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Welcome to the 5 th European Bifurcation Club 16-17 September 2009 - BERLIN

Welcome to the 5 th European Bifurcation Club 16-17 September 2009 - BERLIN. Stent Thrombosis in Coronary Bifurcation After DES Implantation. Insight From J- Cypher Registry and Asian Multicenter Registry. Sunao Nakamura. FACC, FAHA, FESC, FSCAI.

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Welcome to the 5 th European Bifurcation Club 16-17 September 2009 - BERLIN

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  1. Welcome to the 5th European Bifurcation Club 16-17 September 2009 - BERLIN Stent Thrombosis in Coronary Bifurcation After DES Implantation Insight From J-Cypher Registry and Asian Multicenter Registry

  2. Sunao Nakamura FACC, FAHA, FESC, FSCAI Department of Cardiology : New Tokyo Hospital Department of Advanced Cardiovascular Medicine : Kumamoto University Takeshi Kimura MD. Kyoto University Hospital Toshihiro Tamura MD. Kyoto University Hospital Kazuaki Mitsudo MD. Kurashiki Central Hospital Takeshi Morimoto MD. Kyoto University Hospital Kazushige Kadota MD. Kurashiki Central Hospital On behalf of the j-Cypher Registry Investigators

  3. J-Cypher Paticipating Centers Ehime Prefectural Central Hospital Ogaki Municipal Hospital Osaka City General Hospital Osaka Red Cross Hospital Saiseikai Noe Hospital Kanazawa Cardiovascular Hospital Shonan Kamakura General Hospital Kawasaki Social Insurance Hospital Tokusyukai Kisiwada Hospital National Hospital Organization Kyusyu Cardiovascular Center Kyoto University Hospital Kyoto second Red Cross Hospital Kurashiki Central Hospital Gunma Prefectural Cardiovascular Center Noto General Hospital Kokura Memorial Hospital National Cardiovascular Center Saiseikai Kumamoto Hospital Saitama Prefectural Cardiovascular Hospital Sizuoka General Hospital Shinkoga Hospital Shinbeppu Hospital Sendai Kousei Hospital Tsuchiya General Hospital Teikyo University Hospital Tokushima Red Cross Hospital Tominaga Hospital Toyohashi Higashi Hospital Nanpuh Hospital Fukuoka University Hospital FukuyamaCardiovascular Hospital Banbuntane Hotokukai Hospital Hokuto Cardiovascular Hospital Hokkou Memorial Hospital Maizuru Kyosai Hospital Matsue Red Cross Hospital Mie Heart Center Miyazaki Ishikai Hospital Wakayama Red Cross Hospital The j-Cypher Registry

  4. ESC 2008 -Multicenter Registry in Asia- New Tokyo Hospital Sunao Nakamura M.D, Ph.D. (Japan) Damansara Heart Center Tamil Selvan Muthusamy M.D. (Malaysia) Jang-Ho Bae M.D. (Korea) Konyang University Hospital Yeo Hans Cahyadi M.D. (Indonesia) Husada Hospital Chest Disease Institute Sudaratana Tansuphaswadikul M.D. (Thailand) Her Majesty's Cardiac Center, Siriraj Hospital Damras Tresukosol M.D. (Thailand) King Chulalongkorn Memorial Hospital Wasan Udayachalerm M.D. (Thailand)

  5. Stent Thrombosis in Japanese/Asian 1. Low Incidence of Stent Thrombosis J-Cypher and Asian Multicenter Registry The j-Cypher Registry

  6. 0.05 0.04 0.03 0.02 0.01 0 0 365 730 1095 Stent Thrombosis in J-Cypher Registry ARC Definite Between 30 Days and 3 Years Slope 0.28% / Year Follow-up interval (Days) 30 Days 1 Yr. 2 Yrs. 3 Yrs. Cumulative incidences0.36%0.61%0.84%1.18% n of pts at risk 12,824 12,625 11,843 9,036 4,191 # Events: Not yet fully adjudicated

  7. Definite Stent Thrombosis Bern/Rotterdam vs j-Cypher PES Bern / Rotterdam SES Between 30 Days and 3 Years Slope 0.5% / Year Between 30 Days and 3 Years Slope 0.28% / Year j-Cypher Bern / Rotterdam Incidence, SES (%) 1.0 1.1 1.3 1.9 2.5 Patients at Risk (n) 3535 3508 2671 1710 903 j-Cypher Cumulative Incidence (%) 0.3 0.4 0.6 0.8 1.2 Patients at Risk (n) 12682 12625 11843 9036 4191 Daemen J., et al., Lancet 2007; 369: 667–78.

  8. 2.0 2.0 1.5 1.5 1.0 1.0 0.5 0.5 0 0 0 0 6 12 12 18 18 24 24 30 30 36 36 42 42 48 48 54 54 60 60 6 Stent Thrombosis to 5 Years -Asian Multicenter Registry- ARC Definite / Probable BMS vs DES SES vs PES ％ ％ BMS DES SES PES Time (months) Time (months) SAT 0.5%, LAST 0.18%/year

  9. Stent Thrombosis in Japanese 2. Predictor of Stent Thrombosis Multivariate Analysis of Early ST and Late/Very Late ST The j-Cypher Registry

  10. Predictors of Early ST Multivariable analysis Early ST in 43 lesions among 17,050 lesions treated exclusively by Cypher Factors R.R. 95%C.I. P Value Emergency procedure (ACS) 1.88 (1.13 - 2.9) 0.02 Male gender 1.45 (0.95 - 2.49) 0.09 LVEF  40% 1.29 (0.84 - 1.87) 0.23 Those variables with p value <0.1 in the univariable analysis were incorporated into the multivariable model. STEMI was excluded from the final model.

  11. 0.02 0.01 0 0 365 730 1095 Stent Thrombosis in STEMI ARC Definite Log rank p=0.0019 STEMI Others Follow-up interval (Days) 30 Days 1 Yr. 2 Yrs. 3 Yrs STEMI 0.76% 1.01% 1.21% 1.37% 1,321 1,269 1,149 831 342 Others 0.2% 0.36% 0.51% 0.73% 18,354 18,108 17,013 13,013 6,001

  12. Predictors of LST / VLST Multivariable analysis LST / VLST in 67 lesions among 16,801 lesions treated exclusively by Cypher Factors R.R. 95%C.I. P Value Hemodialysis 1.91 (1.29 - 2.65) 0.002 ESRD (e-GFR < 30/Non-HD) 1.81 (1.2 - 2.65) 0.007 Two stents for bifurcation 1.81 (1.17 - 2.59) 0.01 Those variables with p value < 0.1 in the univariable analysis were incorporated into the multivariable model.

  13. Stent Thrombosis in Japanese 3. Discontinuation of Anti-platelet Therapy and Timing of Stent Thrombosis The j-Cypher Registry

  14. 0.5 0.4 0.3 0.2 0.1 0 0 365 730 1095 Surgery During Follow-up Cumulative Incidence Follow-up interval (Days) 30 Days 6 Mos. 1 Yr. 2 Yrs. 3 Yrs n of pts 0.3% 2.0% 4.2% 8.6% 12.8% at risk 12824 12,607 12,062 11,289 3,944 758 Excluding endovascular treatment and CABG

  15. 1 0.5 0.8 0.4 0.6 0.3 0.4 0.2 0.1 0.2 0 0 0 365 730 1095 0 7 14 21 28 Discontinuation of Anti-platelet Therapy and Timing of Stent Thrombosis ST within 30 Days after Discontinuation of APT All Stent Thrombosis From around 7 Days Later Incidence of stent thrombosis Incidence of stent thrombosis Days after discontinuation of anti-platelet therapy Days after discontinuation of anti-platelet therapy Days after discontinuation 30 90 365 730 Cumulative incidence 23% 40% 67% 85% Number of events 11 18 31 40 Number of patients at risk 48 37 30 17 8 Days after discontinuation 7 14 21 28 Cumulative incidence 4% 15% 19% 21% Number of events 2 7 9 10 Number of patients at risk 48 46 41 39 38

  16. Stent Thrombosis in Japanese 4. Role of Thienopyridine 6 months after Implantation of DES The j-Cypher Registry

  17. Anti-platelet Therapy Discontinuation Stent Thrombosis and Discontinuation of Aspirin and/or Thienopyridine Incidence of Definite Stent Thrombosis Discontinuation of both thienopyridine and aspirin, but not discontinuation of thienopyridine therapy alone, was associated with an increased risk of ST

  18. 6-Month Landmark Analysis Landmark analysis did not suggest an apparent clinical benefit of thienopyridine use beyond 6 months after SES implantation

  19. Left Main Substudy From J-Cypher Registry Comparing 1. Bifur. vs Non Bifur. 2. One Stent vs Two Stent The j-Cypher Registry

  20. Left Main Substudy from the j-Cypher Registry j-Cypher registry (August 2004-November 2006) 12824 patients with first registration 582 patients underwent PCI for ULMCA (4.5% of whole population) 12242 patients underwent PCI for non-ULMCA Main-Analysis Vs. Patients excluded: 74 patients with non-SES treatment for ULMCA (non-stent, BMS or other type of DES) Patients excluded: 28 patients with hybrid treatment for ULMCA (SES and BMS or other type of DES) Patients excluded: 4 patients missing information on lesion location of ULMCA or bifurcation stent strategy 476 patients treated exclusively with SES for ULMCA Sub-Analysis Toyofuku M, et al. Circulation 2009 in press.

  21. Left Main Substudy from the j-Cypher Registry Baseline and Procedural Characteristics

  22. Left Main Substudy from the j-Cypher Registry Unadjusted Survival Adjusted Survival 93.9% 92.6% 90.8% 85.4% P < 0.0001 P =0.12 Survival Survival Non-ULMCA Non-ULMCA ULMCA ULMCA Days after stent implantation Days after stent implantation

  23. Lesion Location and Clinical Outcome Ostial / Shaft versus Bifurcation (A) Cardiac Mortality (B) Target Lesion Revascularization 92.4% 96.4% 90.2% 82.9% Bifurcation Lesion !! P=0.41 P=0.0047 Freedom from TLR Survival Ostial/shaft Lesion Ostial/shaft Lesion Distal Bifurcation Lesion Distal Bifurcation Lesion Days after stent implantation Days after stent implantation

  24. Bifurcation Strategies and Clinical Outcome One-stent versus Two-stents (A) Cardiac Mortality (B) Target Lesion Revascularization 94.5% 88.9% 87.8% Two Stent !!! Two Stent !!! 69.1% P=0.018 P<0.0001 Survival Freedom from TLR Bifurcation One Bifurcation Two Bifurcation One Bifurcation Two Days after stent implantation Days after stent implantation

  25. Bifurcation Substudy From J-Cypher Registry Predictor of Target Lesion Revascularization in Elective Two-Stent Technique The j-Cypher Registry

  26. Bifurcation stenting strategy 2250 Bifurcation lesions Elective stenting N=272 (12.1%) Provisional stenting N=1978 (87.8%) Crossover 0 89( 4.5% ) 1889 272 Two stenting N=361 (16.0%) One stenting N=1889 (84.0%) The j-Cypher Registry

  27. Strategy of Elective Two-stent approach Provisional : 1978 Crush technique 26.8% Kissing 5.1% Elective : 272 Culotte technique 15.4% T-Stenting 52.6% The j-Cypher Registry

  28. Cumulative incidence of Definite Stent Thrombosis 3.0 (%) 2.0 Incidence of stent thrombosis 1.0 0 Days after stent implantation 1095 730 365 Days after stent implantation 1.7% 1.7% 1.2% Cumulative incidence 4 4 3 Number of events The j-Cypher Registry

  29. Multivariate Analysis for the Predictors of TLR TLR P Value Odds ratio (95% C.I.) Postprocedural main vessel reference diameter Total stent length Crush stenting Two stent in Cx lesion Postprocedural side branch reference diameter 0.08 (0.01-0.38) 1.03 (1.01-1.05) 3.10 (1.20-14.1) 1.69 (1.09-2.60) 6.18 (1.25-33.2) 0.0010 0.0014 0.0163 0.0198 0.0250 The j-Cypher Registry

  30. Bifurcation Substudy From J-Cypher Registry Role of Final Kissing Balloon Technique in Single Main Branch Stenting The j-Cypher Registry

  31. Bifurcation stenting strategy 2250 Bifurcation lesions Provisional stenting N=1978 (87.8%) Elective stenting N=272 (12.1%) Crossover 0 89( 4.5% ) 1889 272 One stenting N=1889 (84.0%) Two stenting N=361 (16.0%) The j-Cypher Registry

  32. Multivariate Analysis for the Predictors of TLR TLR P Value Odds ratio (95% C.I.) 0.0018 0.0027 0.0033 0.0053 0.0077 0.025 0.48 (0.30-0.76) 1.54 (1.17-1.97) 1.02 (1.01-1.03) 1.44 (1.11-1.94) 1.61 (1.15-2.17) 1.23 (1.03-1.48) Postprocedural main vessel Reference diameter Severe calcification Total stent length Gender (Male) Hemodialysis DM The j-Cypher Registry

  33. One stenting N=1889 (84.0%) Unknown:18 N=1053(56.3%) N=818(43.7%) %DS <50% > %DS 50% SB %DS after MB stenting FKB (-) N=491 (46.6%) FKB (+) N=376 (46.0%) FKB (-) N=442 (54.0%) FKB (+) N=562 (53.4%)

  34. Role of FKB in Lesions <50% Side-branch Stenosis after Main-branch Stenting Definite ST TLR (%) (%) 1.0 30 FKB (-) FKB (-) 20 FKB (-) 0.5 Cumulative survival-free of ST Cumulative survival-free of TLR FKB (-) 10 P=n.s. P=n.s. 0 0 Days after stent implantation Days after stent implantation No significant differences regarding TLR between FKB group and non-FKB group.

  35. Role of KBT in Lesions ≥50% Side-branch Stenosis AfterMain-branch Stenting TLR Definite ST (%) (%) 30 1.0 FKB (-) FKB (-) 20 FKB (-) 0.5 Cumulative survival-free of ST Cumulative survival-free of TLR FKB (-) 10 P=n.s. P=n.s. 0 0 0 Days after stent implantation Days after stent implantation Even if the side branch %diameter stenosis was more than 50% after main branch stenting , the FKB did not provide the benefit regarding TLR.

  36. Summary • The incidence of stent thrombosis in Asian races is relatively low. 0.6% BMS 0.14% BMS 0 BMS SAT LAST VLAST : 0.5% DES : 0.2% DES : 0.4%/2y DES at mean follow-up 5 years • Emergent procedure for AMI was an only predictor of ST in early ST • and Hemodialysis, chronic renal failure(e-GFR < 30/Non-HD)and usage • of two stent in bifurcation were predictor of late and very late ST. 3. Discontinuation of both thienopyridine and aspirin, but not discontinuation of thienopyridine therapy alone, was associated with an increased risk of Stent Thrombosis. 4. Landmark analysis did not suggest an apparent clinical benefit of thienopyridine use beyond 6 months after SES implantation

  37. Patients with ostial /body LMCA lesion had extremely low rate of TLR. Summary Left Main Substudy from the j-Cypher Registry 1. The adjusted survival rate was comparable between the Non LMT stenting group and LMT stenting group of patients. • Among patients treated for ULMCA, bifurcation two stenting was associated with markedly higher rate of TLR and significantly higher rate of cardiac death.

  38. Patients with ostial /body LMCA lesion had extremely low rate of TLR. Summary Left Main Substudy from the j-Cypher Registry 1. The adjusted survival rate was comparable between the Non LMT stenting group and LMT stenting group of patients. • Among patients treated for ULMCA, bifurcation two stenting was associated with markedly higher rate of TLR and significantly higher rate of cardiac death.

  39. Bifurcation Substudy from the j-Cypher Registry Summary Predictor of Target Lesion Revascularization in Elective Two-Stent Technique • True bifurcatiion lesion was seen in 64% of J-cypher: bifurcation. And among them, Elective two-stent strategy was used in 12.1% of all bifurcation lesions. 2. The incidence of death are 9.2% and TLR and definite stent thrombosis were 18.5 and 1.7%. 3. Total stent length, postprocedual main and side vessel diameter, two stent in circumflex and crush stenting were the predictor of TLR. The j-Cypher Registry

  40. Bifurcation Substudy from the j-Cypher Registry Summary Role of Final Kissing Balloon Technique in Single Main Branch Stenting 1. The incidence of cardiac death, TLR and definite stent thrombosis were 3.5%, 9.5% and 0.72% at 3 year. 2. post main vessel diameter, severe calcification,total stent length, gender(Male), Hemodialysis and DM were the predictor of TLR. • There was no significant differences regarding TLR between FKB group and non-FKB group. (Even if the side branch %diameter stenosis was more than 50% after main branch stenting, the FKB did not provide the benefit regarding TLR.) The j-Cypher Registry

  41. Twenty years ago…

  42. Shunsuke Nakamura Daisuke Matsui Espanyol／Spain Grenoble／France Takayuki Morimo Junichi Inamot Catania／Italy Stade Rennais／France Makoto Hasebe Wolfsburg／Germany Shinji Ono Bochum／Germany Sho Ito Koki Mizuno Takahito Soma Grenoble／France Celtic／Scotland Maritimo／Portugal

  43. Let’s Join Bifurcation Club EBC and JBC

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