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, ABIOMED, CSI, Trireme Medical Annapoorna S. Kini, MBBS, FACC Nothing to disclose Sameer Mehta, MBBS, FACC Consulting Fees – The Medicines Company

3. January 19th 2016 Case #79: RO, 78 yrs M
Presentation:
Patient with long standing history of stable angina, presented with new onset of CCS Class III angina and + stress MPI for moderate anterior and inferior ischemia. A cardiac cath done on October 20th 2015 revealed two vessel CAD; 80% prox LCx and 100% proximal LAD lesions and LVEF 50%. Pt underwent Promus Premier DES to pLC (2.75/24mm) and did well
Prior History:
Hypertension, Asthma, COPD, s/p PPM
Medications: All once daily dosage
ASA 81mg, Carvedilol 12.5mg, Clopidogrel 75mg, ISMN 30mg, Simvastatin 40mg, Enalapril 5mg, Inhalers 3

4. Case# 79: cont… Cardiac Cath 10/20/2015: Right Dominance
SYNTAX Score was: 26.5
Cardiac Cath 10/20/2015: Right Dominance
II V CAD with LVEF 50% due to antero-apical hypokinesis
LM: mild diffuse disease
LAD: 100% prox LAD, distal vessel fills well via RCA collaterals
LCx: 80% proximal LCx
Hospital course: Pt underwent Promus Premier DES (2.75/24) to prox LCx post dilated by 3/12mm NC Quantum balloon with excellent results. Pt continued to have class II angina symptoms
Plan Today:
Planned PCI of LAD CTO via antegrade or retrograde approach (Syntax score 23) 4

5. Appropriateness Criteria for Coronary Revascularization

6. Issues Involving The Case
MACE & femoral vascular complications in relation
to radial procedure volume in contemporary practice
Changing predictors of CTO recanalization
success in contemporary practice

7. Issues Involving The Case
MACE & femoral vascular complications in relation
to radial procedure volume in contemporary practice
Changing predictors of CTO recanalization
success in contemporary practice

9. MATRIX Trial: Clinical Outcomes%
Primary endpoint All-cause MI Stroke Urgent TVR ST BARC bleed
(mortality/MI/stroke) mortality def/prob , 3, or 5
p=0.03
p=<0.0001
p=0.66
p=0.34
p=1.00
p=0.20
p=0.05
Radial access (n=4197)
Femoral access (n=4207)
Valgimigli et al., Lancet 2015;385:2465

10. MATRIX Trial: Co-Primary Composite Outcomes
at 30 Days
All-cause mortality, MI or Stroke
All-cause mortality, MI, Stroke, or BARC Bleeding 3 or 5
Valgimigli et al., Lancet 2015;385:2465

11. MATRIX Trial: Stratified Analysis of Co-primary Outcomes
All-Cause Mortality, MI, or Stroke or BARC Bleeding 3 or 5
Valgimigli et al., Lancet 2015;385:2465

12. MATRIX Trial: Radial vs. Femoral Access in ACS
Differential MACE Rates in Various Radial Centers
Death/MI Bleeding Mortality Death/MI/ Bleeding Mortality Death/MI Bleeding Mortality
Stroke Stroke Stroke
Radial
Femoral %
p=<0.02 for Radial PCI in High vs Low Radial Center
p=< for Femoral PCI in High vs Low Radial Center
Low Radial PCI Center Intermediate Radial PCI Center High Radial PCI Center
(14.9 – 64.4%) ( %) (80.0 – 98.0%)
Many Letters to the editor for Valgimigli et al., Lancet 2015;385:2465

17. The Campeau Radial Paradox Study Population
Azzalini et al., J Am Coll Cardiol Intv 2015;8:1854

18. The Campeau Radial Paradox: Vascular Access Site Complications
Azzalini et al., J Am Coll Cardiol Intv 2015;8:1854

19. The Campeau Radial Paradox: VASC Rates
All catheterizations across historical vs contemporary cohorts
Diagnostics and therapeutic catheterizations separately
Azzalini et al., J Am Coll Cardiol Intv 2015;8:1854

20. The Campeau Radial Paradox: VASC Stratified by VASC Risk Score
Azzalini et al., J Am Coll Cardiol Intv 2015;8:1854

21. The Campeau Radial Paradox:
VASC Stratified by Propensity of Undergoing FA
Azzalini et al., J Am Coll Cardiol Intv 2015;8:1854

23. Possible Reasons for Radial Paradox:
- First, the higher the VASC rates observed in contemporary FA patients remained clinically meaningful and statistically significant despite adjustment with an accurate multivariate model .
- Second, the attributable risk of VASCs showed an inverse relationship with the number of comorbid conditions: the risk of a femoral VASC attributable to RA was greatest in patients with the lowest baseline risk of a VASC and in patients with the lowest propensity of undergoing FA, that is, the patients with clinical characteristics for which the operator would usually favor using RA.
- Third, these findings were consistent in patients undergoing diagnostic catheterizations and hence not influenced by improving interventional devices and techniques.
- Fourth, these findings have recently been alluded by the other groups who also observed unusually high rates of VASCs in FA patients in radial centers.

24. Recommendations to minimize the Radial Paradox
- Improve femoral access by use of fluoroscopy, ultrasound and
micro-puncture techniques
- Use of Bivalirudin as anti-coagulations
- Properly trained vascular closure device use
- Delay systemic anticoagulation during radial procedures until
selective coronary angiogram has been done, to avoid FA
puncture in fully anticoagulated pt in case of crossover to FA
Continuous education of young Interventionalists in FA access techniques with formal teaching, training on simulators and maintaining a minimal FA procedural volume.

25. RIVAL Trial: Various Outcomes by Radial PCI Volume
Jolly et al., Lancet 2011;377:1409

26. MATRIX Trial: Forest Plot of the Updated Meta-Analysis of trial Patients with ACS
Valgimigli et al., Lancet 2015;385:2465

27. PCI inHosptals Without On-Site Surgical Backup
Focused Update Sept 2015
Primary PCI: indications and Procedural Aspects
Vascular Access
The use of radial artery access can be useful to decrease access site complications.
PCI inHosptals Without On-Site Surgical Backup I
IIa
IIb
III A

28. Issues Involving The Case
MACE & femoral vascular complications in relation
to radial procedure volume in contemporary practice
Changing predictors of CTO recanalization
success in contemporary practice

29. Predictors of CTO Procedural Success
Multivariate analysis from TOAST-GISE
Variables
Hazard Ratio p
Length ≥15 vs. <8 mm
3.9
0.028
Severe calcification
3.5
0.023
Duration ≥ 180 days
3.1
0.013
Multi-vessel disease
2.3
0.009
Bridge collaterals present
2.2
Stump morphology
0.048
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Olivari et al., J Am Cardiol Coll 2003;41:1672 29 29

31. Overall procedural success was 72.5% in 1657 consecutive CTO Lesions;
Scoring model was developed in the derivation cohort of 1143 (70%) and then validated in 514 (30%) pts.

32. Multivariable Analysis
Angiographic Score Predicting CTO PCI Success
Multivariable Analysis
Alessandrino et al., J Am Coll Cardiol Intv 2015;8:1540

33. Angiographic Score Predicting CTO PCI Success
Independent Predictive Variables Scored According to OR OR
Score
Severe calcified lesion
2.72 +2
Previous CABG
2.49
+1.5
Lesion length ≥ 20 mm
2.04
Previous MI
1.60 +1
Blunt stump
1.39
Non-LAD CTO location
1.56
Alessandrino et al., J Am Coll Cardiol Intv 2015;8:1540

34. Angiographic Score Predicting CTO PCI Success
Procedural Success Rate According to CL-Score Value in the Derivation and Validation Groups
Class Class Class Class 3
Cl-SCORE CL-SCORE >1 < CL-SCORE ≥ < CL-SCORE ≥ 5
Derivation
Validation
Alessandrino et al., J Am Coll Cardiol Intv 2015;8:1540

36. The Evaluating Xience and Left Ventricular Function in PCI on Occlusions After STEMI (EXPLORE) Trial
The Impact of PCI for Concurrent CTO on Left Ventricular Function in STEMI Patients

37. Patients with STEMI + CTO LVEF and LVEDV MRI at 4 month
EXPLORE Trial Design
Patients
Patients with STEMI treated with pPCI and
with a non-infarct related CTO.
Patients with STEMI + CTO
Design
Global, multi-center, randomized, prospective
two-arm trial with either PCI of the CTO or no
CTO intervention after STEMI.
Blinded evaluation of endpoints.
1:1
CTO-PCI < 7d
No CTO-PCI
Objective
To determine whether PCI of the CTO
within 7 days after STEMI results in a
higher LVEF and a lower LVEDV
assessed by MRI at 4 months
LVEF and LVEDV MRI at 4 month
Henriques, TCT 2015

38. EXPLORE Trial: Flowchart
304 patients randomly assigned
150 randomized to CTO-PCI
154 randomized to No CTO-PCI
2 withdrew consent
0 withdrew consent
148 CTO-PCI
(1 refusal of CTO-PCI)
154 No CTO-PCI
148 with clinical follow-up
154 with clinical follow-up
12 primary imaging endpoints not available
6 poor imaging quality
6 Imaging not available
10 primary imaging endpoints
not available
5 with poor imaging quality
5 imaging not available
136 analyzed for primary imaging endpoints
144 analyzed for primary imaging endpoints
Henriques, TCT 2015

39. EXPLORE Trial: CTO-PCI Treatment Arm
CTO-PCI (n=147)
Number of days from primary PCI to CTO PCI (mean, SD) 5
(+2)
Number of days from randomization to CTO PCI (mean, SD) 2
Multiple CTO arteries treated 6
(4%)
Technique CTO procedure Antegrade only
124
(84%)
Retrograde 23
(16%)
Crossboss/ Stingray
(3%)
PCI successful, self-reported
117
(80%)
PCI successful, corelab adjudicated
106
(72%)
Everolimus eluting stent 95
(90%)
Number of stents used (median, IQR)
(1-3)
Henriques, TCT 2015

40. EXPLORE Trial: Primary Endpoint #1
(LVEF at 4months)
CTO-PCI (n=136)
No CTO-PCI (n=144)
LVEF (%)
p=0.60
CTO-PCI (n=136)
No CTO-PCI (n=144)
Difference (95%CI) p
LVEF (%)
44∙1
(12∙2)
44∙8
(11∙9)
-0∙8
(-3∙6 to 2∙1)
0∙60
Henriques, TCT 2015

41. EXPLORE Trial: Primary Endpoint #2
(LVEDF at 4months)
CTO-PCI (n=136)
LVEF (%)
No CTO-PCI (n=144)
p=0.70
CTO-PCI (n=136)
No CTO-PCI (n=144)
Difference (95%CI) p
LVEDV (mL)
215∙6
(62∙5)
212∙8
(60∙3)
2∙8
(-11.6 to 17.2)
0.70
Henriques, TCT 2015

42. Take Home Message: Higher MACE/Vascular complications in high radial centers and Predictors of first time CTO success
Recent data have suggested higher MACE and vascular complications at centers with high radial procedure volume. This may just be due to lack of expertise in femoral access due to too much emphasis on radial technique. Hence continuing femoral access technique education is of prime importance in ‘emerging breed of radial interventionalists’
Clinical and lesion related factors can easily identify CTO lesions likely to be associated with successful procedure. Hence these factors can easily be used in selecting the CTO lesions likely to be associated with +outcomes. Initial short term randomized data have shown no effect in LV functional parameters with CTO recanalization

43. Question # 1
Following statements are true for the radial paradox except:
Higher femoral complications in high vs low radial centers
Higher MACE rates in high vs low radial centers
C. Higher vascular complications in low vs high radial centers
D. Higher femoral vascular complications with both diagnostic and therapeutic procedures in high vs low radial centers
E. Higher femoral complications at high radial centers in patients at low risk of vascular complications

44. Question # 2
Meta-analysis of RCT in ACS have shown that the Radial procedures are associated with following lower adverse cardiac events compared to femoral procedures;
Mortality
Non-CABG bleeding
Myocardial infarction
Stent thrombosis
A and B
A, B and C

45. Question # 3
Following are the independent predictors of successful CTO recanalization except:
A. Severe calcified lesion
B. Prior CABG
C. Blunt stump
D. Non-LAD CTO location
E. Duration of CTO

46. Question # 1 The correct answer is C
Following statements are true for the ‘radial paradox’ except:
Higher femoral complications in high vs low radial centers
Higher MACE rates in high vs low radial centers
C. Higher vascular complications in low vs high radial centers
D. Higher femoral vascular complications with both diagnostic and therapeutic procedures in high vs low radial centers
E. Higher femoral complications at high radial centers in patients at low risk of vascular complications
The correct answer is C

47. Question # 2 The correct answer is D
Meta-analysis of RCT in ACS have shown that the Radial procedures are associated with following lower adverse cardiac events compared to femoral procedures;
Mortality
Non-CABG bleeding
Myocardial infarction
A and B
A, B and C
The correct answer is D

48. Question # 3 The correct answer is E
Following are the independent predictors of successful CTO recanalization except:
A. Severe calcified lesion
B. Prior CABG
C. Blunt stump
D. Non-LAD CTO location
E. Duration of CTO
The correct answer is E