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Bioresorbeerbare “stents”

Bioresorbeerbare “stents”. Dokter Luc Janssens Imeldaziekenhuis Bonheiden. Elewijt , 21 september 2013. Bioresorbable Vascular Scaffolds: A New Paradigm in the Treatment of Coronary Artery Disease. PCI Historical Perspective. 1977. 1988. 2001 - 2003.

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Bioresorbeerbare “stents”

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  1. Bioresorbeerbare “stents” Dokter Luc Janssens Imeldaziekenhuis Bonheiden Elewijt, 21 september 2013

  2. Bioresorbable Vascular Scaffolds: A New Paradigm in the Treatment of Coronary Artery Disease

  3. PCI Historical Perspective 1977 1988 2001 - 2003 Andreas Gruntzig performs the first PTCA in Zurich, Switzerland Julio Palmaz and Richard Schatz develop a stainless steel stent for coronary applications Drug eluting stents are introduced to the European and U.S. markets 1 Balloon Angioplasty (PTCA) 1977 3 2 Researchers develop early concepts of bioresorbable devices aimed at functioning as a temporary scaffold in the coronary vessel Coronary Drug Eluting Stents (DES) Abbott Vascular enrolls 30 patients in ABSORB, the first ever human clinical trial testing a fully bioresorbable drug eluting scaffold BareMetal Stents (BMS) Japanese researchers implant bioresorbable PLLA scaffold in human coronary arteries (Igaki-Tamai device) Abbott Vascular establishes the BVS development team 1983 1999 2003 2006 • The idea for developing a temporary coronary scaffold began in the 1980s

  4. ABSORB EXTEND Clinical Results – MACE at 12 Months‘ 1977 2000 A.B. ,the 1st PTCA by Andreas Gruentzig on September 29, 1977, attended and spoke at the 30th Anniversary on September 30, 2007 in Zurich, an incredible tribute to the breakthrough made by Andreas 30 years ago1 In patients who did not suffer sub-acute closure due to dissections, or restenosis due to negative remodeling in the first few months, long term results following balloon angioplasty were very encouraging and durable, with loss in MLD not seen until 17 years post procedure2 1. Meier, B., N Engl J Med. 2001; 344: 144-145. 2. Hatrick, R., et al. EuroIntervention. 2009;5:121-126.

  5. Interventional cardiology treatment:a historical unmet need‘ • Success of early PCI treatment (POBA) has been demonstrated for as long as 17 yearsx Long-termPOBA Serial AngiographyStudies 1977 3 2.5 * 2 MLD (mm) Guiteras Val MLD (mm) 1.5 Hatrick 1 2000 0.5 0 Post 17 yrs 4.5 yrs 6-months Baseline 10 years Meier, B., N Engl J Med. 2001; 344: 144-145 • POBA is limited by acute recoil, sub-acute closure, and dissections Guiteras-Val, P., et al. Am J Cardiol. 1999;83:868-874. / Hatrick, R., et al. EuroIntervention. 2009;5:121-126.

  6. The Clinical Need for a Bioresorbable Vascular Scaffold’ Rationale Vessel scaffolding is only needed transiently* Vision Improve Long Term Outcomes for Patientsby Leaving No Scaffold Behind1 Potential Benefits • Restore the vessel to a more natural state, capable of natural vascular function • Eliminate chronic sources of vessel irritation and inflammation • Vessels remain free for future treatment options • Reduce the need for prolonged DAPT2 • Allows for use of non-invasive imaging techniques (CCTA) • Improve patient quality of life *Serruys PW, et al., Circulation 1988; 77: 361. Serial study suggesting vessels stabilize 3-4 months following PTCA. 1 – Small platinum markers at scaffold edges remain for fluoroscopic landmarking. 2. The Absorb IFU indicates DAPT for a minimum of 6 months.

  7. ‘Caged’ (Stented) Vessel’ Delayed Healing  Stent Thrombosis? * uncovered struts1 Benign NIH Neo-Atheroma  Stent Thrombosis? In-Stent Restenosis Late Acquired Malapposition  Stent Thrombosis? 1. Virmani, R. Tissue responses in pre-clinical models; CIT 2010 NIH: NeoIntimalHyperplasia

  8. Potential of a Fully*Bioresorbable Vascular Scaffold’ Benign NIH Expansive Remodeling1 Late Lumen Gain In-Scaffold Restenosis Plaque Regression2 Since struts disappear, issues related to very late persistent strut malapposition and chronically uncovered struts become irrelevant 1Serruys, PW, ABSORB Cohort B 1-year results; ACC 2011 / 2Serruys, PW, et al. Lancet. 2009; 373: 897-910. *Small platinum markers at scaffold edges remain for fluoroscopic landmarking. NIH: NeoIntimal Hyperplasia

  9. The Clinical Need for a Bioresorbable Vascular Scaffold’ Rationale Vessel scaffolding is only needed transiently* Vision Improve Long Term Outcomes for Patientsby Leaving No Scaffold Behind1 Potential Benefits • Restore the vessel to a more natural state, capable of natural vascular function • Eliminate chronic sources of vessel irritation and inflammation • Vessels remain free for future treatment options • Reduce the need for prolonged DAPT2 • Allows for use of non-invasive imaging techniques (CCTA) • Improve patient quality of life *Serruys PW, et al., Circulation 1988; 77: 361. Serial study suggesting vessels stabilize 3-4 months following PTCA. 1 – Small platinum markers at scaffold edges remain for fluoroscopic landmarking. 2. The Absorb IFU indicates DAPT for a minimum of 6 months.

  10.                                            How Absorb Resorbs • Water in surrounding vascular cells and blood penetrates polymer matrix • Long polymer chains become shorter and shorter Initially, hydrolysis preferentially cleaves amorphous tie chains, leading to a decrease in molecular weight without altering radial strength Tie chains When enough tie chains are broken, the device begins losing radial strength Support Molecular Weight Mass Loss 3 12 18 1 24 Months 6

  11. The Absorb BVS scaffoldis replaced by functional cellular Matrix

  12. Resorption: Vascular Response Resorption Site Absorb BVS Polymer is replaced by an increasingly cellular provisional matrix 1 month 6 months 12 months 24 months 30 months 36 months 42 months XIENCE V Representative photomicrographs of porcine coronary arteries, 2x, Movat’spentachrome Images on file with Abbott Vascular

  13. Resorption: Vascular Response Resorption Site Absorb BVS Polymer is replaced by an increasingly cellular provisional matrix 1 month 6 months 12 months 24 months 30 months 36 months 42 months XIENCE V Representative photomicrographs of porcine coronary arteries, 20x, Hematoxylin and Eosin Images on file with Abbott Vascular

  14. Absorb Conformability Absorb provides better conformability compared to metallic platforms 88° 91° Absorb BVS Serruys, PW. , Seeing is believing: the clinical evidence so far; PCR 2010; J. Gomez-Lara, JACC Cardiovascular Interventions. 2010; 3: 1190-8.

  15. Restore : Preliminary Evidence of Vasomotion Suggests Improved Long-term Outcomes 1 12 Months2 6 Months1 24 Months3 ABSORB Cohort B1 ABSORB Cohort B2 ABSORB Cohort A (N=6) (N=13) (N=9) (N=7) (N=15) (N=19) Vasodilation 0.5 (pre-drug infusion to post-drug infusion)  in Vessel Diameter (mm) 0 Vasoconstriction -0.5 Acetylcholine Methergine -1 B 1. Adapted from Serruys, PW. ACC 2011 / 2. Adapted from Serruys, PW. ACC 2011 / 3. Adapted from Serruys, PW, et al. Lancet 2009; 373: 897-910.

  16. Restore: Late Lumen Gain Offers the Potential for Reduced TLR* Post-PCI 6 Months 2 Years n = 33 n = 33 n = 33 ABSORB Scaffold Area Lumen Area 6.53 mm2 Cohort B 6.36 mm2 6.85 mm2  1.7% Serial Analysis* Lumen Area  7.2% Late Loss = 0.19 mm B *Serruys, PW., TCT 2011

  17. There is still room for improvement Current PCI Options for Treating CAD Serruys, PW. PCR 2010 B Serruys, PW. PCR 2010

  18. ABSORB EXTEND Clinical Results MACE at 12 Months Intent to Treat (ITT) Analysis – Interim Snapshot The datasets are from different trials and displayed for descriptive purposed only. MACE: a composite of cardiac death, MI, and ischemia-driven TLR Chevalier, ABSORB EXTEND 12-month outcomes in the first 450 patient enrolled, Rotterdam EuroPCR Focus on BVS 2013

  19. The Absorb BVS System Meeting an unmet clinical need? Rationale Vessel scaffolding is only needed transiently* Vision Improve Long Term Outcomes for Patientsby Leaving No Scaffold Behind1 Potential Benefits • Restore the vessel to a more natural state, capable of natural vascular function • Eliminate chronic sources of vessel irritation and inflammation • Vessels remain free for future treatment options • Reduce the need for prolonged DAPT2 • Allows for use of non-invasive imaging techniques (CCTA) • Improve patient quality of life *Serruys PW, et al., Circulation 1988; 77: 361. Serial study suggesting vessels stabilize 3-4 months following PTCA. 1 – Small platinum markers at scaffold edges remain for fluoroscopic landmarking. 2. The Absorb IFU indicates DAPT for a minimum of 6 months.

  20. Absorb May be Especially Beneficial for Certain Patient Types Patients at risk for future interventions First time, young patients* • Young patients may need futureinterventions that can be complicatedor compromised by a permanent implant • Bioresorbable vascular scaffolds willpreserve more treatment options forfuture interventions Non-invasive assessmentof patients by MSCT Patients with metal allergy • Non-invasive imaging for early and late follow-up is feasible with BVS • Population with nickel allergy is estimatedto be 8.6% of the general population1Allergic reactions to nickel and molybdenumreleased from stents may be one of thetriggering mechanisms for in-stent restenosis2 *Young patient defined as <65 years of age / 1. Thyssen et al. Contact Dermatitis 2007/ 2. Koster, Lancet, Vol 356, 12/2/00

  21. It’s difficultto make predictionsespeciallyabout the futureAl Gore

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