Presentation is loading. Please wait.

Presentation is loading. Please wait.

Dokter Luc Janssens Imeldaziekenhuis Bonheiden Elewijt, 21 september 2013.

Similar presentations


Presentation on theme: "Dokter Luc Janssens Imeldaziekenhuis Bonheiden Elewijt, 21 september 2013."— Presentation transcript:

1 Dokter Luc Janssens Imeldaziekenhuis Bonheiden Elewijt, 21 september 2013

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

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

4 A.B.,the 1 st PTCA by Andreas Gruentzig on September 29, 1977, attended and spoke at the 30 th Anniversary on September 30, 2007 in Zurich, an incredible tribute to the breakthrough made by Andreas 30 years ago 1 1. Meier, B., N Engl J Med. 2001; 344: 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 procedure 2 2. Hatrick, R., et al. EuroIntervention. 2009;5:

5 Meier, B., N Engl J Med. 2001; 344: Long-term POBA Guiteras-Val, P., et al. Am J Cardiol. 1999;83: / Hatrick, R., et al. EuroIntervention. 2009;5: * Baseline Post 6-months 4.5 yrs 10 years 17 yrs MLD (mm) Guiteras Val Hatrick MLD (mm) Serial Angiography Studies Success of early PCI treatment (POBA) has been demonstrated for as long as 17 yearsx POBA is limited by acute recoil, sub-acute closure, and dissections

6 Vessel scaffolding is only needed transiently* Rationale Potential Benefits Improve Long Term Outcomes for Patients by Leaving No Scaffold Behind 1 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 DAPT 2 Allows for use of non-invasive imaging techniques (CCTA) Improve patient quality of life 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 DAPT 2 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. Vision

7 Delayed Healing  Stent Thrombosis? Benign NIH In-Stent Restenosis Late Acquired Malapposition  Stent Thrombosis? Neo-Atheroma  Stent Thrombosis? * uncovered struts 1 1. Virmani, R. Tissue responses in pre-clinical models; CIT 2010NIH: NeoIntimal Hyperplasia

8 Benign NIH In-Scaffold RestenosisPlaque Regression 2 Expansive Remodeling 1 Late Lumen Gain Since struts disappear, issues related to very late persistent strut malapposition and chronically uncovered struts become irrelevant NIH: NeoIntimal Hyperplasia *Small platinum markers at scaffold edges remain for fluoroscopic landmarking. 1 Serruys, PW, ABSORB Cohort B 1-year results; ACC 2011 / 2 Serruys, PW, et al. Lancet. 2009; 373:

9 Vessel scaffolding is only needed transiently* Rationale Potential Benefits Improve Long Term Outcomes for Patients by Leaving No Scaffold Behind 1 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 DAPT 2 Allows for use of non-invasive imaging techniques (CCTA) Improve patient quality of life 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 DAPT 2 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. Vision

10 Water in surrounding vascular cells and blood penetrates polymer matrix Long polymer chains become shorter and shorter Months Support Mass Loss Tie chains Initially, hydrolysis preferentially cleaves amorphous tie chains, leading to a decrease in molecular weight without altering radial strength When enough tie chains are broken, the device begins losing radial strength                                 Molecular Weight 1218           

11

12 Representative photomicrographs of porcine coronary arteries, 2x, Movat’s pentachrome Resorption Site Images on file with Abbott Vascular Absorb BVS Polymer is replaced by an increasingly cellular provisional matrix XIENCE V 24 months1 month12 months30 months36 months6 months42 months

13 Representative photomicrographs of porcine coronary arteries, 20x, Hematoxylin and Eosin Resorption Site Images on file with Abbott Vascular Absorb BVS XIENCE V Polymer is replaced by an increasingly cellular provisional matrix 24 months1 month12 months30 months36 months6 months42 months

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

15 B  in Vessel Diameter (mm) Methergine Acetylcholine (N=15) 6 Months 1 (N=6) (N=19) 12 Months 2 (N=13)(N=9) 24 Months 3 (N=7) Vasodilation Vasoconstriction ABSORB Cohort B1 ABSORB Cohort B2 ABSORB Cohort A (pre-drug infusion to post-drug infusion) 1. Adapted from Serruys, PW. ACC 2011 / 2. Adapted from Serruys, PW. ACC 2011 / 3. Adapted from Serruys, PW, et al. Lancet 2009; 373:

16 B ABSORB Cohort B Serial Analysis* Lumen Area 6.53 mm mm mm 2 n = 33 Scaffold Area  1.7% Lumen Area  7.2% Late Loss = 0.19 mm Post-PCI6 Months2 Years *Serruys, PW., TCT 2011

17 B Serruys, PW. PCR 2010 There is still room for improvement Serruys, PW. PCR 2010

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

19 Vessel scaffolding is only needed transiently* Rationale Potential Benefits Improve Long Term Outcomes for Patients by Leaving No Scaffold Behind 1 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 DAPT 2 Allows for use of non-invasive imaging techniques (CCTA) Improve patient quality of life 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 DAPT 2 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. Vision

20 Young patients may need future interventions that can be complicated or compromised by a permanent implant Non-invasive imaging for early and late follow- up is feasible with BVS *Young patient defined as <65 years of age / 1. Thyssen et al. Contact Dermatitis 2007 / 2. Koster, Lancet, Vol 356, 12/2/00 First time, young patients* Non-invasive assessment of patients by MSCT Bioresorbable vascular scaffolds will preserve more treatment options for future interventions Patients at risk for future interventions Population with nickel allergy is estimated to be 8.6% of the general population 1 Allergic reactions to nickel and molybdenum released from stents may be one of the triggering mechanisms for in-stent restenosis 2 Patients with metal allergy

21


Download ppt "Dokter Luc Janssens Imeldaziekenhuis Bonheiden Elewijt, 21 september 2013."

Similar presentations


Ads by Google