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1 Switch and Non-Switch in P2Y12 Inhibition: The Real-Life Use of Clopidogrel and Prasugrel in Patients with Acute Myocardial Infarction. Insights from the FAST MI 2010 Registry. F. Schiele (Besançon), E. Puymirat (HEGP), L. Lorgis (Dijon), G.Dentan (Clinique de Fontaine, Fontaine-les-Dijon), E. Faure (CH de Valence), G. Rouault (CH Quimper), F. Leclercq (Montpellier), Ms E. Drouet (Paris, SFC), T. Simon (St Antoine, Paris), N. Danchin (HEGP) No conflict of interest to declare

2 Rationale In patients with ACS, guidelines recommend DAPT as early as possible and provide rules for selecting the most appropriate P2Y12 inhibitor. In 2010, Prasugrel was available in France. Eligible patients were ACS patients treated with PCI, without previous stroke, age<75 and body weight 60 kg. No mention about Switch with P2Y12 inhibitors. Thus, the choice of P2Y12 inhibitor depends on information that is not always available early and therefore may vary during hospitalization. When the initial choice is sub-optimal, due to indications or occurrence of clinical event, a switch between P2Y12 inhibitors appears attractive, but is not clearly recommended.

3 Aims 1. To assess the real-life use of DAPT at admission and at discharge. Particular attention to the Switch between P2Y12 inhibitors. 2. To determine the compliance with eligibility for Prasugrel in patients treated with Clopidogrel or with Prasugrel, at admission and at discharge. 3. To determine the predictors for use of Prasugrel at admission and at discharge. 4. To compare outcomes between matched patients (with vs without Switch) : bleeding events, thrombotic events and net clininal outcomes (CV death, re-infarction, stroke, any TIMI bleeding)

4 Methods: Switch study Groups according to first and last P2Y12 inhibitor : Clopidogrel alone. Matched cohorts Prasugrel alone. Switch from Clopidogrel to Prasugrel. Matched cohorts Switch from Prasugrel to Clopidogrel. Eligibility for Prasugrel at admission: patients intended for PCI, age<75 years, body weight 60kg, no history of stroke or transient ischemic attack. at discharge: same, but actually treated with PCI. Predictors of use of Prasugrel at admission and at discharge: Multivariate logistic regression. Comparison of outcomes: matched cohorts Bleeding events (TIMI and BARC classifications). Thrombotic events (CV/re-infarction/stroke/stent thrombosis) Net clinical outcome (CV death, infarction, stroke, TIMI major/ moderate or BARC3b/3c bleeding, stent thrombosis).

FAST-MI: population characteristics Nationwide Registry; 213 participating centers, 81 (1month) + 132(2months). 4970 patients included in FAST-MI 552 (11.1%) patients excluded (no acute MI) 249 (5.

5 FAST-MI: population characteristics Nationwide Registry; 213 participating centers, 81 (1month) + 132(2months) patients included in FAST-MI 552 (11.1%) patients excluded (no acute MI) 249 (5.0%) patient refusal 4169 (83.9%) patients included Whole population N=4169 STEMI= 2241 (54%) NSTEMI=1928 (46%) Mean age 65.8± ± ±14 Elderly (>75) 1246(30%) 534(24%) 721(37%) Diabetes 835(20%) 509(26%) 326(15%) Killip IV 70(7%) 27(1.5%) 43(2%) GRACE risk score 142±37 145±36 138±38

6 P2Y12 Inhibitors During Hospitalization 4169 patients with acute MI Aspirin<48 h: 4033(96.7%) No P2Y12 inhibitors 55 (1.3%) Clopidogrel first 3520 (84.4%) Prasugrel first 581 (13.9%) Stent thrombosis n=9 TIMI Bleeding n=19 Clopidogrel only 2842 (69.3%) Clopidogrel to Prasugrel 669 (16.4%) Prasugrel only 391 (9.5%) Prasugrel to Clopidogrel 171 (4.2%)

7 Time of first dose of oral antiplatelets -- Aspirin -- Clopidogrel -- Prasugrel STEMI NSTEMI Pre-Tx Pre-Hosp Adm- 24h 24-48h Discharge

8 Results: Eligiblity for Prasugrel PCI; no previous stroke/tia; <75 years; 60kg Intended PPCI (STEMI) Clopi alone, n=2842 (69.5%) Prasu alone, n=391 (10.0%) Switch C P, n=669 (16.5%) Switch P C, n=171 (4.6%) 913 (66.4%) 265 (88.9%) 339 (71.8%) 113 (77.9%) No PCI (all) 782 (27.5%) 27 (6.9%) 33 (4.9%) 14 (7.4%) TIA or Stroke 179 (6.3%) 4 (1.0%) 8 (1.2%) 0 Weight (12.7%) 12 (3.1%) 16 (2.4%) 13 (7.6%) Age > (40.4%) 11 (2.8%) 34 (5.1%) 7 (4.1%) Eligible at admission Eligible at discharge 1119 (39.4%) 327 (90.3%) 584 (90.3%) 156 (83.4%) 1565 (55.8%) 346 (91.1%) 617 (92.5%) 169 (90.4%)

9 Predictors of Prasugrel Use At Admission Indicator Predictors Statistics of Prasugrel for use each at admission study Odds ratio and 95% CI Odds Lower Upper ratio limit limit p-value Male vs Female Age (per year) STEMI vs NSTEMI Previous stroke Previous MI Cath-lab on site Less Favours Prasugrel A More Favours Prasugrel B Meta Analysis Typical patient for Prasugrel at admission: male, young, STEMI, No history of stroke, admitted to a center with cathlab onsite

10 Predictors of Prasugrel Use At Discharge Indicator Predictors Statistics of Prasugrel for use each at discharge study Odds ratio and 95% CI Odds Lower Upper ratio limit limit p-value Male vs Female Body Weight<60kg STEMI vs NSTEMI Previous stroke Previous PCI Radial access GP2b3a use Pre Tx with Clopidogrel Less Favours Prasugrel A More Favours Prasugrel B Typical patient for Prasugrel at discharge: male, STEMI treated with PPCI, no contra indication to Prasugrel, low bleeding risk. Avoiding the switch : less Prasugrel use if already under Clopidogrel Meta Analysis

11 Clopidogrel Alone vs Switch to Prasugrel Propensity paired matched dataset: 624 matched pairs, c-stat=0.76 Clopi alone, n=624 Switch Prasu n=624 P value Age 55±10 56± OR(95%CI) GRACE score 126±25 124± STEMI 425(68%) 427(68%) 0.68 Diabetes 95(15%) 93(15%) 0.87 GFR 91±31 90± In Hosp Death 6(1%) 2(0.3%) [0.07; 1.6] Throm Event 5(0.8%) 22(3.5%) [1.7; 12] Hb decrease >3g/dL 38(6.1%) 46(7.4%) [0.7; 1.9] Any TIMI 51(8.2%) 47(7.5%) [0.6; 1. 4] Net clinical endpoint 21(3.4%) 30(4.5%) [0.8; 2.6]

12 Prasugrel Alone vs Switch from Clopidogrel Propensity paired matched dataset: 350 matched pairs, c-stat=0.62 Prasu alone, n=350 Switch Prasu, n=350 P value Age 56±11 57± OR(95%CI) GRACE score 127±27 128± STEMI 262(76%) 257(74%) 0.66 Diabetes 43(12%) 41(13%) 0.81 GFR 89±29 87± In Hosp Death 1(0.3%) 2(0.6%) [0.2; 42] Throm Event 4(1%) 12(3.4%) [1.0; 11] Hb decrease >3g/dL 17(5%) 28(8%) [0.9; 3.2] Any TIMI 33(9.4%) 24(6.7%) [0.4; 1.2] Net clinical endpoint 14(4%) 16(5%) [0.5; 2.4]

13 Discussion FAST-MI database: strong methodology, variables specifically defined to capture the complex use of DAPT. Choice between Clopidogrel and Prasugrel remains a difficult task, change in eligibility between admission and discharge. Switch: 2/3 of Prasugrel use at discharge. Based on eligibility more than on clinical events, performed at day 2: awareness of physicians to provide the most appropriate P2Y12. Pre treatment with Clopidogrel: predictor of non use of Prasugrel : reluctance of physicians to Switch. No Thrombotic Bleeding complications related to the Switch.

14 Conclusions Under-use of Prasugrel : First use of Clopidogrel is good practice when indication for PCI is uncertain (NSTEMI patients); 73% of patients admitted with acute MI are discharged under Clopidogrel, despite eligibility for Prasugrel in 55%. Switch from Clopidogrel to Prasugrel: 16% of all patients and 2/3 of patients discharged under Prasugrel. Switch is not related to excess of bleeding or thrombotic events. Switch allows a reduction of missed opportunities for Prasugrel, i.e. in case of sub optimal initial option. Will Ticagrelor makes things more simple or add complexity?

Optimal lenght of DAPT in different clinical scenarios

Optimal lenght of DAPT in different clinical scenarios After PCI with DES in the light of recent and ongoing studies Dr Grégoire Rangé / CH Chartres / France DAPT duration depend on the evolution of risk