What s New in Antiplatelet Therapy and DES in 2016

Transcription

1 What s New in Antiplatelet Therapy and DES in 2016 Peter Pollak MD Director of Structural Heart Disease & Intervention Mayo Clinic Florida 2016 slide-1 Disclosures Financial None Off-label - None 2016 slide-2 1

2 Outline Antiplatelet Therapy Cangrelor Bioabsorbable Polymer SYNERGY Different from BVS ABSORB Dual Anti-Platelet Therapy (DAPT) Stopping & Continuing Bare Metal Stents? NORSTENT 2016 slide-3 Case 59yo male with sudden severe chest pain Began 2 hours ago Brought by ambulance Past Medical History: Diabetes, Hypertension, Hyperlipidemia Medications: Metformin, Lisinopril, Aspirin Exam: BP 150/80, Pulse 60, Resp 15 Uncomfortable and anxious Extremities warm No murmur slide-4 2

3 ECG slide-5 RCA slide-6 3

4 slide slide-8 4

5 Ostial LAD Disease Occluded Mid-LAD Severe LCX Lesion slide-9 What is the best approach: What drugs? Balloon result & CABG? Heart team approach? DES vs. BVS LIMA in future? slide-10 5

6 FREEDOM Trial 1900 pts with DM & MVCAD Death/Stroke/MI, % PCI/DES CABG Logrank P=0.005 PCI/DES CABG 0 5-Year Event Rates: 26.6% vs. 18.7% Years post-randomization 2016 slide slide-12 6

7 What about Cangrelor? A new IV antiplatelet drug 2016 slide-13 Cangrelor CHAMPION Trials Direct platelet P2Y 12 receptor antagonist Parenteral administration T1/2 = 3 to 6 minutes Offset = 60 minutes 8716 patients undergoing PCI Pre-treated with 600mg Clopidogrel 2016 slide-14 7

8 Cangrelor Pharmacodynamics Platelet Activity Plasma Concentration 2016 slide-15 Cangrelor transition to other drugs 2016 slide-16 8

9 Cangrelor Summary Intravenous & Reversible antiplatelet effect Cannot load Clopidogrel or Prasugrel until infusion has stopped Cannot bind until Cangrelor is off site Can load Ticagrelor during infusion 2016 slide slide-18 9

10 Returns for Staged LCX Intervention What kind of DES to use? 2016 slide-19 Anatomy of a Drug Eluting Stent Drug Polymer Stent Frame 2016 slide-20 10

11 Bioabsorbable Polymer Stent SYNERGY 2016 slide-21 Thinner stent Drug only on vessel wall side SYNERGY Promus Premier 2016 slide-22 11

12 Drug and Polymer disappear 2016 slide-23 No significant difference in outcomes 2016 slide-24 12

13 Low Stent Thrombosis rate Lucky? 2016 slide-25 Bioabsorbable Polymer Summary Low profile stent More deliverable? Drug and polymer on vessel side only Bio-resorbable BMS after 3 months Use & advantage? Transplant patients? Diabetics with bleeding risk or need for surgery? 2016 slide-26 13

14 Bioresorbable Vascular Scaffold ABSORB BVS stents 2016 slide-27 Poly L-lactide scaffold 150 µm thick Bioresorbably polymer Everolimus Exciting Possibilities Return of vasomotor fxn Less late lesions Possible grafting 2016 slide-28 14

15 9/17/ slide-29 Meta-analysis of 3738 patients at 1 year ABSORB BVS vs. Xience CoCr EES Odds Ratio TLF TLR 0.97 MI Death Cassese et al LANCET 2016; 387:537 ST 2016 slide-30 15

16 Some Hiccups Many exclusions in trials (and package insert) Bifurcation lesions Ostial lesions Small (<2.5mm) or large (>3.5mm) vessels Long lesions (>24mm) In Use Vessel pre-dilatation required Careful sizing required QCA, IVUS, or OCT High pressure post-dilatation required Less deliverable? 2016 slide slide-32 16

17 How long should I treat with DAPT? 2016 slide-33 Continuum of Coagulability & Bleeding Jeopardy SIHD ACS STEMI 2016 slide-34 17

18 1 month 3 months 6 months 12 months slide-35 DAPT after ACS Class I recommendation for 12 Months Class IIB >12 Months slide-36 18

19 DAPT in Stable Ischemic Heart Disease (shorter, only Clopidogrel) Class I recommendation for 6 Months Class IIB >6 Months slide-37 DAPT continuation 12 to 30 months 9961 patients randomized to continue thyenopyridine vs. placebo Questionable catch-up phenomenon noted Mauri et al NEJM slide-38 19

20 DAPT Study Data 7.0% 6.0% 5.0% 4.0% 4.3% Thienopyridine 5.9% 4.1% Placebo 3.0% 2.0% 1.4% 2.5% 2.1% 2.0% 1.5% 1.6% 1.0% 0.4% 0.0% Stent Thrombosis MACCE Myocardial Infarction Death* Mod/Svr Bleeding * P=0.05 for Death Mauri et al NEJM slide-39 DAPT >1 Year after MI Hazard Ratio Death/MI/Stroke Major Bleeding Bittl et al Circ slide-40 20

21 6 4 2 Prolonged DAPT per 1000 treated patients Stent Thrombosis MI Major Bleed Bittl et al Circ slide slide-42 21

22 2016 slide-43 DAPT Calculator 2016 slide-44 22

23 2016 slide slide-46 23

24 Bare Metal Stents New Again? 2016 slide Patients SIHD & ACS Randomized BMS vs. DES 2016 slide-48 24

25 No Difference in Primary Outcome (Death or MI) 2016 slide-49 Still Some Differences DES BMS P< % 16.5% P< % 5.3% P= % 1.2% TLR Any Revasc. Def. ST 2016 slide-50 25

26 Summary Points Cangrelor Rapid acting IV antiplatelet New Stent technologies Bioabsorbable Polymer SYNERGY Vessel healing? BVS ABSORB Gone in few years Concerns about stent thrombosis Prolonged DAPT Calculator Bare Metal Stents better than used to be 2016 slide-51 Thank Questions? 2016 slide-52 26