Bioresborbable scaffolds in acute coronary syndromes
Attractiveness of BVS
• Vessel enlargement
• Vasomotor restoration
• Completely dissolvable- uncaging of vessel
– Feasible for future CABG options
• Permits assessment with non-invasive CT
angiography
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Bioresborbable Scaffolds in Acute Coronary Syndromes Koh Tian Hai Senior Consultant, Dept of Cardiology Senior Advisor National Heart Centre, Singapore 14th VNCC Danang 10-14 Oct 2014 Conflicts of Interest • Abbott – trial grant & travel support • BSC, Biosensors- travel support 2014 ESC Guideline on evaluation & revascularisation in ACS S Windecker , P Kolh et al. EHJ 2014; 35: 2541-2619 DES with randomised Trials with primary clinical endpoint - ESC S Windecker , P Kolh et al. EHJ 2014; 35: 2541-2619 Some Current BRS undergoing trials A Lelasi & M Tespii Fut Card 2014; 10: 409-20 Attractiveness of BVS • Vessel enlargement • Vasomotor restoration • Completely dissolvable- uncaging of vessel – Feasible for future CABG options • Permits assessment with non-invasive CT angiography BRS: Late Lumen Enlargement P W Serruys at TCT 2013 Porcine Model-IVUS: Increase in Lumen area: BVS vs EES after 12mths JP Lane et al. JACCIntv 2014; 7: june online 70 pigs with 109 BVS and 70 EES implanted in various arteries; Serial angio, IVUS and histomorphometry at various timepoints 1-42 mths Porcine IVUS : Increase in lumen area after 12mth & pulsatility with BVS vs EES after 6mth JP Lane et al. JACCIntv 2014; 7: june online Plaque Sealing with BRS P W Serruys at TCT 2013 BVS Case Illustration RCA-RAO view showing Severe tortuosity 2 RCA tortuosity ++ -LAO cranial view 1 Final post BVS - LAO cranial 4 Trackability of BVS 3 3 Gen DES & BVS for LAD long CTO Synergy Tracking Pre PCI CTO Prox LAD - BVS Final Angio & 9mth follow-up Final 9 mths angio ABSORB Cohort A: MACE to 5 years Y Onuma et al. JACCIntv 2013; 6:999-1009 30 patient Cohort No MACE beyond 6 months No cardiac deaths No Stent Thrombosis All 18 pts with MSCT at 5yrs show patent Scaffolds Why do we need to implant BVS in ACS? • Younger patients, less Coro Atherosclerosis – Free patients from permanent stents • Does not obviate CABG for long lesions. • ? Long term reduction in need for antiplatelet Rx. • ? Safety to stop all antiplatelets temporarily for surgical procedures. • ? Plaque sealing of vulnerable plaques. V Kocka et al. EHJ 2014l 35: 787-94 142 ppci pts 3 groups Non randomised Baseline Characteristics V Kocka et al. EHJ 2014l 35: 787-94 Prague 19: MACE outcomes at 6 mths V Kocka et al. EHJ 2014l 35: 787-94 BRS in ACS Trials & Registries Trial Active arm n MACE ST Control n (non random) MACE ST p STEMI-First 49 2.6% @ 30 days 0 123 PRAGUE-19 STEMI 41 5% @ 6 mths 1 57 93% - 0.6 Kajima- NUHCS STEMI 11 9.1% @ 53 days - T Gori-ACS UAP,NSTEMI- STEMI 150 10-7% @ 30 days 3 103 15.5% 2 >0.8 J Weibe- STEMI 25 8.3% @ 137 days 0 - C Naber @ TCT 2014 Proportion of ACS patients in ABSORB FIRST C Naber @ TCT 2014 Cardiac Death & MI to 30 days C Naber @ TCT 2014 ABSORB II BVS VS EES 1yr secondary clinical outcomes PW Serruys et al. Lancet; online 14 Sept 2014 501 pt, 2:1 BVS : EES Randomised Multicentre ABSORB II at 1yr: Secondary MACE Endpoints PW Serruys et al. Lancet; online 14 Sept 2014 Absorb N=335 EES N=166 P=0.28 R Dilleti @ BRS 2014 A Arbb-Zadeh et al. Circ 2012; 25: 1147-56 Should we stent the Vulnerable Plaque? GW Stone et al. NEJM 2011; 364: 226-35 PROSPECT STUDY GW Stone @ BRS 2014 GW Stone @ BRS 2014 GDMT=guideline determined med therapy ABSORB II at 1yr: Stent Thrombosis (Define or Probable) PW Serruys et al. Lancet; online 14 Sept 2014 Absorb N=335 EES N=166 P=0.55 Ghost Multicentre Registry-1189 patients Def/Prob Scaffold Thrombosis to 6 mths D Capodanno et al. EuroIntv 2014 July online ST= 1.5% at 30 days, 2.1% at 6 mths Conclusions : BRS in ACS • BRS implantation seems feasible in ACS patients. • Stent thrombosis seems to be of some concern in nonrandomised real-world BRS studies – appears higher than latest generation of DES. • Vessel sizing important to prevent malapposition. • Better low profile device needed. • Major randomised BRS studies in ACS needed, with hard clinical endpoints. 21st to 24th January 2015 Thank You C Tamburino @ TCT 2014 DES with angio efficacy data S Windecker , P Kolh et al. EHJ 2014; 35: 2541-2619 Biosolve I: Vasoreactivity at 6 mths M Haude at EuroPCR may 2014
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