EURO CTO CLUB Madrid 2014

26 / 9/ 2014

Update Japanese Multicenter Registry: 14:35- 14:50

Based on WEB registry 2013

Masahisa Yamane , MD, FACCOLV Cardiovascular Center,

Aalst, BelgiumSt Luke‘s International Hospital ,

Tokyo, JapanSaitamaSekishinkai Hospital,

Saitama, Japan

Session 7 Registries

Purpose of Retrograde Summit

Retrograde Summit was originally established to investigate clinical results of percutaneous coronary intervention to treat chronic total occlusions (CTO) treated by retrograde approach.

From year 2012, all procedure data for CTO recanalization including attempted by antegrade approach were acquired so as to deeply understand clinical outcomes in real-world and investigate long-term efficacy of successful CTO recanalization.

26 / 9/ 2014

Definitions of terms• CTO - TIMI flow grade 0 on coronary angiogram and occlusion

period with > 3 months or unknown• Retrograde Approach - Any CTO-PCI attempt, with wiring through collateral channels• MACCE (Major Adverse Cardiac and Cerebrovascular Event) - Death, Myocardial Infarction, Stroke, Emergent CABG and/or

TVR• Procedure Success - Recanalization of target lesion with restoration of TIMI flow

grade 3 and residual stenosis <50%

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Annual change of enrollment

2009 2010 2011 2012 20130

400

800

1200

1600 1542 1472 14171553

1676

378(24.5%)

423(28.7%) 365

(25.8%)

490(31.6%)

538（ 32.1% ）

CTO-PCI Retrograde

Num

ber o

f CTO

pro

cedu

res

WEB registry started from 2012 26 / 9/ 2014

57 Participant Hospitals (2013)Saiseikai Yokohama-City Eastern HospitalSapporo Cardio Vascular ClinicSakurabashi Watanabe HospitalToyohashi Heart CenterSaitama Cardiovascular and Respiratory CenterSaitama Sekishinkai HospitalTakase ClinicThe Cardiovascular InstituteHigashi Takarazuka Satoh Hospital Sanda City Hospital Edogawa Hospital Nagoya Heart Center Seirei Hamamatsu General HospitalHoshi General Hospital Tokorozawa Heart CenterSaiseikai Fukuoka General Hospital Hokkaido Social Insurance HospitalYotsuba Circulation ClinicShiga Medical Center for AdultsNagoya Tokushukai HospitalRinku General Medical Center Kusatsu Heart CenterKakogawa East City Hospital Fukaya Red Cross Hospital Hokko Memorial Hospital Showa University HospitalNagoya Daini Red Cross HospitalDaini Okamoto General HospitalMie Heart Center

Kyoto Katsura HospitalKushiro City General HospitalShowa General HospitalShinkoga Hospital Kanagawa Cardiovascular and Respiratory CenterTokeidai Memorial HospitalIwaki Kyouritsu HospitalHyogo Brain and Heart CenterYokohama Sakae Kyosai HospitalHyogo Prefectural Amagasaki HospitalIwate Prefectural Central HospitalShuuwa General HospitalOsaka Saiseikai Izuo HospitalItabashi Chuo HospitalNTT East Sapporo HospitalTodachuo General HospitalHamada Medical CenterHokusetsu General HospitalTokuyama Chuo HospitalOsaki Citizen HospitalTokushima Red Cross HospitalKobe Redcross HospitalYokohama Shintoshi Neurosurgical HospitalOhta General Hospital Ohta Nishinouchi Hospital

Toho University Omori Medical CenterTsukuba Memorial HospitalMimihara General HospitalKansai Medical University Takii Hospital

In order of entry number

Jan 2012 – Dec 2013

The number of registry : 3294

Registered Hospital : 57

Case enrollment : 3,294 CTO-PCIs

Final subject for analysis:3,229 CTO-PCIs

Total (n) 2012 (n) 2013 (n)CTO-PCIs 3,229 1,553 1,676 - Antegrade alone 2,201 1,063 1,138 - Retrograde 1,028 490 538

65 cases were excluded due to insufficient case card information

Registry Data 2012-2013

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Procedure flowchart based on each procedure

CTO-PCI cases

Success

Antegrade Retrograde

Failure

Switched to Retrograde

Antegrade failure

Success Failure

Switched to Antegrade

Retrograde failure

Antegrade alone Retrograde

RetrogradeRetrograde RetrogradeAntegrade alone

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Patient characteristics (1)2012 (1553) 2013 (1676) P

Age, yo 67.8±10.3 67.7±10.5 0.9133

Male 82.8% 84.1% 0.3262

Family history of CAD 17.0% 18.0% 0.5247

Previous MI 38.9% 40.8% 0.2831

Previous CABG 8.8% 8.5% 0.7667

Previous PCI 60.0% 61.7% 0.3235

# of diseased vessel - 1-vessel - 2-vessel - 3-vessel

35.4%38.2%26.4%

41.1%37.1%21.8%

0.0009

Hypertension 80.1% 79.7% 0.7689

Diabetes 43.3% 45.6% 0.1839

Diabetes, type 1 6.5% 8.2% 0.0682

Hyperlipidemia 69.9% 70.9% 0.5131

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Patient characteristics (2)2012 (1553) 2013 (1676) P

Smoker 47.8% 47.6% 0.9364

Unstable angina 8.6% 7.6% 0.3255

CCS classification - 0 - I - II - III - IV

30.7%29.1%31.0%6.9%2.3%

27.7%30.6%33.7%5.6%2.4%

0.1626

NYHA classification - I - II - III - IV - Not applicable

30.5%15.2%4.1%2.6%

47.6%

31.6%15.7%3.7%2.6%

46.4%

0.9158

Pre creatinine >2.5mg/dl 7.5% 8.3% 0.3661

Hemodialysis 5.9% 7.3% 0.1071

LVEF <35% 10.0% 10.3% 0.7565

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Lesion characteristics (1)

2012 (1553) 2013 (1676) PRe-attempt case 11.6% 9.0% 0.0155

Previous strategy in re-attempt case - Antegrade - Retrograde - Both - NA

79.7%2.8%

11.3%6.2%

64.2%4.7%

20.9%10.1%

0.0206

Previous failure reason - Failure to cross CTO by GW - Failure to cross collateral by GW - Delivery failure of treatment device - NA

79.1%1.1%4.5%

15.3%

80.4%4.0%6.0%9.5%

0.1468

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Lesion characteristics (2)2012 (1553) 2013 (1676) P

Target vessel - RCA - LAD - LCx - LMT

46.6%31.8%21.4%0.3%

49.0%29.9%20.9%0.2%

0.5070

Reference diameter <3.0mm 41.0% 38.8% 0.2262Occlusion length >20mm 61.7% 55.8% 0.0017Instent occlusion 14.7% 14.9% 0.9256

Occlusion period - > 1 year - 3m - 1 year - Unknown

8.4%9.0%

82.5%

9.3%6.4%

84.2%

0.0188

Collateral filling grade - CC 0 - CC 1 - CC 2

9.6%57.7%32.7%

7.1%59.4%33.4%

0.0774

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Lesion characteristics (3)

Moderate Severe0%

20%

40% Lesion calcification

Moderate Severe0%

20%

40% Proximal tortuosity

2012 2013

Moderate Severe0%

20%

40% Lesion bending

Blunt Funnel/Tapered

None/NA-20%

0%

20%

40%

60% CTO stump

P<0.05

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J-CTO score

*Score was counted based on judgment more than “moderate” grade for calcification and bending

2012(1553)

2013(1676) P

Blunt tip/none or unclear tip 53.7% 52.3% 0.4235

Calcification* 33.7% 37.9% 0.0132

Bending* 8.5% 7.9% 0.5504

Occlusion length >20mm 61.7% 55.8% 0.0017

Re-try lesion 11.6% 9.0% 0.0155

Average JCTO-score 1.6±1.1 1.5±1.1 0.0610

Easy (0) Intermediate (1) Difficult (2) Very difficult (>3)

0%

10%

20%

30%

40% Change of score distribution20122013P<0.05

Morino et al. JACC Interv 2011;4:231-211)

Procedure outcome2012 (1553) 2013 (1676) P

Successful CTO crossing by GW 89.6% 89.6% 0.9925Number of guidewire used for CTO approach 3.1±2.2 3.2±2.3 0.1788

Stent deployment 93.5% 100.0% <0.0001Number of stent 1.8±1.0 1.9±0.9 0.0033Total stent length, mm 51.8±24.9 55.4±27.9 0.0008Use of drug-eluting stent 98.0% 98.8% 0.0907Procedure success 88.3% 88.4% 0.9437Procedure time, min 142.7±83.4 153.2±88.0 0.0012Contrast dose, ml 228.7±107.2 226.2±103.4 0.5187Fluoroscopy time, min 64.2±42.4 70.6±47.8 0.0002Air Kerma, mGy 4715.8±3760.8 4920.3±3879.7 0.2031

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MACCE

2012 (1553) 2013 (1676) P

MACCE 0.7% (11) 0.7% (11) NS

- Cardiac death 0.2% (3) 0.2% (3) NS

- Non cardiac death 0.1% (2) 0.2% (4) NS

- MI 0.3% (4) 0.1% (1) NS

- Stroke / non-bleeding 0.1% (2) 0.1% (1) NS

- Emergent CABG - 0.1% (2) NS

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Other procedural complications2012 (1553) 2013 (1676) P

- Cardiac tamponade 0.5% (7) 0.1% (2) NS

- Heart failure - 0.1% (1) NS

- Transient Cerebral Ischemic Attack 0.1% (1) 0.1% (2) NS

- Stent thrombosis 0.1% (2) 0.2% (3) NS

- Thrombosis formation - 0.1% (1) NS

- Contrast induced nephropathy 0.1% (2) 0.1% (2) NS

- Radiation dermatitis - 0.1% (2) NS

- Access route complication 0.4% (6) 0.4% (7) NS

- Dissection caused by Guiding Catheter - 0.1% (2) NS

- Coronary perforation due to guidewire due to balloon NA

0.8% (12)0.3% (4)0.1% (2)0.4%(6)

2.7% (46)0.9% (15)0.1% (2)

1.7% (29)

<0.0001

- Guidewire fracture 0.1% (2) 0.1% (2) NS

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Including minor events

Retrograde approach relevant complications

2012 (490) 2013 (538) P

Retrograde approach relevant 11.8% (58) 8.2% (44) NS

- Channel injury Additional treatment required Cardiac tamponade

11.0% (54)4.1% (20)0.4% (2)

8.0% (43)3.0% (16)0.2% (1)

NS

- Donor artery trouble 0.2% (1) - NS

- Other events 0.6% (3) 0.2% (1) NS

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J-CTO score and Success Rate2012 vs. 2013

Easy (0) Intermediate (1) Difficult (2) Very difficult (>3)

0%

20%

40%

60%

80%

100% 93.6%89.4% 86.9% 84.4%

97.2%91.3% 88.0%

74.9%

2012 2013

P<0.05 NS NS P<0.05

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Procedure characteristics (1)Antegrade alone

Single wire

Parallel wire

IVUS guided

re-entry

STAR NA0%

20%

40%

60%

80%

100%83%

12%3% 2%

82%

15%

2% 1%

2012 2013

Corsair use: 78.1%

Easy (0) Intermediate (1)

Difficult (2) Very Difficult (>3)

0%

20%

40%

22%

43%

27%

8%

28%

39%

25%

8%

2012 2013

Successful CTO crossing strategy J-CTO score for “single wire” technique

Total (2201) 2012 (1063) 2013 (1138) P

Procedure success 91.6% (2016) 90.8% (965) 92.4%(1051) 0.1835

P<0.05P< 0.05

Soft Intermediate Hard Very hard0%

20%

40%

60%

80%

100%

Easy (0) Intermediate (1) Difficult (2) Very Difficult (>3)

P<0.0001

Soft (<1g) Intermediate (1-3g)

Hard (3-9g) Very Hard (>9g)

0%

20%

40%

60%2012 2013

Guidewire for CTO crossing (1)Antegrade alone

Guidewire by J-CTO scoreGuidewire by tip load

P< 0.05

Gaia 2 for 23→67%

Gaia 1 for 38→81%

Guidewire for CTO crossing (2)Antegrade alone

XT se-

ries; 31%

Con Pro; 10%

Gaia 1; 10%Gaia 2; 6%

Wizard 3; 4%

UL-TIM 3; 4%

SION; 4%

FFC; 4%

Other; 26%

2012

Total (2201) 2012 (1063) 2013 (1138) P

Guidewire cross 92.7% (2040) 91.8% (976) 93.5% (1064) 0.1300

XT se-

ries; 30%

Gaia 1; 23%Gaia 2; 20%

Con Pro; 6%

Con Pro 12; 2%

Gaia 3; 2%

UL-TIM3;

2%SION;

2%

Other; 12%

2013

2012 20130%

20%

40%

60% 53.3%

44.6%

0%

20%

40%

60%51.2%

40.8%

5.8%2.1%

Primary retrograde approach

Background of retrograde approach Annual change from 2012 to 2013

P<0.05

Procedure characteristics (1)Retrograde cases

Primary retrograde approach has been decreasing

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Procedure characteristics (2)Collateral approach

48%

19%

11%

10%3%

11%

SION XT-RSION blue Fielder FCSUOH SION blackother

2012 61%

18%

3%

3%4

%

4%

7%

60%26%

7%3% 4%

SeptalEpicardialACIpsilateralBypass graft

68%

17%

7%3%

6%

2013

Total (1028) 2012 (490) 2013 (538) P

Guidewire cross 76.9% (791) 77.6% (380) 76.4%(411) 0.6600

2012 2013P<0.001

Successful guidewire

Successful collateral route

P<0.05

P<0.05

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Reverse CART Retrogradewire cross

Kissing wire cross

CART0%

20%

40%

60%51%

35%

14%

1%

61%

26%

13%

1%

2012 2013

Sumitsuji et al. JACC Cardiovasc Interv 2011

Patterns of Success in Retrograde Approach

IVUS was used in 69.2% of Reverse CART

Procedure characteristics (3)CTO crossing

Total (1028) 2012 (490) 2013 (538) P

Guidewire cross 65.5% (673) 69.0% (338) 62.3%(335) 0.0033

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67.2%

24.1%

3.8%4.9%

Couldn't cross collateral channelCouldn't cross CTO by GWCouldn't cross CTO by any catheterProcedure discontinuation due to complication

Reason of retrograde procedure failure (370)

Retrograde Procedure Outcome (1)Retrograde cases (1028)

Switched to antegrade approach ; 80.0% (296)

Total (1028) 2012 (490) 2013 (538) P

Procedure success 64.0% (658) 66.5% (326) 61.7%(332) 0.1078

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Single wire Parallel wire IVUS guided re-entry

0%

40%

80%60.6%

30.3%

9.1%

Successful CTO crossing strategy by antegrade approach

Failure reason N=116Couldn’t cross CTO by guidewire 84.5% (98)Couldn’t cross CTO by any catheter 7.8% (9)Procedure discontinuation due to complication

5.2% (6)

NA 2.6% (3)

Retrograde Procedure Outcome (2)In case switched to antegrade after retrograde (n=296)

Total 2012 2013 P

Antegrade procedure success switched after retrograde failure

60.8% (180/296)

64.8% (81/125)

57.9% (99/171) 0.2294

Overall procedure success in retrograde cases

81.5%(838/1028)

83.1%(407/490)

80.1%(431/538) 0.2236

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N =690

MACCE 120 (17.4%)

- Cardiac death 6 (0.9%)

- Non cardiac death 12 (1.7%)

- Stroke 8 (1.2%)

- CABG 6 (0.9%)

- TVR 53 (7.7%)

- TLR 35 (5.1%)

12M FU : MACCEFollow up rate: 37.3% (690/1848)

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Follow up rate: 33.3% (616/1848)

CCS 0 CCS I CCS II CCS III CCS IV0

50

100

150

200

197180

138

2911

522

13

3

1 1

1

5

6

2

1

1

CCS 0 CCS I CCS II CCS III CCS IV

Before PCI

12M FU : CCS classification

26 / 9/ 2014

EURO CTO CLUB Madrid 2014

26 / 9/ 2014

Current limitations of ante grade approach and retrograde approaches

Year No. ofCTO PCI

No. ofRetrograde

RetrogradeFailure

Change toAntegrade

Antegradesuccess

2009 1542 378(24.5%)

112(29.6%)

88 (78.6%)

52 (59.1%)

2010 1472423

(28.7 ％ )119

(28.1%)90

(75.6%)57

(63.3%)

2011 1471 365(25.8%)

102(27.9%)

73 (72.6%)

43 (58.9%)

2012 1573 480(30.5%)

165(34.4%)

125(75.8%)

83(66.4%)

2013 1671 538(32.1%)

206(38.2%)

171(83.0%)

99(57.9%)

Limitations Selection of approach for CTO was physician- or hospital-

dependent Due to registry method, case report form was not always

completed and some cases were excluded from analysis because of too much of missing data

In the subanalysis using J-CTO score, our criteria for each lesion difficulty were not always exact same as original definition by J-CTO study

For lower clinical follow-up rate, we are still under data collecting from participant centers

26 / 9/ 2014

Summery in 2014 In 2013, overall procedure success is 88.4%, which was

unchanged from 2012 In antegrade approach alone, our data shows an excellent

procedure success rate (over 90%) In retrograde approach( the volume had decreased), there

are no significant difference with overall procedure success

Total MACCE rate was 0.7% in over 3200 cases 12 month follow up MACCE rate was 17% among 690

follow-up, with TLR/TVR rate of 12.8% Change of registry system

26 / 9/ 2014

EURO CTO CLUB Madrid 2014

26 / 9/ 201432

CCT 2014 , 10-30 to 11-1, in Kobe, Japan

Difference of baseline & procedure characteristicsRetrograde cases

2012 (490)

2013 (538) P

Male 84.7% 87.5% NSAge 60.9% 62.7% NSPrevious MI 45.1% 42.0% NSPrevious CABG 14.6% 13.8% NSMulti-vessel disease 64.1% 57.0% <0.05Hypertension 79.8% 78.7% NSDM 46.0% 46.5% NSHyperlipidemia 71.0% 75.6% NSSmoking 52.6% 51.1% NSFamily history of CAD 16.2% 19.5% NSUnstable angina 7.1% 5.4% NSPrevious PCI 65.8% 66.5% NSPre creatinine >2.5mg/dl 8.2% 5.7% NSLVEF<35% 12.4% 11.0% NS

Target vessel - RCA - LAD - LCx - LMT

61.4%26.5%11.4%0.6%

63.9%25.8%9.7%0.6%

NS

2012 (490)

2013 (538) P

Lesion calcification 45.3% 49.3% NSProx. Tortuosity 13.6% 12.3% NSLesion bending 14.7% 13.1% NSBlunt /no or unclear stump 69.4% 70.2% NSOcclusion length >20mm 77.1% 72.2% NSRef. Diameter <3.0mm 27.7% 29.1% NSOcclusion period - > 1year 60.3% 75.5% <0.05ISR-CTO 9.6% 7.9% NSRe-try case 22.3% 18.9% NSCollateral channel(CC) grade - CC 0 - CC 1 - CC 2

6.1%56.3%37.6%

2.7%60.0%37.3%

<0.05

Average J-CTO score 2.1±1.1 2.1±1.1 NS

Procedure time, min 201.4±90.9 225.7±88.5 <0.05Contrast dose, ml 268.6±119.9 270.1±113.1 NSFluoroscopic time, min 94.2±46.7 108.0±49.7 <0.05Air Karma , mGy 6132.5±4407.1 6639.3±4512.0 NS

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Difference of baseline & procedure characteristicsAntegrade alone cases

2012 (1063)

2013 (1138) P

Male 81.9% 82.5% NSAge 64.1% 63.4% NSPrevious MI 36.0% 40.2% <0.05 Previous CABG 6.1% 6.0% NSMulti-vessel disease 64.8% 59.8% <0.05 Hypertension 80.2% 80.2% NSDM 42.0% 45.2% NSHyperlipidemia 69.3% 68.7% NSSmoking 45.6% 45.9% NSFamily history of CAD 17.4% 17.4% NSUnstable angina 9.2% 8.6% NSPrevious PCI 57.3% 59.4% NSPre creatinine >2.5mg/dl 7.1% 9.6% <0.05 LVEF<35% 8.8% 10.0% NS

Target vessel - RCA - LAD - LCx - LMT

39.7%34.2%26.0%0.1%

42.0%31.8%26.2%0.0%

NS

2012 (1063)

2013 (1138) P

Lesion calcification 28.3% 32.4% <0.05 Prox. Tortuosity 8.2% 9.9% NSLesion bending 5.7% 5.5% NSBlunt /no or unclear stump 46.5% 43.8% NSOcclusion length >20mm 54.6% 48.2% <0.05 Ref. Diameter <3.0mm 47.1% 43.3% NSOcclusion period - > 1year 39.7% 48.1% NSISR-CTO 17.1% 18.1% NSRe-try case 6.6% 4.3% <0.05 CC grade from contralateral - CC 0 - CC 1 - CC 2

11.6%58.4%29.9%

9.7%59.7%31.1%

NS

Average J-CTO score 1.3±0.9 1.2±1.0 NS

Procedure time, min 114.4±62.3 119.5±64.2 NSContrast dose, ml 209.4±94.7 205.4±91.5 NSFluoroscopic time, min 49.5±30.9 52.8±34.9 <0.05Air Karma , mGy 3987.5±3144.7 4091.6±3225.1 NS