Newer trends in interventional cardiology

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Newer trends in interventional cardiology

  1. 1. Dr. Prashant Jagtap Sr. Interventional Cardiologist Wockhardt Hospitals , NAGPUR Newer Trends in Interventional Cardiology
  2. 2. Cardiovascular Disease 1.2 Million Heart Attacks
  3. 3. Outline
  4. 4. Outline
  5. 5. Coronary Artery Disease <ul><li>Result of accumulation of atherosclerotic plaque </li></ul><ul><li>Arteries supplying the heart muscle are occluded </li></ul><ul><li>Oxygen-rich blood does not reach the heart </li></ul><ul><li>Symptoms are angina and myocardial infarction </li></ul>http://www.nhlbi.nih.gov/health/dci/Diseases/Cad/CAD_WhatIs.html
  6. 6. Coronary Atherosclerosis
  7. 7. Angiogram <ul><li>Visualize blockages </li></ul><ul><li>Catheter is inserted into the leg or arm </li></ul><ul><li>Contrast dye for visualization </li></ul><ul><li>X-ray is taken of the arteries </li></ul>Health Care Guideline: Stable Coronary Artery Disease. Institute for Clinical Systems Improvement . !3th ed., 2009 Other Tests <ul><li>EKG </li></ul><ul><li>Stress test </li></ul><ul><li>Echocardiograph </li></ul><ul><li>Blood work </li></ul>
  8. 8. Treatment Algorithm
  9. 9. Treatments for CAD Health Care Guideline: Stable Coronary Artery Disease. Institute for Clinical Systems Improvement . !3th ed., 2009
  10. 10. History of Angioplasty First stainless steel Stent inserted in human artery 1986 2006 30 patients enrolled in the first ever human clinical trial testing a fully Bioabsorbable Drug-eluting Stent (ABSORB trial, Abbott) Drug eluting stents introduced to EU and USA markets 2001-2003 1999 First bioabsorbable PLLA stent in human coronary arteries (Igaki-Tamai) 1977 First Coronary Angioplasty Dr. Andreas Gruentzig
  11. 11. Evolution of Angioplasty Lobodzinski, S. S. (2008). Bioabsorbable Coronary Stents. Cardiology Journal , 15(6), 569-571. Pros Cons Balloon Angioplasty <ul><li>Enlarges narrow artery </li></ul><ul><li>Relieves chest pain </li></ul><ul><li>Elastic recoil of artery </li></ul><ul><li>High early restenosis </li></ul>Bare Metal Stents <ul><li>Permanently prop open vessel  less elastic recoil </li></ul><ul><li>Lower early restenosis </li></ul><ul><li>Metal scars endothelial tissue </li></ul><ul><li>Leads to neointimal growth response </li></ul><ul><li>Contributes to late restenosis </li></ul>Drug Eluting Stent <ul><li>Antiproliferative drug mitigates adverse response to metal  reduce restenosis </li></ul><ul><li>Incomplete healing  induce chronic inflammatory response </li></ul><ul><li>Increased risk of thrombosis </li></ul>
  12. 13. Video: Stenting Procedure <ul><li>http://www.youtube.com/watch?v=gvRtP3wl_AY </li></ul>
  13. 14. Outline
  14. 15. Three Generations of Stents Ormiston et al. (2007). Catheterization and Cardiovascular Intervention, 69: 129-131
  15. 16. Restenosis http://www.evgn.org/home/imagesnew/stentv2web.jpg Restenosis and Neo-Intimal Hyperplasia Tissue re-growth into the stent area
  16. 17. Drug Eluting Stents: The Problem Curfman GD, Morrissey S, Jarcho JA, Drazen JM. Drug-eluting coronary stents—promise and uncertainty. NEJM . 2007;256:1059-1060
  17. 18. Stent Thrombosis Cola, C. Brugaletta, S., Yuste, V. M., Campos, B., Angiolillo, D. J. & Sabete, M. (2009). Diabetes mellitus: a prothrombotic state implications for outcomes after coronary revascularization. Vascular Health and Risk Management , 5, 101-119.
  18. 19. Thrombosis: Early vs. Late Events Cola, C. Brugaletta, S., Yuste, V. M., Campos, B., Angiolillo, D. J. & Sabete, M. (2009). Diabetes mellitus: a prothrombotic state implications for outcomes after coronary revascularization. Vascular Health and Risk Management , 5, 101-119.
  19. 20. DES: The Market Leader Xience outperforms Taxus Express in SPIRIT IV, Dave Fornell, Diagnostic and Invasive Cardiology. Retrieved on Nov 26th, 2009 from http://www.dicardiology.net/node/34463/3 Sipkoff, M. (2009, Jul 1). Drug-eluting stents make a comeback. ModernMedicine. Retrieved online http://www.modernmedicine.com/modernmedicine/Modern+Medicine+Feature+Articles/Drug-eluting-stents-make-a-comeback/ArticleStandard/Article/detail/607928
  20. 21. Stents: Product Label – On or Off? <ul><li>FDA approved lesion parameters </li></ul><ul><ul><li>Lesion length < 30 mm </li></ul></ul><ul><ul><li>Vessel diameter: 2.5 mm to 3.75mm </li></ul></ul><ul><li>Off label examples </li></ul><ul><ul><li>Lesion in by pass graft </li></ul></ul><ul><ul><li>Bifurcation lesion </li></ul></ul>Source: FDA Guidance Document on Drug Eluting Stents
  21. 22. Outline
  22. 23. Kirk. N. Garratt. (2009). Update on DES and Biodegradable Stents 2009
  23. 24. BVS Functionality Ormiston et al. (2007). Catheterization and Cardiovascular Intervention, 69: 129-131
  24. 25. The BVS Stent: Polymers <ul><li>PLLA (Poly-L-Lactic Acid) backbone </li></ul><ul><li>PDLLA (Poly-D,L-lactic acid) coating </li></ul><ul><li>Both degrade to lactic acid </li></ul><ul><li>Entire stent absorbs in 2 years </li></ul>Ormiston et al. (2007). Catheterization and Cardiovascular Intervention, 69: 129-131
  25. 26. BVS vs. DES: The Thrombosis Issue Curfman GD, Morrissey S, Jarcho JA, Drazen JM. Drug-eluting coronary stents—promise and uncertainty. NEJM . 2007;256:1059-1060 Drug – Eluting Stent Bioabsorbable stent Polymer not biocompatible Polymers are biocompatible All the drug is not eluted 100% drug is eluted in 4 months Incomplete healing of endothelium Complete healing of endothelium Problems with late and very late ST No reports of ST from phase I study
  26. 27. Advantages of the BVS Stent
  27. 28. ABSORB: First In-man Study <ul><li>30 patients, single de novo lesions </li></ul><ul><li>Composite endpoint: </li></ul><ul><ul><li>Cardiac death, Myocardial Infarction, Target lesion revascularization (TLR) </li></ul></ul><ul><li>Secondary end points: </li></ul><ul><ul><li>In-stent late loss, late ST </li></ul></ul><ul><li>Results: </li></ul><ul><ul><li>0% thrombosis, 0% TLR, MACE (3.3%) </li></ul></ul>Ormiston et al. (2007). Catheterization and Cardiovascular Intervention, 69: 129-131
  28. 29. Bare-Metal vs. Drug-Eluting vs. Bioabsorbable Stents Results taken from the 2006 Spirit IV trial (3, 690 patients), 2002 Sirius trial (1,058 patients) and the Absorb trial (30 patients). All trials were done in patients with similar lesions. The results reported are after 1-year follow-up.
  29. 30. Second Generation BVS Stent <ul><li>More even support of arterial wall </li></ul><ul><li>Lower late stent area loss </li></ul><ul><li>Higher radial strength </li></ul>Ormiston et al. (2007). Catheterization and Cardiovascular Intervention, 69: 129-131
  30. 31. Regulatory Pathway for BVS Based on Drug-Eluting Stents Drug Eluting Stent Stent Platform and Delivery System Drug Carrier “Polymer” PMA – Class III Device Source: Food and Drug Administration, U.S.A Center for Devices and Regulatory Health Center for Drug Evaluation and Research
  31. 32. Bioabsorable Vascular Solution
  32. 33. Bioresorbable Device Components Bioresorbable Coating <ul><li>PDLLA coating </li></ul><ul><li>Fully biodegradable </li></ul><ul><li>Similar dose and release rate to XIENCE V </li></ul>Everolimus <ul><li>Poly (Lactic Acid) (PLLA) </li></ul><ul><li>Naturally absorbed, fully metabolized </li></ul>Bioresorbable Device Platform MULTI-LINK VISION Stent Delivery System <ul><li>Seven generations of MULTI-LINK success </li></ul><ul><li>World-class deliverability </li></ul>All illustrations are artists’ renditions
  33. 34. Bioabsorbable Vascular Solutions Program Goals <ul><li>Naturally absorbed, fully metabolized </li></ul><ul><li>Acutely perform like a metallic DES: deliverability, conformability, radial strength </li></ul><ul><li>Long-term: restore vasomotion, improved clinical outcomes, lower restenosis </li></ul><ul><li>Compatible with CT imaging </li></ul>
  34. 35. Bioresorbable Polymer <ul><li>Everolimus/PDLLA Matrix Coating </li></ul><ul><li>Thin coating layer </li></ul><ul><li>Amorphous (non-crystalline) </li></ul><ul><li>1:1 ratio of Everolimus/PLA matrix </li></ul><ul><li>Conformal Coating, 2-4  m thick </li></ul><ul><li>Controlled drug release </li></ul><ul><li>PLLA Backbone </li></ul><ul><li>Highly crystalline </li></ul><ul><li>Provides device integrity </li></ul><ul><li>Processed for increased radial strength </li></ul>Polymer backbone Drug/polymer matrix
  35. 36. Performance Criteria for a Fully Bioresorbable Device 1 3 6 2 Yrs Mos Forrester JS, et al., J. Am. Coll. Cardiol. 1991; 17: 758. Full Mass Loss & Bioresorption Platelet Deposition Leukocyte Recruitment SMC Proliferation and Migration Matrix Deposition Re-endothelialization Vascular Function Everolimus Elution Support Mass Loss
  36. 37. ABSORB Cohort A Excellent 3-Year Clinical Data <ul><li>ABSORB Cohort A 3-Year Data: </li></ul><ul><ul><li>One MACE* (NQMI); No additional MACE between 6 months and 3 years </li></ul></ul><ul><ul><li>No stent thrombosis through 3 years </li></ul></ul><ul><ul><li>Lumen enlargement from 6 months to 2 years by IVUS and OCT </li></ul></ul><ul><ul><li>Restoration of vasomotion – including the treated segment </li></ul></ul><ul><ul><li>Bioabsorption of device </li></ul></ul>
  37. 38. Key Players in the Bioabsorbable Stent Market
  38. 39. Outline
  39. 40. Quantitative Analysis Assumptions <ul><li>Costs remain the same in: </li></ul><ul><li>Cost differential occurs in: </li></ul><ul><li>Procedure </li></ul><ul><li>Initial hospitalization </li></ul><ul><li>Routine follow-ups </li></ul><ul><li>Acquisition of stent </li></ul><ul><li>Serious adverse events </li></ul><ul><li>Anti-platelet therapy (DAT) </li></ul>Cohen, D.J. et al. Cost Effectiveness of Sirolimus-Eluting Stents for Treatment of Complex coronary Stenoses. Circulation 2004; 110: 508-514. Cost Total = Cost Stent + Cost Serious Adverse Events + Cost DAT
  40. 41. Cost-Benefit Analysis of BVS on Thrombosis and TLR Rates Filion, K. B., Roy, A. M., Baboushkin, T., Rinfret, S. & Eisenberg, M. J. (2009). Cost-Effectiveness of Drug-Eluting Stents Including the Economic Impact of Late Stent Thrombosis. The American Journal of Cardiology, 103(3): 338-44. Price of stents : $2200 DES (Cypher) $3000 BVS (Abbott)
  41. 42. Cost Effectiveness(CE) Analysis <ul><li>Incremental Cost Effectiveness Ratio (ICER) </li></ul><ul><li>The lower the ICER, the better </li></ul><ul><li>Compare CE of BVS to DES </li></ul>Cohen, D.J. et al. Cost Effectiveness of Sirolimus-Eluting Stents for Treatment of Complex coronary Stenoses. Circulation 2004; 110: 508-514.
  42. 43. Equations for ICER Calculation Cohen, D.J. et al. Cost Effectiveness of Sirolimus-Eluting Stents for Treatment of Complex coronary Stenoses. Circulation 2004; 110: 508-514. ICER – Incremental Cost Effectiveness Ratio BVS – Bioabsorbable Stents SAE – Serious Adverse Events BMS – Bare Metal Stents DAT – Dual Anti-platelet Therapy Freq - Frequency
  43. 44. Historical Precedence ICER (BMS vs Balloon) $5000/SAD Avoided ICER (DES vs BMS) $5098/SAD Avoided Cohen, D.J. et al. Cost Effectiveness of Sirolimus-Eluting Stents for Treatment of Complex coronary Stenoses. Circulation 2004; 110: 508-514.
  44. 45. ICER of BVS with Three Estimates of Study Outcome
  45. 46. Stent Feature Matrix Bare-Metal Stents Drug-eluting Stent Bioabsorbable drug- eluting Stent Reduced Dual-Antiplatelet Therapy No neointimal hyperplasia Restoration of Vasomotion Material (Biocompatible) Lobodzinski, S. S. (2008). Bioabsorbable Coronary Stents. Cardiology Journal , 15(6), 569-571.
  46. 47. Conclusion <ul><li>Large coronary stent market </li></ul><ul><li>BVS improves on thrombosis </li></ul><ul><li>BVS has the potential to be economically feasible for device manufacturer and healthcare insurers </li></ul>
  47. 48. Acknowledgements <ul><li>Dr. Jayson Parker, M.Biotech </li></ul><ul><li>Dr. Michael Kutryk, St. Michael’s Hospital </li></ul><ul><li>Dr. Geoff Puley, Trillium Health Center </li></ul><ul><li>Jennie Kim, Abbott Vascular, U.S.A </li></ul><ul><li>Dr. Robert Cottone, Orbis Neich </li></ul><ul><li>Dr. Janarthan Nikhil, Credit Valley </li></ul><ul><li>Dr. Sidney Kremer, Credit Valley </li></ul><ul><li>Dr. Kirandeep Nagi, Credit Valley </li></ul><ul><li>Joanne Barrette, Abbott Vascular </li></ul><ul><li>Margaret Chong, Abbott Vascular </li></ul><ul><li>Dr. Jeffrey Pang, Sunnybrook Health Sciences Center </li></ul><ul><li>Dr. Linda Mackeigan, Leslie Dan School of Pharmacy </li></ul><ul><li>Dr. Peter Seidelin, Toronto General Hospital </li></ul>
  48. 49. Breakthrough Technology for Mitral Regurgitation MITRACLIP <ul><li>video </li></ul>
  49. 50. <ul><li>Thank you for listening. </li></ul><ul><li>Questions? </li></ul>

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