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Dr. Fausto Feres Instituto de Cardiología Dante Pazzanese São Paulo- Brasil Dr. Juan Gaspar Centro Cardiovascular Montevideo -Uruguay DAPT y DES.

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Presentación del tema: "Dr. Fausto Feres Instituto de Cardiología Dante Pazzanese São Paulo- Brasil Dr. Juan Gaspar Centro Cardiovascular Montevideo -Uruguay DAPT y DES."— Transcripción de la presentación:

1 Dr. Fausto Feres Instituto de Cardiología Dante Pazzanese São Paulo- Brasil Dr. Juan Gaspar Centro Cardiovascular Montevideo -Uruguay DAPT y DES

2 A- 3 meses B- 6 meses ¿Por cuánto tiempo mantiene usted al paciente en terapia antiplaquetaria dual luego del implante de un DES? C- 12 meses D- 24 meses E- Siempre

3 C- 12 meses D- 24 meses E- Siempre A- 3 meses B- 6 meses ¿Por cuánto tiempo mantiene usted al paciente en terapia antiplaquetaria dual luego del implante de un DES?

4 Terapia antiplaquetaria dual: ¿Por cuánto tiempo? ¿Por qué el DAPT para siempre?

5 Eisenstein EL et al. JAMA 2007;297: on line Duke Database Death/MI Analysis N=637N=579N=417N=1976 Adjusted death/MI rates at 24 months in patients without events at 6 months Clopidogrel status at 6 months Overall P value = 0,07; P int = 0,12 Clopidogrel status at 12 months Overall P value < 0,001; P int = 0,003 N=252N=276N=346N=1644

6 Temporal Trends in DAPT Compliance and Incidence of ST while On or Off Thienopyridine Therapy Is Thienopyridine Discontinuation a Cause or Epiphenomenon? Airoldi F, Colombo A, et al. Circulation. 2007;116: Thienopyridine Adherence Over Tim

7 Relación entre la descontinuación de las tienopiridinas y la ST SAT (0.9%) LST 30 – 180 days (0.4%) LST 180 – 360 days (0.3%) VLST 360 – 540 days (0.2%) Median time from clopidogrel discontinuation and ST: ST within first 6 months: 13.5 days (IQR range, 5.2 to 25.7) ST after the first 6 months: 90 days (IQR, 30 to 365 days) Days post-PCI 58 Patients with Stent Thrombosis Airoldi F, Colombo A, et al. Circulation. 2007;116:

8 Tasa de ST en pacientes en terapia antiplaquetaria dual y en pacientes que descontinuaron la terapia con tienopiridinas Airoldi F, Colombo A, et al. Circulation. 2007;116: * Aalen-Nelson estimate of cumulative hazard function Event Rates No. of Patients Discontinued Thienopyridine On Thienopyridine Pacientes que descontinuaron la terapia con tienopiridinas 58 cases of ST through 540 Days (1.9%) Pacientes que NO descontinuaron la terapia con tienopiridinas

9 Time since PCI in years Cumulative Incidence, % Cumulative Incidence of ARC Def/Prob ST over 4 yrs after DES (CYPHER & TAXUS) 5.7% [95% CI] CYPHER & TAXUS (n=8,146) Bern-Rotterdam 2 2 Wenaweser et al. J Am Coll Cardiol 2008;52:

10 Hong M e cols. Circulation. 2004;109: Serruys PW e cols. Circulation. 2002;106: Tanabe K e cols. Circulation. 2005;111: Cypher ® 1216 days post procedure Taxus 331 days post procedure Late Incomplete Stent Apposition What is the real incidence ? Is it a predictor for late stent thrombosis ? Why does it happen ?

11 Late Incomplete Apposition and Late Thrombosis Cook S, et al. Circulation. 2007;115: patients with late thrombosis > 1 year post procedure X 144 controls without late thrombosis Incomplete apposition % P < 0,001 ST = Stent Thrombosis

12 Siqueira, et al. European Heart J 2007; 28: patients with DES Conclusion : Late Incomplete Apposition in 5.1% Late Malaposition Persistent Malapposition Without Malapposition Late Incomplete Apposition and Late Thrombosis

13 SAT 8/39 stents, LST 11/39 stents All BMS with complete endothelialization Predictors Stent across ostia of major sidebranch Strut penetration of necrotic core Stent malapposition Increasing stent length Hypersensitivity Focal delayed no healing (absence of intima) 35 Autopsy Examinations Following Stent Placement (N = 32 DES, 7 BMS) Joner, Virmani, et al. Circulation. 2005;112:3210. Predictors of DES Thrombosis

14 Why DAP therapy for one year ? Is DAP therapy safe ? Can we avoid it ? Are all stents equal ? One year DAP for all ? Can we use the same data (Cypher and Taxus) to do the prescription of DAP for one year for other DES pts ? For how long ? Dual Antiplatelet Therapy : For How Long and for All ?

15 Angio / IVUS follow up 63 pts ( 94 % ) without ISA4 pts ( 6 % ) with acute ISA No pts with late ISA No pts with persistent ISA Baseline ( after stenting ) 67 pts Endeavor 67 pts Endeavor Incomplete Stent Apposition Post -Endeavor Implantation: IVUS Findings from a Non-Selected Population Feres F et al ACC 2008

16 OPTIMIzed Duration of Clopidogrel Therapy Following Treatment with the Endeavor Zotarolimus-Eluting Stent in the Real-World Clinical Practice OPTIMIZE Trial PI : Fausto Feres

17 Optimize Trial Minimally selected patients undergoing PCI with implantation of the Endeavor ZES; N=3200 Clopidogrel therapy 3-month N= month N=1.600 Clinical follow-up at 1, 3, 6, and 12 months, and yearly up to 5 years PRIMARY Endpoint: Rates of NACCE (Net Adverse Cardiac and Cerebral Events) at 12 m f-up Death, MI, CVA and major bleeding

18 Safety of Long-Term Clopidogrel 3 Placebo Controlled Trials P=0.001 NEJM 2006;354: N=15, year FU GUSTO major + moderate bleed N=12,563 1 year FU CURE major bleed NEJM 2001;345; N=2,116 1 year FU TIMI major bleed JAMA 2002;288: P=0.07 P<0.001

19 DATP y Cuadro Clínico Síndromes coronarios agudos sin elevación de la ST Acceso transradial Inhibidores Iib IIIa 600 mg Clopidogrel (menos de 2 hs ) 300 mg Clopidogrel (más de 2 hs)

20 What is the Optimal Trial for the Optimal DAPT Duration? DAPT durations, inclusion of BMS, landmarking and event-free patients Inclusion Group, N DAPT Duration DES Type1° Endpoint2° Endpoint(s) DAPT 20, month event free 12 vs 30 months All DES1.D/MI/Stroke at 33 mos 2.Def/prob ST at 33 mos GUSTO Bleeding ISAR-SAFE 6,000 6-month event free 6 vs 12 months All DESD/MI/Stroke/TIMI major bleed at 15 mos Individual component endpoints REAL-LATE 2, month event free 12 vs 24 months All DES2-yr Cardiac D/MIARC ST, Bleeding ZEST-LATE 2, month event free 12 vs 24 months SES, PES, ZES 2-yr D/MIARC ST, Bleeding OPTIMIZE 3,120 non-STEMI 3 vs. 12 months Endeavor ZES 1-yr D/MI/Stroke/TIMI major bleed ARC ST SEASIDE 900 non-ACS6 monthsEndeavor ZES 1-yr D/MI/StrokeGUSTO Bleeding CYP2C19


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