医学交流课件：All the DES Equal

1、 0.01 mm0.01 mm C D Kolandaivelu et al 2011 Thin Struts allow for Low blood flow perturbance Easy struts nesting to the vessel wall Added flexibility and conformability Improved, faster endothelialization Improved clinical outcome Strut thickness Cypher 140 m Taxus 132 m Endeavor 91 m Xience V 81 m

2、Element 81 m X 500 50mm 12 57 DES Synergy 74 m X 500 50mm 12 57 DES Low Strut Thickness with Potential to minimize vessel injury Platinum-ChromiumPlatinum-ChromiumStainless SteelStainless SteelCobalt-ChromiumCobalt-Chromium 2.6% Molybdenum Nickel Composition (by weight (%) Element Stent Series Radia

3、l Strength CoCr AlloyPtCr Alloy Element Stent Series Minimize Recoil CoCr AlloyStainless Steel Alloy Stainless Steel Alloy Conformability Measures the ability of the stent to naturally conform to the vessel Stent Models and optimal drug Elution 4 Stent Models for consistent stent to artery ratios, a

4、nd uniform drug delivery ModelDiameter SV2.25 mm SWH2.50 mm SWH2.75 mm WH3.00 mm WH3.50 mm LV4.00 mm ModelDiameter Small2.25 mm Small2.50 mm Small2.75 mm Small3.00 mm Medium3.50 mm Medium4.00 mm ModelDiameter Small2.25 mm Small2.50 mm Small2.75 mm Medium3.00 mm Medium3.50 mm Medium4.00 mm PROMUS Ele

5、ment Stent 4 Stent Models Xience V Meredith, et al. Eurointervention 2011;7:84. SPIRIT III: Stone, et al. JAMA. 2008;299:1903. Results from different studies are not directly comparable. Information provided for educational purposes only. Post-Procedure Incomplete Stent Apposition p 0.001 Late Incom

6、plete Stent Apposition PLATINUM QCA Trial* PLATINUM QCA Trial 9-Month Results (n = 90)(n =88)(n = 90) PLATINUM QCA Study Incomplete Stent Apposition Results in Perspective 83% Reduction SPIRIT III Trial SPIRIT III Trial 8-Month Results ENDEAVOR II Trial# 8-Month Results ENDEAVOR II Trial# *PLATINUM

7、QCA Trial; Meredith, et al. Eurointervention 2011;7:84. SPIRIT III: Stone, et al. JAMA. 2008;299:1903. #ENDEAVOR II: Endeavor DFU. RESOLUTE: Circulation Journal Aug 3, 2010. SPIRIT Clinical Trials are sponsored by Abbott. Results from different studies are not directly comparable. Information provid

8、ed for educational purposes only. PLATINUM QCA Trial*RESOLUTE Trial Acute Incomplete Stent Apposition (%) Late Incomplete Stent Apposition (%) SPIRIT Prime Trial Not Reported Not Reported PROMUS Element Stent Endeavor Stent Xience V Stent Resolute Stent Xience Prime Stent (n =90) (n = 90)(n = 81) (n

9、 = 69) (n = 104)(n = 88) PROMUS Element Stent Endeavor Stent Xience V Stent Resolute Stent Xience Prime Stent PLATINUM QCA Trial* 9-Month Results RESOLUTE Trial 8-Month Results SPIRIT Prime Trial (n = 145) (n = 125) PLATINUM QCA Trial Incomplete Stent Apposition results in perspective Presented by G

10、regg W. Stone, MD, ACC 2012. Study Objective: Evaluate the safety and effectiveness of the PROMUS Element Everolimus-Eluting Coronary Stent System for the treatment of patients with up to 2 de novo atherosclerotic coronary artery lesions compared to the Xience V Stent. Study Design:Prospective, rand

11、omized, controlled, single-blind, non-inferiority trial in patients with up to 2 de novo target lesions; lesion length 24 mm; reference vessel diameter 2.50 4.25 mm. Primary Endpoint:Target Lesion Failure (Ischemia-Driven TLR, target vessel MI, or target vessel cardiac death) at 12 months. Additiona

12、l Endpoints:Components of TLF and ARC ST (Def/Prob), Technical Success, Clinical Procedural Success. Patient Population*: PROMUS Element Stent n = 758 Xience V Stentn = 749 Number of Sites:132 (U.S., EU, Japan ACC 2012 PLATINUM Workhorse Clinical Trial 2-Year Clinical Results * Patients who received

13、 a study stent. TLF=Ischemia-driven (ID) target lesion revascularization (TLR), cardiac death related to the target vessel (TV) or myocardial infarction (MI) related to the TV. Presented by Gregg W. Stone, MD, ACC 2012. *Not presented, BSC data on file. Incidence Rate (%) p = 0.28p = 0.12 p= 0.98 Co

14、mponents of TLF PROMUS Element Stent (n = 758) Xience V Stent (n = 749) p = 0.32 Primary endpoint was TLF at 1-year *TLF=Ischemia-driven (ID) target lesion revascularization (TLR), cardiac death related to the target vessel (TV) or myocardial infarction (MI) related to the TV. TVR: target vessel rev

15、ascularization. ST: stent thrombosis. Incidence Rate (%) p = 0.30 p = 0.12 p = 0.54 p = 0.15 p = 0.80 PROMUS Element Stent (n = 758) Xience V Stent (n = 749) p = 0.99 PROMUS Element Stent demonstrated numerically lower events p = 0.33p = 0.32 Presented by Gregg W. Stone, MD, ACC 2012. Significant Re

16、duction in Bail-out Stenting Incidence Rate (%) p = 0.004p = 0.36 p = 0.01p = 0.06 PROMUS Element Stent (n = 768) Xience V Stent (n = 762) Overall RateCited Reason for Bail-out Stent PLATINUM Workhorse Trial: Stone, et al. JACC 2011; 57:1700. Intent to Treat Analysis. PLATINUM Workhorse Clinical Tri

17、al Peri-procedural Unplanned Bail-Out Stenting Target Lesion Failure (%) Months Since Index Procedure 2-Year Landmark Analysis TLF = cardiac death or MI related to the target vessel or ischemia-driven TLR; Patients with Study Stents. 3691215182124 3.0% 1.2% 1-yr HR 95% CI = 1.12 0.63, 1.99 P = 0.70

18、0 Treatment GroupPROMUS Element 1Y PROMUS 1Y PROMUS Element 1-2Y PROMUS 1-2Y 3.3% 3.0% 1-yr to 2-yr HR 95% CI = 0.44 0.20, 0.97 P = 0.04 CoCr-EES (N=749 at time 0, n=722 at 1 year) PtCr-EES (N=758 at time 0, n=736 at 1 year) Ischemia-Driven TLR (%) Months Since Index Procedure 2-Year Landmark Analys

19、is 3691215182124 CoCr-EES (N=749 at time 0, n=722 at 1 year) PtCr-EES (N=758 at time 0, n=736 at 1 year) 1-yr HR 95% CI = 0.98 0.47, 2.07 P = 0.97 0 1-yr to 2-yr HR 95% CI = 0.33 0.12, 0.90 P = 0.02 Treatment GroupPROMUS Element 1Y PROMUS 1Y PROMUS Element 1-2Y PROMUS 1-2Y 2.2% 0.7% 1.9% 1.9% TLR =

20、target lesion revascularization CoCr (%) PtCr (%) Relative Risk (95% CI) Relative Risk (95% CI) P Interaction All randomized (n=1507)5.8%4.6%0.78 (0.50-1.22)0.28 Age 65.0 yrs (n=779)7.0%3.9%0.55 (0.29-1.03) 0.10 Age 65.0 yrs (n=728)4.4%5.3%1.20 (0.61-2.36) Male (n=1074)4.8%4.5%0.93 (0.53-1.63) 0.30

21、Female (n=433)8.4%4.8%0.57 (0.27-1.22) Diabetic (n=351)7.9%5.9%0.75 (0.34-1.69) 0.86 Nondiabetic (n=1156)5.1%4.2%0.82 (0.48-1.40) Single vessel Tx (n=1399)6.0%4.5%0.76 (0.48-1.20) 0.56 Dual vessel Tx (n=108)4.1%5.3%1.29 (0.22-7.41) BMI 2.62 mm (n=728)5.3%3.6%0.67 (0.33-1.35) Lesion 13.0 mm (n=870)5.

22、3%4.2%0.79 (0.43-1.45) 0.94 Lesion 13.0 mm (n=636)6.6%5.0%0.76 (0.40-1.47) TLF at 2 Years PtCr betterCoCr better 102 Binary Rates Presented by Dominic Allocco, MD, PCR 2012. Ian T. Meredith MBBS, PhD is the PI. Study Objective: Evaluate the safety 2.25 mm to 24 and 34 mm in length, 2.50 mm to 4.25 m

23、m in diameter Study Design:Prospective, single-arm, multi-center Primary Endpoint:12-month TLF (ID-TLR or TV-CD or TV-MI) against a performance goal of 19.4% (based on historical TAXUS Express results) in the per protocol population Number of Patients: PROMUS Element Stent n = 102 Number of Sites:30

24、 sites (U.S., Australia, New Zealand, Belgium, France, Japan, Latvia) Presented by Paul S. Teirstein, MD, TCT 2011. PROMUS Element and TAXUS Express are trademarks of Boston Scientific Corporation or its affiliates. All other trademarks are the property of their respective owners. This material is n

25、ot intended for the U.S. or Japan. Please see glossary. * Intent-to-treat population. Results from different clinical trials are not directly comparable. Information provided for educational purposes only. *PROMUS Element has a dedicated small vessel 2.25mm stent model. Xience V is the 2.50-3.00 mm

26、model crimped to a 2.25mm balloon. #PLATINUM SV Presented by Ian T. Meredith, MBBS, PhD, PCR 2011. +Xience DFU. The SPIRIT Clinical Trials are sponsored by Abbott. -RESOLUTE US Trial, Leon, et al. JACC 2011; 57;1778-1783. Resolute is a trademark of Medtronic Vascular, Inc. This material is not inten

27、ded for the U.S. or Japan. Please see glossary. * Xience PRIMEis ARC to protocol . Presented at 2011TCT by Marco A,Costa MD* Resolute Long DES IV based on protocol analysis , presented at 2011TCT by Seung Jung Park. SPIRIT Prime Long Lesion Trial*+ Xience Prime Stent (n = 136) RVD = 2.13 mm Lesion Length = 13.38 mm PLATINUM Long Lesion Trial*# PROMUS Element Stent* RVD = 2.56 mm Lesion Length = 24.38 mm (n = 102) Incidence rates % Incidence rates % Resolute Long DES IV Trial*- Resolute Stent* (n = 250) Incidence rates %