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1 Post ACS Care 2013 Clinical dilemmas Christopher Granger, MD Professor of Medicine

2 Disclosure Research contracts: AstraZeneca, GSK, Merck, Sanofi- Aventis, BMS, Pfizer, The Medicines Company, Medtronic Foundation, and Boehringer Ingelheim Consulting/Honoraria: AstraZeneca, GSK, BMS, Pfizer, Lilly, Novartis, Roche, Boehringer Ingelheim, Johnson and Johnson, The Medicines Company, and Sanofi- Aventis For full listing see ww.dcri.duke.edu/research/coi.jspcoi.jsp

3 High-risk ACS 80 year old woman with history of hypertension, CABG 1986, MI and stents to LAD in 2003, right CEA, TIA, and asthma Increased CP episodes for one week, and continued chest pain in ED. Treated with nitrates, morphine; beta blocker, with immediate wheezing treated with prednisone. BP 126/68, pulse 101, 80 kg, mild CHF Creatinine 1.7 mg/dl dl; TnT 0.27 ng/ml ECG showed 1mm anterolateral ST depression; echo EF 45% GRACE risk score death in-hospital 25% death/mi 6 months 50%

4 Treatment options (in addition to 81 mg aspirin/d) A. Clopidogrel B. Prasugrel C. Ticagrelor A. UFH B. enoxaparin A. Cath <24hrs B. Cath > 24 hrs C. Med therapy

5 Primary Endpoint CV Death, MI, Stroke 15 Prim mary Endp point (% ) 10 5 HR 0.77 P= HR 0.80 P= Clopidogrel Prasugrel 12.1 (781) (643) HR 0.81 ( ) P= NNT= 46 ITT= 13,608 LTFU = 14 (0.1%) Days

6 4 Clopidogrel Prasugrel Bleeding Events Safety Cohort (N=13,457) ICH in Pts w Prior Stroke/TIA (N=518) % Even nts Clop 0 (0) % Pras 6 (2.3)% (P=0.02) 02) 0 TIMI Major Bleeds Life Threatening Nonfatal Fatal ICH ARD 0.6% ARD 0.5% ARD 0.2% ARD 0.3% ARD 0% HR 1.32 P=0.03 NNH=167 HR 1.52 P=0.01 P=0.23 P=0.002 P=0.74

7 Major efficacy endpoints All patients* Ticagrelor (n=9,333) Clopidogrel (n=9,291) HR for (95% CI) p value Primary objective, n (%) CV death + MI + stroke 864 (9.8) 1,014 (11.7) 0.84 ( ) <0.001 Secondary objectives, n (%) Myocardial infarction CV death Stroke 504 (5.8) 593 (6.9) 0.84 ( ) (4.0) 442 (5.1) 0.79 ( ) (1.5) 106 (1.3) 1.17 ( ) 0.22 Total death 399 (4.5) 506 (5.9) 0.78 ( ) <0.001 The percentages are K-M estimates of the rate of the endpoint at 12 months.

8 Is there a role for continued anticoagulation after ACS?

9 Meta-analysis: analysis: Secondary prevention with warfarin and ASA after ACS Rate ratio (95% CI) Death (077 ( ) MI 0.56 ( ) 0.69) Ischaemic stroke 0.46 ( ) 0.77) Major bleeding event (167 3 ( ) Minor bleeding event 2.65 ( ) Warfarin + ASA better Rate ratio ASA better 10 trials; N=5,938 Rothberg MB, et al. Ann Intern Med ;143:

10 PRIMARY EFFICACY ENDPOINT: CV Death / MI / Stroke (%) Incidence umulative I timated Cu Est Placebo Rivaroxaban (both doses) 2 Yr KM Estimate 10.7% 8.9% HR 0.84 ( ) 0.96) mitt p = ITT p = ARR 1.8% NNT = 56 No. at Risk Months After Randomization Placebo Rivaroxaban Mega NEJM 2011 HR and 95% confidence interval estimates from Cox model stratified by thienopyridine use are provided per mitt approach; Stratified log-rank p-values are provided for both mitt and ITT approaches.

11 EFFICACY ENDPOINTS: Very Low Dose 2.5 mg BID 12% ce (%) Estima ated Cumula ative inciden CV Death / MI / Stroke HR 0.84 mitt p=0.020 ITT p=0.007 Cardiovascular Death 5% 5% Placebo HR 0.66 HR 0.68 Rivaroxaban 25mgBID 2.5 NNT = % 9.1% mitt p=0.002 ITT p=0.005 Placebo Rivaroxaban 25mgBID 2.5 NNT = % 2.7% All Cause Death mitt p= ITT p=0.004 Placebo Rivaroxaban 25mgBID 2.5 NNT = Months Months Months 4.5% 2.9% Mega NEJM 2011

12 Considerations for more potent antithrombotics (versus standard dose clopidogrel) Drug CV death, Major MI, stroke Bleeding Death HD Clopidogrel 6% 24% -- Prasugrel (intended PCI) 19% 32% -- Ticagrelor 16% 4% * 22% Rivaroxaban (+ clopid) 16% 350% 22% Other key considerations Each reduced stent thrombosis by 30 to 50% Prasugrel increased fatal bleeding, particularly in high risk group of elderly, prior stroke, low weight Prasugrel data limited to intended PCI; in STEMI, risk benefit for prasugrel more favorable *Ticagrelor increased non-cabg bleeding by 19%

13 80 year old woman with high-risk ACS Cardiac cath day after admission, patent grafts to RCA and LCX; 75% stenosis in stented segment of LAD, received Cypher drug eluting stent t Creatinine increased to 2.2 mg/dl Day 3, developed d atrial fibrillation ill with RVR, some worse dyspnea

14 ACS, DES, plus Afib with CHADS score of 4, CHADS- VASc of 7

15 Treatment options A. Aspirin, clopidogrel, warfarin for one year B. Aspirin, clopdiogrel, warfarin; stop clopidogrel after 3 months C. Aspirin, ticagrelor, warfarin; stop ticagrelor after 3-6 months D. Aspirin and clopidogrel alone, due to high risk of bleeding

16 CHA 2 DS 2 -VASc Assessment of Thromboembolic Risk Annual stroke Score CHF/ LV dysfunction 1 rate, % Hypertension 1 n Age Diabetes mellitus Stroke/TIA/TE Vascular disease 1 Age Sex category (female) 1 Score 0 9 Validated in 1084 NVAF patients not on OAC with known TE status at 1 year in Euro Heart Survey Lip GYH, et al. Chest 2009 Olesen JB et al. BMJ 2011;342:124

17 Lancet 2009; 374:

18 Registry cohort study of all Danish pts surviving first-time time hosp for AF between 1997 and ,854 of 118,606 pts had prescription filled for warfarin, ASA, or clopidogrel after discharge. During follow-up of 3.3 yrs, 13,573 pts (11.4%) had nonfatal or fatal bleeding. Arch Intern Med. 2010;170:

19 ESC 2012 update: AF, ACS, stenting a period of triple therapy is needed (OAC plus aspirin plus clopidogrel), followed by the combination OAC plus single antiplatelet t l t drug and, after one year, management can be with OAC alone in stable patients, where OAC can be adjusted-dose dose VKA therapy or probably a NOAC. Use triple therapy for minimum time (3-6 mo after DES) Use low dose aspirin Be extra careful to avoid high INR Consider PPI

20 How about dropping aspirin, using warfarin plus clopidogrel?

21 WOEST ESC, Hotline III, Munchen, August 28th, 2012 The WOEST Trial: First randomised d trial comparing two regimens with and without aspirin in patients on oral anticoagulant therapy undergoing coronary stenting Willem Dewilde, Tom Oirbans, Freek Verheugt, Johannes Kelder, Bart De Smet, Jean-Paul Herrman, Tom Adriaenssens, Mathias Vrolix, Antonius Heestermans, Marije Vis, Saman Rasoul, Kaioum Sheikjoesoef, Tom Vandendriessche, Carlos Van Mieghem, Kristoff Cornelis, Jeroen Vos, Guus Brueren, Nicolien Breet and Jurriën ten Berg 279 (double) vs 284 (triple) 65% DES with DAPT plus OAC for one year 70% Afib; 28% ACS at baseline The WOEST Trial= What is the Optimal antiplatelet and anticoagulant therapy in patients with oral anticoagulation and coronary StenTing (clinicaltrials.gov NCT )

22 WOEST Primary Endpoint: Total number of TIMI bleeding events Cumulative incid dence of bleeding 50 % Triple therapy group Double therapy group 40 % 30 % 20 % 44.9% 19.5% 10 % p< % HR= %CI[ ] 0.50] Days n at risk:

23 WOEST % Primary Endpoint: Bleeding events TIMI classification p<0.001 p< Double therapy 25 group p< Triple 16.7 therapy 15 group TIMI Minimal 11.2 TIMI Minor p= TIMI Major Any TIMI bleeding

24 WOEST Secondary Endpoint (Death, MI,TVR,, Stroke, ST) 20 % Triple therapy group Double therapy group 17.7% 15 % Cumulative incid dence 10 % 11.3% 5 % p= % HR= %CI[ ] 0.94] Days n at risk:

25 WOEST p= Secondary Endpoint p= p= Double therapy group Triple therapy group p=0.128 p= Death MI TVR Stroke ST MI=any myocardial infarction; TVR= target vessel revascularisation (PCI + CABG); ST= stent thrombosis

26 In absence of AF or need for OAC, how long should you continue clopidogrel after stenting?

27 72 year old woman with diabetes, NSTMI, insurance, treated with everolimus DES to mid LAD with diffuse disease. What is your preferred antiplatelet strategy, in addition to 81 mg aspirin? Drug 1. Clopidogrel 2. Prasugrel 3. Ticagrelol 4. Begin with prasugrel, switch to clopidogrel Duration 1. One year 2. 2 years 3. > 2 years

28 PRODIGY Study Flow Chart Intent-to-stent 1:1:1:1 Balancing Randomization Xience V Taxus Endeavor BMS 2013 patients 75% ACS 2 yr follow-up 30-Days Short DAPT 1:1 1 Endpoint Randomization Prologned DAPT Aspirin Clopidogrel Aspirin Clopidogrel 6 mos 6 Mos * 6 mos 6 mos 12 mos 12 mos 12 mos 18 mos 18 mos 18 mos 24 mos 24 mos *: <6 months clopidogrel was allowed in BMS pts with stable CAD at the time of PCI Circulation. 2012;125: Mos

29 Primary Efficacy and Safety Outcomes with Shorter vs Longer DAPT 24 mo DAPT 6 mo DAPT Overall Death, MI or CVA Type II, III or V BARC bleeding % 1% % 8 P= % 4 P= % HazardRatio:098( ( ) HazardRatio:046( ( ) Circulation. 2012;125:

30 Summary Ticagrelor and prasugrel provide meaningful advantages over clopidogrel Triple therapy is likely of important benefit for patients with coronary stenting and AF with high risk, but also high risk of bleeding Dual antiplatelet therapy may have greater risk than benefit if continued after 6 mo for elective drug eluting stenting and 12 months for ACS More trials defining if aspirin could be dropped with warfarin and P2Y12 antagonist are needed

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