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.
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
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
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
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.
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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
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
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)
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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.
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Notas del editor
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
Decision to be made and decision criteria
Decision to be made and decision criteria
-expand on CABG Stents improve the diameter of the arteries add link to procedure after here:
Decision to be made and decision criteria
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
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
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
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
What is non Q wave? – look it up
**change TLR to 0%
More uniform strut distribution Unchanged: Material thickness Strut thickness
Decision to be made and decision criteria
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
-mention stent price is assumed for BVS Second price point same slide Literature of comparison for these #s
Analytical tool used by insurance agencies for reimbursement
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
Neointimal Growth Response changed to positive growth response, meanin
