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Which is the role of post-dilation after DES implantation? Enrico Romagnoli 1,2 M.D., Ph.D.

Which is the role of post-dilation after DES implantation? Enrico Romagnoli 1,2 M.D., Ph.D. 1 Policlinico Casilino , Roma 2 Opedale San Raffaele, Milano. Basic principle of stent-based PCI.

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Which is the role of post-dilation after DES implantation? Enrico Romagnoli 1,2 M.D., Ph.D.

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  1. Which is the role of post-dilation after DES implantation? Enrico Romagnoli1,2 M.D., Ph.D. 1Policlinico Casilino, Roma 2Opedale San Raffaele, Milano

  2. Basic principle of stent-based PCI Optimization of stent deployment during percutaneous coronary intervention (PCI) is a key element to obtain most favorable immediate and long-term results. The bigger = The better

  3. Bigger stent expansion = better outcome Colombo A, et al. Intracoronary stenting without anticoagulation accomplished with intravascular ultrasound guidance. Circulation 1995;15;91:1676–88. Conclusions: the Palmaz-Schatz stent can be safely inserted incoronary arteries without subsequent anticoagulation providedthat stent expansion is adequate. High-pressure final balloon dilatations (14.9 ± 3.0 atm) and confirmation of adequate stent expansion by intravascularultrasound provide assurance that anticoagulation therapy canbe safely omitted. This technique significantly reduces hospital timeand vascular complications and has a low stent thrombosis rate (1.6%).

  4. Bigger DES expansion = better outcome? After the introduction of drug-eluting stents (DES), the importance of optimal stent deployment was initially underestimated, leading to less use of high pressure deployment and/or balloon post-dilation.

  5. Bigger DES expansion = better outcome? Conclusion: SES had a considerably lower optimal MSA threshold compared to BMS Cypher Bx Velocity Sonoda S, et al. J Am CollCardiol2004

  6. Bigger DES expansion = better outcome? A comparison study between SIRIUS-US (pre- and post-dilation) and E-SIRIUS (direct stenting and non mandatory post-dilation) IVUS results showed that, although the less aggressive stent implantation in E-SIRIUS resulted in a relatively lower stent expansion, no detrimental effects were observed in major adverse cardiac events. Hoffmann R,et al. Catheter CardiovascInterv 2005

  7. Bigger DES expansion = better outcome? = edge restenosis Sakurai R, et al. Am J Cardiol2005

  8. Bigger DES expansion = better outcome? = edge restenosis Sakurai R, et al. Am J Cardiol2005

  9. Magnitude of suboptimal stent expansion Because stent under-expansion is poorly recognized by angiography, the real incidence of suboptimal stent deployment is likely to be underestimated.

  10. Before post-dilation After post-dilation

  11. Determinants of Suboptimal Stent Deployment • Stent undersizing (balloon to artery ratio <1): • (certainly the first and the most important) • severe and diffuse target vessel; • small vessel; • acute coronary syndrome; • severe stenosis; • direct stenting. In case of undersizing of the stent delivery balloon, high-pressure deployment can compensate for the balloon undersizing only in part!

  12. Determinants of Suboptimal Stent Deployment • Balloon compliance and pressure deployment: • (the most unknown) • Stent manufacturers provide a compliance chart relating balloon deployment pressure and the stent diameter based on in vitro measurement (in air or in water). • Several IVUS studies found that the real MSD after stent deployment was 20-26% less than the unconstrained stent size displayed in the compliance chart on the stent box. • These differences were independent of stent manufacturer, length, diameter, and deployment pressure and related to the inherent resistance of dilating stent within an atherosclerotic artery.

  13. Intravascular ultrasound assessment of drug-eluting stent expansion According to the compliance chart, DES achieved 75% ± 10% of predicted MSD 66% ± 17% of predicted MSA 24% of SES and 28% of PES did not achieve a final MSA of 5 mm2 De Ribamar Costa Am Heart J 2007

  14. Intravascular ultrasound assessment of drug-eluting stent expansion no significant difference in stent expansion between DES and their BMS equivalent De Ribamar Costa Am Heart J. 2007

  15. Determinants of Suboptimal Stent Deployment • Plaque and vessel compliance: • (the most unpredictable) • In IVUS studies, arterial expansion seemed to be the primary mechanism of lumen enlargement after stenting, accounting for approximately 70% of luminal gain, whereas the relative contribution of plaque reduction ranged between 6% and 34%. • Causes of impaired compliance: • vessel fibrosis • calcium • high plaque burden • previous stent implantation Boschat J et al.Int J Cardiovasc Imaging 2002

  16. Intravascular ultrasound assessment of drug-eluting stent expansion Stent expansion cannot be predicted from pre-intervention IVUS lesion assessment De Ribamar Costa Am Heart J. 2007

  17. Determinants of Suboptimal Stent Deployment Plaque and vessel compliance: high plaque burden 67.6% IVUS success rate % 45.7% Yoon Sc, et al. Catheter Cardiovasc Interv. 2002

  18. Determinants of Suboptimal Stent Deployment Plaque and vessel compliance: Calcium minimal/maximal stent diameter P = 0.001 Stent symmetry index Albrecht D, et al. Cathet Cardiovasc Diagn 1996

  19. Determinants of Suboptimal Stent Deployment Plaque and vessel compliance: Calcium Baseline Stent 16 atm Stent at 20 atm Vavuranakis M, et al. Cathet Cardiovasc Intervent 2001

  20. Determinants of Suboptimal Stent Deployment • Lesion characteristics: • (certainly the most predictable) • Specific lesion subsets are associated with a lower success rate and required more care and tools to obtain an optimal stent deployment: • bifurcation lesion (side branch ostium, kissing balloon); • ostial lesion (fibrosis) • long lesion (proximal-distal vessel sizemismatch, overlap) • small vessel (vessel overstretch) • in stent restenosis

  21. Determinants of Suboptimal Stent Deployment Stent undersizing (balloon to artery ratio <1) Balloon compliance and pressure deployment Plaque and vessel compliance Lesion characteristics For these causes, the use of a noncompliant balloon post-dilation represents a good compromise to achieve good stent expansion and symmetry without increasing risk of dissection or rupture of the vessel.

  22. High pressure stent deployment vs. non-compliant balloon postdilation Despite high-pressure deployment, lumen dimensions after stenting are only 57% of maximal achievable. Inadequate balloon expansion and elastic recoil are responsible for residual lumen stenosis Bermejo J, et al.Circulation 1998

  23. Post-dilation with the stent balloon is not sufficient High pressure stent deployment vs. non-compliant balloon postdilation Jose de Ribamar Costa et al, American Heart Journal 2007

  24. (mm2) IVUS Derived Final stent CSA Mean Minimum Stent CSA According to Post-dilation Balloon Size 15 10 5 0 2.5 3.0 3.5 4.0 Balloon Size (mm)

  25. Efficacy of Post-deployment BalloonDilatation for Bare Metal Stentsas Assessed by Intravascular Ultrasound Minimal stent area Stent volume index 7.5 7.4 6.6 6.4 P <0.001 P <0.001 Seung-Ho Hur. Am J Cardiol 2001

  26. Efficacy of Post-deployment BalloonDilation for Bare Metal Stents as Assessed by Intravascular Ultrasound

  27. Efficacy of Post-deployment BalloonDilation for Bare Metal Stents as Assessed by Intravascular Ultrasound Stent CSA / reference CSA After stent deployment (stent/vessel ratio 1.1) After non compliant post dilation (balloon vessel/ratio 1.1) Seung-Ho Hur. Am J Cardiol 2001

  28. POST-IT Trial protocol Lesion predilation Stenting with delivery balloon (ballon/vessel ratio 1.1) IVUS assessment IVUS criteriafor optimum stent deploymentmet? No Yes Post-dilatewith NC balloon (ballon/vessel ratio 1.1) Procedure end IVUS assessment IVUS criteria for optimum stent deployment met? Yes Brodie BR, et al. Catheter CardiovascInterv 2003

  29. High pressure stent deployment vs. non-compliant balloon postdilation 42% 7,8% 6,6% P < 0.01 21% MUSIC criteria satisfied MSA Brodie BR, et al. Catheter CardiovascInterv 2003

  30. High pressure stent deployment vs. non-compliant balloon postdilation 3.0 x 18 mm stent delivery balloon at 14 atm 3.0 x 15 mm non-compliant balloon at 14 atm MSD 2.2 MSD 2.5 Brodie BR, et al. Catheter CardiovascInterv 2003

  31. Risk of “dog bone”/edge effect with an SC balloon at high pressure NC balloon at high pressure Semi-compliant vs. non-compliant balloon Semi Compliant Non Compliant

  32. Semi-compliant vs. non-compliant balloon Non compliant balloon Quantum 4.0 x 15 mm Standard stent delivery balloon 4.0 x 16 mm

  33. Pre-Optimization Post-Optimization High pressure stent deployment vs. non-compliant balloon postdilation Avoid the Donkey effect!

  34. Benefits of a NC balloon post-dilation after DES implantation • In-stent restenosis: • complete stent struts apposition; • higher luminal MSA (<5 mm2 threshold); • stent symmetry (homogeneous drug release) Observational data suggest that stent under-expansion might be one of the most important causes of DES failure, advocating that, once neo-intimal hyperplasia is suppressed, the optimum stent deployment is still fundamental

  35. Under deploymentis a cause forIn-Stent Restenosis 20% Results from a retrospective study of 1.090 patients Castagna MT, et al. American Heart Journal 2001

  36. Benefits of a NC balloon post-dilation after DES implantation • Stent thrombosis (0.4%-0.6% of RCT up to 1.3-4.9 of registry) • complete stent struts apposition; • stent underexpansion (shear stress); • reduced edge dissection • shorter dual antiplatelet therapy In this view, the less care used by operators to obtain an optimal stent deployment and a lower use of post-dilation might represent a possible explanation of the higher rates of stent thrombosis observed with DES

  37. Under deployment is the main causefor subacute thrombosis 78% Results from 7484 consecutive patients without acute MI Cheneau E, et al. Circulation. 2003

  38. Stent underexpansion is an independent predictor of subacute stent thrombosis Stent thrombosis group (SES) Matched control group (SES) vs. +/- 1.9 +/- 0.14 6.2 0.85 +/- 1.6 +/- 0.18 p < 0.001 4.3 0.65 Minimum stent CSA Stent expansion Fujii, K, et al. Journal of the American College of Cardiology 2005

  39. How to select and post-dilate with an non-compliant balloon

  40. Which is the role of post-dilation after DES implantation? Conclusions • In clinical practice, a considerable number of patients might benefit from repeat inflations with non-compliant balloons at higher pressures and/or with larger diameter size. • Data from the literature suggest that achieving adequate stent expansion during PCI is important to reduce restenosis and the need for TVR, but it might also minimize the risk of stent thrombosis in the DES era.

  41. Which is the role of post-dilation after DES implantation? Conclusions • None of the baseline clinical or angiographic variables seemed able to predict the final MSA or MSD after stenting. Similarly, neither quantitative IVUS lesion measurements nor qualitative IVUS assessment of plaque morphology could predict stent expansion. • These observations would suggest that the impact of plaque and vessel compliance on the final stent expansion can be limited by an appropriate use of post-dilation.

  42. Which is the role of post-dilation after DES implantation? Conclusions • Although there are not enough randomized data to support its use, it seems wise to perform post-dilation with non-compliant balloons at high pressures in the majority of patients undergoing both BMS and DES implantation. • Particularly in IVUS-guided procedures, the recommended strategy to achieve an optimal stent deployment should be to select a noncompliant balloon whose size matches the media-to-media IVUS measurement.

  43. Which is the role of post-dilation after DES implantation? Enrico Romagnoli1,2 M.D., Ph.D. Reference: Romagnoli et al. JACC intv. 2008;1:45-56 Slidesavailable at: www. metcardio.org

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