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

Explore findings and implications of the CROSS and PERFECT trials on coronary bifurcation lesions, stenting strategies, and treatment outcomes. Understand the impact of kissing balloon inflation, stent design, IVUS guidance, and more.

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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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