Vo Thanh NhanCap nhat DES 2010 tài liệu, giáo án, bài giảng , luận văn, luận án, đồ án, bài tập lớn về tất cả các lĩnh v...
Cập nhật stent phủ thuốc PGS Võ Thành Nhân ĐH Y Dược – BV Chợ Rẫy TpHCM Percutaneous Coronary Intervention: Progressive improvements in success, safety, and durability as serial new technologies have been launched 40 Event Rate % Failure Em CABG 30 Restenosis Stent thrombosis VLST 20 10 POBA early POBA late Stent early Stent late 1977 1985 1994 1997 Innovations over time Dr Don Baim, FDA Panel Meeting December 2006 DES 2003-present Expanding Clinical Knowledge in DES multi-vessel disease bifurcated lesions •SYNTAX AMI •FREEDOM •SYNTAX •CORPAL-BIF ISR small vessels work -horse •TAXUS IV •TAXUS V •REALITY -TAXUS •RAVEL •SIRIUS •REALITY -CYPHER •TAXUS V •REALITY -TAXUS •SES-SMART •ISAR -SMART long lesions •TAXUS VI •TAXUS V •Park LL2 diabetes •TAXUS VI •TAXUS V •Horizons •TAXUS V ISR •SISR •RIBS II •ISAR -DESIRE •TAXUS IV -DIABETES •CARDIA •ISAR -DIABETES Increasing complexity left main disease •SYNTAX Increase in Complexity of PCI-treated Patients Challenges technology for continuing improvements Left Main Three Vessels CTO CABG PCI Complexity Bifurcation Two Vessels Small Vessels Long Lesions Single Vessel Time Today Advancing DES technology Drug Eluting Stents,… a delivery balloon and catheter, a polymer (or not!), a stent platform and a drug all can be better International Drug-Eluting Stent Projected Timelines 2003 through 2013+ Projections* 2003 2004 2005 2006 TAXUS™ Express™ Stent 2007 2008 2009 TAXUS™ Liberté™ Long BSC JNJ 2011 2012 TAXUS™ Element™ Stent TAXUS™ Liberté™ Stent PROMUS™ Element™ Plus Stent** PROMUS™ Element™ Stent Cypher™ Stent 2013+ Metallic Bioabosrbable Stent*** Element Bare Stent*** PROMUS™ Stent MDT ABT 2010 Polymer Bioabosrbable Stent*** Synergy Program*** NEVO™ Stent*** XIENCE V™ Stent Endeavor™ Stent Endeavor™ Endeavor™ Sprint Resolute Stent** Stent XIENCE Prime™ Stent XIENCE ThinMan Stent*** Integrity™ Stent** *Estimated launch dates as of March 2010 TAXUS™ Element™ Stent Pending CE Mark, not for sale in EEA, U.S or Japan **CAUTION: Investigational device Limited to investigational use PROMUS Stent is a private-labeled XIENCE V™ Everolimus Eluting Coronary Stent System manufactured by Abbott and distributed by Boston Scientific Corporation ***Concept device Not for sale Based on CVpipeline database and internal estimates Data provided for information purposes only, not meant as a promotional tool nor as an indicator of regulatory approvals BSC internal estimates Integrity™ DES Stent** BVS Stent*** Thin Strut Impacts Clinical Outcomes Historical Data with Bare Metal Reduce deep wall trauma ISAR STEREO1 ISAR STEREO2 month binary restenosis month binary restenosis Thin Thick Multi-link™ Thin Thick Multi-link™ Strut thickness appears to have a significant impact on long-term restenosis after stent implantation.1,2 1ISAR STEREO II JACC Vol 41, No 8, 2003 April 16, 2003:1283-8 2ISAR STEREO I Circulation June 12, 2001 SCAAR Registry DES Results at Years (Adjusted) Probability of Restenosis 8% TAXUS™ Express2™ Stent vs TAXUS™ Liberté™ Stent 1.24 (1.05 - 1.47) HR(95%C.I.) 6% 4% EndeavorTM Stent N=3,531 2% TAXUSTM Express2TM Stent N=9,629 CypherTM Stent N=11,282 TAXUS™ LibertéTM Stent N=11,036 0% Years After PCI Presented by B Lagerqvist MD, ESC 2008 TAXUS™ ATLAS Studies TAXUS™ ATLAS Small Vessel Study TLR results at years2 25.00% 0.5 0.44 mm P = 0.03 0.4 0.28 mm (mm) 0.3 12 0.1 5.00% 10.4 % P = 0.01 1.Dr M Turco et al J Am Coll Cardiol Intv 2008;1:699 –709 TAXUS ATLAS Clinical 2.Program sponsored by Boston Scientific, Data on file year data presented by 1.Dr M Turco at TCT 2009 TLR at years MI/ST results at years2 8.1% 3.9 % 2.9 % 1.5 % TAXUS™ Express2TM TAXUS™ Liberte™ 0.00% P = 0.01 10% TAXUS™ ATLAS Long Lesion Study 10 15.00% 10.00% Instent Late Loss at Months P = 0.008 20.00% 0.2 Percent Given that the stents use the same stent material, polymer coating, drug dose, and release kinetics, the observed clinical benefits are likely the result of the more uniform strut pattern and thinner strut design.1 22.10 % P=0.03 0% Total MI NQWMI Stent Thrombosis ARC ST Definite/ Probable Taking the Challenge-Platform Development Paclitaxel and Everolimus Eluting Stents 2003 2004 2005 2006 2007 2008 2009 2010 Timeline Reflects CE Mark Approval (Actual or Anticipated dates) TAXUS™ Express™ Stent TAXUS™ Liberté™ Stent TAXUS™ Element™ Stent PROMUS™ Stent PROMUS™ Element™ Stent Trial Design PERSEUS WH PERSEUS Workhorse (WH), ≥2.75mm - ≤4.0mm, ≤28mm NON-INFERIORITY Design, Randomized 3:1 TAXUS™ Element™ Paclitaxel-Eluting Stent (N=942) TAXUS™ Express™ Paclitaxel-Eluting Stent (N=320) Primary Endpoint: TLF* (12 mos) Secondary Endpoint: in-segment %DS (9 mos)** *TLF=ischemia-driven TLR or MI/cardiac death related to target vessel **QCA cohort randomly assigned Statistical Methods Bayesian analysis used to power the 1o and 2o endpoints Success criteria: ≥95% Bayesian probability that TAXUS Element Stent is non-inferior to TAXUS Express Stent Predefined delta: 4.1% (TLF); 0.20 ln (%DS)* Standard (frequentist) method used for all other endpoints Presented by Dean J Kereiakes, MD at ACC 2010 12-Month Clinical Outcomes PERSEUS WH TAXUS™ Express™ Stent (N=320) TAXUS™ Element™ Stent (N=942) P=0.78 P=0.48 P=0.60 5.6 4.5 Pts at 313 922 TLF risk 2.9 0.3 0.5 313 922 Cardiac Death 313 3.8 2.2 MI 922 313 TLR 922 Page 24 of 32 6.1 P>0.99 5073 March 2010 Event Rates (per Patient, %) 10 *12m DAPT compliance 89%, both groups Presented by Dean J Kereiakes, MD at ACC 2010 *TLF: ischemia-driven TLR, or MI/cardiac death related to the target vessel Not intended for use in the United States Please see glossary © 2010 Boston Scientific Corporation or its affiliates All rights reserved 12-Month Clinical Outcomes - Safety PERSEUS WH TAXUS™ Express™ Stent (N=320) TAXUS™ Element™ Stent (N=942) P>0.99 P>0.99 P=0.48 P=0.34 P=0.17 P>0.99 0.3 0.5 0.6 0.7 Pts at 313 922 risk Cardiac Death 314 922 All Death 2.9 2.2 1.6 0.0 313 922 MI 0.5 313 922 Q-Wave MI 0.3 0.4 313 922 Non-Q MI 313 918 ST* ARC Def/Prob Page 25 of 32 2.9 5073 March 2010 Event Rates (per Patient, %) 10 *12m DAPT compliance 89%, both groups Presented by Dean J Kereiakes, MD at ACC 2010 Not intended for use in the United States Please see glossary © 2010 Boston Scientific Corporation or its affiliates All rights reserved PLATINUM QCA Trial 9-Month QCA and Clinical Results Study Objective: To compile 30-day and 9-month PROMUS™ Element™ Stent clinical data, and to assess 9-month angiographic & intravascular ultrasound data versus performance goals derived from historical data Study Design: Prospective, single-arm, multicenter, observational trial Primary Endpoint: 30-day MACE (composite of cardiac death, MI, TLR and ARC definite/probable stent thrombosis) Secondary Endpoints: In-stent late loss at months in workhorse lesion subset* PROMUS Element Stent (N = 100) Number of Sites: 14 (Asia Pacific Region) Presented by Ian Meredith, MBBS, PhD, TCT 2010 *Workhorse lesions: (visual RVD >2.5 &