TAXUS Landmark Analysis Impact of Long-Term Clopidogrel Usage on Death, Myocardial Infarction and Stent Thrombosis Gregg W. Stone, MD Stephen G. Ellis,

Slides:



Advertisements
Similar presentations
SPIRIT IV A Prospective, Randomized Trial Comparing an Everolimus-Eluting Stent and a Paclitaxel-Eluting Stent in Patients with Coronary Artery Disease.
Advertisements

ENDEAVOR IV Acronym: ENDEAVOR IV. Lead investigator: Dr Martin Leon from Columbia University, New York Source: Transcatheter cardiovascular Therapeutics,
Clinical Trial Results. org Clopidogrel Use and Long-term Clinical Outcomes After Drug-Eluting Stent Implantation Eric Eisenstein, DBA; Kevin Anstrom,
Clopidogrel Use and Death/MI After Stent Implantation in a Diabetic Population Somjot S. Brar, Simerjeet K. Brar, John Kim, Ray Zadegan, Michael Ree, In-lu.
J. Mehilli, MD, G. Richard, F-J. Neumann, S. Massberg, K-L. Laugwitz, J. Pache, J. Hausleiter, I. Ott, M. Fusaro, T. Ibrahim, A. Schömig, A. Kastrati Deutsches.
Five-Year Follow-up of Safety and Efficacy of the Resolute Zotarolimus-Eluting Stent: Insights from the RESOLUTE Global Clinical Trial Program in Approximately.
Slide 1 Increased Risk of Ischemic Events Upon Discontinuation of Prasugrel After 12 or 30 Months of Therapy Following Placement of the TAXUS Liberté Paclitaxel-
2 Year Clinical Outcomes from the Pivotal RESOLUTE US Study Laura Mauri MD, MSc on behalf of the RESOLUTE US Investigators Brigham and Women’s Hospital.
DR ALEX CHASE REGIONAL HEART CENTRE MORRISTON SWANSEA SLIDE MATERIAL:PERSONAL COMMUNICATION WITH AUTHORS ABBOTT, BOSTON SCIENTIFIC, CORDIS, MEDTRONIC TCT.
TITAX AMI Trial Y. Giraud-Sauveur on behalf of P.Karjalainen, MD, PhD : Principal Investigator BCIS 2009 London, UK A Prospective, Randomized Trial Comparing.
The Synergy between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery: The SYNTAX Study One Year Results of the PCI and CABG Registries.
NOBORI New Generation Drug Eluting Stent Clinical Data Danny Detiege Clinical Manager - Cardiology Terumo Europe N.V. Leuven, Belgium.
EXAMINATION Objective Assess the safety and performance of a new-generation DES vs. a BMS in the setting of primary PCI for treatment of patients with.
Upendra Kaul, MD for the TUXEDO INDIA Investigators Paclitaxel Eluting Versus Everolimus Eluting Stents in Patients with Diabetes Mellitus and Coronary.
Endeavor Safety: Pooled Analysis of Early and Late Safety of a Zotarolimus-Eluting Stent Laura Mauri, MD, MSc Brigham and Women’s Hospital Harvard Clinical.
CARDIOLOGIA INV 1 CAREGGI - FIRENZE Objective To determine whether nonresponsiveness to clopidogrel as revealed by high in vitro residual platelet reactivity.
Two-Year Outcomes After Everolimus- or Sirolimus- Eluting Stents in Patients With Coronary Artery Disease in the ISAR-TEST 4 Trial Robert A. Byrne, Adnan.
Clinical Experience with the Bio Active Stent (BAS) in FINLAND 9 e CFCI Hotel Meridien Etoile Paris, France 10 Octobre 2007 Pasi Karjalainen, MD, PhD.
Endeavor 4: A Randomized Comparison of a Zotarolimus- Eluting Stent and a Paclitaxel- Eluting Stent in Patients with Coronary Artery Disease Martin B.
Gregg W. Stone MD for the ACUITY Investigators Gregg W. Stone MD for the ACUITY Investigators A Prospective, Randomized Trial of Bivalirudin in Acute Coronary.
Boston Scientific Drug eluting stent program A Scientific Approach Identify therapeutic agent Identify appropriate polymer carrier Evaluate a broad range.
ISAR-CABG Objective To compare the efficacy of DES with BMS in a randomized trial powered for clinical events Sample 610 patients with de novo SVG lesions.
M. Valgimigli, MD, PhD University of Ferrara, ITALY On behalf of the PRODIGY Investigators PROlonging Dual antiplatelet treatment after Grading stent-induced.
For OMA distribution only. © 2014 Medtronic, Inc. All rights reserved DOC_1A 03/14 Four-Year Outcomes Following Resolute Zotarolimus-Eluting Stent.
Early and Late Stent Thrombosis Rates in 5,054 Real-World Patients from XIENCE V USA With and Without Dual Antiplatelet Therapy Interruptions James Hermiller,
Is there any role for intravascular ultrasound in bifurcation lesions? Giuseppe Biondi-Zoccai, MD University of Turin, Turin, Italy.
Gregg W. Stone MD for the ACUITY Investigators A Prospective, Randomized Trial of Bivalirudin in Acute Coronary Syndromes Final One-Year Results from the.
A Prospective, Randomized Trial of a Paclitaxel coated Balloon vs. uncoated Balloon Angioplasty in Patients with Drug- Eluting Stent Restenosis PEPCAD-DES.
RAVEL 4 YEAR FOLLOW-UP - Cordis Cardiology / Cardialysis – Euro-PCR – Sousa – 24 May 2005 RAVEL A RAndomised, double-blind study with the Sirolimus-eluting.
Final 5 year results from the all-comer COMPARE trial: a prospective randomized comparison between Xience-V and Taxus Liberté TCT 2013 San Francisco Pieter.
Durable Polymer DES: 5 Year Outcomes RESOLUTE Update Sigmund Silber, MD FESC, FACC, FAHA Heart Center at the Isar Munich, Germany On Behalf of the RESOLUTE.
Prof. Dr. Sigmund Silber, FESC, FACC On behalf of the RESOLUTE
Background & Study Design
Everolimus-eluting Bioresorbable Vascular Scaffolds in Patients with Coronary Artery Disease: ABSORB III Trial 2-Year Results Stephen G. Ellis, MD,
Disclosures Speaker’s bureau: Research support: Consulting: Equity
Stent Thrombosis and Optimal Duration of DAPT
XIENCE V vs TAXUS: Game Over! The Studies are Definitive
on behalf of the ABSORB II Investigators
Three-year results from the multicentre PROMUS Element European Post-Approval (PE-Prove) Registry: outcomes in 1010 unselected patients treated with a.
TAXUS II: Slow Release Formula An International, Randomized, Multicenter, Blinded Trial of TAXUSTM NIRxTM SR Stent Presented at TCT 2002.
12 Month Outcomes in Patients with Diabetes Mellitus Implanted with a Resolute Zotarolimus-eluting Stent: Initial Results from the RESOLUTE Global Clinical.
For the HORIZONS-AMI Investigators
LONG-DES II Trial Randomized Comparison of the Efficacy of Sirolimus-Eluting Stent Versus Paclitaxel-Eluting Stent in the Treatment of Long Native Coronary.
On behalf of all principal COMPARE II investigators:
TAXUS IV Trial Slow-rate release polymer-based paclitaxel-eluting stent compared with bare stent in patients with single de novo coronary lesions Presented.
DES Should be Used as the Default Stent in ACS!
on behalf of the ABSORB II Investigators
Second Generation DES Associated with Less Late and Very Late Stent Thrombosis Compared to First Generation DES Donald E. Cutlip, MD Beth Israel Deaconess.
on behalf of the ABSORB II Investigators
TAXUS II and IV: two-year follow-up
TAXUS II: Moderate Release Formula An International, Randomized, Multicenter, Blinded Trial of TAXUSTM NIRxTM MR Stent Presented at TCT 2002.
How and why this study may change my practice ?
3-Year Clinical Outcomes From the RESOLUTE US Study
ENDEAVOR IV: 5 Year Final Outcomes
Comparison of Everolimus- and Biolimus-Eluting Coronary Stents With Everolimus-Eluting Bioresorbable Vascular Scaffolds: 2-year Outcomes of the EVERBIO.
For the HORIZONS-AMI Investigators
For the HORIZONS-AMI Investigators
Five-Year Cumulative Rates of Clinical Events after Cypher™ Stent Implantation: Insights from a Patient-Level Pooled Analysis of Four Randomized Trials.
Large-Scale Registry Examining Safety and Effectiveness of Zotarolimus-Eluting and Sirolimus-Eluting Stents in Patients with Coronary Artery Disease Western.
STENT THROMBISIS Insights on Outcomes and Impact of DUAL ANTIPLATELET THERAPY Permanent Discontinuation SPIRIT II, SPIRIT III, SPIRIT IV and COMPARE.
On behalf of all principal COMPARE II investigators:
ENDEAVOR II Five-Year Clinical Follow-up
FOR DISTRIBUTION BY MEDTRONIC OFFICE OF MEDICAL AFFAIRS ONLY.
Gregg W. Stone, MD Columbia University Medical Center
ENDEAVOR III Multicenter Randomized Trial Clinical/MACE Angio/IVUS
Updated 3-Year Meta-Analysis of the TAXUS Clinical Trials Safety and Efficacy Demonstrated in 3,445 Randomized Patients Time allocation for this talk.
Martin B. Leon, David R. Holmes, Dean J. Kereiakes, Jeffrey J
Long Term Clinical Results from the Endeavor Program: 5-Year Follow up
Maintenance of Long-Term Clinical Benefit with
Comparison of Everolimus-Eluting and Paclitaxel-Eluting Stents: First Report of the Five-Year Clinical Outcomes from.
Presentation transcript:

TAXUS Landmark Analysis Impact of Long-Term Clopidogrel Usage on Death, Myocardial Infarction and Stent Thrombosis Gregg W. Stone, MD Stephen G. Ellis, Antonio Colombo, David F. Kong, Mark I. Friedman, Donald S. Baim Gregg W. Stone, MD Stephen G. Ellis, Antonio Colombo, David F. Kong, Mark I. Friedman, Donald S. Baim

TAXUS II-SR (5y), IV (5y), V de novo (3y) Thienopyridine Landmark Analysis – G. Stone - 2 TCT – October 23, 2007 – Late Breaking Trial Conflict of Interest Disclosures Study and presentation supported by Boston Scientific Corporation Moderate (M; US$10,000) sources of support are indicated. Gregg W. Stone Research Support (S): Boston Scientific Stephen G. Ellis Consultant/Advisory Board (M): Cordis, BSC, Abbot Vascular Other research support (M): Centocor David F. Kong Research grant: AHRQ, Procter and Gamble, Terumo Corporation, International Machines (IBM) (S) Speakers Bureau: Novartis (M) Consultant: Allmed Healthcare Mgmt (M) Antonio Colombo None Mark Friedman Ownership interest: Biogen Idec, BSC (M) Employment: BSC (S) Donald S. Baim Ownership interest: Biogen Idec, BSC (S) Employment: BSC (S)

TAXUS II-SR (5y), IV (5y), V de novo (3y) Thienopyridine Landmark Analysis – G. Stone - 3 TCT – October 23, 2007 – Late Breaking Trial Thienopyridine Landmark Study JAMA Jan 10;297(2): Non-blinded, observational landmark study from uncontrolled registry data Thienopyridine Use >1yr May reduce death and MI in patients who have received drug-eluting stents.

TAXUS II-SR (5y), IV (5y), V de novo (3y) Thienopyridine Landmark Analysis – G. Stone - 4 TCT – October 23, 2007 – Late Breaking Trial Reduced 2-Year Death or MI Rates in DES Patients on Clopidogrel at 6-Months

TAXUS II-SR (5y), IV (5y), V de novo (3y) Thienopyridine Landmark Analysis – G. Stone - 5 TCT – October 23, 2007 – Late Breaking Trial Objective We performed a similar examination of TAXUS stent in the prospective, randomized, double- blind TAXUS trials.

TAXUS II-SR (5y), IV (5y), V de novo (3y) Thienopyridine Landmark Analysis – G. Stone - 6 TCT – October 23, 2007 – Late Breaking Trial Analysis Design Patients free of Death, MI, TVR, or ARC ST* at 1-year (n=2171) ON (T+) Thienopyridine n=447 ON (T+) Thienopyridine n=517 OFF (T-) Thienopyridine n=624 OFF (T-) Thienopyridine n=583 Subsequent events tabulated (to 2 years and 5 years) BMS (n=1030)TAXUS (n=1141) *Academic Research Consortium (Cutlip et al., Circulation 115:2344)

TAXUS II-SR (5y), IV (5y), V de novo (3y) Thienopyridine Landmark Analysis – G. Stone - 7 TCT – October 23, 2007 – Late Breaking Trial TAXUS Landmark Analysis Individual Trial Characteristics Stent PlatformNIRxExpress ITT Patients266 (SR only) Primary Endpoint % net volume obstruction (6m) TVR (9m) RVD Lesion Length Max. Planned Stents122 Latest Available Follow-up 5 Years 3 Years

TAXUS II-SR (5y), IV (5y), V de novo (3y) Thienopyridine Landmark Analysis – G. Stone - 8 TCT – October 23, 2007 – Late Breaking Trial Baseline Results in TAXUS Patients OFF (n=624)ON (n=517)P Value Age (years) 63.1± ± Male, % (n) 71.0 (443)73.1 (378) 0.47 Diabetic, % (n) 19.9 (124)29.4 (152) Insulin-requiring, % (n) 5.4 (34)7.9 (41) 0.09 Current Smoker, % (n) 22.6 (141)21.5 (111) 0.67 Total # of Stents 1.1±0.41.3±0.5 < Total Stent Length (mm) 22.0± ±11.8 < RVD (mm) 2.75± ± Lesion Length (mm) 13.7± ± MLD (mm) 0.9±0.30.9± Diameter Stenosis (%) 66.8± ±

TAXUS II-SR (5y), IV (5y), V de novo (3y) Thienopyridine Landmark Analysis – G. Stone - 9 TCT – October 23, 2007 – Late Breaking Trial Baseline Results in BMS Patients OFF (n=583)ON (n=447)P Value Age (years) 61.8± ± Male, % (n) 71.5 (417)73.2 (327)0.58 Diabetic, % (n) 23.2 (135)26.2 (117)0.27 Insulin-requiring, % (n) 8.2 (48)6.5 (29)0.34 Current Smoker, % (n) 21.4 (125)20.1 (90)0.64 Total # of Stents 1.1±0.41.2± Total Stent Length (mm) 21.6± ±11.4 < RVD (mm) 2.78± ± Lesion Length (mm) 13.9± ± MLD (mm) 0.9± Diameter Stenosis (%) 66.2± ±

TAXUS II-SR (5y), IV (5y), V de novo (3y) Thienopyridine Landmark Analysis – G. Stone - 10 TCT – October 23, 2007 – Late Breaking Trial Thienopyridine Use to 5 Years BMS (T+): 56.5% % Patients PES (T+) PES (T-) BMS (T+) BMS (T-) PES (T+): 56.9% 5-Years BMS (T-): 15.7% PES (T-): 14.7% ON Thienopyridine at 1 Year OFF Thienopyridine at 1 Year

TAXUS II-SR (5y), IV (5y), V de novo (3y) Thienopyridine Landmark Analysis – G. Stone - 11 TCT – October 23, 2007 – Late Breaking Trial Impact of Thienopyridine Use on All-cause Death to 2-Years Events After 1 Year (in patients death/MI/ST/TVR free at 1 year) 5% 0% 10% Cumulative Event Rate Event Rate ± 1.5 SE, Log-Rank p value 15%2y1y Index Procedure 0-1 yr Events (all patients) PES (T+):1.4% (7) PES (T-): 0.6% (4) BMS (T+):2.0% (9) BMS (T-):1.4% (8) P=0.22 P=0.41

TAXUS II-SR (5y), IV (5y), V de novo (3y) Thienopyridine Landmark Analysis – G. Stone - 12 TCT – October 23, 2007 – Late Breaking Trial Impact of Thienopyridine Use on All-cause Death to 5-Years Events After 1 Year (in patients death/MI/ST/TVR free at 1 year) 5% 0% 10% Cumulative Event Rate Event Rate ± 1.5 SE, Log-Rank p value 15%2y3y4y5y1y Index Procedure 0-1 yr Events (all patients) PES (T+):6.0% (25) PES (T-): 7.4% (37) BMS (T+):6.9% (21) BMS (T-):6.6% (35) P=0.83 P=0.67

TAXUS II-SR (5y), IV (5y), V de novo (3y) Thienopyridine Landmark Analysis – G. Stone - 13 TCT – October 23, 2007 – Late Breaking Trial Impact of Thienopyridine Use on Death or MI to 2-Years Events After 1 Year (in patients death/MI/ST/TVR free at 1 year) 5% 0% 10% Cumulative Event Rate Event Rate ± 1.5 SE, Log-Rank p value 15%2y1y Index Procedure 0-1 yr Events (all patients) PES (T+):1.8% (9) PES (T-): 1.9% (12) BMS (T+):2.5% (11) BMS (T-):1.9% (11) P=0.82 P=0.51

TAXUS II-SR (5y), IV (5y), V de novo (3y) Thienopyridine Landmark Analysis – G. Stone - 14 TCT – October 23, 2007 – Late Breaking Trial Impact of Thienopyridine Use on Death or MI to 5-Years Events After 1 Year (in patients death/MI/ST/TVR free at 1 year) 5% 0% 10% Cumulative Event Rate Event Rate ± 1.5 SE, Log-Rank p value 15%2y3y4y5y1y Index Procedure 0-1 yr Events (all patients) PES (T+):8.3% (35) PES (T-): 9.8% (51) BMS (T+):7.9% (25) BMS (T-):9.2% (48) P=0.75 P=0.28

TAXUS II-SR (5y), IV (5y), V de novo (3y) Thienopyridine Landmark Analysis – G. Stone - 15 TCT – October 23, 2007 – Late Breaking Trial Impact of Thienopyridine Use on Stent Thrombosis* to 2-Years Events After 1 Year (in patients death/MI/ST/TVR free at 1 year) 5% 0% 10% Cumulative Event Rate Event Rate ± 1.5 SE, Log-Rank p value 15%2y1y Index Procedure 0-1 yr Events (All patients) *ARC Definite/Probable PES (T+):0.0% (0) PES (T-): 0.7% (4) BMS (T+):0.2% (1) BMS (T-):0.0% (0) P=0.07 P=0.25

TAXUS II-SR (5y), IV (5y), V de novo (3y) Thienopyridine Landmark Analysis – G. Stone - 16 TCT – October 23, 2007 – Late Breaking Trial Impact of Thienopyridine Use on Stent Thrombosis* to 5-Years Events After 1 Year (in patients death/MI/ST/TVR free at 1 year) 5% 0% 10% Cumulative Event Rate Event Rate ± 1.5 SE, Log-Rank p value 15%2y3y4y5y1y Index Procedure 0-1 yr Events (All patients) *ARC Definite/Probable PES (T+):0.8% (4) PES (T-): 1.4% (8) BMS (T+):0.2% (1) BMS (T-):0.7% (3) P=0.43 P=0.59

TAXUS II-SR (5y), IV (5y), V de novo (3y) Thienopyridine Landmark Analysis – G. Stone - 17 TCT – October 23, 2007 – Late Breaking Trial Impact of Thienopyridine Use on Death, MI, or Stent Thrombosis* to 2-Years Events After 1 Year (in patients death/MI/ST/TVR free at 1 year) 5% 0% 10% Cumulative Event Rate Event Rate ± 1.5 SE, Log-Rank p value 15%2y1y Index Procedure 0-1 yr Events (All patients) *ARC Definite/Probable PES (T+):1.8% (9) PES (T-): 1.9% (12) BMS (T+):2.5% (11) BMS (T-):1.9% (11) P=0.82 P=0.51

TAXUS II-SR (5y), IV (5y), V de novo (3y) Thienopyridine Landmark Analysis – G. Stone - 18 TCT – October 23, 2007 – Late Breaking Trial Impact of Thienopyridine Use on Death, MI, or Stent Thrombosis* to 5-Years Events After 1 Year (in patients death/MI/ST/TVR free at 1 year) 5% 0% 10% Cumulative Event Rate Event Rate ± 1.5 SE, Log-Rank p value 15%2y3y4y5y1y Index Procedure 0-1 yr Events (All patients) *ARC Definite/Probable PES (T+):8.3% (35) PES (T-): 9.8% (51) BMS (T+):7.9% (25) BMS (T-):9.2% (48) P=0.75 P=0.28

TAXUS II-SR (5y), IV (5y), V de novo (3y) Thienopyridine Landmark Analysis – G. Stone - 19 TCT – October 23, 2007 – Late Breaking Trial Summary Rate, % (n)P Values HR [95% CI]T+T- Treat- ment Inter- action 2-YEAR EVENTS Death PES0.47 [0.14, 1.61] 1.4% (7)0.6% (4) BMS0.67 [0.26, 1.74] 2.0% (9)1.4% (8)0.41 Death or MI PES1.11 [0.47, 2.63] 1.8% (9)1.9% (12) BMS0.76 [0.33, 1.74] 2.5% (11)1.9% (11)0.51 ST PES N/A0.0% (0)0.7% (4)0.07 N/A BMS N/A0.2% (1)0.0% (0)0.25 Death, MI, or ST PES 1.11 [0.47, 2.63]1.8% (9)1.9% (12) BMS 0.76 [0.33, 1.74]2.5% (11)1.9% (11) YEAR EVENTS Death PES 1.06 [0.63, 1.76]6.0% (25)7.4% (37) BMS 1.13 [0.66, 1.94]6.9% (21)6.6% (35)0.66 Death or MI PES 1.07 [0.70, 1.65]8.3% (35)9.8% (51) BMS 1.31 [0.80, 2.12]7.9% (25)9.2% (48)0.28 ST PES 1.61 [0.49, 5.36]0.8% (4)1.4% (8) BMS 1.84 [0.19, 17.84]0.2% (1)0.7% (3)0.59 Death, MI, or ST PES 1.07 [0.70, 1.65]8.3% (35)9.8% (51) BMS 1.31 [0.80, 2.12]7.9% (25)9.2% (48) (Log-rank) (Cox model) T+ Worse T+ Better

TAXUS II-SR (5y), IV (5y), V de novo (3y) Thienopyridine Landmark Analysis – G. Stone - 20 TCT – October 23, 2007 – Late Breaking Trial Thienopyridine Use and Stent Thrombosis in TAXUS-treated Patients Time Post-Procedure 1 Yr2 Yrs3 Yrs4 Yrs5 Yrs Individual ST Patients (each bar represents 1 patient) Procedure Off Thienopyridine On Thienopyridine ON at 1 Yr OFF at 1 Yr (days to ST)

TAXUS II-SR (5y), IV (5y), V de novo (3y) Thienopyridine Landmark Analysis – G. Stone - 21 TCT – October 23, 2007 – Late Breaking Trial Conclusions Patients on thienopyridines at 1 year are more likely to remain on it at 5 years Patients on thienopyridines at 1 year display a trend toward fewer safety events through 5 years – a trend that does not reach statistical significance It is impossible to attribute any observed benefit to thienopyridine use itself (rather than to disease-specific factors) given the significant differences at baseline Benefit in other high-risk groups not examined in this analysis cannot be excluded e.g. CTO, AMI, etc. This analysis does not provide clear evidence for routinely extending thienopyridine use beyond 1 year