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

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

3. January 20th 2015 Case #67: CG, 83 yrs F
Presentation:
Patient with cresendo angina CCS Class III and dyspnea on minimal exertion for last 2 weeks. Pt has known moderate ULM+ 2V CAD on cath in 2009 and being managed medically after declining CABG and remained stable until few weeks ago. A Cardiac cath done on 1/12/2015 revealed distal ULM bifurcation disease with normal LVEF and normal right heart pressures. Heart team consultation took place and pt elected for PCI
Prior History:
Hypertension, Hyperlipidemia, PUD, H/o DVT
Medications: All once daily dosage
Atenolol 50mg, Amlodipine 10mg, Simvastatin 40mg, ASA 81mg,
Fenofibrate 48mg, Ranolazine 1000mg, Esomeprazole 40mg 3

4. Case# 67: cont… Cardiac Cath 1/12/2015: Right Dominance
LM+2 V CAD with LVEF 60%
RCA: mild diffuse disease, large size
LM: 70% calcific bifurcation disease
LAD: 60-70% heavily calcified ostial LAD, large size, mild diffuse D1
LCx: 80% heavily calcified prox LCx lesion, large size vessel
SYNTAX Score was : 24
Plan Today:
PCI of calcified distal LM lesion involving OCT, Rotational atherectomy and planned 2 Stent approach. 4

5. Appropriateness Criteria for Coronary Revascularization

6. Appropriate Mode of Revascularization for Multi-vessel and LM CAD
CABG
PCI
Two-vessel CAD with proximal LAD stenosis A
Three Vessel CAD with low CAD burden (i.e., three
focal stenosis, low SYNTAX score)
Three-vessel CAD with intermediate to high CAD burden (i.e., multiple diffuse lesions, presence of CTO, or high SYNTAX score >32) U
Isolated left main stenosis
Left main stenosis and additional CAD with low CAD burden (i.e., one to two vessel additional involvement, low SYNTAX score <33)
Left main stenosis and additional CAD with intermediate to high
CAD burden (i.e., three vessel involvement, presence of CTO, or high SYNTAX score >32) I 6

7. Issues Involving The Case
Update on Unprotected Left Main (ULM) PCI
Risk of Non-cardiac Surgery after Coronary
Stenting

8. Issues Involving The Case
Update on Unprotected Left Main (ULM) PCI
Risk of Non-cardiac Surgery after Coronary
Stenting

9. LMCA Stenosis Location
LCX
About two third of LMCA
Lesions include distal bifurcation; 1/3rd are ostial/shaft lesions
66%
Bifurcation
LMCA
26%
Ostium 8%
Body-Shaft
LAD

11. SYNTAX Trial: 5-Year Outcomes in Pts
with LM Disease Treated with PCI or CABG
CABG (n=348)
TAXUS (n=357)
p=<0.001 %
p=0.53
p=0.03
p=0.03
Mohr et al., Lancet 2013;381:629

12. Cumulative Event Curves for MACCE by Baseline SYNTAX Score Tercile
Overall Cohort
Left Main Coronary Disease Subgroup
Three-Vessel Disease Subgroup
Mohr et al., Lancet 2013;381:629

14. SYNTAX Score-ll Eight Predictors
Anatomical SYNTAX Score
Age
Creatinine clearance
Left ventricular ejection fraction (LVEF)
Presence of unprotected left main coronary artery (ULMCA) disease
Peripheral vascular disease (PVD)
Female Sex
Chronic obstructive pulmonary disease (COPD)
Farooq et al., Lancet 2013;381:639

15. All other interaction P values <0.10
SYNTAX Score II: Designed to Objectively Discriminate Between CABG and PCI
Interactions
All other interaction P values <0.10 2
CrCl
Syntax score
Age
LVEF 1
Pint = 0.30
Log HR -1
PCI
PCI
PCI
PCI
CABG
CABG
CABG
CABG -2 20 40 60 60 70 80 90 30 60 90
120 10 20 30 40 50 60
Log HR 2 1 -1 -2
PVD
3VD vs LM
Gender
COPD
Pint = 1.0
PCI
PCI
PCI
PCI
CABG
CABG
CABG
CABG
3VD
LMS F M No
Yes No
Yes
Farooq V et al. Lancet 2013;381:639.

17. Event Rates Stratified by the SYNTAX Score-ll Through 5 Years
All-cause death MI
Ischemic-driven TVR
Xu et al., J Am coll Cardiol Intv 2014;7:1128

18. MACCE Rates Stratified by the SYNTAX Score-ll Through 5 Years
Xu et al., J Am coll Cardiol Intv 2014;7:1128

20. Bifurcation Angle (BA) Analysis
2-D Single-Plane Angiographic Images
LM bifurcation in LAO caudal view
LM bifurcation in RAO caudal view
New BA parameter:
Systolic-diastolic range (SDR) defined as absolute
difference between diastolic & systolic distal BA values (<10 vs >100)
3-D Reconstructed Image
Proximal BA defined between the LM stem and LCx; distal BA defined between LAD and LCx
Post PCI, proximal BA is enlarged, the distal BA gets narrower
Girasis et al., J Am Coll Cardiol 2010;3:41

21. Impact of PCI Diastolic Distal Bifurcation Angle (BA) on 5-Year MACCE
All-cause death, CVA, MI and Repeat Revascularization
MACCE at 5 yrs – pre-PCI distal BA
Pts with 1 stent in LMCA bifurcation (n=75)
MACCE at 5 yrs – pre-PCI distal BA
Pts with ≥2 stents in LMCA bifurcation (n=110)
Girasis et al., J Am Coll Cardiol Intv 2013;6:1250

22. Impact of Post-PCI Systolic-Diastolic Range (SDR)
of the Distal BA on 5-Year MACCE
All-cause death, CVA, MI and Repeat Revascularization
MACCE at 5 yrs – post-PCI BA SDR
Pts with 1 stent in LMCA bifurcation (n=75)
MACCE at 5 yrs – post-PCI BA SDR
Pts with ≥2 stents in LMCA bifurcation (n=110)
Girasis et al., J Am Coll Cardiol Intv 2013;6:1250

23. DELTA Registry: Cumulative Incidence of MACCE
at Follow-up of 5 Yrs
PCI Overall (n=1874)
CABG Overall (n=900) %
Chieffo et al., J Am Coll Cardiol Intev 2012;5:718

24. DELTA Registry: Study Population Flow Chart
Naganuma et al., J Am Coll Cardiol Intev 2014;7:354

25. DELTA Registry: Cumulative Incidence of MACCE
at 5 Yrs in Ostial/mid Shaft LM Lesions
PCI group (n=482) - 1 DES
P= 0.06
CABG group (n=374) %
P= NS
P= 0.009
P= NS
P= NS
Naganuma et al., J Am Coll Cardiol Intev 2014;7:354

26. Proposed Approach to LM PCI Single Stent Crossover
DK Crush II
T stenting
SKS/V stent
Culotte stent
Single Stent Crossover
Sign
LCX
50%
Insign
or small
LCX
Small LM
4 mm
Large LM

27. Bifurcation Left Main Stenting
An approach for bifurcational lesions when using 2 stents as planned strategy
Bifurcational lesion with short disease proximal to the bifurcation or very short left main and each branch is large size
Bifurcational lesion with main branch disease extending proximal to the bifurcation and side branch which has origin with about 900 angle
Bifurcational lesion with main branch disease extending proximal to the bifurcation and side branch which has origin with about 600 angle
DK/MINI Crush
SKS/V-STENT
T-STENT

28. DKCRUSH III Study: Clinical Follow-up at 12 Months
DK Group (n=210)
p=0.001
Culotte Group (n=209)
p=0.02 %
p=0.38
p=1.00
p=0.62
Chen et al., JACC 2013;61:1482

29. Method of Revascularization of Multi-vessel and LM Coronary Artery disease
CABG
PCI
Two-vessel CAD with proximal LAD stenosis A
Three Vessel CAD with low CAD burden (i.e., three
focal stenosis, low SYNTAX score)
Three-vessel CAD with intermediate to high CAD burden (i.e., multiple diffuse lesions, presence of CTO, or high SYNTAX score >32)/DM
U/I
Isolated left main stenosis U
Left main stenosis and additional CAD with low CAD burden (i.e., one to two vessel additional involvement, low SYNTAX score <33)
Left main stenosis and additional CAD with intermediate to high
CAD burden (i.e., three vessel involvement, presence of CTO, or high SYNTAX score >32) I 29

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

31. Completed Randomized Studies Evaluating Unprotected
Left Main Revascularization with PCI vs CABG
Noble
Excel
N patients, sites
1200; 26 European sites
1900; 126 sites in 17 countries
DES
BES Biomatrix®
EES, Xience, V/Prime®
LM location
Ostial, shaft, or bifurcation
LM severity
Angio DS >50% or FFR ≤0.80
Angio DS ≥70% or ≥50% - <70% + either FFR ≤0.80 or IVUS MLA ≤6.0 mm2 or extensive ischemia
Other anatomic inclusion criteria
≤3 additional non-complex lesions (excludes length >25 mm, CTO, 2-stent bifurcation, calcified or tortuous vessels)
SYNTAX Score ≤32
Primary endpoint
Death, CVA, non-index MI, revascularization
Death, CVA, MI
Timing of primary EP
2 years
Median 3 years
Duration of follow-up
5 years
5 year
Completed

32. Issues Involving The Case
Update on Unprotected Left Main (ULM) PCI
Risk of Non-cardiac Surgery after Coronary
Stenting

34. Risk of MACE Following Non-Cardiac Surgery
in Patients with Coronary Stents
Time Between Stent and Surgery Associated with MACE at 24 Months (N=124,844)
p = <0.001 %
Hawn et al., JAMA 2013;310:1462

35. 61,770 matched pts at VA centers who underwent stenting were compared in gps;
who underwent non-cardiac surgery vs who did not undergo surgery in 1:2 ratio

36. Cumulative Incidence of Adverse Cardiac Events Following Coronary Stent Placement
Holcomb et al., J Am Coll Cardiol 2014;64:2730

37. Adverse Cardiac Events and All-Cause Mortality at 30-Days
Post-Operative Time Interval: Surgical vs Nonsurgical Cohort
Event
All-Patients
(N=16,770)
Stent/Surg
(N=20,590)
Stent Only
(N=41,180) p
Overall Risk Difference, %
(95% CI)
Composite MACE
2.3
3.1
1.9
<0.001
1.3 (1.0 to 1.5) MI
1.6
2.5
1.1
1.4 (1.2 to 1.7)
Revascularization
1.0
0.37
0.1 (-0.1 to 0.3)
Al-cause mortality
0.7
1.4
0.4
1.0 (0.9 to 1.2)
Holcomb et al., J Am Coll Cardiol 2014;64:2730

38. Outcomes and Risk Differences in Surgical vs Nonsurgical Cohorts
30-Day Adverse Cardiac Event Rates (Surgical and Nonsurgical Cohorts)
Rates for Surgical and Nonsurgical Cohorts Immediately Post-Stent
Holcomb et al., J Am Coll Cardiol 2014;64:2730

39. Incremental Risk of Non-Cardiac Surgery
<6 Weeks (n=3222)
6 Weeks to 6 Months (n=13,419)
>6 Months to 24 Months (n=45,129) %
Composite cardiac MI Revascularization All-cause
mortality
Holcomb et al., J Am Coll Cardiol 2014;64:2730

40. ∆Risk Difference for Adverse Cardiac Events in the Stent/Surgery Group
Holcomb et al., J Am Coll Cardiol 2014;64:2730

41. Risk Difference in Adverse CE 30 Days
Following Surgery for Pts with Coronary Stents
Holcomb et al., J Am Coll Cardiol 2014;64:2730

42. After DAPT Interruption
Xience V USA Registry: Late ST Rates (30 D – 1 Year)
After DAPT Interruption
Overall
Standard (Low) Risk
Subsequent Late ST (ARC Def/Prob) (%)
0.49
0.37
0.26
0.16
13/ /1272
2/435 0/157
1/378 0/147
0/292 0/120
No Interruption
Interruption
After 30 Days
Interruption
After 90 Days
Interruption
After 180 Days
Krucoff, Hermiller, Sharma et al. JACC Intervent 2011;4:1298.

44. Stepwise Approach to Perioperative Cardiac Assessment for CAD
Fleisher et al., J Am Coll Cardiol 2014;64:2373

45. Summary of Recommendations for Supplemental Perioperative Evaluation
Fleisher et al., J Am Coll Cardiol 2014;64:2373

46. Summary of Recommendations for Perioperative Therapy
Fleisher et al., J Am Coll Cardiol 2014;64:2373

47. Algorithm for Antiplatelet Management in Patients with PCI and Non-Cardiac Surgery
DES: 6 mths
Fleisher et al., J Am Coll Cardiol 2014;64:2373

48. Clinical Outcomes With Short (≤6 Months)
vs Standard (At Least 12 Months) DAPT
Stefanini et al., J Am Coll Cardiol 2014;64:953

50. Take Home Message: Updates on ULM PCI and Risk of Non-cardiac surgery after stenting
Recent data support use of PCI in low-to-moderately complex ULM lesions with outcomes similar to CABG especially ostial/shaft lesions. In more complex lesions (Syntax score >32), CABG remains the standard choice. Results of completed EXCEL trial will have the final answer on this issue. ?BA prediction
Risk of non-cardiac surgery after stenting is highest in first 6 week period and then continue to decline overtime with significant reduction after 6 months. Hence unless really urgent, non-cardiac surgery should be deferred after 6 months post stenting.

51. Question # 1
In which SYNTAX score group of LM disease, CABG was superior to
PCI at 5 years with lower MACCE:
SYNTAX score <23
SYNTAX score >23
SYNTAX score 23-32
SYNTAX score >32
All SYNTAX groups

52. Question # 2
Which ULM pt will be Class III indication for PCI as per ACC Guidelines:
Isolated ULM lesion with SYNTAX score 32
ULM lesion with 2 V CAD and SYNTAX score 33 and low surgical risk
ULM lesion with 2 V CAD and SYNTAX score 33 and high surgical risk
ULM lesion with 3 V CAD and SYNTAX score 22
ULM lesion with 1 CTO and SYNTAX score 31

53. Question # 3
Recent data have suggested deferring non-cardiac surgery post stenting for……….. months to significantly reduce cardiac events:
A. 1.5 months
B. 3 months
C. 6 months
D. 12 months
E. >12 months

54. Question # 1 The correct answer is D
In which SYNTAX score group of LM disease, CABG was superior to
PCI at 5 years with lower MACCE:
SYNTAX score <23
SYNTAX score >23
SYNTAX score 23-32
SYNTAX score >32
All SYNTAX groups
The correct answer is D

55. Question # 2 The correct answer is B
Which ULM pt will be Class III indication for PCI as per ACC Guidelines:
Isolated ULM lesion with SYNTAX score 32
ULM lesion with 2 V CAD and SYNTAX score 33 and low surgical risk
ULM lesion with 2 V CAD and SYNTAX score 33 and high surgical risk
ULM lesion with 3 V CAD and SYNTAX score 22
ULM lesion with 1 CTO and SYNTAX score 31
The correct answer is B

56. Question # 3 The correct answer is C
Recent data have suggested deferring non-cardiac surgery post stenting for……….. months to significantly reduce cardiac events:
A. 1.5 months
B. 3 months
C. 6 months
D. 12 months
E. >12 months
The correct answer is C