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This video deals with the Newer trends in interventional cardiology
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Dr. Prashant JagtapSr. Interventional CardiologistWockhardt Hospitals , NAGPUR
Newer Trends in Interventional Cardiology
Cardiovascular Disease
1.2 Million Heart
Attacks
Outline
Outline
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
Coronary Atherosclerosis
AngiogramVisualize blockagesCatheter is inserted into the
leg or armContrast dye for visualizationX-ray is taken of the arteries
Health Care Guideline: Stable Coronary Artery Disease. Institute for Clinical Systems Improvement. !3th ed., 2009
Other TestsEKGStress testEchocardiographBlood work
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 AngioplastyDr. Andreas Gruentzig
Evolution of Angioplasty
Pros Cons
Balloon Angioplasty
-Enlarges narrow artery-Relieves chest pain
-Elastic recoil of artery -High early restenosis
Bare Metal Stents
-Permanently prop open vessel less elastic recoil-Lower early restenosis
-Metal scars endothelial tissue-Leads to neointimal growth response-Contributes to late restenosis
Drug Eluting Stent
-Antiproliferative drug mitigates adverse response to metal reduce restenosis
-Incomplete healing induce chronic inflammatory response -Increased risk of thrombosis
Lobodzinski, S. S. (2008). Bioabsorbable Coronary Stents. Cardiology Journal, 15(6), 569-571.
Video: Stenting Procedure
http://www.youtube.com/watch?v=gvRtP3wl_AY
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?
• 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
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• 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
BVS vs. DES: The Thrombosis Issue
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
Curfman GD, Morrissey S, Jarcho JA, Drazen JM. Drug-eluting coronary stents—promise and uncertainty. NEJM. 2007;256:1059-1060
Advantages of the BVS Stent
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
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
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
Regulatory Pathway for BVS Based on Drug-Eluting Stents
Drug Eluting Stent
Stent Platform and Delivery
System
DrugCarrier
“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
33
Bioresorbable Device Components
Bioresorbable Coating
• PDLLA coating
• Fully biodegradable
• Similar dose and release rate to XIENCE V
Everolimus
• Poly (Lactic Acid) (PLLA)
• Naturally absorbed, fully metabolized
Bioresorbable Device Platform
MULTI-LINK VISION Stent Delivery System
• Seven generations of MULTI-LINK success
• World-class deliverability
All illustrations are artists’ renditions
34
• Naturally absorbed, fully metabolized
• Acutely perform like a metallic DES: deliverability, conformability, radial strength
• Long-term: restore vasomotion, improved clinical outcomes, lower restenosis
• Compatible with CT imaging
Bioabsorbable Vascular Solutions Program Goals
Bioresorbable Polymer
Everolimus/PDLLA Matrix Coating
Thin coating layerAmorphous (non-
crystalline)1:1 ratio of Everolimus/PLA
matrixConformal Coating, 2-4 m
thickControlled drug release
PLLA BackboneHighly crystallineProvides device integrityProcessed for increased
radial strength
Polymer backbone
Drug/polymer matrix
Performance Criteria for a Fully Bioresorbable Device
1 3 6 2 Yrs
Full Mass Loss & Bioresorption
Mos
Platelet Deposition
Leukocyte Recruitment
SMC Proliferation and Migration
Matrix Deposition
Re-endothelialization
Vascular Function
Everolimus Elution
Support
Mass Loss
Forrester JS, et al., J. Am. Coll. Cardiol. 1991; 17: 758.
37
• ABSORB Cohort A 3-Year Data:– One MACE* (NQMI); No
additional MACE between 6 months and 3 years
– No stent thrombosis through 3 years
– Lumen enlargement from 6 months to 2 years by IVUS and OCT
– Restoration of vasomotion – including the treated segment
– Bioabsorption of device
ABSORB Cohort AExcellent 3-Year Clinical Data
Key Players in the Bioabsorbable Stent Market
Outline
Quantitative Analysis Assumptions
Costs remain the same in:
Cost differential occurs in:
ProcedureInitial
hospitalizationRoutine follow-ups
Acquisition of stentSerious adverse
eventsAnti-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.
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
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.
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 StentsDAT – 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 Large coronary stent market BVS improves on thrombosis
BVS has the potential to be economically feasible for device manufacturer and healthcare insurers
Acknowledgements Dr. Jayson Parker, M.Biotech
Dr. Michael Kutryk, St. Michael’s Hospital
Dr. Geoff Puley, Trillium Health Center
Jennie Kim, Abbott Vascular, U.S.A
Dr. Robert Cottone, Orbis Neich
Dr. Janarthan Nikhil, Credit Valley
Dr. Sidney Kremer, Credit Valley
Dr. Kirandeep Nagi, Credit Valley
Joanne Barrette, Abbott Vascular
Margaret Chong, Abbott Vascular
Dr. Jeffrey Pang, Sunnybrook Health Sciences Center
Dr. Linda Mackeigan, Leslie Dan School of Pharmacy
Dr. Peter Seidelin, Toronto General Hospital
Breakthrough Technology for Mitral Regurgitation
MITRACLIPvideo
Mitraclip.flv
Thank you for listening.
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