Bioabsorbable Drug-Eluting Cardiac Stent Analysis

download Bioabsorbable Drug-Eluting Cardiac Stent Analysis

of 68

  • date post

    11-May-2015
  • Category

    Education

  • view

    11.706
  • download

    12

Embed Size (px)

description

A presentation regarding a analysis of the marketplace for stents and also how Abbott could enter the market with their new stent technology in order to acquire the most amount of customers.

Transcript of Bioabsorbable Drug-Eluting Cardiac Stent Analysis

  • 1.Abbotts Bioabsorbable-Everolimus Eluting StentsThe Future Of Coronary Stents Meghana Venkatesh, Sean Wadel,Shirley Cai, Miki Stanikic & Abi Saiyanthan

2. Cardiovascular Disease1.2 Million Heart Attacks 3. Does the proposed fix:

  • Prove the improved safety and efficacy of the bioabsorbable stent over drug-eluting stents in a high risk population?
  • Increase market share for the bioabsorbable stent?

4. Decision Criteria for Implementing Our Proposal 5. Outline 6. Outline 7. Coronary Artery Disease

  • Result of accumulation of atherosclerotic plaque
  • Arteries supplying the heart muscle are occluded
  • Oxygen-rich blood does not reach the heart
  • Symptoms are angina and myocardial infarction

http://www.nhlbi.nih.gov/health/dci/Diseases/Cad/CAD_WhatIs.html 8. Coronary Atherosclerosis 9. Angiogram

  • Visualize blockages
  • Catheter is inserted into the leg or arm
  • Contrast dye for visualization
  • X-ray is taken of the arteries

Health Care Guideline: Stable Coronary Artery Disease.Institute for Clinical Systems Improvement . !3th ed., 2009 Other Tests

  • EKG
  • Stress test
  • Echocardiograph
  • Blood work

10. Treatments for CAD Health Care Guideline: Stable Coronary Artery Disease.Institute for Clinical Systems Improvement . !3th ed., 2009 11. 12. Video: Stenting Procedure

  • http://www.youtube.com/watch?v=gvRtP3wl_AY

13. Outline 14. Three Generations of StentsOrmiston et al. (2007). Catheterization and Cardiovascular Intervention, 69: 129-131 15. Restenosishttp://www.evgn.org/home/imagesnew/stentv2web.jpg Restenosis andNeo-Intimal HyperplasiaTissue re-growth into the stent area 16. Drug Eluting Stents: The Problem Curfman GD, Morrissey S, Jarcho JA, Drazen JM. Drug-eluting coronary stentspromise and uncertainty.NEJM . 2007;256:1059-1060 17. 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. 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. DES: The Market LeaderXience outperforms Taxus Express in SPIRIT IV, Dave Fornell, Diagnostic and Invasive Cardiology. Retrieved on Nov 26th, 2009 from http://www.dicardiology.net/node/34463/3Sipkoff, 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. Stents: Product Label On or Off?

  • FDA approved lesion parameters
    • Lesion length < 30 mm
    • Vessel diameter: 2.5 mm to 3.75mm
  • Off label examples
    • Lesion in by pass graft
    • Bifurcation lesion

Source: FDA Guidance Document on Drug Eluting Stents 21. Outline 22. Kirk. N. Garratt. (2009). Update on DES and Biodegradable Stents 2009 23. BVS Functionality Ormiston et al. (2007). Catheterization and Cardiovascular Intervention, 69: 129-131 24. The BVS Stent: Polymers

  • PLLA (Poly-L-Lactic Acid) backbone
  • PDLLA (Poly-D,L-lactic acid) coating
  • Both degrade to lactic acid
  • Entire stent absorbs in 2 years

Ormiston et al. (2007). Catheterization and Cardiovascular Intervention, 69: 129-131 25. BVS vs. DES:The Thrombosis Issue Curfman GD, Morrissey S, Jarcho JA, Drazen JM. Drug-eluting coronary stentspromise 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 andvery late ST No reports of ST fromphase I study 26. Advantages of the BVS Stent 27. ABSORB: First In-man Study

  • 30 patients, single de novo lesions
  • Composite endpoint:
    • Cardiac death, Myocardial Infarction, Target lesion revascularization (TLR)
  • Secondary end points:
    • In-stent late loss, late ST
  • Results:
    • 0% thrombosis, 0% TLR, MACE (3.3%)

Ormiston et al. (2007). Catheterization and Cardiovascular Intervention, 69: 129-131 28. 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. Second Generation BVS Stent

  • More even support of arterial wall
  • Lower late stent area loss
  • Higher radial strength

Ormiston et al. (2007). Catheterization and Cardiovascular Intervention, 69: 129-131 30. Regulatory Pathway for BVS Based on Drug-Eluting StentsDrug Eluting StentStent Platform and Delivery SystemDrug Carrier Polymer PMA Class III DeviceSource: Food and Drug Administration, U.S.A Center for Devices and Regulatory HealthCenter for Drug Evaluation and Research 31. Key Players in the Bioabsorbable Stent Market 32. Outline 33. Diabetes Mellitus (DM)

  • Characteristics:
  • More progressive, diffuse and multi-vessel coronary disease
  • Complicated lesions in DM patients
  • Pro-inflammatory and pro-thrombic states
  • High platelet reactivity

Win, H. K., Caldera, A. E., Maresh, K., Lopez, J., Rihal, C. S., Parikh, M. A., Granada, J. F., Marulkar, S., Nassif, D., Cohen, D. J. & Kleiman, N. S. (2007). Clinical Outcomes and Stent Thrombosis Following Off-Label Use of Drug-Eluting Stents.The Journal of the American Medical Association,297(18), 2001-2009. 34. Cypher: Benchmark Stent in Diabetic Population Machecourt, J. et al. (2007). Risk Factors for Stent Thrombosis After Implantation of Sirolimus-Eluting Stents in Diabetics and Non-Diabetic Patients: The EVESTENT Matched-Cohort Registry.Journal of the American College of Cardiology,(50)6, 501-508 35. Value Proposition for Proposed Study in Diabetics 36. Proposal to Abbott Vascular: ABSORB DIABETES trial

  • Budget:$7.4 million

37. ABSORB DIABETES: Endpoints

  • Ormiston et al.(2008). A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novocoronary artery lesions(ABSORB): a prospective open-label trial.The Lancet . 371, 899-907
  • Personal communication with Dr. Robert Cottone, Orbus Neich

38. Yearly Revenue Projections ROI = 39.5%3% 5% 10% 8% 8% 6% Price of stents : $2200 DES (Cypher)$3000 BVS (Abbott) 39. Break Even PointBreak Even:5.2 months Cost= Marginal Cost of 35% + trial budget 40. Quantitative Analysis Assumptions

  • Costs remain the same in:
  • Cost differential occurs in:
  • Procedure
  • Initial hospitalization
  • Routine follow-ups
  • Acquisition of stent
  • Serious adverse events
  • Anti-platelet therapy (DAT)

Cohen, D.J. et al. Cost Effectiveness of Sirolimus-Eluting Stents for Treatment of Complex coronary Stenoses. Circulation 2004; 110: 508-514. CostTotal= CostStent+ CostSerious Adverse Events+ CostDAT 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. Cost Effectiveness(CE) Analysis

  • Incremental Cost Effectiveness Ratio (ICER)
  • The lower the ICER, the better
  • Compare CE of BVS to DES

Cohen, D.J. et al. Cost Effectiveness of Sirolimus-Eluting Stents for Treatment of Complex coronary Stenoses. Circulation 2004; 110: 508-514. 43. Equations for ICER CalculationCohen, 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 RatioBVS Bioabsorbable Stents SAE Serious Adverse EventsBMS Bare Metal Stents DAT Dual Anti-platelet TherapyFreq - Frequency 44. Historical Precedence ICER (BMS vs Balloon)$5000/SAD AvoidedICER (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 MatrixBare-Metal Stents Drug-eluting Stent Bioabsorbable drug- eluting StentReduced Dual-Antiplatelet Therapy No neointimal hyperplasiaRestoration of Vasomotion Material (Biocompatible) Lobodzinski, S. S. (2008). Bioabsorbable Coronary Stents.Cardiology Journal , 15(6), 569-571. 47. Conclusion

  • Large coronary stent market
  • BVS improves on thrombosis
  • Proposed trial : to demonstrate favourability