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Anatomical and Functional Approaches for Bifurcation Lesions “CROSS and PERFECT” Trials

Anatomical and Functional Approaches for Bifurcation Lesions “CROSS and PERFECT” Trials. Young-Hak Kim, MD, PhD, Seung-Jung Park, MD,PhD And on behalf of CROSS and PERFECT investigators. Cardiac Center, University of Ulsan College of Medicine Asan Medical Center, Seoul, Korea.

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Anatomical and Functional Approaches for Bifurcation Lesions “CROSS and PERFECT” Trials

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  1. Anatomical and Functional Approaches for Bifurcation Lesions “CROSS and PERFECT” Trials Young-Hak Kim, MD, PhD, Seung-Jung Park, MD,PhD And on behalf of CROSS and PERFECT investigators. Cardiac Center, University of Ulsan College of Medicine Asan Medical Center, Seoul, Korea

  2. MessagesFrom Trials • NORDIC • Single-DES is good with TIMI 3 flow in SB. • CACTUS • Two-DESs is also good with optimal stenting technique.

  3. However, we need a clinical trial integrating the major and minor issues. • Need for kissing balloon inflation • Impact of current stent design on the SB occlusion • Role of IVUS guidance • Limitation of angiographic assessment • Functional assessment • Need of complex stenting strategy according to the lesion classification • Clinical implication of bifurcation software

  4. Popular Use of Kissing Balloon Inflation % Period I : 1996 ~ 1997 Period II : 1997 ~ 1998 Lefevre et al. Catheter Cardiovasc Intervent 2000;49:274

  5. Fate of SB Occlusion in RAVEL Change of SB TIMI Flow at Follow-up Flow improvement % Flow deterioration 24/30 2/106 13/19 4/115 Tanabe T et al. Am J Cardiol 2002;90:937

  6. Only 27% among SB with > 75% has FFR < 0.75 QCA vs FFR Fractional Flow Reserve Percent Stenosis (%) Koo BK et al JACC 2005; 46: 633

  7. When do we need two stents ? % Cross-over from Single Stent to Two Stent % TIMI flow <3 Dissection > B DS > 50% >50% DS >50% DS And TIMI<3 TIMI<3 after balloon dilatation • Colombo A, et al. SIRIUS Bifurcation Study, Circulation 2004;109:1244-9 • Pan M, et al. Am Heart J 2004;148:857-64. • Steigen TK, et al. NORDIC Study, Circulation 2006;114:1955-61.

  8. What is CROSS and PERFECT trials ? Study Design

  9. CROSS PERFECT CROSS & PERFECT Trials Coronary bifurcation lesions Side branch stenosis < 50% Side branch stenosis  50% Single Stent cross-over Randomization If, Poststenting SB stenosis 50% Provisional T Crushing Randomization Leave alone Kissing balloon inflation If, SB ―TIMI2, or Dissection C TAP PI: Seung-Jung Park, MD

  10. Purposes of Trials • Understanding of the mechanism of SB compromise • Effect of kissing balloon inflation • Treatment guided by anatomical and functional evaluation using angiography, IVUS and FFR • Comparison of treatment strategies for bifurcation with or without SB stenosis

  11. Choice of optimal stRategy fOr bifurcation leSions with normal Side branchCROSS Trial • Objectives • To assess the incidence of stent jail according to the DES type • To assess the influence of kissing balloon inflation on the durability of SB patency • To assess the effective blood flow reflected by FFR in the SB after MB stenting • To assess the IVUS findings in the SB and MB

  12. CROSS TrialInclusion CriteriaElective bifurcation PCI for Bifurcations without SB Stenosis MEDINA Class proximal distal 1:0:0 0:1:0 1:1:0 1:1:1 0:0:1 1:0:1 0:1:1

  13. CROSS Trial Bifurcation without SB stenosis by angiography • Stratified by sites 1st Randomization: type of stent SES (N=200) PES (N=200) ZES (N=200) After MV stenting SB DS  50% & TIMI 3 flow TIMI  2 flow SB DS < 50% & TIMI 3 flow Registry Registry 2nd Randomization • Treatment at the operator’s discretion • IVUS exam in MV • FFR in SB (selected sites) • Stratified by sites Kissing balloon group (estimated N=90) Leave it alone group (estimated N=90) • FFR in SB before kissing balloon • Rewire into SB • Kissing balloon inflation • IVUS exam in MV • FFR in SB (selected sites) SB DS  70% or TIMI  2 or Dissection  class C SB DS < 70% & TIMI 3 Dissection none or  class B • FFR in SB (selected sites) • Provisional T stenting in SB * • IVUS in both branches • IVUS in MV • FFR in SB (selected sites) * The decision can not be influenced by the value of FFR.

  14. CROSS Trial Bifurcation without SB stenosis by angiography • Stratified by sites 1st Randomization: type of stent SES (N=200) PES (N=200) ZES (N=200) After MV stenting SB DS  50% & TIMI 3 flow TIMI  2 flow SB DS < 50% & TIMI 3 flow Registry Registry 2nd Randomization • Treatment at the operator’s discretion • IVUS exam in MV • FFR in SB (selected sites) • Stratified by sites Incidence of SB occlusion according to DES type Kissing balloon group (estimated N=90) Leave it alone group (estimated N=90) • FFR in SB before kissing balloon • Rewire into SB • Kissing balloon inflation • IVUS exam in MV • FFR in SB (selected sites) SB DS  70% or TIMI  2 or Dissection  class C SB DS < 70% & TIMI 3 Dissection none or  class B • FFR in SB (selected sites) • Provisional T stenting in SB * • IVUS in both branches • IVUS in MV • FFR in SB (selected sites) * The decision can not be influenced by the value of FFR.

  15. CROSS Trial Bifurcation without SB stenosis by angiography • Influence of Kissing Balloon Inflation • Morphologic Evaluation by IVUS • Functional Assessment by FFR • Stratified by sites 1st Randomization: type of stent SES (N=200) PES (N=200) ZES (N=200) After MV stenting SB DS  50% & TIMI 3 flow TIMI  2 flow SB DS < 50% & TIMI 3 flow Registry Registry 2nd Randomization • Treatment at the operator’s discretion • IVUS exam in MV • FFR in SB (selected sites) • Stratified by sites Kissing balloon group (estimated N=90) Leave it alone group (estimated N=90) • FFR in SB before kissing balloon • Rewire into SB • Kissing balloon inflation • IVUS exam in MV • FFR in SB (selected sites) SB DS  70% or TIMI  2 or Dissection  class C SB DS < 70% & TIMI 3 Dissection none or  class B • FFR in SB (selected sites) • Provisional T stenting in SB * • IVUS in both branches • IVUS in MV • FFR in SB (selected sites) * The decision can not be influenced by the value of FFR.

  16. CROSS TrialStudy Design • Primary outcomes • Frequency of post-procedural stent jail according to the DES type • 8-month diameter stenosis in SB between the kissing balloon vs. leave alone • Design and hypothesis : Two-step randomization • Ha for ‘stent jail study’ : SES > PES, ZES > PES, SES = ZES • Ha for ‘kissing balloon study’ : Leave alone  Kissing balloon

  17. OPtimal StEnting StRategy For TruE BifurCaTion PERFECT Trial • Objectives • To compare the outcomes of provisional T stenting versus Crush technique with SES in true bifurcation lesions • To assess the influence of kissing balloon inflation in the jailed SB having normal FFR (> 0.75) after MB stenting • To assess the IVUS findings in SB and MB

  18. PERFECT TrialInclusion CriteriaElective bifurcation PCI for Bifurcations with SB Stenosis MEDINA Class proximal distal 1:0:0 0:1:0 1:1:0 1:1:1 0:0:1 1:0:1 0:1:1

  19. PERFECT Trial True bifurcation by angiography Wire insertion into both branches Randomization First Randomization Crush group (N=240) Provisional-T Group (N=240) SB Evaluation after MB Stenting • TIMI  2 flow or • Dissection  class C or • FFR < 0.75 • TIMI 3 flow and • Dissection  class B and • FFR  0.75 Leave Alone Kissing Balloon Inflation Second Randomization

  20. PERFECT TrialStudy Design • Primary outcome • 8-month overall restenosis rate in MB or SB • Hypothesis for sample size estimation • Ha : Provisional T  Crush technique

  21. Current Status From March 2008 CROSS Study PERFECT Study • ~ 150 enrolled • ~ 80 randomization to kissing vs. leave alone • ~ 80 randomization

  22. Examples

  23. Significant Stensis at SBPERFECT Patient LAD Negative remodeling without plaque in Diagonal branch

  24. Randomized to Provisional TStenting with Cypher (3.5x33mm) and Post-dilation

  25. FFR AssessmentDue to TIMI 3 flow and no dissection

  26. Randomized to Kissing Balloon

  27. Final Result with FFR

  28. Intermediate Stenosis at SBCROSS Patient

  29. Main Branch StentingRandomized to Endeavor Stent Endeavor 3.5 x 30mm High pressure dilatation to 4.1mm

  30. Significant SB jail with TIMI 3 flow • FFR before kissing • Randomization to kissing balloon

  31. Final FFR after Kissing • Post-procedure FFR

  32. Final Angiogram

  33. Insights From the Early Experiences of CROSS and PERFECT • Significant SB jail by anatomical and functional evaluation was very low. • With our guideline, SB stenting in the provisional T stenting group has been required in < 10%. • Negative remodeling in SB was not uncommon.

  34. From CROSS and PERFECT • We will reveal that anatomical combined with functional approach provide profound information on bifurcation coronary anatomy and may resulted in improved long-term clinical outcomes.

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