Update on ABSORB EXTEND Study

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

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.
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 Keith D Dawkins MD FRCP FACC Southampton University Hospital United Kingdom EuroSTAR The European Cobalt Stent with Antiproliferative for.
A Randomized Comparison of Everolimus-­ Eluting Absorb Bioresorbable Vascular Scaffolds vs. Everolimus-Eluting Metallic Stents: One-Year Angiographic and.
FRONTIER Registry The Guidant MULTI-LINK FRONTIER ™ Coronary Stent System for the Treatment of Pts with Native De Novo or Restenotic Bifurcation Coronary.
Compare Trial 2 year follow-up Peter Smits Maasstad Ziekenhuis Rotterdam The Netherlands.
Disclosure Statement of Financial Interest
RAVEL 4 YEAR FOLLOW-UP - Cordis Cardiology / Cardialysis – Euro-PCR – Sousa – 24 May 2005 RAVEL A RAndomised, double-blind study with the Sirolimus-eluting.
Philippe Généreux, MD for the Tryton Bifurcation Trial Investigators Columbia University Medical Center Cardiovascular Research Foundation New York City.
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.
Prof. Dr. Sigmund Silber, FESC, FACC On behalf of the RESOLUTE
Background & Study Design
The OPTIMAX first-in-man study Mid-term clinical outcome of Titanium-Nitride-Oxide-coated Cobalt Chromium stents in patients with de novo coronary artery.
FANTOM II FANTOM II: Six-Month Clinical and Angiographic Results With a Radiopaque Desaminotyrosine Polycarbonate-Based Sirolimus-Eluting Bioresorbable.
Disrupt CAD Study Design
Everolimus-eluting Bioresorbable Vascular Scaffolds in Patients with Coronary Artery Disease: ABSORB III Trial 2-Year Results Stephen G. Ellis, MD,
Disclosures Runlin Gao has received a research grant
Ospedale San Raffaele, Milan, Italy
My initial ABSORB experience Assoc. Prof. I. Petrov
Latvian Centre of Cardiology real-life registry
Runlin Gao, M.D. On behalf of ABSORB China Investigators
New Generation Resolute Integrity Drug-Eluting Stent Superior to Benchmark Xience Drug-Eluting Stent: Primary Endpoint Results from the PROPEL Study –
The Abbott Vascular DES Pipeline
on behalf of the ABSORB II Investigators
Final Five-Year Follow-up of the SYNTAX Trial: Optimal Revascularization Strategy in Patients With Three-Vessel Disease and/or Left Main Disease Patrick.
BRANCH Bare Metal BifuRcAtion SteNt Clinical Trial in Humans Early Clinical Experience by Raoul Bonan, MD On behalf of the BRANCH study investigators.
­ Up date on the Absorb Extend Trial
Novel Stent Technologies: Update on Bioresorbable Stents
12 Month Outcomes in Patients with Diabetes Mellitus Implanted with a Resolute Zotarolimus-eluting Stent: Initial Results from the RESOLUTE Global Clinical.
BRS Next Large Trials: What is on the Horizon?
Final Five-Year Outcomes Following Implantation of the Promus Element® Platinum Chromium Everolimus-Eluting Stent in De Novo Coronary Artery Lesions in.
Summary and Conclusion
Gregg W. Stone, MD Columbia University Medical Center
ABSORB Japan: 3-year Clinical and Angiographic Results of a Randomized trial Evaluating the Absorb Bioresorbable Vascular Scaffold vs. Metallic Drug-eluting.
The Tryton Bifurcation Trial:
On behalf of all principal COMPARE II investigators:
BVS Expand: First Results of Wide Clinical Applications
TCT 2016, Washington convention center
OCT-Guided PCI What needs to be done to establish criteria?
on behalf of the ABSORB II Investigators
On behalf of J. Belardi, M. Leon, L. Mauri,
DESolve® SERIES OF CLINICAL STUDIES
SPIRIT IV 2 Year Results and The SPIRIT Women Clinical Trial
on behalf of the ABSORB II Investigators
FINAL FIVE-YEAR CLINICAL OUTCOMES OF THE NOBORI2 TRIAL
Two-Year Extended Follow-up in Patients Receiving a Zotarolimus-eluting Stent in the E-Five Registry Martin T. Rothman, Ian T. Meredith, Keyur Parikh,
Kyoto University Hospital, Japan
3-Year Clinical Outcomes From the RESOLUTE US Study
ENDEAVOR IV: 5 Year Final Outcomes
for the SPIRIT IV Investigators
The Synergy between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery: The SYNTAX Study One Year Results of the PCI and CABG Registries.
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.
Incidence and management of restenosis after treatment of unprotected left main disease with drug-eluting stents: 70 restenotic cases from a cohort of.
On behalf of all principal COMPARE II investigators:
for the SPIRIT IV Investigators
SORT-OUT III: A Prospective Randomized Comparison of Zotarolimus-Eluting and Sirolimus-Eluting Stents in Patients with Coronary Artery Disease Michael.
FOR DISTRIBUTION BY MEDTRONIC OFFICE OF MEDICAL AFFAIRS ONLY.
12-month clinical and 13-month angiographic outcomes from a randomized trial evaluating the Absorb Bioresorbable Vascular Scaffold vs. metallic drug-eluting.
Gregg W. Stone, MD Columbia University Medical Center
The Synergy between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery: The SYNTAX Study One Year Results of the PCI and CABG Registries.
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.
Presented at TCT 2006.
Martin B. Leon, David R. Holmes, Dean J. Kereiakes, Jeffrey J
Maintenance of Long-Term Clinical Benefit with
ISAR-LEFT MAIN: A Randomized Clinical Trial on Drug-Eluting Stents for Unprotected Left Main Lesions J. Mehilli, MD Deutsches Herzzentrum Technische.
Comparison of Everolimus-Eluting and Paclitaxel-Eluting Stents: First Report of the Five-Year Clinical Outcomes from.
Presentation transcript:

Update on ABSORB EXTEND Study Preliminary Data from ABSORB EXTEND: A Report of the 6-month Clinical Outcomes from the First 200 Patients Enrolled Alexandre Abizaid, MD, PhD, FACC Antonio L. Bartorelli MD; Robert Whitbourn MD; Lee Clark PhD; Bernard Chevalier MD; Karine Miquel-Hebert PhD; Xiaolin Li MS; Robert Jan Van Geuns MD, PhD; Didier Carrié MD, PhD; Pieter C. Smits MD, PhD; John A. Ormiston MBChB, PhD; Robert McGreevy PhD; Ashok Seth MD; Patrick W. Serruys MD, PhD on behalf of the ABSORB EXTEND Investigators

Alexandre Abizaid, MD, PhD Consulting Fees: Abbott Vascular BSC

Conflicts of Interest Alexandre Abizaid; Instituto Dante Pazzanese, Sao Paulo, Brazil Participation in the Advisory Board for Boston Scientific and Abbott Vascular. Antonio L. Bartorelli; Centro Cardiologico Monzino, IRCCS, University of Milan, Milan, Italy Participation in the Advisory Board for Abbott Vascular. Robert Whitbourn MD; St. Vincent’s Hospital, Fitzroy, Australia Lee Clark, Xiaolin Li, and Robert McGreevy; Abbott Vascular, Santa Clara, CA Karine Miquel-Hebert; Abbott Vascular, Diegem, Belgium Employees of Abbott Vascular. Bernard Chevalier; Institut Jacques Cartier, Massy, France Consultant for Abbott Vascular, Biotronik, Terumo, and Medtronic. Recipient of research grant from Cordis. Robert Jan Van Geuns; Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands No Conflicts of Interest Didier Carrié; Hôpital Rangueil, Toulouse, France Pieter C. Smits; Maasstad Ziekenhuis, Rotterdam, The Netherlands Recipient of research grants from Cordis, Boston Scientific and Terumo. Recipient of travel and speaking fees from Abbott Vascular. A consultant for Blue Medical. John A. Ormiston; Mercy Angiography, Mercy Hospital, Auckland, New Zealand Participation in the Advisory Board for Abbott Vascular and Boston Scientific with minor honoraria. Ashok Seth; Escorts Heart Institute and Research Centre, New Delhi, India Participation in the Advisory Board for Abbott Vascular for BVS. Patrick W. Serruys; Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands 3

The ABSORB Family of Trials ABSORB EXTEND 5 year F/U* 2 year F/U** Enrolling Cohort A Cohort B EXTEND Safety and Performance Safety and Performance after assessing safety at 180 days in the Cohort A patients Continuation of assessment of Safety and Performance International N=30 4 sites International N=101 12 sites International N  1,000 Up to 100 sites Single de novo lesion Up to two de novo lesions Up to two de novo lesions, longer lesions, overlapping scaffolds The ABSORB Trials are sponsored and funded by Abbott Vascular, Santa Clara, California * 5-year clinical data from ABSORB Cohort A will be presented at AHA 2011 ** 2-year clinical data from ABSORB Cohort B (Group 1) and 18 month data from the full cohort (Group 1 + 2) will be presented at TCT 2011 4

Background Results from ABSORB Cohort A continue to be encouraging, with only 1 MACE and no scaffold thrombosis through 5 years of follow- up*. The results from ABSORB Cohort B, performed with an ABSORB device with improved mechanical properties, confirm the performance and safety established in the Cohort A investigation: The 12-month angiographic results from Cohort B (Group 1) demonstrated an in-segment late loss of 0.16 mm MACE rate of 6.9% for the full cohort of 101 subjects at 12 months** (3 Non-Q wave MI, 4 ID-TLR) No scaffold thrombosis events out to 12 months * 5-year clinical data from ABSORB Cohort A will be presented at AHA 2011 ** 2-year clinical data from ABSORB Cohort B (Group 1) and 18 month data from the full cohort (Group 1 + 2) will be presented at TCT 2011

ABSORB EXTEND Non-Randomized, Single-Arm, Continued Access Trial 30 d 6 mo 12 mo 24 mo 36 mo Clinical follow-up MSCT follow-up (n=100) OCT follow-up (n=50)  1000 subjects Up to 100 International sites Note: The ABSORB EXTEND Rev 3.0 protocol is currently pending approval. *FPI: First Patient In Study Objective: Endpoints: Continued Access trial. FPI*: Jan 11, 2010 No hypothesis-testing, typical PCI clinical endpoints Treatment: Up to 2 de novo lesions in different epicardial vessels Planned overlapping allowed in lesions >22 and ≤ 28 mm Device Sizes: Scaffold diameters: 2.5, 3.0 mm Scaffold lengths: 18, 28 mm

ABSORB EXTEND: Status as of Oct. 17, 2011 44 sites are open 397 patients are enrolled, shown by country EMEA (198) ANZ (53) APJ (135) LA (11) Number enrolled 7

ABSORB EXTEND Trial Management Principal Investigator: Alexandre Abizaid, MD, PhD; San Paulo, Brazil Regional Co-Principal Investigators: Antonio Bartorelli, MD; Milano, Italy; Robert Whitbourn, MD; Fitzroy Victoria, Australia; Chairman: Patrick W. Serruys, Prof, MD, PhD; Rotterdam, The Netherlands Imaging Corelab: Cardialysis B.V.; Rotterdam, The Netherlands CEC: Claude Hanet, MD, Ralph Tölg, MD, Angela Hoye, MD, Benno Rensing, MD, Karel Koch, MD, Eugene McFadden, MD, Vadim A. Kuznetsov, MD DSMB: Jan G.P. Tijssen, PhD, Philip Urban, MD, Marcus Wiemer, MD Sponsor: Abbott Vascular

Key Inclusion & Exclusion Criteria Up to two de novo lesions can be treated, each located in a separate native epicardial vessel Target vessel diameter range is ≥ 2.0 mm and ≤ 3.3 mm Target lesion length is ≤ 28 mm (planned overlapping allowed in lesions >22 and ≤ 28 mm) Target lesion(s) meeting any of the following criteria are excluded: Left main location; Located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft; Involves a bifurcation with a side branch  2 mm in diameter and ostial lesion > 40% stenosed or side branch requiring predilatation; Total occlusion (TIMI flow 0), prior to wire crossing; Excessive tortuosity proximal to or within the lesion; Heavy calcification.

Quantitative Vessel Sizing - Online QCA The recommended range for target vessel diameter is assessed in terms of the online QCA parameters distal Dmax and proximal Dmax, which refer to maximum lumen diameter evaluated at the distal and proximal ends of the target segment to be scaffolded, respectively. Distal and proximal ends of target segment where Dmax is evaluated Target Vessel Diameter Distal and Proximal ABSORB BVS Diameter to be Used ≥ 2.0 mm and ≤ 3.0 mm 2.5 mm ≥ 2.5 mm and ≤ 3.3 mm 3.0 mm Picture adapted from Site Initiation Visit Toolkit for ABSORB EXTEND.

Planned Overlap Proximal segment Distal segment Proximal: Post-implant Pre-dil balloon markers Proximal segment Distal segment Pre-dil balloon markers Proximal: Post-implant contrast Post-dil balloon markers Distal: Post-implant contrast Post-dil balloon markers

6 Month Clinical Follow-up (All Subjects Enrolled)  Covers an enrollment period of January 11, 2010 to March 19, 2011 *F/U window ±14 days

Sites, Study Investigators, and Patient Enrollment (5 or more patients) France, Bernard Chevalier 23 The Netherlands, Patrick Serruys 20 Australia, Robert Whitbourn 13 France, Didier Carrie 12 New Zealand, John Ormiston 11 The Netherlands, Pieter Smits Israel, Ran Kornowski 9 Denmark, Leif Thuesen Italy, Antonio Bartorelli 8 India, Tejas Patel Switzerland, Stephan Windecker Australia, Ian Meredith 7 India, Kuman Srineevas Belgium, Bernard De Bruyne 6 India, Pravin Goel 5 New Zealand, Dougal McClean

ABSORB EXTEND - Baseline Demographics (All subjects enrolled) Male (%) 74.0 Mean age (years) 62.4 Prior Cardiac Intervention on Target Vessel (%) 5.5 Previous MI (%) 27.5 Unstable Angina (%) 32.0 Diabetes mellitus (%) 21.5 Dyslipidemia req. med. (%) 65.0 Hypertension req. med. (%) 64.0 Current smoker (%) 18.5 Cohort B (N = 101) 72.3 62.3 5.9 25.0 14.9 16.8 78.2 62.0 17.0

ABSORB EXTEND - Baseline Angiography (All subjects enrolled) EXTEND (L = 213) Lesion Location (%) LAD LCX RCA LMCA 39 33 28 0.5 QCA pre-procedure RVD (mm) MLD (mm) % DS (%) Proximal Dmax (mm) Distal Dmax (mm) 2.58 1.03 60 2.81 2.67 Cohort B (L = 102) 43 23 33 1 2.61 1.06 59 NA Note: L is the total number of target lesions.

ABSORB EXTEND – Lesion Characteristics (All subjects enrolled) Angulation (≥ 45°) Calcification (Moderate/Severe) Eccentric Thrombus 4 12 96 0.9 ACC/AHA Lesion Classification (%) A B1 B2 C 3 58 33 6 Lesion Length (mm) Mean Range (min, max) 11.42 (3.13, 24.86) Cohort B (L=102) 4 15 99 3 1 55 40 4 9.91 (2.92, 22.93) Note: L is the total number of target lesions.

Procedural Parameters (All subjects enrolled) EXTEND (N=200) (S=225) Number of Target Lesions (%) 1 lesion subjects 93.0 2 lesion subjects 7.0 Planned Overlapping (%) – per subject 6.0 Bailout (%) – per subject 5.0 with BVS 2.0 metallic DES 3.0 Device Usage (%) – per scaffold 3.0 x 18 mm BVS 78.2 3.0 x 28 mm BVS 12.4 2.5 x 18 mm BVS 9.3 Cohort B (N=101) (S=225) 99.0 1.0 NA 4.0 0.0 100 Note: S is the total number of study scaffolds.

ABSORB EXTEND – Clinical Outcomes (All subjects enrolled) Non-Hierarchical % (n) 30 Days 6 Months (N=200) Cardiac Death % (n) 0.0 (0) 0.5 (1) * Myocardial Infarction % (n) 2.0 (4) Q-wave MI 1.0 (2) Non Q-wave MI Ischemia driven TLR % (n) 0.5 (1) CABG PCI Ischemia driven non-TL TVR % (n) Hierarchical MACE % (n) 2.5 (5) Hierarchical TVF % (n) 3.0 (6) *A non-BVS was implanted in the target lesion. 18

Time Post Index Procedure (Days) MACE Through 6 Months 5 10 30 60 90 120 150 180 210 240 2.5% 5.0% Δ = 2.5% 194-day HR 1.99 [0.58,6.87] p=0.27* Cohort B EXTEND MACE (%) Time Post Index Procedure (Days) Number at risk Time after index procedure (days) 37 194 Cohort B 101 99 96 EXTEND 200 195 * P-value is not from formal hypothesis testing and is displayed for descriptive purpose only.

Time Post Index Procedure (Days) TVF Through 6 Months Δ =2.0% 30 60 90 120 150 180 210 240 3.0% 5.0% 194-day HR 1.66 [0.51,5.44] p=0.40* TVF (%) Time Post Index Procedure (Days) Cohort B EXTEND 5 10 Number at risk Time after index procedure (days) 37 194 Cohort B 101 99 96 EXTEND 200 195 193 * P-value is not from formal hypothesis testing and is displayed for descriptive purpose only.

Time Post Index Procedure (Days) MI Through 6 Months 30 60 90 120 150 180 210 240 Δ = 1.0% 2.0% 3.0% 194-day HR 1.49 [0.33, 6.65] p=0.60* MI (%) Time Post Index Procedure (Days) Cohort B EXTEND 5 10 Number at risk Time after index procedure (days) 37 194 Cohort B 101 99 98 EXTEND 200 195 * P-value is not from formal hypothesis testing and is displayed for descriptive purpose only.

Time Post Index Procedure (Days) ID-TLR Through 6 Months 30 60 90 120 150 180 210 240 Δ = 1.5% 0.5% 2.0% 194-day HR 3.94 [0.36, 43.46] p=0.23* ID-TLR (%) Time Post Index Procedure (Days) Cohort B EXTEND 5 10 Number at risk Time after index procedure (days) 37 194 Cohort B 101 99 EXTEND 200 198 197 * P-value is not from formal hypothesis testing and is displayed for descriptive purpose only.

Time Post Index Procedure (Days) ID-TVR Through 6 Months 30 60 90 120 150 180 210 240 Δ = 1.0% 1.0% 2.0% 194-day HR 1.97 [0.28, 13.99] p=0.49* ID-TVR (%) Time Post Index Procedure (Days) Cohort B EXTEND 5 10 Number at risk Time after index procedure (days) 37 194 Cohort B 101 99 EXTEND 200 198 196 * P-value is not from formal hypothesis testing and is displayed for descriptive purpose only.

Scaffold Thrombosis (ARC) through 6 Months (Definite/Probable) ABSORB EXTEND (N = 200) Acute (<1 day) - Definite 0.0% (0/200) - Probable - Definite/probable Subacute (1-30 days) 0.5% (1/200) Late (>30 days) 0.0% (0/199) The overall definite/probable ST rate out to 194 days is 0.5%.

Conclusions This snapshot of 200 subjects from ABSORB EXTEND included follow-up data out to 6 months. Comparison of the ABSORB EXTEND subject demographics and lesion characteristics showed: Longer mean lesion length than in ABSORB Cohort B Planned overlapping treatment permitted (6.0% of subjects) Over twice the percent of unstable angina subjects than in Cohort B Based on 6 months outcomes in 200 subjects, the data showed: Comparable MACE rates to ABSORB Cohort B MACE rate driven primarily by MI events within 30 days post-procedure Low rate of revascularization out to 6 months. Despite an increase in complexity in ABSORB EXTEND, the data to date demonstrates the consistency in clinical outcomes between ABSORB EXTEND and ABSORB Cohort B.