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ECLIPSE Trial: Ensure’s Vascular Closure Device Speeds Hemostasis

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Presentation on theme: "ECLIPSE Trial: Ensure’s Vascular Closure Device Speeds Hemostasis"— Presentation transcript:

1 ECLIPSE Trial: Ensure’s Vascular Closure Device Speeds Hemostasis
S. Chiu Wong MD Director, Cardiac Catheterization Laboratories New York Presbyterian Hosp.- Cornell Campus Professor of Medicine Weill Medical College of Cornell University SCAI / ACCi Late Breaking Trial April 2nd Chicago, IL

2 Presenter Disclosure Information
ECLIPSE Trial: Ensure’s Vascular Closure Device Speeds Hemostasis The following relationships exist related to this presentation: S. Chiu Wong MD Consultant Cordis Modest Level James Hermiller Speakers Bureau Cordis Modest Level Dennis Donohoe Employee Cordis Herbert Hutman Employee Cordis William Bachinsky No relationships to disclose Patrick Cambier No relationships to disclose Robert Stoler No relationships to disclose Janah Aji No relationships to disclose Jason Rogers No relationships to disclose Ravi Nair No relationships to disclose 2

3 ECLIPSE Trial Background (1)
In 2007, it has been estimated that ~6 million interventional and diagnostic procedures (cardiac & Peripheral) were performed in the U.S.with 90% via the femoral approach The currently approved femoral closure devices account for about 33% of access site closures following these percutaneous invasive procedures 3

4 ECLIPSE Trial Background (2)
Although most of the currently available access site closures devices have demonstrated reduced time to ambulation and hemostasis with similar complication rates compared to manual compression, the adoption rate is relatively low due to limitations associated with these devices

5 ECLIPSE Trial Eclipse® Closure Device
The investigational ExoSeal device (Cordis, Miami FL) is a novel 3rd generation 6 Fr. extra-vascular closure device with an unique deployment mechanism that delivers a poly-glycolic acid (PGA) “felt-like” plug atop the femoral artery anchored by the neuro-vascular bundle sheath.

6 ECLIPSE Trial Degradation of PGA
The PGA plug undergoes hydrolysis in the body and is degraded into CO2 and H2O via the Kreb Cycle over a 3-month period

7 ECLIPSE Trial Pre-clinical Murine Gluteal Model: Evaluate Absorption & Tissue Reaction
No adverse tissue reaction to plugs at 14, 30 or 60 days post-implantation The PGA Plugs were almost completely absorbed at 60 days 3-day 7-day 14-day 30-day 60-day 90-day

8 ECLIPSE Trial ECLIPSE Trial Design
U.S. multicenter pivotal study comparing ExoSeal and manual compression with 2:1 randomization to assess the safety and efficacy of ExoSeal in patients undergoing 6Fr. diagnostic and interventional procedures in the coronary and peripheral vasculatures

9 ECLIPSE Trial Objectives
Two primary effectiveness endpoints to be tested for superiority: Time to hemostasis (TTH) Time to ambulation (TTA) Primary safety endpoint to be tested for non-inferiority: 30-day combined rate of access site related complications including bleeding, infection, ischemia or injury requiring medical or surgical treatment

10 ECLIPSE Trial Sample Size Justification (1)
A minimum sample size of 390 randomized patients (260 VCD patients and 130 MC patients) is required to: Detect a 5 minute reduction in mean TTH for VCD vs. MC with over 90% power and a 5% two-sided (2.5% one-sided) type I error Detect a 2-hour reduction in mean TTA for VCD vs. MC with over 90% power and a 5% two-sided (2.5% one-sided) type I error 10

11 ECLIPSE Trial Sample Size Justification (2)
Rule out ≥ 4% disadvantage for VCD vs. MC in the incidence of major complications using a 95% upper confidence bound with 80% power and a 5% one-sided type I error In order to ensure that a minimum of 390 patients enrolled into the trial with complete follow-up, a total of 400 patients study was proposed

12 ECLIPSE Trial Key Inclusion Criteria
Age between 18 and 85 years Ability to undergo emergent vascular surgery if complication relates to VCD or MC occurs. Placement of a 6F arterial sheath in the common femoral artery Target vessel lumen diameter  5mm

13 ECLIPSE Trial Key Exclusion Criteria
Uncontrolled HTN at time of sheath removal (BP  180/110mmHg) BMI > 40 kg/m2 Prior femoral vascular surgery or vascular graft Planned repeat arterial access at closure site  30 days post procedure Previous target femoral artery closure  30 days Calcium or atherosclerostic plaque  1 cm from the puncture site

14 ECLIPSE Trial Study Definitions
Time to Hemostasis (TTH): Time to achieve no or minimal subcutaneous oozing and absence of expanding or developing hematoma following sheath removal Time to Ambulation (TTA): Time from sheath removal to patient able to stand and walk at least 10 meters without re-bleed Time to Eligibility for Hospital Discharge:·        Time of the access site closure to the time when patient is eligible for discharge as per the judgment of the treating physician Time to Discharge: Time of access site closure to time of patient actually being discharged

15 ECLIPSE Trial Study Definitions
Device Success: Successful deployment of PGA plug, removal of intact delivery system, and hemostasis achieved  5 minutes Procedural Success: Initial hemostasis achieved by assigned method with none of the primary safety endpoint related major adverse events on day of procedure and at 30 days

16 ECLIPSE Trial Study Definitions
Major Adverse Events: Vascular injury requiring vascular repair (via surgery, ultrasound-guided compression, transcatheter embolization, or stent graft) Access site-related bleeding requiring transfusion Access site-related infection requiring IV/IM antibiotics and/or extended hospitalization Any new ipsilateral lower extremity ischemia Permanent (>30 days) nerve injury at the access site or surgery for it

17 ECLIPSE Trial Study Enrollment
Investigational Site Study Investigator Randomized Roll-in Total Pinnacle Health at Harrisburg William Bachinsky, MD 65 7 72 New York Presbyterian Hospital S. Chiu Wong, MD 51 6 57 Morton Plant Hospital Patrick Cambier, MD 45 5 50 Baylor Research Institute Robert Stoler, MD 39 Cooper Health Systems Janah Aji, MD 35 8 43 UC Davis Medical Center Jason Rogers, MD 32 38 Heart Center of Indiana James Hermiller, MD 26 4 30 University Hospitals of Cleveland Ravi Nair, MD 23 29 Wake Heart Research Lee Jobe, MD 18 3 21 LDS Hospitals Peter Casterella, MD 15 20 Barnes-Jewish Hospital John Lasala, MD, PhD 14 Sutter memorial Hospital David Roberts, MD 13 17 St. Joseph’s Hospital Health Center Mike Fischi, MD 9 Hahnemann Hospital Daniel McCormick, DO 10 Mayo Clinic Hospital John Sweeny, MD Stanford University Medical Center Alan Yeung, MD Swedish Medical Center Paul Huang , MD 2

18 ECLIPSE Trial Deployment Procedure
Insert device into sheath to level of black marker band Retract sheath checking for pulsatile flow Retract while compressing green cowling to secure Retract sheath & device until non-pulsatile flow Indicator window changes to black, depress plug deployment button Remove ExoSeal® device and sheath

19 ExoSeal® 6F VCD (17 U.S. Sites) N = 488 Manual Compression (n=134)
ECLIPSE Trial Patient Enrollment ExoSeal® 6F VCD (17 U.S. Sites) N = 488 Withdrawn N = 4 (4.6%) Roll-in N = 87 Randomized N = 401 30 day FU N = 83 (95.4%) ExoSeal® (N=267) Manual Compression (n=134) Withdrawn N = 8 (3.0%) Withdrawn N = 6 (4.5%) 30-day FU N=259 ( 97.0%) 30-day FU N=128 (95.5%)

20 ECLIPSE Trial Baseline Demographics
Roll-in (N=87) ExoSeal® (N=267) MC (N=134) p-value Mean Age (years) 63.3 ± 11.61 63.3 ± 11.13 61.4 ± 10.47 0.0896 Female (%) 33.3 31.8 38.1 0.2206 Diabetes Mellitus (%) 24.1 25.5 32.8 0.1265 Renal Insufficiency (%) 8.1 8.6 6.7 0.5636 Body Mass Index (kg/m2) 29.7 ± 4.64 28.9 ± 4.99 29.5 ± 5.40 0.4445 Baseline Hematocrit (%) 40.4 41.4 40.5 0.1654 GP IIb/IIIa Use Pre and/or During Procedure (%) 13.8 14.2 11.2 0.4379 P-values are based on the comparison of the two randomized cohorts 20

21 ECLIPSE Trial Procedural Characteristics
Roll-in (N=87) ExoSeal® (N=267) MC (N=134) p-value Type of Procedure (%) Diagnostic Interventional 0.9158 Type of Catheterization(%) Cardiac Peripheral 0.2351 ACT Level (seconds) Prior to Sheath Removal 168.4 ± 54.79 181.3 ± 56.01 142.1 ± 33.94 <0.0001 P-values are based on the comparison of the two randomized cohorts

22 ECLIPSE Trial Results: Primary Effectiveness Endpoints
Roll-in (N=87) ExoSeal® (N=267) MC (N=134) p-value Procedure Success 95.4% 91.8% 91.0% 0.8500 Device Success 89.1% - TTH (min.) 4.68  19.4 4.38  11.6 20.05  22.5 <0.0001 TTA (hr.) 1.98  2.59 2.54  5.02 6.24  13.34 0.0028 TT Eligibility for Hospital Discharge (hr.) 9.72  14.2 12.57  13.9 16.26  27.5 0.1540 TT Hospital Discharge (hr.) 13.64  18.5 16.77  19.8 19.35  29.2 0.3612 TT Device Deployment (min.) 0.94  1.13 1.01  2.12 1° Endpoint P-values are based on the comparison of the two randomized cohorts

23 Manual Compression (N=134)
ECLIPSE Trial Time to Hemostasis: Randomized Patients ExoSeal® (N=267) Manual Compression (N=134) P=0.0080 P=0.1430 23

24 ECLIPSE Trial TTH & TTA: Patients Receiving GP IIb/IIIa During Procedure

25 ECLIPSE Trial Results: Primary 30-Day Safety Endpoints
Roll-in (N=87) ExoSeal® (N=266) MC (N=134) Composite Major Adverse Event 0.0% Vascular Repair Access Site Related Bleeding Requiring Transfusion Access Site Related Infection Requiring Treatment Any New Documented Ipsilateral Lower Extremity Ischemia Surgery for Access Site-Related Nerve Injury zero!

26 ECLIPSE Trial Results: Secondary Safety Endpoints
Roll-in (N=87) ExoSeal® (N=266) MC (N=134) p- value Rebleeding following initial hemostasis 3.4% (3) 5.3% (14) 2.2% (3) 0.1953 Access site related bleeding requiring >30 min. for hemostasis 1.1% (1) 0.4% (1) 0.7% (1) 1.0000 Access site hematoma  6cm 1.9% (5) 0.6683 Transient access site-related nerve injury 0.0% (0) Retroperitoneal bleeding 0.8% (2) 0.5533 Ecchymosis  6cm 0.3350 Decrease in pedal pulse 0.0% (1) -- No incidence of pseudoaneurysm not requiring treatment; treated pseudoaneurysm; documented AV fistula; post-hospital discharge access site related bleeding; ipsilateral lower extremity arterial emboli; transient loss of ipsilateral lower extremity pulse; ipsilateral DVT; access site related vessel laceration; access site wound dehiscence; treated, localized access site infection; ipsilateral peripheral artery total occlusion; intraluminal plug delivery not requiring surgical intervention; or death P-values are based on the comparison of the two randomized cohorts

27 ECLIPSE Trial Conclusions (1)
In this multi-center randomized trial in pts following 6 Fr. diagnostic/interventional procedures, a significant reduction in the TTH and TTA (primary effectiveness endpoints) was achieved in pts treated with the investigational ExoSeal device compared with MC Device deployment was achieved promptly in about 1 minute on average following procedure There was no difference in procedural success rates in both the ExoSeal® and MC groups

28 ECLIPSE Trial Conclusions (2)
Remarkably, there were no 30-day combined access site related complications (primary safety endpoint) reported in either treatment cohort Exoseal is non-inferior to MC in composite major adverse event at the pre-specified 4% margin level Exoseal® compares favorably to manual compression for arteriotomy site management post 6 Fr. invasive/interventional procedures.

29 Treatment of Calcified Lesion
Thank You !!!

30 Back-up Slides

31 ECLIPSE Trial Patients with Retroperitoneal Bleeding
Retroperitoneal bleed in 2 patients (0.8%) in randomized VCD arm First patient (interventional / cardiac): Diagnosed on CT scan / leg Ultrasound normal No documented back pain Ambulation was delayed No transfusion given HCT decreased from 41.3 to 32.1 at discharge Length of Hospital stay 4/17/07 - 4/20/07 Second patient (interventional / cardiac): Localized swelling noted on routine groin check (Pt complaining of right groin discomfort, no documented back pain, hypotension or nausea) CT confirmed small, confined retroperitoneal bleed HCT decrease from 27.8 to 25.4, HCT 31.3 at discharge Length of Hospital stay 5/22/07 - 5/26/07 31

32 ECLIPSE Trial Time to Discharge: Diagnostic vs. Interventional

33 ECLIPSE Trial Patient Disposition
Roll-in (N=87) ExoSeal® (N=267) MC (N=134) Treated Randomized (ITT) -- 267/267 (100.0%) 134/134 (100.0%) Per Protocol 233/267 (87.3%) 115/134 (85.8%) Safety Population 87/87 (100.0%) 266/267 (99.6%) Completed Study 83/87 (95.4%) 259/267 (97.0%) 128/134 (95.5%) Withdrew from Treatment 4/87 (4.6%) 8/267 (3.0%) 6/134 (4.5%) Reasons for Early Withdrawal Withdrew Consent 1/87 (1.1%) 0/267 (0.0%) 1/134 (0.7%) Adverse Event 0/87 (0.0%) 1/267 (0.4%) 0/134 (0.0%) Lost to Follow-up 3/87 (3.4%) 7/267 (2.6%) 4/134 (3.0%) Death Other 33

34 ECLIPSE Trial Device / Procedural Failures with ExoSeal®
Site Patient Randomized Treatment Time to Hemostasis Hemostasis Achieved MAEs 025 003 Roll-in 7 Yes No 004 10 035 002 21 266 011 VCD 5 031 9 401 026 11 095 009 12 039 419 14 022 15 196 010 20 417 036 416 028 23 25 280 30 012 042 34 Procedural failures were due to failure to achieve hemostasis by assigned method

35 Other Vascular Closure Devices Definitions of Procedural & Device Success
Mynx Device Success 93.2% Deploy delivery system, deliver the sealant and achieve hemostasis Procedure Success 99.5% Hemostasis using any method with freedom from major complications MATRIX 90.5% Deploy delivery system, inject the precursor and achieve hemostasis 97.9% StarClose 94.1% Hemostasis using StarClose or adjunctive compression in 5 minutes, and freedom from major vascular complications 100% Hemostasis using any method and freedom from major vascular complications

36 Other Vascular Closure Devices Published TTH and TTA
Vascular Closure Device (VCD) N TTH (min) TTA (hrs) Major Complications Minor Complications VCD MC Angiolink (6 Fr.) 50 5.9 21.2 3.1 6.3 0.0% 5.3% 9.7% 15.8% Angioseal 100 2.0 10.6 NA 12% 14% Duett 630 7.0 20.0 5.1 11.8 3.6% 1.7% Sponge 141 8.2 14.1 2.7 7.1 5.9% 8.9% Mynx non-randomized 190 1.3 2.6 0.5% 3.7% In the randomized studies, TTH and TTA were significantly improved with VCDs as compared with manual compression. Complication rates were not significantly different between both treatments in any of these randomized studies.

37 Manual Compression (N=134)
ECLIPSE Trial Time to Ambulation: Randomized Patients ExoSeal® (N=267) Manual Compression (N=134) P=0.0021 P=0.7299 37

38 ECLIPSE Trial Time to Discharge: Diagnostic vs. Interventional

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