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3. 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

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

5. May 19th 2015 Case #71: BS, 66 yrs F Presentation:
Patient with NIDDM presented with new onset CCS Class II angina and positive ETT, underwent cardiac cath on April 9th 2015 revealing 2 V CAD (multiple lesions in prox-mid LAD and CTO RCA with retrograde collaterals from LAD), LVEF 60% and SYNTAX score 26. Heart team discussion took place and patient elected for PCI. Pt underwent DES PCI (Xience Alpine x2) to prox-mid LAD and did well.
Prior History:
NIDDM, Hyperlipidemia
Medications: All once daily dosage
Metoprolol XL 50mg, Lisinopril 5mg, Metformin XL 1000mg, Simvastatin 40mg, Amlodipine 5mg, ASA 81mg 5

6. Case# 71: cont… Cardiac Cath 4/9/2015: Right Dominance
II V CAD with LVEF 60%
LM: No obstruction
LAD: multiple % lesions in prox-mid LAD, 70% S1
LCx: mild diffuse disease, 30% OM1
RCA: 100% occlusion prox RCA, distal vessel is large and fills via LAD-septal collaterals
Pt underwent PCI of LAD with Xience Alpine (3/33 & 3/12) with excellent results
SYNTAX Score was : 26
Plan Today:
PCI of CTO RCA via retrograde approach using LAD-
3rd septal collaterals 6

7. Appropriateness Criteria for Coronary Revascularization

8. Issues Involving The Case
Retrograde CTO Recanalization
2 Key trials from SCAI 2015: PROMETHEUS, TRIAGE

9. Issues Involving The Case
Retrograde CTO Recanalization
2 Key trials from SCAI 2015: PROMETHEUS, TRIAGE

10. Retrograde Wire Technique of CTO Recanalization

12. Temporal Trends and Learning Curve for High Volume, Retrograde, Experienced Operators
Operators in the retrograde-experienced, high volume group
CTO PCI Procedural and In-hospital Outcomes
Thompson et al., J Am Coll Cardiol Intv 2009;2:834

13. Temporal Success of Antegrade and Retrograde Techniques
Success with Both Approaches Improved for the Retrograde Operators Over Time
Thompson et al., J Am Coll Cardiol Intv 2009;2:834

14. Increased Use of Retrograde Approach and Technical Success Rate Over Time
2006
2007
2008
2009
2010
2011
30% %
Michael et al., Am J Cardiol 2013;112:488 14

15. Summary of Published Retrograde CTO PCI Series
Study
Year N
Prior CABG %
Septal CollateralUsed %
Reverse CART, %
Technical Success %
Major Complic %
Flouroscopy Time, min, mean ± SD
Contrast Use, ml mean ± SD
Sianos
2008
175
10.9
79.4 NR
83.4
4.6
59 ± 29
421 ± 167
Rathore
2009
157
17.8
67.5
84.7
4.5
Kimura
224
17.6
79.0
14.0
92.4
1.8
73 ± 42
457 ± 199
Tsuchikane
2010 93
10.8
82.8
60.9
98.9
0.0
60 ± 26
256 ± 169
Morino
136
9.6
63.9
79.2
US Registry
2012
462
50.0
71.0
41.0
81.4
2.6
61 ±
345 ± 177
Karmpaliotis et al., JACC Cardio Interv 2012;5:1273 15

17. Retrograde Techniques for CTO Recanalization
Typically reserved for LAD or RCA CTOs via septal collaterals; avoid using epicardial collaterals
Four techniques:
Direct retrograde crossing
Kissing wire crossing
Controlled Antegrade and Retrograde Subintimal Tracking (CART); balloon dilatation or knuckle wire
Reverse CART

18. Retrograde Wire Technique for Chronic Total Occlusion Recanalization
Four Patterns of Success in Retrograde CTO Recanalization
Sumitsuji et al. J Am Coll Cardiol Intv 2011;4:941.

19. The procedure involves five key steps:
Retrograde PCI: 5 Steps
Retrograde PCI for recanalization of CTOs has gained acceptance as a necessary technique to improve success
The procedure involves five key steps:
Wiring of the collateral from the donor artery into the distal bed of the recipient artery, usually with the use of hydrophilic jacketed guidewires
Delivery of over-the-wire microcatheters especially Corsair channel dilator to allow an exchange for a CTO-specific guidewire
Crossing the total occlusion with the CTO guidewire and dilating the CTO with the retrograde small balloon ( /8-10mmsize)
Placing an antegrade guidewire into the distal bed through the recanalized CTO. Rarely exteriorization of the long retrograde guidewire (Viper wire 360cm) is needed to advance antegrade monorail or over-the-wire small balloon
5. Stenting the lesion over the antegrade guidewire

20. Retrograde Wire Technique for CTO Recanalization
When to do Retrograde technique?
Minimum 200 CTO cases via antegrade technique
Dedicated setup, equipments and ability to handle compl.
Usually after failed antegrade (once or twice) approach
Ostial stump occlusion (RCA, LAD, LCx)

21. Fundamental Wire Technique and Current Strategy for Chronic Total Occlusion PCI
Procedural Steps of Current CTO-PCI
Cotralateral
Dual Injection
CTO - PCI
Single Wire Technique
Antegrade approach x2
Parallel Wire Technique
Retrograde approach (ostial)
Retrograde Wire Cross
Kissing Wire Cross
IVUS guide re-entry
CART
Reverse CART
Success
Failure

22. Issues Involving The Case
Retrograde CTO Recanalization
2 Key trials from SCAI 2015: PROMETHEUS, TRIAGE

23. Late Breaking Trial: PROMETHEUS Study
SCAI 2015
Late Breaking Trial: PROMETHEUS Study
Clinical Assessment of Patients with Acute Coronary Syndrome Managed with Percutaneous Coronary Intervention and Treated with Prasugrel or Clopidogrel using Academic Center Databases - The PROMETHEUS Study -
Presented by
Usman Baber, MD

24. PROMETHEUS Study: Study Schema
Hospitalization for Index PCI
Post-Hospitalization for Index PCI
Index
PCI
Day 30*
Day 90*
Day 180*
Day 365*
*Time (Day) from Index PCI
Hospital
Admission
for index PCI
Hospital
Discharge
for index PCI

25. PROMETHEUS Study: Data Extraction and Analysis
Data Elements pre-specified by Steering Committee
Extraction Sheet
Local Sites
Data Extraction
Data Coordinating Center
Validation/Quality Check
Aggregation
Analysis

26. Propensity Score Histograms Probability to Receive Prasugrel
PROMETHEUS Study:
Propensity Score Histograms
Prasugrel
Clopidogrel
Probability to Receive Prasugrel

27. PROMETHEUS Study: Sites
19,914 patients over 8 US Sites from 01 Jan 2010 to 30 June 2013
Aurora Healthcare Anthony DeFranco
Mount Sinai Medical,
Annapoorna Kini
Minneapolis Heart Institute, Craig Strauss
UPMC,
Catalin Toma
Cleveland Clinic,
Samir Kapadia
Christiana Care,
Sandra Weiss
Intermountain Heart Institute,
Brent Muhlestein
Mount Sinai Medical Center (n = 5344)
Cleveland Clinic (n = 3146)
Christiana Care (n = 2751)
Minneapolis Heart Institute (n = 2464)
Intermountain Heart Institute (n = 1893)
University of Pittsburgh Medical Center (n = 1710)
Duke University (n = 1651)
Aurora Healthcare (n = 955)
Duke University, Sunil Rao

28. PROMETHEUS Study: Statistical Methods
Sample Size Assumptions
MACE rate ~ 8.0% at 90 days
Relative reduction with prasugrel ~ 20%
Minimum of 4,300 prasugrel patients required to achieve 80% power
Propensity score adjustment
Stratification (Primary)
Inverse Probability weighting
Matching
Covariate adjustment

29. PROMETHEUS Study: CAD Presentation in Overall Cohort
Prasugrel and Clopidogrel Use in Overall Cohort
CAD Presentation by Therapy

30. PROMETHEUS Study: Procedural Characteristics*
Prasugrel
(n = 4,058)
Clopidogrel
(n = 15,856)
Multivessel disease
1672 (41.2%)
6723 (42.4%)
PCI vessel
Left Main
84 (2.1%)
583 (3.9%)
LAD
1972 (48.6%)
6926 (43.7%)
Circumflex
1100 (27.1%)
4795 (30.2%)
RCA
1430 (35.2%)
5368 (33.9%)
At least one B2/C type lesion
2848 (71.7%)
10763 (75.3%)
At least one lesion with moderate/severe calcification
468 (12.0%)
2694 (19.3%)
Total stent length
31.4 ± 20.2
30.50 ± 20.9
Minimum stent diameter
3.01 ± 0.49
2.96 ± 0.50
At least one 1st gen DES
297 (7.3%)
2496 (15.7%)
At least one 2nd gen DES
3297 (81.2%)
10525 (66.4%)
At least one BMS
569 (14.0%)
3927 (24.8%)
Procedural anticoagulation
Bivalirudin
2743 (67.6%)
11730 (74.0%)
GP2b3a inhibitor
1178 (29.0%)
3391 (21.4%)
*p <0.05 for all except multivessel disease (p=0.17) and RCA (0=0.096)

31. PROMETHEUS Study: Overall Unadjusted MACE
Clopidogrel (n=15856)
Prasugrel (n=4058)
40%
p-value<0.001
3.5 [ ]
5.7 [ ]
8.3 [ ]
12.1 [ ]
30%
6.2 [ ]
9.6 [ ]
14.3 [ ]
20.7 [ ]
MACE %
20%
10% 0% 30 90
180
365
Days After PCI

32. PROMETHEUS Study: Hazard Ratios for Overall MACE

33. PROMETHEUS Study: Hazard Ratios for Overall MACE

34. PROMETHEUS Study: Hazard Ratios at 90 Days (Primary Endpoint)

35. PROMETHEUS Study: Hazard Ratios for MI

36. PROMETHEUS Study: Hazard Ratios for
All-Cause Death

37. PROMETHEUS Study: Hazard Ratios for Bleeding

38. PROMETHEUS Study: Hazard Ratios for Bleeding

39. PROMETHEUS Study: Conclusions
The clinical profile of ACS patients treated with clopidogrel as compared to prasugrel differs substantially across US academic medical centers
The overall burden of risk factors for both ischemic and hemorrhagic events are much lower in patients treated with prasugrel
Although in this study prasugrel use was associated with lower rates of ischemic adverse events, the magnitude of benefit attenuated and was no longer statistically significant after adjusting for baseline differences
Analogously, lack of adjusted bleeding difference with prasugrel may reflect selection of patients at very low risk for hemorrhagic complications
Recalibrating ‘real-world’ use of prasugrel to better approximate a patient’s ischemic risk may yield a more appreciable therapeutic benefit. Broader use of prasugrel in eligible patients may achieve the therapeutic results seen in clinical trials.

40. Late Breaking Trial: TRIAGE Study
SCAI 2015
Late Breaking Trial: TRIAGE Study
Impact of an integrated treatment algorithm based on platelet function testing and clinical risk assessment: Results of the TRIAGE study

41. TRIAGE Study: Objective
Compare outcomes in patients treated with prasugrel vs. clopidogrel at PCI following determination of platelet reactivity in conjunction with clinical risks:
Primary Efficacy Endpoint at 1 year
MACE = composite of death, non-fatal MI, definite or probable stent thrombosis
Primary Safety Endpoint at 1 year
Bleeding = BARC 2, 3 or 5

42. TRIAGE STUDY ALGORITHM
PRU tested in the cath lab prior to PCI
PRU ≥ 230 = HTPR
PRU < 230 = LTPR
Group 2 - Age <75y, Weight ≥60kg, No stroke/TIA/malignancy
Group 1 - Age ≥ 75y, Weight <60kg, Previous stroke/TIA, malignancy
Clopidogrel 75mg
HIGH ISCHEMIC RISK
Yes No
Clopidogrel 75mg
Or Prasugrel 5mg
HIGH BLEEDING RISK
HIGH BLEEDING RISK
PRU = P2Y12 reactivity units, VerifyNow Assay (Accumetrics)
PRU = P2Y12 reactivity units
HTPR = High on treatment platelet reactivity
LTPR = Low on treatment platelet reactivity
Yes No
Yes No
Prasugrel 5mg
Prasugrel 10mg
Clopidogrel 75mg
Or Prasugrel 5mg
Prasugrel 10mg

43. TRIAGE Study: Overall Cohort
Mean age of years and 19% women
40% patients at high ischemic risk by study criteria,
58% patients with PRU ≥230 and/or high ischemic risk by study criteria;
34% patients at high bleeding risk by study criteria
72% received Clopidogrel, 28% received Prasugrel

44. Primary Efficacy Endpoint: MACE (Death, MI, ST)
TRIAGE Study:
Primary Efficacy Endpoint: MACE (Death, MI, ST)
Clopidogrel (n=228)
Prasugrel (n=90)
0.15
LogRank Test
0.10
p=0.70
Cumulative incidence, %
4.4%
0.05
3.5%
0.00 30 90
180
365
Days from index PCI

45. Secondary Ischemic Endpoints
TRIAGE Study:
Secondary Ischemic Endpoints
Clopidogrel (n=228)
Prasugrel (n=90)
p=NS %
Death/ST/Peri-proc Death ST Non-fatal MI Peri-procedural TVR
and non-fatal MI MI

46. TRIAGE Study: Primary Safety Endpoint: BARC Bleeding 2, 3, or 5
LogRank Test
p=0.47
0.00
0.05
0.10
0.15 30 90
180
365
Clopidogrel (n=228)
Prasugrel (n=90)
Cumulative incidence, %
7.9%
5.6%
Days from index PCI

47. Secondary Bleeding Endpoints
TRIAGE Study:
Secondary Bleeding Endpoints
Clopidogrel (n=228)
Prasugrel (n=90)
p=NS %

48. TRIAGE Study: Conclusions
Use of a clinical risk algorithm to triage real-world PCI patients for choice and intensity of thienopyridine prescription resulted in similar ischemic outcomes in HTPR patients receiving prasugrel and primarily LTPR patients on clopidogrel.
There was no untoward increase in bleeding with prasugrel compared with clopidogrel with this algorithm.

49. Take Home Message: Retrograde CTO recanalization and Current trends in type & choice of antiplatelet therapy
Retrograde technique of CTO revascularization is technically challenging requiring extra skills and increases the overall procedural success rates of CTO. It should be attempted after failed antegrade approach(s) except in cases of flush ostial CTOs
PROMETHEUS study showed that clinicians consider bleeding ahead of the efficacy in selecting the type of antiplatelet therapy. Also simple algorithms incorporating bleeding and ischemic risk, may minimize the bleeding complications while maintaining the efficacy of the APT .

50. Question # 1
Following are the Retrograde approaches to CTO recanalization except:
Kissing wire technique
CART technique
Reverse CART technique
Direct retrograde wire technique
STAR technique

51. Question # 2
PROMETHEUS study showed that Prasugrel is being used in following % of PCI cases in ACS:
<10%
10-30%
30-40%
40-50%
>50%

52. Question # 3
TRIAGE study of PRU based choice of antiplatelet therapy showed the following;
A. Significantly lower MACE with Prasugrel vs Clopidogrel
B. Significantly lower peri-procedural MI with Prasugrel vs Clopidogrel
C. Numerically lower BARC 2,3,5 bleeding with Prasugrel vs Clopidogrel
D. Significantly higher bleeding with Prasugrel vs Clopidogrel
E. Significantly lower ST with Prasugrel vs Clopidogrel

53. Question # 1 The correct answer is E
Following are the Retrograde approaches to CTO recanalization except:
Kissing wire technique
CART technique
Reverse CART technique
Direct retrograde wire technique
STAR technique
The correct answer is E

54. Question # 2 The correct answer is B
PROMETHEUS study showed that Prasugrel is being used in following % of PCI cases in ACS:
<10%
10-30%
30-40%
40-50%
>50%
The correct answer is B

55. Question # 3 The correct answer is C
TRIAGE study of PRU based choice of antiplatelet therapy showed the following;
A. Significantly lower MACE with Prasugrel vs Clopidogrel
B. Significantly lower peri-procedural MI with Prasugrel vs Clopidogrel
C. Numerically lower BARC 2,3,5 bleeding with Prasugrel vs Clopidogrel
D. Significantly higher bleeding with Prasugrel vs Clopidogrel
E. Significantly lower ST with Prasugrel vs Clopidogrel
The correct answer is C