1. Complex Coronary Cases
Supported by:
Abbott Vascular
Boston Scientific Corporation
Medtronic, Inc.
AstraZeneca
St Jude’s Medical
Abiomed
Vascular solution
CSI Inc.

2. Disclosures
Samin K. Sharma, MBBS, FACC Speaker’s Bureau – Boston Scientific Corporation, Abbott Vascular Inc, AngioScore, Daiichi Sankyo Inc, Abiomed, CSI 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

3. Feb 18th 2014 Case #20: CS, 82 yrs M Presentation:
Patient presented with new onset exertional dyspnea and negative stress MPI, but coronary CTA revealed extensive calcific three vessel CAD. A cardiac cath on Jan 10th 2014 revealed complex calcific 3 V CAD with normal lV function (SYNTAX score 36). Heart team discussion took place and CABG was recommended but declined by the pt and family. Pt was placed on MMT.
Prior History:
Hypertension, Hyperlipidemia, prior CVA in 2001 with no deficit
Medications: All once daily dosage
Metoprolol XL 25mg, ISMN 60mg, ASA 81mg, Atorvastatin 20mg, Valsartan 80mg 3

4. Case# 20: cont… SYNTAX score 36
Cardiac Cath 01/10/2014: Right Dominance
3 V CAD with LVEF 60%
Left Main: no obstruction
LAD: 80% calcified lesions in prox and mid LAD, 90% D1/D2
LCx: multiple 80-90% lesions in prox, OM1/OM2 and LPL
RCA: 90% calcified lesion in prox with moderate diffuse disease in large vessel and 80% diffuse RPDA lesion
CABG was recommended after Heart team discussion and pt declined and went home on MMT to think over about CABG. Pt continued to have DOE symptoms <1block (CCS class III).
Plan Today:
- PCI of calcific RCA as 1st part of staged multi-vessel PCI
SYNTAX score 36 4

5. Appropriateness Criteria for Coronary Revascularization

6. Issues Involving The Case
Status of Trans Radial Intervention (TRI-PCI)
Role of Kissing Balloon Inflation (KBI) in PCI

7. Issues Involving The Case
Status of Trans Radial Intervention (TRI-PCI)
Role of Kissing Balloon Inflation (KBI) in PCI

9. Adoption of Radial Access in PCI in US
Trend in the Use of r-PCI Over Time in the Overall & Key Subgroups
All Patients 20 18 16 14 12 10 8 6 4 2
16.1%
% Radial
Overall % Radial PCI
Qtr
Qtr
Qtr
Qtr
Qtr
Qtr
Qtr
Qtr
Qtr
Qtr
Qtr
Qtr
Men and Women
Pts with Stable angina, NSTE ACS, STEMI 20 18 16 14 12 10 8 6 4 2 20 18 16 14 12 10 8 6 4 2
Female
Male
UA/NSTEMI
STEMI
Stable Angina
% Radial
% Radial
Qtr
Qtr
Qtr
Qtr
Qtr
Qtr
Qtr
Qtr
Qtr
Qtr
Qtr
Qtr
Qtr
Qtr
Qtr
Qtr
Qtr
Qtr
Qtr
Qtr
Qtr
Qtr
Qtr
Qtr
Feldman et al., Circulation 2013;127:2295

10. Adoption of Radial Access in PCI
Unadjusted Rates of the Primary Outcomes of r-PCI and f-PCI
r-PCI
f-PCI %
Feldman et al., Circulation 2013;127:2295

11. Adoption of Radial Access in PCI
Unadjusted and Adjusted Association Between r-PCI and Primary Outcomes (f-PCI as Reference)
Unadjusted
Adjusted
Odds Ratio
Outcome
OR (95% CI)
p Value
C Index
Procedural Success
1.24 ( )
<0.001
1.13 ( )
0.651
Any bleeding compl
0.42 ( )
0.51 ( )
0.774
Any vasc compl
0.36 ( )
0.39 ( )
0.672
Feldman et al., Circulation 2013;127:2295

13. Radial Access in STEMI PCI
Temporal Trend in Use of TRI for STEMI PCI from 2007 to 2011
Baklanov et al., JACC 2013;61:420

14. Radial Access in STEMI PCI
Procedural Characteristics in Patients with STEMI Treated with Radial and Femoral Access PCI
Baklanov et al., JACC 2013;61:420

15. Radial Access in STEMI PCI In-Hospital Outcomes of TRI in STEMI
Baklanov et al., JACC 2013;61:420

16. SAFE-PCI for Women: Objective
To Determine the Efficacy and Feasibility of Transradial PCI in Women

17. SAFE-PCI for Women Trial: Study Design
Female patient undergoing PCI or cardiac cath w/poss. PCI
Radial
Femoral
N=3000 pts randomized for 1800 PCI pts
Patent hemostasis required
Vascular closure devices allowed
Best background medical therapy
Bivalirudin, P2Y12 inhibitors
2b3a at investigator’s discretion
Primary Efficacy Endpoint (72 hrs or hospital discharge):
BARC Types 2, 3, or 5 bleeding or Vascular Complications requiring intervention
Primary Feasibility Endpoint: Access site crossover
Secondary endpoints: Procedure duration, total radiation dose, total contrast volume, 30-day death/vascular complications/unplanned revas.
Rao et al, TCT 2013

18. SAFE-PCI for Women: Endpoint Definitions
Primary Efficacy Endpoint
Primary Feasibility Endpoint
BARC Bleeding
Type 2: Overt, actionable bleeding not meeting criteria for type 3, 4, or 5 bleeding
Type 3:
Overt bleeding with hgb drop ≥ 3 g/dL (corrected for transfusion)
Transfusion with overt bleeding
cardiac tamponade
bleeding requiring surgical intervention or intravenous vasoactive drugs
intraocular bleeding or ICH
Type 5: Fatal bleeding
Vascular complications requiring intervention
AV fistula
Pseudoaneurysm
Arterial access site occlusion
Access site crossover
Inability to complete the procedure from the assigned access site
CEC Adjudication of all suspected bleeding or vascular complication events
Rao et al, TCT 2013

19. SAFE-PCI for Women Trial: Methods Workflow
Randomization
Demographics
Medical Hx
Procedural data
Autopopulate
Unique pages for trial
Analytic
Database
Rao et al, TCT 2013

20. SAFE-PCI for Women Trial: Conduct
After 1120 women had been randomized, routine review of trial endpoints by DSMB
Primary efficacy event rate markedly lower than expected
Trial unlikely to show a difference at the planned sample size
Recommended termination of the trial
No harm noted in either the radial or femoral groups
Steering committee voted to continue study until enrollment in a quality-of-life sub-study was complete (N=300)
Rao et al, TCT 2013

21. SAFE-PCI for Women Trial: Final Recruitment
1787 women randomized
At 60 US sites
893 women assigned to Radial
894 women assigned to Femoral
ITT: Primary 72 hr or
discharge endpoints
891 women
345 underwent PCI
884 women
Secondary 30-day endpoints
290 PCI pts
292 PCI pts
96.7% of sites enrolled ≥ 1 patient
70.9% of sites enrolled ≥ 10 patients
Rao et al, TCT 2013

22. SAFE-PCI for Women Trial: Baseline Characteristics
Total Randomized Cohort
Radial
(N=893)
Femoral
(N=894)
Median age, yrs
63.4 (55.1, 72.2)
63.9 (55.7, 72.0)
Median BMI, kg/m2
30.5 (26.1, 35.1)
30.8 (26.5, 35.8)
Current or Recent smoker
27.2%
24.2%
HTN
79.5%
79.9
Prior MI
17.9%
19.6%
Prior CABG
4.5%
6.4%
Dialysis
0.3%
PAD
5.7%
6.0%
Diabetes
35.2%
35.0%
CAD presentation
Non-ACS
NSTEACS
STEMI
46.8%
52.7%
0.4%
43.5%
56.3%
0.2%
Rao et al, TCT 2013

23. SAFE-PCI for Women Trial: Primary Efficacy and Feasibility Endpoints
Total Randomized Cohort
Radial (n=893)
Radial (N=893)
Femoral (N=894) OR
(95% CI) P
BARC 2, 3, 5 bleeding or Vasc Complications
0.6%
1.7%
0.3 ( )
0.03
Access site crossover
6.7%
1.9%
3.7 ( )
<0.001
Femoral (n=894)
p=<0.001 %
p=0.03
BARC bleeding Access site
or vasc compl crossover
Most common reason for needing to convert from radial to femoral access to complete the procedure was radial artery spasm (43.6% of crossovers)
Only one patient did not have the procedure successfully completed – was randomized to femoral
Rao et al, TCT 2013

24. SAFE-PCI for Women Trial: Primary Efficacy and Feasibility Endpoints
PCI Cohort
Radial (n=345)
Radial (N=345)
Femoral (N=346) OR
(95% CI) P
BARC 2, 3, 5 bleeding or Vasc Complications
1.2%
2.9%
0.4 ( )
0.12
Access site crossover
6.1%
1.7%
3.6 ( )
0.006
Femoral (n=346)
p=0.006 %
p=0.12
BARC bleeding Access site
or vasc compl crossover
Most common reason for needing to convert from radial to femoral access to complete the procedure was radial artery spasm (42.9% of crossovers)
Interactions not significant for ACS vs. Non-ACS, tertiles of site radial volume, or PCI vs. no PCI
Rao et al, TCT 2013

25. SAFE-PCI for Women Trial: Secondary Endpoints
PCI Cohort
Radial
(N=290)
Femoral
(N=291) P
Procedure duration (min)
51.6 ± 32.3
49.9 ± 30.5
0.46
Total radiation dose (mGy)
1604 ± 1394
1472 ± 1274
0.26
Total contrast volume (mL)
152.7 ± 76.9
165.6 ± 82.7
0.03
30-day death, vascular complications, or unplanned revasc
5.2%
3.4%
Patient prefers assigned access site for next procedure
71.9%
23.5%
0.01
Rao et al, TCT 2013

26. SAFE-PCI for Women Trial: Conclusions
The SAFE-PCI for Women Trial represents several “firsts”
The first randomized trial comparing interventional strategies in women
The first multicenter randomized trial comparing radial with femoral access in the United States
The first registry-based randomized trial in the United States
In this trial that did not reach its planned enrollment due to early termination, radial access
Did not significantly reduce bleeding or vascular complications in the subgroup of women undergoing PCI
Did significantly reduce bleeding or vascular complications in the larger sample size of all women undergoing cardiac catheterization or PCI
Was preferred over femoral approach by the majority of women undergoing PCI
Increased the need for conversion to femoral access in ~6% of cases
Rao et al, TCT 2013

28. RADIAL-CABG Trial: Patient Screening & Enrollment
Screened
n=237
109 patients were not included for the following reasons:
Abnormal Allen’s test, n=29
Participation in other trials, n=33
Known severe peripheral vascular disease, n=18
CTO interventions, n=17
Known occluded grafts, n=4
Declined participation, n=6
Elevated INR, n=2
Randomized
n=128
Transfemoral approach
n=64
Transradial approach
n=64
Had diagnostic cath only (n=34)
Had diagnostic cath + PCI (n=29)
Had PCI only (n=1)
Crossover TR access (n=0)
Hand diagnostic cath only (n=40)
Had diagnostic cath + PCI (n=23)
Had PCI only (n=1)
Crossover to TF access (n=1)
Michael et al., JACC Cardiovasc Interv 2013;6:1138

29. RADIAL-CABG Trial:
Procedural Outcomes and Resource Use in Patients Undergoing Diagnostic Coronary Angiography
Michael et al., JACC Cardiovasc Interv 2013;6:1138

30. RADIAL-CABG Trial:
Procedural Outcomes and Resource Use in Patients Undergoing Coronary Intervention
Michael et al., JACC Cardiovasc Interv 2013;6:1138

31. RADIAL-CABG Trial: Patients’ Access Preference
for Future Catheterization
TR Group
TF Group
Others in Radial group:
Lower adhoc PCI
Higher access crossover 17%
Similar vascular complications
p=<0.001 %
Michael et al., JACC Cardiovasc Interv 2013;6:1138

32. Status of Trans-Radial PCI: Recommendations
STEMI
ACS
↓MACE +
↓Bleeding
- High risk of bleeding
- Overweight
- PAD
- ? Women
- ? Routine
Benefit in ↓ Bleeding or Vascular Compl
CABG pt
Radial spasms/AV fistula
Aortic Arch anomaly
No Benefit
or harm
Increasing TRI Volume

33. Issues Involving The Case
Status of Trans Radial Intervention (TRI-PCI)
Role of Kissing Balloon Inflation (KBI) in PCI

34. Kissing Balloon Inflation
Rules Guiding the Choice of the Balloon Diameters for Kissing Balloon Inflation
Squeglia and Chevalier, JACC Cardiovasc Interv 2012;5:803

36. Kissing Balloon Inflation
Summary of Clinical Trials Assessing the Clinical Utility of KB Inflation in PCI
Study N
(KB vs Non-KB) %
F/U
Cardiac Death
(KB vs Non-KB) % MI
TLR
MACE ST
(KB vs Npn-KB)
THUEBIS
56 vs 54
6 mos
0 vs 3.7
3.6 vs 1.9
17.9 vs 14.8
23.2 vs 24.1
Nordic III
238 vs 239
0.8 vs 0
0.4 vs 1.3
1.3 vs 1.7
2.1 vs 2.5
0.4 vs 0.4
CORPAL Kiss
124 vs120
12 mos
0.8 vs 1.7
3.2 vs 1.7
4.0 vs 1.7
9.0 vs 6.0
0.8 vs 0.8
Squeglia and Chevalier, JACC Cardiovasc Interv 2012;5:803

37. Outcome of Kissing Balloon Inflation in Single Stent Strategy in Randomized Trials
KB Inflation
Non-KB Inflation
P =NS in all %
TLR MACE ST TLR MACE ST TLR MACE ST
THUEBIS Study (n=110)
Nordic III Study (n=477)
CORPAL Kiss Study (n=224)
Squeglia and Chevalier, JACC Cardiovasc Interv 2012;5:803

38. Stent Deformation caused by PTCA via MV Stent: Rationale for final Kissing Balloon Inflation (KBI)
Provisional
T-Stent

39. Kissing Balloon Inflation
Influence of Main Vessel Stent Cell Rewiring on Stent Deformation Following Kissing Balloon
Better scaffolding pushes the struts inward towards the main vessel lumen
Bench testing showing wire crossing through strut closest to the carina
Squeglia and Chevalier, JACC Cardiovasc Interv 2012;5:803

41. Provisional SB Stenting
Proximal Optimization Technique (POT)
Inflating a short, bigger balloon just proximal to the carina
Good proximal stent apposition
Restoring the normal carina configuration

42. Optimization of Stent Result
Choose the stent diameter related to the size of the distal main vessel
The proximal part of the stent is then post-dilated (Proximal Optimization Technique (POT)
- Optimize stent apposition in the
proximal MV
- Facilitates a “distal’ cross as opposed
to a proximal one to improve a
scaffolding of the ostium of the side
branch

43. Contemporary Bifurcation Intervention
Contemporary provisional Side Branch Stenting
Facilitates distal MV stent strut wire passage during guide wire exchange
POT performed by post-dilating MV stent prox to carina
Short NC balloon sized for prox MV reference diameter
Creation of stent scaffold at ostium of SB following KBI
Mylotte et al., Cath and Cardiovasc Interv 2013;82:E437

44. Kissing Balloon or Sequential Dilation of the Side Branch and Main Vessel for Provisional Stenting of Bifurcations
Flow Chart and Representative Planar Radiographic Images
Post-Dilation in Bifurcation Stenting
Foin et al., JACC Interven 2012;5:47. 44

45. Kissing Balloon or Sequential Dilation of the Side Branch and Main Vessel for Provisional Stenting of Bifurcations
Post-Dilation in Bifurcation Stenting
Finite Element Analysis in the Model Bifurcation
Foin et al., JACC Interven 2012;5:47. 45

46. Post-Dilation in Bifurcation Stenting
Kissing Balloon or Sequential Dilation of the Side Branch and Main Vessel for Provisional Stenting of Bifurcations
Post-Dilation in Bifurcation Stenting
Ostial Stenosis and Strut Malapposition Measured in the Bifurcation and Proximal Stent Edge
Foin et al., JACC Interven 2012;5:47. 46

47. Diameter Stenosis after Main Vessel Stenting, %
Functional Assessment of Jailed Side Branches in Coronary Bifurcation lesions Using FFR
Diameter Stenosis after Main Vessel Stenting, %
Ahn et al., JACC 2012;5:155

48. OPTIMIZING TECHNIQUE of BIFURCATION STENTING:
Indications for KBI
Sidebranch compromise; decrease flow, FFR <0.8
PTCA of SBr via stent struts
2 stent strategy
Downstream lesion for future need of PCI

49. Take Home Message Status of Transradial PCI & Role of Kissing Balloon Inflation
Transradial PCI use is on gradual rise in the US with latest reports being in high teens. TRI is trended with lower bleeding & vascular complications but significantly higher access site crossover to trans-femoral approach. In STEMI pts, TRI has shown to be especially beneficial by reducing bleeding and perhaps mortality
Few randomized trials have shown the futility of routine kissing balloon inflation in bifurcation lesions. If SBr PTCA is required after main vessel stenting, then KBI is routinely recommended. Sequential balloon inflation rather then KBI has shown promising results. Final KBI is essential in bifurcation lesions requiring 2-stent approach

50. Question # 1
For the SAFE-PCI trial, following statement is correct for the radial approach :
Higher crossover to femoral approach
Lower cross over to femoral approach
Lower fluoroscopy duration
Significantly lower bleeding/vascular complications in all pts
Significantly lower mortality

51. Question # 2
What percent of pts usually cross over to femoral approach from radial approach in the trials of TRI PCI ?
<5%
5-10%
>10-15%
>15-20%
>20%

52. Question # 3
Following statement is true for routine kissing balloon inflation in the treatment of bifurcation lesions:
A. KBI reduces TLR
B. KBI reduces stent thrombosis
C. KBI reduces peri-procedure MI
D. KBI reduces overall MACE
E. KBI is not beneficial routinely

53. Question # 1
For the SAFE-PCI trial, following statement is correct for the radial approach :
Higher crossover to femoral approach
Lower cross over to femoral approach
Lower fluoroscopy duration
Significantly lower bleeding/vascular complications in all pts
Significantly lower mortality
The correct answer is A as SAFE-PCI trial showed about 6% crossover to femoral approach in the radial group while other parameters were not significantly different

54. Question # 2
What percent of pts usually cross over to femoral approach from radial approach in the trials of TRI PCI ?
<5%
5-10%
>10-15%
>15-20%
>20%
The correct answer is B as SAFE-PCI and other trials comparing TRI vs. TFI have shown about 6-8% crossover to femoral approach in the radial group.

55. Question # 3
Following statement is true for routine kissing balloon inflation (KBI) versus no-KBI in the treatment of bifurcation lesions:
A. KBI reduces TLR
B. KBI reduces stent thrombosis
C. KBI reduces peri-procedure MI
D. KBI reduces overall MACE
E. KBI is not beneficial routinely
The correct answer is E as 3 randomized trials have shown no benefit of routine KBI vs. no-KBI in treatment of bifurcation lesions.