• Abbott Vascular
• Boston Scientific Corporation
• Medtronic, Inc.
• Astrazeneca

Samin 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

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

SYNTAX score 25
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)

Appropriateness Criteria for Coronary Revascularization

Issues Involving The Case
•
•

Issues Involving The Case
•

Interventional Bifurcation Techniques
One Stent
Technique (OST)
Kissing Stent
Technique (SKS)
Crush Stent
Technique (CrST)
OST with SBR
Dilatation (SBT)
‘T’ Stent
Technique (TST)
Culotte Stent
Technique (CUT)

Clinical Outcomes in Trials Comparing One-DES (1S) vs. Two-DES (2S) Strategy in Treating Coronary
Bifurcations
25
MACE
TLR
20
19
18.0
15.2
15
15.8
%
15
13.6
12.9
11.9
12.8
11.4
10
8.0
10.9
9.5
8.9
7.2
5 5.6
5.8 5.6
4.5
0
1S 2S
Colombo et al.
SES stents
(n=85)
1S 2S
Hildick et al.
BBC ONE
(n=500)
1S 2S
Ferenc et al.
T-stenting
(n=202)
2.9
3.4
4.5
1.9
1S
1.0
2S
Steigen et al.
NORDIC Trial
(n=413)
1S 2S
Colombo et al.
CACTUS trial
(n=85)
2.1
1S 2S
Pan et al.
SES stents
(n=91)
12.0
8.0
4.0
1S 2S
Sharma et al.
PRECISE-SKS
(n=100)

Clinical Outcomes in Trials Comparing One-DES (1S) vs.
Two-DES (2S) Strategy in Treating Coronary Bifurcations
Incidence of Reported Stent Thrombosis
5
1S group
2S group
4
3.5
3.0
3.0
3
%
2
2.0
2.0
1.7
1.1
1
0
0
0.4
0.5
0 0
1S 2S
Colombo et al.
SES stents
(n=85)
1S 2S
Hildick et al.
1S 2S
Ferenc et al.
BBC ONE T-stenting
(n=500) (n=202)
1S 2S
Steigen et al.
NORDIC Trial
(n=413)
1S 2S
Colombo et al.
CACTUS trial
(n=85)
1S 2S
Pan et al.
SES stents
(n=91)
0 0
1S 2S
Sharma et al.
PRECISE-SKS
(n=100)

DKCRUSH Technique for Bifurcation Lesions
1.
SBr stenting
2.
Balloon crush
3.
1 st Kissing balloon inflation
4.
MV stent and crush
5.
Final Kissing balloon inflation
Chen S et al. J Interven Cardiol 2009;22:127

A Randomized Clinical Study Comparing Double Kissing
Crush With Provisional Stenting for Treatment of Coronary
Bifurcation Lesions: DK Crush II Study
% p<0.001
22.2
Conventional (n= 185)
DK Crush (n=185) p=0.017
p=0.07
17.3
14.6
p=0.036
10.3
9.7
p=0.37
6.5
4.9
3.8
Main Vessel Side Vessel
Angiographic Restenosis
TVR
0.5
2.2
ST MACE
Chen S et al, JACC 2011;57:914

DK-CRUSH III Study
Flowchart of Study Design
Chen et al., JACC 2013 In Press

TVR-Free Survival Rate at 12 M MACE-Free Survival Rate at 12 M
Chen et al., JACC 2013 In Press

DK Group (N = 210)
p=0.001
Culotte Group (N = 209)
p=0.03
%
p=0.38
p=1.00
p=0.62
Chen et al., JACC 2013 In Press

Forest Plots of 1-Year MACE Rate in Pre-Specifies Subgroups
Chen et al., JACC 2013 In Press

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

Issues Involving The Case
•

1. 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

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
Généreux, TCT 2012

n = 6,855 patients
Moderate/Severe
None/Mild
Généreux, TCT 2012

%
1-Year Ischemic Outcomes:
ACS Population (N= 6855 patients) p=0.001
None/Mild
Moderate/Severe p=0.22
p=0.002
p=0.0002
p=0.001
p=0.007
Généreux, TCT 2012

Compliant or
Non-compliant Balloon
AngioSculpt

- 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
Longitudinal microtomes
Indications:
-Mild calcified
-Inelastic/chronic
-Ostial
-ISR
AngioSculpt balloon

%
2
p=<0.001
Costa et al., Am J Cardiol 2007;100:812

% Optimal Stent Expansion
Soft
Calcific
Fibrotic
Mixed
Pre-dilatation with AngioSculpt
87
90
87
87
Pre-dilatation with POBA
75
75
82
77
Direct Stent
74
72
77
76
Costa et al., Am J Cardiol 2007;100:812

240 patients with calcified lesions enrolled between August 2006 and
March 2010 at 3 clinical sites in Germany
Mean age 71
DM 28%
MVD 74%
1:1 randomization
Rotoblator + PES
(n=120)
IVUS not used
PTCA + PES
(n=120)
Ostial 18%
Bifurc 48%
B2/C 90%
- 2 patients died in-hospital
- 6 patients withdrew consent
- 5 patients lost at follow-up
Clinical follow-up at
9 months in 96.2%
(n=227)
Angio follow-up at
9 months in 80.5%
(n=190)
*Primary endpoint: In-stent late loss
Richert, TCT 2011

%
p=0.46
ROTA + PES (n=123)
PTCA + PES (n=132) p=0.73
p=0.84
p=0.79
p=0.78
p=1.0
* Defined as death, MI and TVR
Richert, TCT 2011

ORBITAL ATHERECTOMY: Unique Mechanism of Action
Crown will only sand the hard components of plaque
Differential Orbital Sanding
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 speed 2
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
• 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

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 >90 ⁰ of calcium via IVUS
• Compared to ORBIT II
• Shorter lesions
• Less B2/C lesions
MACE Rate
Cardiac Death
Q-wave MI
Non Q-wave MI
TLR
30 days 1
6%
0%
0%
6%
2%
6 months 1
8%
2%
0%
6%
2%
2 years
15%
6%
0%
9%
3%
2 3 years
18.2%
9.1%
0%
9.1%
3%
2
1. Parikh et al., Catheter Cardiovasc Interv 2012, March 5
2. Parikh et al., JACC Cardiovasc Interv 2013;6:Suppl 5

• 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 FDAapproved 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, ACC 2013

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
ORBIT II
Study
SEVERELY
CALCIFIED
ARTERIES
DIALYSIS
PATIENTS
INCLUDED
EF < 35%
INCLUDED
Chambers, TCT 2012

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%
Freedom from 30 Day MACE = 89.8%
Performance Goal = 83%
95% CI = 87.0%, 92.7%
80% 85% 90% 95% 100%
Chambers, ACC 2013

The ORBIT II Trial: Primary Efficacy Endpoint
Procedural Success Components:
Successful Stent Delivery:
Less than 50% residual stenosis:
97.7%
98.6%
In-hospital MACE: 9.5%
MI (CK-MB >3x ULN)/TVR/TLR: 9.3%
Non- Q-wave
Q-wave
8.6%
0.7%
TVR 0.7%
Cardiac death: 0.2%
Performance Goal = 82% Procedural Success = 89.1%
95% CI = 85.8%, 91.8%
80% 85% 90% 95% 100%
Chambers, ACC 2013

The ORBIT II Trial: 30 Day Results (N=443) Patients with
Severely Calcified Coronary Lesions Underwent
Diamondback 360 ⁰ Orbital Atherectomy at 49 States
Primary Safety Endpoint of
Freedom from MACE
Primary Efficacy Endpoint of
Procedural Success
% %
Successful <50% In-hospital MI TVR Cardiac stent residual MACE death delivery stenosis
Chambers, ACC 2013

 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

Orbital atherectomy trials have shown 9-12M MACE rate of:
A. 6-10%
B. 11-15%
C. 16-20%
D. 21-25%
E. >25%

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

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
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%
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
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.