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Elvin Kedhi Gregg. W. Stone, Dean J. Kereiakes, Patrick W. Serruys,

STENT THROMBISIS Insights on Outcomes and Impact of DUAL ANTIPLATELET THERAPY Permanent Discontinuation SPIRIT II, SPIRIT III, SPIRIT IV and COMPARE. Elvin Kedhi Gregg. W. Stone, Dean J. Kereiakes, Patrick W. Serruys, Helen Parise, Martin Fahy, Charles A. Simonton,

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Elvin Kedhi Gregg. W. Stone, Dean J. Kereiakes, Patrick W. Serruys,

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  1. STENT THROMBISISInsights on Outcomes and Impact ofDUAL ANTIPLATELET THERAPY Permanent Discontinuation SPIRIT II, SPIRIT III, SPIRIT IV and COMPARE Elvin Kedhi Gregg. W. Stone, Dean J. Kereiakes, Patrick W. Serruys, Helen Parise, Martin Fahy, Charles A. Simonton, Krishnankutty Sudhir, Poornima Sood, Pieter C. Smits.

  2. Background Recent studies have suggested that EES may reduce ST compared to PES, but no individual trial has been adequately powered for this endpoint The on-going propensity of the first generation DES for ST has lead towards longer DAPT regimens in current practice (Current guidelines: 1 year or more), despite the associated risks of such treatment and despite the lack of evidence that such an approach improves clinical outcomes post PCI Whether DAPT duration with newer generation DES can be shortened is unknown

  3. Objective • To investigate • ST incidence with second generation EES as compared to first generation PES • relation between the 2 year ST rates and permanent discontinuation of DAPT in EES and PES treated patients from a patient level pooled analysis SPIRIT II, SPIRIT III, SPIRIT IV and COMPARE trials

  4. Design Summary of the four (EES vs PES) Trials Pooled for the Analysis (n=6789) EES : Xience V Abbott Vascular, Santa Clara (CA) USA PES : Taxus Boston Scientific, Natick (MA) USA

  5. Methods • Baseline clinical, angiographic and procedural data of the four trials were pooled to allow for a patient-level analysis • Events as adjudicated in each trial were utilized • To adjust for slight differences in the baseline characteristics of the study population, a propensity score matching analysis was performed • The ST analyses were performed using time-to-event data and were compared with the log-rank test before and after PS adjustment

  6. RESULTSBaseline patient demographic characteristics

  7. RESULTSBaseline patient demographic characteristics

  8. RESULTSBaseline procedural characteristics

  9. RESULTSBaseline procedural characteristics

  10. DAPT compliance during 2y FU

  11. EES PES 3 HR 0·30 [95% CI: 0·19 to 0·47] p = <0·0001 HR: 0.30 [95% CI: 0.19, 0.47] <0.0001 p= <.001 2.3% 2·3% 2 Unadjusted ARC Definite/Probable (%) Unadjustzd ARC Definite/Probable (%) 1 0.7% 0 0 3 6 9 12 15 18 21 24 Time in Months Number at risk EES 4247 4177 4082 3998 3479 EES PES PES 2542 2463 2408 2350 2110 Unadjusted def/prob (ARC) ST at 2y HR:0.21 95%CI:[0.10,0.46] p<0.0001

  12. EES PES EES PES EES PES 3 3 HR: 0.37 [95% CI: 0.22, 0.63] HR 0·30 [95% CI: 0·19 to 0·47] p = <0·0001 HR: 0.30 [95% CI: 0.19, 0.47] p= <.001 <0.0001 2.2% p= <.001 2.3% HR 0·37 [95% CI: 0·22 to 0·63] p = <0·001 2·3% 2.2% 2 2 Adjusted ARC Definite/Probable (%) Unadjusted ARC Definite/Probable (%) Unadjustzd ARC Definite/Probable (%) Adjusted ARC Definite/Probable (%) 1 1 0.9% 0.7% 0.9% 0 0 0 3 6 9 12 15 18 21 24 Time in Months 0 3 6 9 12 15 18 21 24 Time in Months Number at risk EES 4247 4177 4082 3998 3479 EES PES Number at risk PES 2542 2463 2408 2350 2110 EES 2348 2310 2263 2218 1959 PES 2348 2283 2236 2186 1968 Unadjusted and PS adjusted definite/probable ST (ARC)

  13. EES PES 3 HR: 0.30 [95% CI: 0.18, 0.52] HR 0·30 [95% CI: 0·18 to 0·52] p = <0·001 p= <.001 2 1.6% Unadjusted ARC Definite (%) 1·6% Unadjusted ARC Definite (%) 1 0·5% 0.5% 0 0 0 3 6 9 12 15 18 21 24 Time in Months Number at risk EES 4247 4178 4084 4001 3483 PES 2542 2466 2413 2358 2121 Unadjusted definite ST (ARC) at 2y

  14. Unadjusted and PS adjusted definite ST at 2 years (ARC) EES EES PES PES 3 EES PES 3 HR 0·37 [95% CI: 0·19 to 0·70] p = 0·001 HR: 0.30 [95% CI: 0.18, 0.52] HR 0·30 [95% CI: 0·18 to 0·52] p = <0·001 HR: 0.37 [95% CI: 0.19, 0.70] p= <.001 p= 0.001 2 2 Adjusted ARC Definite (%) Unadjusted ARC Definite (%) Unadjusted ARC Definite (%) 1.5% 1.5% 1·6% 1.6% Adjusted ARC Definite/Probable (%) 1 1 0.6% 0·5% 0.6% 0.5% 0 0 0 0 3 6 9 12 15 18 21 24 0 3 6 9 12 15 18 21 24 Time in Months Time in Months Number at risk Number at risk EES 2348 2311 2265 2221 1962 EES 4247 4178 4084 4001 3483 PES 2542 2466 2413 2358 2121 PES 2348 2286 2240 2193 1978

  15. ST Incidence Rate 1 year

  16. ST (ARC) Incidence Rate at 2 years Does EES improved safety profile have an impact on DAPT duration?

  17. PCI 1 month 6 months 12 months 24 months DAPT permanent discontinuation analysis(either aspirin and/or a thienopyridine) DAPT status at 0,1,6, 12 and 24 months as well as at event time was known in all studies 1-6 m NO DAPT ST 2y DAPT 6-12 m NO DAPT DAPT 12-24m DAPT Patients in whom a ST occurred while not on DAPT were included in the respective DAPT interruption group based on their DAPT status at the time of the event, regardless of DAPT usage afterwards

  18. ST at 2 years according DAPT discontinuation timing

  19. Two-year Cumulative Def/Prob ST (ARC)according to DAPT Permanent Discontinuation p for trend= 0.75 p for trend = 0.05 No DAPT discontinuation at 24 m DAPT discontinuation 1-6 m DAPT discontinuation 6-12 m DAPT discontinuation 12-24 m

  20. PCI 1 month 6 months 12 months 24 months DAPT permanent discontinuationLANDMARK ANALYSIS 6m ST 2y DAPT Events of first 6m excluded Group 1 6-12m NO DAPT DAPT Group 1 12-24 m NO DAPT DAPT Group 3 >24m DAPT permanent discontinuation

  21. Two-year Cumulative Definite/Probable Stent Thrombosis (ARC) Landmark Analysis Beyond 6 Months 2.5 EES PES p for trend = 0·97 p for trend = 0·04 2 1·7 1.5 p = 0·82 p = 0·51 1·2 Stent Thrombosis Definite/Probable ARC (%) p = 0·17 p = 0·86 1 p = 0·01 p = 0·89 0·5 1.5 0·4 0·4 0·3 No DAPT discontinuation at 24 m DAPT discontinuation 6-12 m DAPT discontinuation 12-24 m No DAPT discontinuation at 24 m DAPT discontinuation 6-12 m DAPT discontinuation 12-24 m

  22. Conclusions • Second generation EES (Xience V) was associated with a significant reduction in definite and definite/probable ST at 2 years as compared to first generation PES (Taxus) • This reduction was already present in early phase and increased in magnitude during the first and second year of FU • The reduction in ST rates with EES was paralleled by a significant reduction in the rate of the composite safety endpoint of Death and Myocardial Infarction

  23. Conclusions • Permanent DAPT discontinuation at any time beyond one month did not impact ST rates at 2 years in EES (Xience V) treated patients, while DAPT treatments longer that 2 years may be safer for PES (Taxus) treated patients • The hypothesis that DAPT could be safely permanently discontinued starting from 6 months after EES implantation is supported from findings of the landmark analysis • These results should be regarded as hypothesis generating and need to be confirmed by larger dedicated randomised studies

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