1. Complex Coronary Cases
Supported by:
Abbott Vascular Inc
Boston Scientific Corp
Terumo Vascular Corp
Vascular Solutions Inc
Cardiovascular Science Inc
AstraZeneca Pharmaceuticals
The Medicines Company
Trireme Medical

2. Disclosures
Samin K. Sharma, MBBS, FACC Speaker’s Bureau – Boston Scientific Corporation, Abbott Vascular Inc, AngioScore, ABIOMED, CSI, Trireme Medical Annapoorna S. Kini, MBBS, FACC Nothing to disclose Sameer Mehta, MBBS, FACC Consulting Fees – The Medicines Company

3. July 21st 2015 Case #73: CW, 79 yrs M Presentation:
Patient with hepatitis, cirrhosis and prior PCI of RCA, presented with new onset CCS Class III angina and dyspnea. A stress MPI revealed 2mm ST-seg depression but normal myocardial perfusion. A cardiac cath on June 12th 2015 revealed distal LM bifurcation with prox LAD and prox circumflex disease, LVEF 60% and SYNTAX score 26. Heart team discussion declined CABg due to cirrhosis. Pt continued to have class II symptoms on MMT.
Prior History:
Hypertension, Hyperlipidemia, Hepatitis and Cirrhosis
Medications: All once daily dosage
Lisinopril 10mg, Rosuvastatin 20mg, ASA 81mg, Prasugrel 5mg, Nebivolol 5mg, ISMN 60mg 3

4. Case# 73: cont… Cardiac Cath 6/12/2015: Right Dominance
SYNTAX Score was : 26
Cardiac Cath 6/12/2015: Right Dominance
dLM CAD with LVEF 60%
LM: 80% distal obstruction, mild obstruction
LAD: 80% prox LAD lesion, distal vessel is large with diffuse disease
LCx: 60% prox LCx lesion, distal vessel is large OM1
RCA: mild diffuse disease, distal vessel is large with 30% disease in RPDA
Plan Today:
PCI of distal ULM bifurcation lesion with IVUS guidance 4

5. Appropriateness Criteria for Coronary Revascularization

6. Indication for CABG vs PCI in Stable CAD with LMCA Involvement
American and European Guidelines

7. Issues Involving The Case
Role of Imaging in peri-procedural MI prediction
Comparison of newer DES vs CABG in MV CAD

8. Issues Involving The Case
Role of Imaging in peri-procedural MI prediction
Comparison of newer DES vs CABG in MV CAD

9. Peri-procedural MI (PMI)
- Occurs in 5-40% of PCI: Macro-size due to dissection, SBr occlusion or micro-size due to distal embolization, microvascular plugging, slow flow, spasm
- Various definitions: Universal definition of PMI Type 4a: cTn > 5x of 99th percentile of URL or SCAI definition of PMI: CK-MB >10x ULN or cTn > 70x ULN. Associated with chest pain, EKG changes, angiographic complication and myocardial loss on imaging
- PMIs are associated with ↑ future CV mortality and various approaches are used to reduce PMIs: pretreatment with oral antiplatelet therapy, high dose statin, GP IIb/IIIa inhibitors, DPD, preconditioning, BB

10. Imaging Parameters for Periprocedural MI
Attenuated plaques by gray-scale intravascular ultrasound (IVUS)
Necrotic core by radiofrequency IVUS (VH)
Thin-capped fibroatheroma (TCFA) by optical coherence tomography (OCT)
Large lipid core plaque by near-infrared spectroscopy (NIRS)

13. CANARY Trial: Patient Flow Diagram
709 consented patients
All eligibility criteria met?
No (n=624)
PCI not done (n=317)
Lesion exclusion (n=123)
Other angiographic exclusion (n=128)
Multi-lesion PCI (n=70)
Physical discretion (n=50)
Elevated biomarkers (n=32)
Distal RVD too small for filter (n=17)
Side branches present (n=12)
Yes (n=85)
Max LCBI 4mm
≥600 (n=31)
Randomized 1:1
<600 (n=54)
PCI with FilterWire EZ
(n=14)
PCI alone
(n=17)
PCI alone
(n=54)
In-hospital follow-up
Stone, Kini et al., J Am Coll Cardiol Intv 2015;8:927

14. CANARY Trial: Procedural MI After
Randomization PCI alone vs. PCI+FilterWire EZ
PCI alone
PCI +FilterWire EZ
PCI alone (n=17)
PCI +FilterWire EZ (n=14)
p=0.58
Post-PCI biomarker elevation meeting Criteria (%)
RR [95%CI] =
1.52 [ ]
p=0.69
p=0.66
p=>0.99
p=>0.99
4/17
5/14
troponin troponin troponin or troponin
>1x ULN ≥5x ULN ≥10x ULN ≥70x ULN
Peak troponin I or T or CK-MB ≥3x ULN
Stone, Kini et al., J Am Coll Cardiol Intv 2015;8:927

15. CANARY Trial: Correlates of Periprocedural MI
Stone, KIni et al., J Am Coll Cardiol Intv 2015;8:927

17. 110 pts underwent OCT, IVUS and NIRS pre-PCI

18. Angiographic and Procedural Findings
Kini, Sharma et al., J Am Coll Cardiol Intv 2015;8:937

19. OCT, IVUS and NIRS Findings
Kini, Sharma et al., J Am Coll Cardiol Intv 2015;8:937

20. OCT, IVUS and NIRS Findings
Kini, Sharma et al., J Am Coll Cardiol Intv 2015;8:937

21. Univariate and Multivariate Logistic Analysis for
Predicting Periprocedural MI by OCT, IVUS, and NIRS
Kini, Sharma et al., J Am Coll Cardiol Intv 2015;8:937

22. Multimodality Imaging of a Representative Case With Periprocedural MI
Coronary angiography depicting significant stenosis in the LAD
OCT image of thin cap fibroatheroma lesion
fibrous cap thickness at thinnest portion is 60 µm (solid arrow)
C, D – location of OCT/IVUS frames
maxLCBI4 mm segment shown by arrows and white line
Lipid arc is 159º
(dashed semicircular arrow)
NIRS indicates high probability of lipid-rich plaque
IVUS showing plaque burden at the site of minimum lumen equal to 78%
Kini, Sharma et al., J Am Coll Cardiol Intv 2015;8:937

25. LCBI and Plaque Burden in Stable CAD
Dohi T, Maehara A, Moreno P, Kini A. EHJ Cardiov Img 2015:16:81

26. Issues Involving The Case
Role of Imaging in peri-procedural MI prediction
Comparison of newer DES vs CABG in MV CAD

27. MACCE to 5-Years Based on SYNTAX Score Tercile: 3 V CAD
CABG
TAXUS DES
Death, MI or CVA
0-22
11.6
p=0.06
23-32
>33
18.8
8.4
18.2
21.1
10.5
p=0.004
p=0.006
171
155
166
181
208
207
Revascularization
p=0.008
p=0.75
p=0.09
22.3
18.6
15.2
14.8 % %
12.4
11.4
171
181
208
207
166
155
0-22
23-32
>33
Mohr et al., Lancet 2013;381:629.

28. Cumulative Event Rate (%) Months Since Allocation
SYNTAX Trial: MACCE to 5 Years by SYNTAX Score Tercile High Scores (33)
TAXUS (N=290)
CABG (N=315)
CABG
PCI
P value
Death
11.4%
19.2%
0.005
CVA
3.7%
3.5%
0.80 MI
3.9%
10.1%
0.004
Death, CVA or MI
17.1%
26.1%
0.007
Revasc
12.1%
30.9%
<0.001
Overall 50
P<0.001
44.0%
Cumulative Event Rate (%) 25
26.8%
SYNTAX 5-Year Report_Randomized_15JUN12.doc exhibit 57 12 24 36 48 60
Months Since Allocation
Cumulative KM Event Rate ± 1.5 SE; log-rank P value
Mohr et al., Lancet 2013;381:629.

29. FREEDOM Trial: Estimates of Key Outcomes at
5 Years after Randomization
PCI (n=943)
p=0.005
CABG (n=957)
p=0.049
p=<0.001
p=0.12 %
p=0.003
Primary Death MI Stroke CV Death
Endpoint
Farkouh et al., N Engl J Med 2012;367:2375 29

31. BEST Trial: Study Design
Park et al., N Engl J Med 2015;372:2104

32. BEST Trial: KM Curves for the Primary Endpoint
and the Major Secondary Endpoint
Primary Composite Endpoint
(Death, MI, TVR)
Secondary Composite Endpoint
(Death, MI, Stroke, rRevasc)
11%
7.9%
Park et al., N Engl J Med 2015;372:2104

33. BEST Trial: Long-Term Clinical Endpoints After Randomization, According to Study Group
PCI (n=438)
CABG (n=442)
p=0.04
p=0.003 %
p=0.03
p=0.30
p=0.11
p=0.72
p=0.21
10 Endpoint Death MI Stroke Any revasc TVR Fatal
death/MI/TVR bleeding
Park et al., N Engl J Med 2015;372:2104

35. Study Population
Bangalore et al., N Engl J Med 2015;372:1213

36. Risk of Primary and Secondary Outcomes
in the Propensity-Score-Matched Cohort
PCI (n=9223)
CABG (n=9223)
p=<0.001 %
p=0.50
p=<0.001
p=<0.001
Death MI Stroke Revascularization
Bangalore et al., N Engl J Med 2015;372:1213

37. Cumulative Risks of the Study Outcomes in
the Matched Cohort
Bangalore et al., N Engl J Med 2015;372:1213

40. EES vs CABG in Diabetic MV CAD: Short-Term Outcomes
Within 30 Days
Bangalore et al., Circ Cardiovasc Interv; ePub July 8, 2015

41. EES vs CABG in Diabetic MV CAD:
Long-Term Outcomes Includes First 30 Days
Death MI
Bangalore et al., Circ Cardiovasc Interv; ePub July 8, 2015

42. EES vs CABG in Diabetic MV CAD:
Long-Term Outcomes Includes First 30 Days
Stroke
Repeat Revascularization
Bangalore et al., Circ Cardiovasc Interv; ePub July 8, 2015

44. EXCEL Trial (Evaluation of Xience Prime vs. CABG
for Examination of LM Disease)
LM disease (±1, 2 or 3 vessel disease) and a SYNTAX score of ≤32
Randomize 2600 pts
Trial has finished enrollment
After 1800 cases
ABBOTT Vascular XIENCE Prime stent
CABG
The primary endpoint is the composite incidence of death, large MI or stroke at a median FU duration of 3 years, powered for sequential non-inferiority and superiority testing.
The major secondary endpoint is the composite incidence of death, MI, stroke or unplanned repeat revascularization. All patients will be followed for 5 years total.

45. Take Home Message: Imaging for PMI prediction and newer DES vs
Take Home Message: Imaging for PMI prediction and newer DES vs. CABG in MV CAD
Multimodality invasive imaging can identify lesions likely to be associated with peri-procedure MI. OCT defined fibrous cap thickness followed by LCBI by NIRS and plaque volume by IVUS are important predictors. The use of strong antiplatelet therapy, GPI, statin and beta-blockers may be recommended to reduce PMI in these risk prone plaques on multimodality imaging (Filter DPD has no role)
Recent randomized and registry data have shown that long-term death is not higher with newer DES (EES type) vs CABG in MV CAD including diabetics. Both MI and TVR is still higher with newer DES while stroke remains higher after CABG.

46. Question # 1
Following are the predictors of periprocedural MI on imaging except:
High LCBI
Lower lumen CSA on IVUS
Thin cap on OCT
Lower plaque burden
Necrotic core on VH

47. Question # 2
Based on the multimodality imaging, which plaque characteristic has the highest OR for peri-procedural MI;
Cap thickness on OCT
LCBI on NIRS
Plaque volume on IVUS
Lumen CSA on IVUS
Necrotic core on VH

48. Question # 3
In recent years, trials of newer DES vs CABG for MV CAD have shown the following except;
A. Higher TVR with PCI
B. Higher CVA with CABG
C. Lower death rate with CABG
D. Higher MI with PCI
E. Higher death, MI and TVR with PCI

49. Question # 1 The correct answer is D
Following are the predictors of periprocedural MI on imaging except:
High LCBI
Lower lumen CSA on IVUS
Thin cap on OCT
Lower plaque burden
Necrotic core on VH
The correct answer is D

50. Question # 2 The correct answer is A
Based on the multimodality imaging, which plaque characteristic has the highest OR for peri-procedural MI;
Cap thickness on OCT
LCBI on NIRS
Plaque volume on IVUS
Lumen CSA on IVUS
Necrotic core on VH
The correct answer is A

51. Question # 3 The correct answer is C
In recent years, trials of newer DES vs CABG for MV CAD have shown the following except;
A. Higher TVR with PCI
B. Higher CVA with CABG
C. Lower death rate with CABG
D. Higher MI with PCI
E. Higher death, MI and TVR with PCI
The correct answer is C