Bioresorbale Stents Just an Alternative or One-Way Street?

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Bioresorbale Stents Just an Alternative or One-Way Street? Georgios I. Papaioannou, MD, MPH, FACC, FSCAI Director, Cardiac Catheterization Laboratory Athens Medical Center 29/10/2015 ΕΚΕ 2015

Bioresorbale Drug-Eluting Stents (BRS) Breakthrough technology (after biodegradable polymers) Stents disappear after their useful function (no local inflammatory reaction) Restore vasomotor tone and endothelialization Increase vessel diameter (positive remodeling) Improve coronary physiology Potentially decrease anginal burden ΕΚΕ 2015

Bioresorbale Drug-Eluting Stents (BRS) Not currently all patients are candidates and lesions are suitable Stent deployment requires optimal pre and post dilatation Low threshold of intracoronary imaging techniques Higher rate of early post-procedural stent thrombosis ΕΚΕ 2015

Optimal BRS Optimal short and mid term radial support with thin struts Adequate deliverability, handling and flexibility for insertion Consistency of drug elution Integrity during resorption ΕΚΕ 2015

Strategies of developing BRS Backbone comprised of L-lactic acid polymer ABSORB stent (BVS): Everolimus-eluting stent (CE Mark, Abbot Vascular) DESolve stent: Myolimus/Novolimus-eluting stent (CE Mark, Elixir Medical Corporation) ART stent: No eluting drug (CE Mark, Terumo Corporation) Magnesium-based scaffolds (with rare earth metals) AMS/DREAMS: Paclitaxel/Sirolimus-eluting stent (Biotronic) Other (Desaminotyrosin, Polylactic anhydrate) REVA BRS/ReZolve: Paclitaxel/Sirolimus-eluting stent (Reva Medical) Ideal Biostent: Sirolimus-eluting stent (Xenogenics) ΕΚΕ 2015

Types of BRS A: Igaki-Tamai stent; B: ABSORB stent; C: DESolve stent; D: DREAMS Magesium alloy; E: ReZove BRS; F: Ideal BioStent ΕΚΕ 2015

Igaki-Tamai Stent PLLA-based BRS Self-expandable when contrast dye heated at 800 C Initial results promising and vessel diameter increased at 3-year follow-up Requires 8F Catheter Heated contrast dye may cause injury ΕΚΕ 2015

Absorb BVS PLLA-based stent 150 μm strut thickness (c/w 90 in current DES) 1:1 mixture of poly-D,L-lactic acid and everolimus Degrades over time to H2O and CO2 Full hydrolytic degadration up to 3 years ΕΚΕ 2015

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ABSORB III – 2008 Patients Outcome Absorb (1322) (%) Xience (686) (%) Target lesion failure 7.8 6.1 0.16 Cardiac death 0.6 0.1 0.29 Target vessel MI 6 4.6 0.18 Ischemia-driven target lesion revascularization 3 2.5 0.5 Ischemia-driven target vessel revascularization 5 3.7 Patient-reported angina 18.3 18.4 0.93 Definite or probable stent thrombosis 1.5 0.7 0.13 ΕΚΕ 2015

Rates of Stent Thrombosis after implantation of BRS vs BMS ΕΚΕ 2015

DESolve BRS PLLA based-stent 150 μm strut thickness Novolimus eluting drug Degrades to H2O and CO2 in 1 year Device resorption time is 2 years Wider range of expansion, reduced strut fracture, self-correction of minor malapposition ΕΚΕ 2015

DESolve Nx Clinical Trial Design Single de novo Coronary Artery Lesion Reference vessel diameter: 2.75-3.0mm Lesion length: <12mm, DAPT 12 months 3.0, 3.25, 3.5mm diameters; 14 and 18mm lengths 13 International Sites Europe, New Zealand and Brazil 126 patients 30d 6mo 5yr 4yr 3yr 2yr Clinical MACE Angiographic IVUS, OCT, MSCT (subset) 1yr Primary Endpoint: 6-month in-scaffold late lumen loss Secondary Endpoints: Clinical: Major Adverse Cardiac Events (cardiac death, target vessel MI, and clinically indicated TLR), Scaffold thrombosis QCA: In-segment late lumen loss, binary restenosis, and percent diameter stenosis IVUS: In-scaffold percent volume obstruction, malapposition OCT: In-scaffold percent obstruction, strut coverage MSCT: Percent diameter stenosis, lumen area The DESolve NX study demonstrated consistent findings through multiple imaging modalities IVUS, OCT, QCA or multi scan CT. EKE 2015

DESolve Nx showed excellent acute performance and low events through 2 years EKE 2015

Case Example 1 - Multi-modality Imaging IVUS/OCT MSCT Angio’s SA = 6.09mm2 SA = 6.48mm2 Mean Scaffold Diameter = 3.1mm Pre Procedure SA = 7.00mm2 Throughout different imaging modalities and timeframes the results remain consistent. Reference: Dr Verheye DESolve First in Man Post-PCI Post-PCI SA = 7.73mm2 SA = 9.50mm2 6 mos FU 6 mos FU 12 mos FU EKE 2015

ART BRS PLLA or PDLA based BRS No eluting drug – next generation with eluting drug (Terumo) Programmed dismantling at 3 months and resorption in 2 years CE Mark based on ARTDIVA study 6 months results ΕΚΕ 2015

DREAMS 2G Magnesium-based BRS 120-150 μm strut thickness Electronegative charge emerges during degradation with antithrombotic function Paclitaxel to sirolimus (2G) eluting drug Resorption time up to 12 months ΕΚΕ 2015

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Safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de-novo coronary artery lesions (BIOSOLVE-II): 6 month results of a prospective, multicentre, non-randomised, first-in-man trial Between Oct 8, 2013, and May 22, 2015, we enrolled 123 patients with 123 coronary target lesions. At 6 months, mean in-segment late lumen loss was 0·27 mm (SD 0·37), and angiographically discernable vasomotion was documented in 20 (80%) of 25 patients. Intravascular ultrasound assessments showed a preservation of the scaffold area (mean 6·24 mm2 [SD 1·15] post-procedure vs6·21 mm2 [1·22] at 6 months) with a low mean neointimal area (0·08 mm2 [0·09]), and optical coherence tomography did not detect any intraluminal mass. Target lesion failure occurred in four (3%) patients: one (<1%) patient died from cardiac death, one (<1%) patient had periprocedural myocardial infarction, and two (2%) patients needed clinically driven target lesion revascularisation. No definite or probable scaffold thrombosis was observed. ΕΚΕ 2015

Conclusions BRS represent an advancement in the interventional treatment of coronary disease Current data are slightly inferior with respect to device success, recoil, MACE, lumen areas and TLR Some possible benefits are only demonstrated in animal testing and small human cohorts Data on various type of patients and lesions are limited Technical considerations of deployment and imaging Optimal duration of double antiplatelet therapy is unclear However, current BRS limitations will likely be resolved in the near future ΕΚΕ 2015