Presentation is loading. Please wait.

Presentation is loading. Please wait.

Four Drug Eluting Stent Trials Keith D Dawkins MD FRCP FACC Southampton University Hospital Keith D Dawkins MD FRCP FACC Southampton University Hospital.

Published byOswald Harvey Modified over 9 years ago

Similar presentations

Presentation on theme: "Four Drug Eluting Stent Trials Keith D Dawkins MD FRCP FACC Southampton University Hospital Keith D Dawkins MD FRCP FACC Southampton University Hospital."— Presentation transcript:

1 Four Drug Eluting Stent Trials Keith D Dawkins MD FRCP FACC Southampton University Hospital Keith D Dawkins MD FRCP FACC Southampton University Hospital

2 The Trials Endeavour I (TCT 2003) Driver + ABT 578 (Medtronic) Future II (TCT 2003) S-Stent + Everolimus (Guidant) New Sirius (AHA 2003) Bx Velocity + Sirolimus (Cordis/J&J) Taxus IV (AHA 2003) Express 2 + Paclitaxel (Boston Scientific) Endeavour I (TCT 2003) Driver + ABT 578 (Medtronic) Future II (TCT 2003) S-Stent + Everolimus (Guidant) New Sirius (AHA 2003) Bx Velocity + Sirolimus (Cordis/J&J) Taxus IV (AHA 2003) Express 2 + Paclitaxel (Boston Scientific)

3 Endeavour I (Medtronic) Safety Study (n=100) Device Driver cobalt-chrome stent PC coating ABT 578 : anti-proliferative action blocks mTOR signal transduction Safety Study (n=100) Device Driver cobalt-chrome stent PC coating ABT 578 : anti-proliferative action blocks mTOR signal transduction

4 Endeavour I (Medtronic) Inclusion Criteria Single de novo lesion Native coronary arteries ACC/AHA A-B 2 Reference vessel diameter 3.0 – 3.5mm Lesion length <15mm Diameter stenosis ≥50% - <100% Follow-up Clinical 1, 4, 9 months, 1- 5 years Angio + IVUS 4 and 12 months Inclusion Criteria Single de novo lesion Native coronary arteries ACC/AHA A-B 2 Reference vessel diameter 3.0 – 3.5mm Lesion length <15mm Diameter stenosis ≥50% - <100% Follow-up Clinical 1, 4, 9 months, 1- 5 years Angio + IVUS 4 and 12 months

5 Complications30 Days12 months MACE * 1%2% Death0% MI (all)1% Q-wave0% Non Q-wave1% TLR0%1% TVR (non-TL)0% Endeavour I (MACE) * Hierarchical

6 Endeavour I (QCA 4 months) Diameter stenosis (%) Pre Post 4m In-Stent In-Segment 70.3% 5.4% 14.4% 16.5% 21.7%

7 Endeavour I (QCA 4 months) Late loss (mm) 0.11mm 0.09 mm 0.33mm Proximal Distal In-Stent 0.2mm In-Segment

8 Future II (Guidant) RCT (2:1) (n=64) Device S-Stent (stainless steel) Bioabsorbable polymer matrix Everolimus : proliferation signal inhibitor, causes cell cycle arrest in the G 1 phase, prevents clonal expansion of activated T-cells RCT (2:1) (n=64) Device S-Stent (stainless steel) Bioabsorbable polymer matrix Everolimus : proliferation signal inhibitor, causes cell cycle arrest in the G 1 phase, prevents clonal expansion of activated T-cells

9 Future II (Guidant) Inclusion Criteria Single de novo lesion Native coronary arteries ACC/AHA A-B 2 Reference vessel diameter 2.5 – 4.0mm Lesion length ≤18mm Diameter stenosis ≥50% - <100% Follow-up Clinical 1, 6, 12 months Angio + IVUS 6 months Inclusion Criteria Single de novo lesion Native coronary arteries ACC/AHA A-B 2 Reference vessel diameter 2.5 – 4.0mm Lesion length ≤18mm Diameter stenosis ≥50% - <100% Follow-up Clinical 1, 6, 12 months Angio + IVUS 6 months

10 ComplicationsEverolimus n=21/21 Control n=40/43 MACE * 17 Death00 MI (all)01 Q-wave 00 Non Q-wave 01 TLR16 Future II (MACE 6 months) * Hierarchical

11 Future II (QCA 6 months) Binary restenosis (%) MS EES In-Stent In-Segment 19.4% 30.6% 0.0% 4.8% MS EES p=0.04 p=ns

12 Future II (QCA 6 months) Late Loss (mm) EES MS In-Stent In-Segment 0.12 0.17 0.85 0.54 EES MS p=0.002 p<0.0001

13 New Sirius * (Cordis/Johnson & Johnson) RCT (1:1) (n= 452) Device Bx Velocity stainless steel stent Two polymers PEVA & PBMA Sirolimus : proliferation signal inhibitor, causes cell cycle arrest in the G 1 phase, upregulates natural cell cycle inhibitors (p27) RCT (1:1) (n= 452) Device Bx Velocity stainless steel stent Two polymers PEVA & PBMA Sirolimus : proliferation signal inhibitor, causes cell cycle arrest in the G 1 phase, upregulates natural cell cycle inhibitors (p27) * Combined data from E-Sirius and C-Sirius

14 New Sirius * (Cordis/Johnson & Johnson) Inclusion Criteria Single de novo lesion Native coronary arteries ACC/AHA A-C Reference vessel diameter 2.5 - 3.0mm Lesion length 15 - 32mm Diameter stenosis ≥50% - 100% Follow-up Clinical 1, 9, 12 months Angio + IVUS 8 months Inclusion Criteria Single de novo lesion Native coronary arteries ACC/AHA A-C Reference vessel diameter 2.5 - 3.0mm Lesion length 15 - 32mm Diameter stenosis ≥50% - 100% Follow-up Clinical 1, 9, 12 months Angio + IVUS 8 months * Combined data from E-Sirius and C-Sirius

15 New Sirius (QCA 8 months) Diameter restenosis (%) Bx Cypher In-Stent In-Segment 42.7% 44.2% 3.1% 5.1% Bx Cypher p<0.001

16 New Sirius (QCA 8 months) Binary restenosis (%) Bx Cypher In-Stent Distal Margin Distal Margin 7.4% 42.3% 2.1% 11.0% p<0.001 p=0.018 Proximal Margin Proximal Margin Bx Cypher 2.0% 3.1% p<0.001

17 Complications Cypher (%) n=45 Control (%) n=60 p value RVD (mm)2.732.77ns Lesion length (mm)14.114.9ns In-Stent late loss (mm)0.231.17<0.001 Restenosis rate (%) In-Stent In-Segment 5.4 10.8 54.5 56.4 <0.001 TLR (%)6.730.00.003 MACE (%)11.133.30.01 New Sirius (Diabetics 12 months)

18 Taxus IV (Boston Scientific) RCT (1:1) (n=1326) Device Express 2 stainless steel stent Translute ™ elastomeric polymer Paclitaxel : binds tubulin interfering with microtubular dynamics, inhibits SMC proliferation & migration, ECM synthesis & secretion RCT (1:1) (n=1326) Device Express 2 stainless steel stent Translute ™ elastomeric polymer Paclitaxel : binds tubulin interfering with microtubular dynamics, inhibits SMC proliferation & migration, ECM synthesis & secretion

19 Taxus IV (Boston Scientific) Inclusion Criteria Single de novo lesion Native coronary arteries ACC/AHA A-C Reference vessel diameter 2.5 - 3.0mm Lesion length 15 - 32mm Diameter stenosis ≥50% - 100% Follow-up Clinical 1, 4, 9 months, 1 – 5 years Angio + IVUS 9 months Inclusion Criteria Single de novo lesion Native coronary arteries ACC/AHA A-C Reference vessel diameter 2.5 - 3.0mm Lesion length 15 - 32mm Diameter stenosis ≥50% - 100% Follow-up Clinical 1, 4, 9 months, 1 – 5 years Angio + IVUS 9 months

20 TAXUS benefit for TLR sustained to 12-months % patients 100 90 80 Days since index procedure TAXUS Control 0306090120150180210240270300330365 Δ 9.3% P<0.0001 96.8% 87.5% Δ 10.7% P<0.0001 95.6% 84.9% Taxus IV: Target lesion revascularisation

21 TLR at 12 months (%) Lesion Length (mm) ControlTAXUS Impact of Vessel Size & Lesion Length > 3.0 2.5-3.0 < 2.5 RVD (mm) Taxus IV: Impact of vessel size & lesion length

22 Impact of Diabetes Mellitus N=489N=507N=163N=155N=54N=51 P<0.0001 P=0.12 P=0.0016 Taxus IV: Impact of Diabetes TLR at 12 months (%) No Diabetes Diabetes Diabetes (Insulin)

23 Conclusions Four effective drugs at reducing restenosis Stent delivery system is critical in optimising drug placement All four devices/drugs are safe (12 months) The ‘ideal’ late loss is yet to be determined (viz. no restenosis vs. minimal restenosis) Cost will be a major factor in selecting a particular product Four effective drugs at reducing restenosis Stent delivery system is critical in optimising drug placement All four devices/drugs are safe (12 months) The ‘ideal’ late loss is yet to be determined (viz. no restenosis vs. minimal restenosis) Cost will be a major factor in selecting a particular product

Download ppt "Four Drug Eluting Stent Trials Keith D Dawkins MD FRCP FACC Southampton University Hospital Keith D Dawkins MD FRCP FACC Southampton University Hospital."

Similar presentations

Clinical Trial Results. org ABSORB Presented at the American College of Cardiology Annual Scientific Session March, 2007 Presented by Dr. Patrick W. Serruys.

Clinical Trial Results. org ABSORB Presented at the American College of Cardiology Annual Scientific Session March, 2007 Presented by Dr. Patrick W. Serruys.
SPIRIT IV A Prospective, Randomized Trial Comparing an Everolimus-Eluting Stent and a Paclitaxel-Eluting Stent in Patients with Coronary Artery Disease.

SPIRIT IV A Prospective, Randomized Trial Comparing an Everolimus-Eluting Stent and a Paclitaxel-Eluting Stent in Patients with Coronary Artery Disease.
ENDEAVOR IV Acronym: ENDEAVOR IV. Lead investigator: Dr Martin Leon from Columbia University, New York Source: Transcatheter cardiovascular Therapeutics,

ENDEAVOR IV Acronym: ENDEAVOR IV. Lead investigator: Dr Martin Leon from Columbia University, New York Source: Transcatheter cardiovascular Therapeutics,
Copyleft Clinical Trial Results. You Must Redistribute Slides PEPCAD II ISR Study Paclitaxel-eluting devices: randomized comparison of the SeQuent™ please.

Copyleft Clinical Trial Results. You Must Redistribute Slides PEPCAD II ISR Study Paclitaxel-eluting devices: randomized comparison of the SeQuent™ please.
Www. Clinical trial results.org The C-SIRIUS Study A The Canadian Multi-Center, Randomized, Double-Blind Study of the Sirolimus-Eluting Stent in the Treatment.

Www. Clinical trial results.org The C-SIRIUS Study A The Canadian Multi-Center, Randomized, Double-Blind Study of the Sirolimus-Eluting Stent in the Treatment.
“Real World”: SVG, De Novo or Restenotic Coronary Artery Lesions Chronic Stable Angina, Silent Ischemia, Acute Coronary Syndromes Vessel Diameters:

“Real World”: SVG, De Novo or Restenotic Coronary Artery Lesions Chronic Stable Angina, Silent Ischemia, Acute Coronary Syndromes Vessel Diameters:
M.Unverdorben; ACC March 2008 Martin Unverdorben Rotenburg/Fulda, Germany and Richmond, VA, USA Clinical Research Institute, Center for Cardiovascular.

M.Unverdorben; ACC March 2008 Martin Unverdorben Rotenburg/Fulda, Germany and Richmond, VA, USA Clinical Research Institute, Center for Cardiovascular.
Complex Lesion Subsets: Indications for DES Andreas Baumbach, MD, FRCP, FESC Bristol Heart Institute.

Complex Lesion Subsets: Indications for DES Andreas Baumbach, MD, FRCP, FESC Bristol Heart Institute.
The TAXUS™ Paclitaxel-Eluting Stent Program. The safety and effectiveness of the TAXUS ™ Express 2 ™ Stent has not been established in patients with coronary.

The TAXUS™ Paclitaxel-Eluting Stent Program. The safety and effectiveness of the TAXUS ™ Express 2 ™ Stent has not been established in patients with coronary.
EXCELLA BD Randomized Trial 12-month Results

EXCELLA BD Randomized Trial 12-month Results
Www. Clinical trial results.org The RAVEL Study A RAndomised (double blind) study with the Sirolimus coated BX™ VElocity balloon expandable stent (CYPHER™)

Www. Clinical trial results.org The RAVEL Study A RAndomised (double blind) study with the Sirolimus coated BX™ VElocity balloon expandable stent (CYPHER™)
Angioplasty’s Fight against Restenosis: Drug Eluting Stents & Bare Metal Stents.

Angioplasty’s Fight against Restenosis: Drug Eluting Stents & Bare Metal Stents.
3rd CEEGI Advisory Board1 Resolute in the DES era: Indications & Limitations Georgios I. Papaioannou, MD, MPH, FACC, FSCAI Athens Medical Center Cardiac.

3rd CEEGI Advisory Board1 Resolute in the DES era: Indications & Limitations Georgios I. Papaioannou, MD, MPH, FACC, FSCAI Athens Medical Center Cardiac.
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.

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.
29th ANNUAL SCIENTIFIC SESSIONS – SCA&I

29th ANNUAL SCIENTIFIC SESSIONS – SCA&I
University Hospital of Caen ClinicalTrials.gov Identifier: NCT

University Hospital of Caen ClinicalTrials.gov Identifier: NCT
DIABETES trial P Jiménez-Quevedo, M Sabaté, DJ Angiolillo, JA Gómez-Hospital, R Hernández-Antolín, J Goicolea, F Alfonso, C Bañuelos, J Escaned, R Moreno,

DIABETES trial P Jiménez-Quevedo, M Sabaté, DJ Angiolillo, JA Gómez-Hospital, R Hernández-Antolín, J Goicolea, F Alfonso, C Bañuelos, J Escaned, R Moreno,
Clinical Result Overview

Clinical Result Overview
Chaim Lotan MD, Yaron Almagor MD, Karel Kuiper MD, M.J. Suttorp MD, William Wijns MD The SICTO Study CYPHER TM Sirolimus-eluting stent in Chronic Total.

Chaim Lotan MD, Yaron Almagor MD, Karel Kuiper MD, M.J. Suttorp MD, William Wijns MD The SICTO Study CYPHER TM Sirolimus-eluting stent in Chronic Total.
As presented by Patrick W. Serruys, MD, PhD, FACC Principal Investigator Thoraxcentre - Erasmus University Rotterdam, The Netherlands PISCES Paclitaxel.

As presented by Patrick W. Serruys, MD, PhD, FACC Principal Investigator Thoraxcentre - Erasmus University Rotterdam, The Netherlands PISCES Paclitaxel.

Similar presentations

Ads by Google