Treatment of in stent restenosis DEB, DES, or BVS

14th Vietnam National Congress of Cardiology Da Nang City Vietnam 2014 Treatment of In-Stent Restenosis: DEB, DES, or BVS? Dr Tan Huay Cheem MBBS, M Med(Int Med) MRCP(UK), FRCP(Edinburgh), FAMS, FACC, FSCAI Director, National University Heart Centre, Singapore Associate Professor of Medicine, Yong Loo Lin School of Medicine National University of Singapore President, Asia Pacific Society of Interventional Cardiology Incidence and Clinical Presentation of In-Stent Restenosis • BMS: - 20-30% (up to 40% in high- risk subsets) • DES: - pivotal trials: < 6% - real world trials: 10-15% • DES & BMS: - Up to 60% presenting with ACS - Up to 20% presenting with acute MI - 50% in need for TVR In-Stent Restenosis Treatment Options • Drug-Eluting Balloon • Drug-Eluting Stent (Same vs Different) • Bioresorbable Vascular Scaffold • POBA • Cutting Balloon • Scoring Balloon • Laser, Rotablation • Vascular brachytherapy • CABG Drug-Coating Balloon In In-Stent Restenosis Advantages of DEB Angioplasty for In-Stent Restenosis Efficacy Predominantly firm fibrous nature of neointimal hyperplastic tissue makes acute vessel wall recoil and abrupt vessel closure after PTCA less likely, obviating need for stent placement Safety • Shorter duration of drug release and lack of second durable polymer/stent platform favours earlier vascular healing, reduced hypersensitivity, and lower likelihood of stent thrombosis • Shorter duration of DAPT results in lower bleeding risk and medical cost Understanding Mechanism of Action of DEB With Angiography & OCT 25 pts with ISR treated with DEB had serial angiographic, OCT and FFR measurements performed before, after procedure and at months • Acutely, DEB mechanically increase lumen and stent volumes by compression of neointimal hyperplasia, with intra-stent dissection; dilatation of old stent • At months, further increase in lumen volume and decrease in neointimal volume, and complete sealing of neointimal dissections ensure vessel patency • Mechanism: Mechanical expansion + local drug release effect PR Stella et al J Am Coll Cardiol Intv 2013; 6: 569-76 Evidence for DEB in ISR • RCT Comparison of DEB vs POBA • Worldwide Registries of DEB • RCT Comparison of DEB vs DES Treatment of Coronary In-Stent Restenosis with a Paclitaxel-Coated Balloon Catheter (PACCOCATH ISR 1) • 52 pts with ISR randomised to DEB and uncoated balloon • Primary endpoint: mth late luminal loss on angiography Conclusions: Treatment of coronary ISR with paclitaxel-coated balloon catheters significantly reduced the incidence of restenosis Inhibition of restenosis by local drug delivery may not require stent implantation & sustained drug release at the site of injury Scheller B et al New J of Medicine 2006; 355: 2113-2124 PEDCAD-DES Multicentre randomised comparison of 110 pts with DES ISR to paclitaxel-coated balloon angioplasty or uncoated balloon angioplasty Clinical Outcomes at Months Drug-Coated Balloon (n=72) Uncoated Balloon (n=38) P Value 11 (15.3%) 14 (36.8%) 0.005 Myocardial infarction (0.0%) (2.6%) 0.35 Cardiac death (1.4%) (10.5%) 0.048 12 (16.7%) 19 (50.0%) [...]... Composite of Death, MI, or TLR p=0.52 % p=0.69 % TLR,% orTLR, MIor Death, Death,MI 50 SES PES 40 P=0.71 30 20 10 0 SES PES 0 2 4 6 8 10 Months after randomization Mehilli J et al JACC 2010; 55: 2710-6 12 Bioresorbable Vascular Scaffold In In -Stent Restenosis Why Bioabsorbable Stents in ISR? • No double or multiple layer of metal • May address both issue of intimal hyperplasia and stent underexpansion... vs VBT for BMS Restenosis Ellis SG et al Eur Heart J 2008; F et al, JACC 2006;29:1625-34 ISAR DESIRE Trial: Same vs Different DES in SES ISR 450 patients with SES -restenosis: SES vs PES Primary Endpoint: Late Luminal Loss mm P = 0.75 Secondary Endpoint Binary Restenosis P = 0.69 ISAR-DESIRE: Clinical Outcomes Angiographic Restenosis at 6 to 8 Months and Clinical Restenosis at 1 Year Composite of Death,... caging of the vessel with permanent impairment of coronary vasomotion • Avoid chronic inflammatory processes (shortened duration of dual antiplatelet therapy) Case Study • 56 yrs old Indian male CVRF smoking, hypt, dyslipidemia • MPI scan showed LAD territory ischemia Status-post PCI to mid LAD Case Study: Post DES PCI Angiography 5 Months Later DES ISR: OCT Imaging MLA 1.7 sq mm DES ISR: BVS 3x18mm Stent. .. DEB vs POBA • Worldwide Registries of DEB • RCT Comparison of DEB vs DES • Inclusion criteria: Diameter stenosis of ≥70% and ≤22 mm in length, with a vessel diameter of 2.5 to 3.5mm • Primary endpoint was angiographic in- segment late lumen loss PEPCAD II: Angiographic follow-up DEB Taxus DES 66 65 Late lumen loss In- segment 0.17 ± 0.42 mm 0.38 ± 0.61 mm 0.03 Binary restenosis rate (In- segment) 7% 20%... Unverdorben M et al Circulation 2009; 119: 2986-2994 PEPCAD II: Clinical Follow-Up at 12 Mths (Freedom from stent thrombosis, target lesion revascularization, myocardial infarction, and death – intention to treat) 100% Event free survival DEB 80% DES 60% p = 0.052 40% Treatment of coronary ISR with PEB was at least as efficacious 20% and as well tolerated as the paclitaxel-eluting stent Inhibition of. .. Non Cardiac Deaths +1 Definitive ST Thrombosis Intention to Treat RIBS IV Trial • 309 pts with DES ISR • Randomised to EES (Xience Prime) vs DEB (SeQuent Please ) F Alfonso TCT 2014 RIBS IV Trial: Clinical Follow-up 1 Year FU 100%; FU Time 360±35 days F Alfonso TCT 2014 ESC Guidelines Eur Heart J 2010; 31: 2501-55 Drug-Eluting Stent In In -Stent Restenosis RIBS II: SES vs POBA For BMS ISR Alfonso F et... re -restenosis does not require a second stent implantation 0% 0 2 4 6 8 10 12 14 months No at risk Drug-coated balloon 66 66 63 61 60 59 58 Drug-eluting stent 65 63 61 58 52 52 52 Unverdorben M et al Circulation 2009; 119: 2986-2994 PEPCAD China ISR Trial • 220 pts with DES-ISR received SeQuent Please PCB or Taxus Liberte PES • Primary endpoint at 9 mth: In- segment late lumen loss in PCB was noninferior... lumen loss in PCB was noninferior to PES • 9 mth rate of binary restenosis and 12-mth composite clinical event rates were not significantly different B Xu et al J Am Coll Cardiol Intv 2014: 7: 204-211 ISAR-DESIRE 3 (DES ISR): Primary Endpoint Diameter Stenosis at Follow-up Angiography Cumulative Frequency (%) 100 Paclitaxel-Eluting Balloon (PEB) 0000 Paclitaxel-Eluting Stent (PES) Balloon Angioplasty... World Wide Registry: DEB in DES & BMS -Restenosis 1523 patients with DES & BMS -restenosis- 9-Month Outcome after paclitaxel-eluting balloon P