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Dr. Prashant Jagtap Sr. Interventional Cardiologist Wockhardt Hospitals , NAGPUR Newer Trends in Interventional Cardiology
Cardiovascular Disease  1.2 Million Heart Attacks
Outline
Outline
Coronary Artery Disease ,[object Object],[object Object],[object Object],[object Object],http://www.nhlbi.nih.gov/health/dci/Diseases/Cad/CAD_WhatIs.html
Coronary Atherosclerosis
Angiogram ,[object Object],[object Object],[object Object],[object Object],Health Care Guideline: Stable Coronary Artery Disease.  Institute for Clinical Systems Improvement . !3th ed., 2009 Other Tests ,[object Object],[object Object],[object Object],[object Object]
Treatment Algorithm
Treatments for CAD Health Care Guideline: Stable Coronary Artery Disease.  Institute for Clinical Systems Improvement . !3th ed., 2009
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
Evolution of Angioplasty Lobodzinski, S. S. (2008). Bioabsorbable Coronary Stents.  Cardiology Journal , 15(6), 569-571.  Pros Cons Balloon Angioplasty  ,[object Object],[object Object],[object Object],[object Object],Bare Metal Stents ,[object Object],[object Object],[object Object],[object Object],[object Object],Drug Eluting Stent ,[object Object],[object Object],[object Object]
 
Video: Stenting Procedure  ,[object Object]
Outline
Three Generations of Stents  Ormiston et al. (2007). Catheterization and Cardiovascular Intervention, 69: 129-131
Restenosis  http://www.evgn.org/home/imagesnew/stentv2web.jpg Restenosis and  Neo-Intimal Hyperplasia  Tissue re-growth into the stent area
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
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.
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.
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
Stents: Product Label – On or Off?  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Source: FDA Guidance Document on Drug Eluting Stents
Outline
Kirk. N. Garratt. (2009). Update on DES and Biodegradable Stents 2009
BVS Functionality Ormiston et al. (2007). Catheterization and Cardiovascular Intervention, 69: 129-131
The BVS Stent: Polymers ,[object Object],[object Object],[object Object],[object Object],Ormiston et al. (2007). Catheterization and Cardiovascular Intervention, 69: 129-131
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
Advantages of the BVS Stent
ABSORB: First In-man Study ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Ormiston et al. (2007). Catheterization and Cardiovascular Intervention, 69: 129-131
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.
Second Generation BVS Stent ,[object Object],[object Object],[object Object],Ormiston et al. (2007). Catheterization and Cardiovascular Intervention, 69: 129-131
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
Bioabsorable Vascular Solution
Bioresorbable Device Components Bioresorbable Coating ,[object Object],[object Object],[object Object],Everolimus ,[object Object],[object Object],Bioresorbable Device Platform MULTI-LINK VISION Stent Delivery System ,[object Object],[object Object],All illustrations are artists’ renditions
Bioabsorbable Vascular Solutions Program Goals ,[object Object],[object Object],[object Object],[object Object]
Bioresorbable Polymer ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Polymer backbone Drug/polymer matrix
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
ABSORB Cohort A Excellent 3-Year Clinical Data ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Key Players in the Bioabsorbable Stent Market
Outline
Quantitative Analysis Assumptions ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],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
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)
Cost Effectiveness(CE) Analysis  ,[object Object],[object Object],[object Object],Cohen, D.J. et al. Cost Effectiveness of Sirolimus-Eluting Stents for Treatment of Complex coronary Stenoses. Circulation 2004; 110: 508-514.
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
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.
ICER of BVS with Three Estimates of Study Outcome
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.
Conclusion  ,[object Object],[object Object],[object Object]
Acknowledgements ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Breakthrough Technology for Mitral Regurgitation MITRACLIP ,[object Object]
[object Object],[object Object]

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Newer trends in interventional cardiology

  • 1. Dr. Prashant Jagtap Sr. Interventional Cardiologist Wockhardt Hospitals , NAGPUR Newer Trends in Interventional Cardiology
  • 2. Cardiovascular Disease 1.2 Million Heart Attacks
  • 5.
  • 7.
  • 9. Treatments for CAD Health Care Guideline: Stable Coronary Artery Disease. Institute for Clinical Systems Improvement . !3th ed., 2009
  • 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.
  • 12.  
  • 13.
  • 15. Three Generations of Stents Ormiston et al. (2007). Catheterization and Cardiovascular Intervention, 69: 129-131
  • 16. Restenosis http://www.evgn.org/home/imagesnew/stentv2web.jpg Restenosis and Neo-Intimal Hyperplasia Tissue re-growth into the stent area
  • 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
  • 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.
  • 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.
  • 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
  • 21.
  • 23. Kirk. N. Garratt. (2009). Update on DES and Biodegradable Stents 2009
  • 24. BVS Functionality 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
  • 27. Advantages of the BVS Stent
  • 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.
  • 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
  • 33.
  • 34.
  • 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
  • 37.
  • 38. Key Players in the Bioabsorbable Stent Market
  • 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)
  • 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
  • 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.
  • 45. ICER of BVS with Three Estimates of Study Outcome
  • 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.
  • 47.
  • 48.
  • 49.
  • 50.

Editor's Notes

  1. Coronary atherosclerotic disease remains the leading cause of mortality in the industrialized world. One American dies from coronary heart disease (CHD) every minute, with an estimated 1.2 million MIs occurring annually in the United States. 1 With the epidemic of obesity in this country and Americans' increasingly sedentary lifestyle, more patients are at risk of developing CHD than ever before (jaapa article) Need better treatments A million Americans undergo procedures to treat blocked arteries every year
  2. Decision to be made and decision criteria
  3. Decision to be made and decision criteria
  4. -expand on CABG Stents improve the diameter of the arteries  add link to procedure after here:
  5. Decision to be made and decision criteria
  6. http://www.topnews.in/files/Drug-eluting22.jpg , http://graphics8.nytimes.com/images/2005/08/18/business/stent.span.jpg , http://www.dicardiology.net/files/D0909_Abbott_ABSORB%20BVS%20stent.jpg Bare Metal Stents No coating Mesh-like tube of wire Drug-Eluting Stents Metal stent platform Polymer coating + drug Bioabsorbable stents Polymer stent platform Polymer coating + drug
  7. Incomplete healing Raw sub-endothelial layer  platelet activating Platalet aggregation  thrombotic event Also, 90% of drug locked in leaches out over time in small amounts preventing healing  late thrombosis DAT given for 1 yr  after DAT period, risk of thrombosis increases
  8. Late-stent thrombosis issues – decline following head-to-head trials – increase in market again Xience V by Abbott – current market leader DES : 90% of market by ‘06 Decline to 60% in ‘07 Increased to 70% by ‘09
  9. Decision to be made and decision criteria
  10. http://www.medgadget.com/archives/img/56675trii.jpg
  11. Use these as features that are used Improved Lesion Imaging Angiography – GOLD standard but high cost and invasive CT – improved resolution and high negative predictive value
  12. What is non Q wave? – look it up
  13. **change TLR to 0%
  14. More uniform strut distribution Unchanged: Material thickness Strut thickness
  15. Decision to be made and decision criteria
  16. This is evidenced by comparable value of the above-mentioned cost associated with drug eluting stents and bare metal stents in studies compiled and compared the individual billing information of patients on drug eluting stents and bare metal stents.  New equations from Shirley
  17. -mention stent price is assumed for BVS Second price point same slide Literature of comparison for these #s
  18. Analytical tool used by insurance agencies for reimbursement
  19. This is evidenced by comparable value of the above-mentioned cost associated with drug eluting stents and bare metal stents in studies compiled and compared the individual billing information of patients on drug eluting stents and bare metal stents.  New equations from Shirley
  20. Neointimal Growth Response  changed to positive growth response, meanin
  21. Need to put M biotech logo as well a