The document discusses newer trends in interventional cardiology, focusing on developments in stent technology, including bare metal stents, drug-eluting stents, and bioabsorbable stents. It describes how stents have evolved from balloon angioplasty to using drugs and biodegradable materials to prevent restenosis. Bioabsorbable stents potentially offer reduced need for long-term blood thinners and restoration of normal vascular function once absorbed. Clinical trials so far show bioabsorbable stents perform similarly to drug-eluting stents with no reported stent thromboses.

1. Dr. Prashant Jagtap Sr. Interventional Cardiologist Wockhardt Hospitals , NAGPUR Newer Trends in Interventional Cardiology

2. Cardiovascular Disease 1.2 Million Heart Attacks

3. Outline

4. Outline

6. Coronary Atherosclerosis

8. Treatment Algorithm

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

14. Outline

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

22. Outline

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

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

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.

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

32. Bioabsorable Vascular Solution

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

38. Key Players in the Bioabsorbable Stent Market

39. Outline

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)

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.