complex coronary cases
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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.
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