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Press Conference Efficacy of Xience/Promus versus Cypher to rEduceLate Loss in stENT Hyo-Soo Kim MD, PhD on behalf of the investigators Seoul National University Hospital, Seoul, Korea
Disclosures I, Hyo-Soo Kim, DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.
Background Everolimus-Eluting Stent Sirolimus-Eluting Stent
Objective To evaluate the safety and long-term efficacyof Xience/Promus compared with the Cypher select Hypothesis EES is non-inferiorto SES in ,[object Object],[object Object]
Study Flow: Angiographic F/U Enrolled and randomized (N=1443) EESN=1079 SESN=364 Randomized  3:1 Received SES  (335 Pts, 414 Lesions) Received EES  (1054 Pts, 1388 Lesions) Angiographic F/U (64.5%) 216 Pts, 267 Lesions Angiographic F/U (67.3%) 709 Pts, 949 Lesions
Baseline Characteristics
Lesion and Procedural Characteristics *comparisons were performed using the generalized estimating equations (GEE). **compared with the Chi-square test, and †with the independent t-test
QCA Data(1) :all lesions *comparisons were performed using the generalized estimating equations (GEE). **compared with the Fishcer’s exact test
1˚ Endpoint In-segment late LL EES(N=935) 0.10±0.36 mm SES(N=266) 0.05±0.34 mm Mean ΔLL: 0.051 mm Upper 1-sided 95% CI: 0.091 mm  Non-inferiority p-value 0.023 Prespecified non-inferiority margin: 0.1 mm Non-inferior Upper 1-sided 95% CI
In-Sement 1˚ Endpoint Minimal Luminal Diameters Before Procedure After Procedure 9-month F/U 100 EES EES EES SES SES SES 80 60 % of Lesions 40 20 0 0.0 1.0 2.0 3.0 4.0 Minimal Luminal Diameter (mm)
Post-hoc In-stent late LL EES(N=935) 0.19±0.33 mm SES(N=266) 0.15±0.33 mm Mean ΔLL: 0.043 mm Upper 1-sided 95% CI: 0.082 mm  Non-inferiority p-value 0.007 Prespecified non-inferiority margin: 0.1 mm Non-inferior Upper 1-sided 95% CI
In-Stent Post-hoc Minimal Luminal Diameters Before Procedure After Procedure 9-month F/U 100 EES EES EES SES SES SES 80 60 % of Lesions 40 20 0 0.0 1.0 2.0 3.0 4.0 Minimal Luminal Diameter (mm)
2˚ Endpoint Hard Endpoints : Composite of cardiac death, or MI 4.0 Log-Rank p-value=0.561 3.0 Cumulative incidence rate (%) SES: 1.9% 2.0 EES: 1.5% 1.0 0.0 0 3 6 9 12 Months after initial procedure
2˚ Endpoint Soft Endpoints  TLR 5.0 Log-Rank p-value=0.400 4.0 3.0 EES: 2.4% Cumulative incidence rate (%) 2.0 SES: 1.7% 1.0 0.0 0 3 6 9 12 Months after initial procedure
2˚ Endpoint Target Lesion Failure : Composite of cardiac death, MI, or ID-TLR 5.0 EES: 3.7% Log-Rank p-value=0.552 4.0 3.0 Cumulative incidence rate (%) SES: 3.0% 2.0 1.0 0.0 0 3 6 9 12 Months after initial procedure
2˚ Endpoint Stent Thrombosis : Definite/Probable ST by ARC definition 1.0 SES: 0.8% Log-Rank p-value=0.281 0.8 0.6 Cumulative incidence rate (%) EES: 0.4% 0.4 0.2 0.0 0 3 6 9 12 Months after initial procedure
Summary : EXCELLENT-RCT ,[object Object]
The incidence of ST was not different between EES and SES although numerically lower in EES.
Tendency of higher late-loss in EES than SES may lead to the intriguing reciprocaltrend between soft versus hard endpoints : higher incidence of TLR but lower incidence of death, MI, or ST.	 should be confirmed in the larger study in the future Long term follow up will tell us whether Xience/Promus will offer similar efficacy along with better long term safety compared with the best 1st generation DES, Cypher.
2˚ Endpoint Clinical Outcomes at 1 Year Myocardial Infarction(%) p=1.000 All-Cause Death (%) p=0.485 Cardiac Death (%) p=0.606 EES N=1,057 SES N=359 EES N=1,057 SES N=359 EES N=1,057 SES N=359
2˚ Endpoint Clinical Outcomes at 1 Year ID-TVR (%) p=0.383 ID-TLR(%) p=0.385 EES N=1,057 SES N=359 EES N=1,057 SES N=359
2˚ Endpoint Composite Endpoints TVF (%) (C-death, MI, TVR) p=0.503 TLF (%) (C-death, MI, ID-TLR) p=0.527 Death or MI (%) p=0.554 EES N=1,057 SES N=359 EES N=1,057 SES N=359 EES N=1,057 SES N=359
2˚ Endpoint ARC Stent Thrombosis Definite/Probable ST p=0.379 Definite ST (%) p=0.175 EES N=1,057 SES N=359 EES N=1,057 SES N=359
Target Lesion Failure 2˚ Endpoint : Composite of cardiac death, MI, or ID-TLR 0.25 0.5 1 2 4 8 Favors EES Favors SES
In-segment & in-stent LL in long lesion or DM subgroup
Baseline Characteristics

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TCT: EXCELLENT Trial

  • 1. Press Conference Efficacy of Xience/Promus versus Cypher to rEduceLate Loss in stENT Hyo-Soo Kim MD, PhD on behalf of the investigators Seoul National University Hospital, Seoul, Korea
  • 2. Disclosures I, Hyo-Soo Kim, DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.
  • 3. Background Everolimus-Eluting Stent Sirolimus-Eluting Stent
  • 4.
  • 5. Study Flow: Angiographic F/U Enrolled and randomized (N=1443) EESN=1079 SESN=364 Randomized 3:1 Received SES (335 Pts, 414 Lesions) Received EES (1054 Pts, 1388 Lesions) Angiographic F/U (64.5%) 216 Pts, 267 Lesions Angiographic F/U (67.3%) 709 Pts, 949 Lesions
  • 7. Lesion and Procedural Characteristics *comparisons were performed using the generalized estimating equations (GEE). **compared with the Chi-square test, and †with the independent t-test
  • 8. QCA Data(1) :all lesions *comparisons were performed using the generalized estimating equations (GEE). **compared with the Fishcer’s exact test
  • 9. 1˚ Endpoint In-segment late LL EES(N=935) 0.10±0.36 mm SES(N=266) 0.05±0.34 mm Mean ΔLL: 0.051 mm Upper 1-sided 95% CI: 0.091 mm Non-inferiority p-value 0.023 Prespecified non-inferiority margin: 0.1 mm Non-inferior Upper 1-sided 95% CI
  • 10. In-Sement 1˚ Endpoint Minimal Luminal Diameters Before Procedure After Procedure 9-month F/U 100 EES EES EES SES SES SES 80 60 % of Lesions 40 20 0 0.0 1.0 2.0 3.0 4.0 Minimal Luminal Diameter (mm)
  • 11. Post-hoc In-stent late LL EES(N=935) 0.19±0.33 mm SES(N=266) 0.15±0.33 mm Mean ΔLL: 0.043 mm Upper 1-sided 95% CI: 0.082 mm Non-inferiority p-value 0.007 Prespecified non-inferiority margin: 0.1 mm Non-inferior Upper 1-sided 95% CI
  • 12. In-Stent Post-hoc Minimal Luminal Diameters Before Procedure After Procedure 9-month F/U 100 EES EES EES SES SES SES 80 60 % of Lesions 40 20 0 0.0 1.0 2.0 3.0 4.0 Minimal Luminal Diameter (mm)
  • 13. 2˚ Endpoint Hard Endpoints : Composite of cardiac death, or MI 4.0 Log-Rank p-value=0.561 3.0 Cumulative incidence rate (%) SES: 1.9% 2.0 EES: 1.5% 1.0 0.0 0 3 6 9 12 Months after initial procedure
  • 14. 2˚ Endpoint Soft Endpoints TLR 5.0 Log-Rank p-value=0.400 4.0 3.0 EES: 2.4% Cumulative incidence rate (%) 2.0 SES: 1.7% 1.0 0.0 0 3 6 9 12 Months after initial procedure
  • 15. 2˚ Endpoint Target Lesion Failure : Composite of cardiac death, MI, or ID-TLR 5.0 EES: 3.7% Log-Rank p-value=0.552 4.0 3.0 Cumulative incidence rate (%) SES: 3.0% 2.0 1.0 0.0 0 3 6 9 12 Months after initial procedure
  • 16. 2˚ Endpoint Stent Thrombosis : Definite/Probable ST by ARC definition 1.0 SES: 0.8% Log-Rank p-value=0.281 0.8 0.6 Cumulative incidence rate (%) EES: 0.4% 0.4 0.2 0.0 0 3 6 9 12 Months after initial procedure
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  • 18. The incidence of ST was not different between EES and SES although numerically lower in EES.
  • 19. Tendency of higher late-loss in EES than SES may lead to the intriguing reciprocaltrend between soft versus hard endpoints : higher incidence of TLR but lower incidence of death, MI, or ST.  should be confirmed in the larger study in the future Long term follow up will tell us whether Xience/Promus will offer similar efficacy along with better long term safety compared with the best 1st generation DES, Cypher.
  • 20. 2˚ Endpoint Clinical Outcomes at 1 Year Myocardial Infarction(%) p=1.000 All-Cause Death (%) p=0.485 Cardiac Death (%) p=0.606 EES N=1,057 SES N=359 EES N=1,057 SES N=359 EES N=1,057 SES N=359
  • 21. 2˚ Endpoint Clinical Outcomes at 1 Year ID-TVR (%) p=0.383 ID-TLR(%) p=0.385 EES N=1,057 SES N=359 EES N=1,057 SES N=359
  • 22. 2˚ Endpoint Composite Endpoints TVF (%) (C-death, MI, TVR) p=0.503 TLF (%) (C-death, MI, ID-TLR) p=0.527 Death or MI (%) p=0.554 EES N=1,057 SES N=359 EES N=1,057 SES N=359 EES N=1,057 SES N=359
  • 23. 2˚ Endpoint ARC Stent Thrombosis Definite/Probable ST p=0.379 Definite ST (%) p=0.175 EES N=1,057 SES N=359 EES N=1,057 SES N=359
  • 24. Target Lesion Failure 2˚ Endpoint : Composite of cardiac death, MI, or ID-TLR 0.25 0.5 1 2 4 8 Favors EES Favors SES
  • 25. In-segment & in-stent LL in long lesion or DM subgroup
  • 27. QCA Data(1) :all lesions *comparisons were performed using the generalized estimating equations (GEE).