ILLUMENATE FIH Direct DCB Cohort 12-Month Results

Transcription

1 ILLUMENATE FIH Direct DCB Cohort 12-Month Results Stephan Duda Berlin Study Investigators: H. Schröder (PI), B. Lux, F. Rücker, M. Martorana, D. Meyer, H. Hartmann, S. Duda

2 Disclosure Speaker name: S. Duda... I have the following potential conflicts of interest to report: Consulting Employment in industry Stockholder of a healthcare company Owner of a healthcare company Other(s) I do not have any potential conflict of interest

3 Direct DCB Technique Potential benefits over pre-dilatation Less time required Fewer devices needed (cost advantage) Risk of geographic miss avoided Unknowns Impact on effectiveness

4 ILLUMENATE FIH Study Design Two Cohorts Direct DCB N=28* 12-Month Follow-up N=22 Withdrew (n=1) Exited (n=2) Visit missed (n=3) Pre-dilatation + DCB N=50 Follow-up through 24 months complete 24-month data collection in process *30 patients enrolled, but data from 2 patients excluded from analyses because they were pre-dilated

5 Study Device Stellarex Drug-Coated Angioplasty Balloon Covidien EverCross 0.035" PTA Balloon Catheter Balloon sizes used in study: 4-6 mm diameter; 40, 60, 80 mm length EnduraCoat TM Proprietary Coating Technology Durable paclitaxel carrier for optimized drug delivery Uniform coating of balloon treatment area Paclitaxel dose = 2µg/mm 2

6 Key Patient Selection Criteria Inclusion Criteria Exclusion Criteria SFA or Popliteal Artery (P1) Acute or sub-acute thrombus in target vessel De novo or restenotic lesion(s) 3 cm and 15 cm and > 70% stenosis Target vessel reference diameter 3 mm and 7 mm Target lesions can be treated with maximum of 2 DCBs Aneurismal disease of the abdominal aorta, iliac or popliteal arteries Prior vascular surgery of the target lesion Known inadequate distal outflow/significant inflow disease Rutherford classification of 2, 3 or 4 GI bleeding or any coagulopathy contradicting the use of anti-platelet therapy Use of adjunctive therapies (i.e. laser/atherectomy, cryoplasty, cutting balloons)

7 Patient Characteristics Similar to pre-dilatation cohort No significant differences between groups FIH (Direct group) FIH (Pre-dil group) Age in Years 65.7±8.1 (28) 69.0±9.3 (50) 65.0 (50.0, 85.0) Female 28.6% (8/28) 38.0% (19/50) Medical History Current Smoker 67.9% (19/28) 52.0% (26/50) Hypertension 82.1% (23/28) 90.0% (45/50) Hyperlipidemia 75.0% (21/28) 80.0% (40/50) Diabetes 50.0% (14/28) 34.0% (17/50) Angina 3.6% (1/28) 10.0% (5/50) Previous PCI /CABG 39.3% (11/28) 34.0% (17/50) Rutherford CC % (6/28) 12.0% (6/50) % (21/28) 86.0% (43/50) 4 3.6% (1/28) 2.0% (1/50)

8 Lesion Characteristics FIH (Direct group) FIH (Pre-dil group) Lesions Treated (N) Proximal Popliteal 10.8% (4/37) 5.2% (3/58) Lesion Length (mm) 63.9±39.5 (37) 72.1±46.7 (58) Percent Stenosis (%) 69.5±16.2 (37) 75.1±17.0 (58) RVD (mm) 5.3±0.8 (37) 5.2±0.9 (58) MLD (mm) 1.7±1.0 (37) 1.3±1.0 (58) Calcified 48.6% (18/37) 62.1% (36/58) Severe 2.7% (1/37) 13.8% (8/58) Total Occlusion 5.4% (2/37) 12.1% (7/58) Run-off 0 0% 1.7% (1/58) 1 5.4% (2/37) 19.0% (11/58) % (17/37) 39.7% (23/58) % (18/37) 39.7% (23/58) No significant differences between groups

9 Procedure Characteristics Direct Cohort Pre-Dilatation Cohort Pre-dilatation 0% 100% Number of DCBs 1.45 per lesion 1.5 per lesion Mean Inflation time 2.2 min/ DCB Data not collected Post-Dilatation* 35.1% (13/37) 12.1% (7/58) Adj. Stent 8.1% (3/37) 5.2% (3/58) Device Success % (33/37) 96.6% (56/58 Lesion Success 2 100% (37/37) 100% (58/58) *p-value = (Fisher s exact) ¹Defined as <50% diameter stenosis by angio core lab post-dcb ²Defined as <50% diameter stenosis by angio core lab post-procedure

10 6 Month Late Lumen Loss 6 Month LLL (0.08±0.79 mm) indicates good drug effect Tepe, G., et al., N Engl J Med, 2008;358: p Werk M., et al., Circ Cardiovasc Interv. 2012;5(6): p Scheinert, D., et al., J Am Coll Cardiol Inv, 2014;7: p Micari, A., et al., J Am Coll Cardiol Inv, 2012;5: p

11 Freedom from TLR Curves: Direct Cohort vs. Pre-Dilatation Cohort 90% at Day % at Day % at Day 730 P= through 12 months Freedom from TLR is 87.9% at day 395 in cohort 1 (other percentages are consistent day 365 through 395 and day 730 through 760) Two TLRs were due to thrombotic occlusions in patients that were not compliant with prescribed anti-platelet medications

12 Direct vs. Pre-Dilatation Patency 89.5% at Day % at day % at Day 730 P= through 12 months Patency rate in cohort 1 is 87.7% at day 395 (other percentages are consistent day 365 through 395 and day 730 through 760) Two TLRs were due to thrombotic occlusions in patients that were not compliant with prescribed anti-platelet medications

13 Major Adverse Events Direct Cohort* % (n/n) Pre-Dilatation Cohort* % (n/n) MAE within 30 Days 0.0% (0/28) 2.0% (1/50) Clinically-Driven TLR within 30 Days 0.0% (0/28) 2.0% (1/50) MAE within 12 Months 14.8% (4/27) 12.0% (6/50) Clinically-Driven TLR within 12 Months 14.8% (4/27) 12.0% (6/50) Cardiovascular Death within 12 Months 0.0% (0/25) 0.0% (0/49) Index Limb Amputation within 12 Months 3.8% (1/26) 0.0% (0/49) *Denominator includes patients that have reached the protocol-defined visit window or have had an event prior to the close of the visit window Two TLRs were due to thrombotic occlusions in patients that were not compliant with prescribed anti-platelet medications Minor amputation in conjunction with one of the thrombotic occlusions; patient did not take prescribed anti-platelet medications

14 Conclusions ILLUMENATE FIH Direct Cohort Data suggest pre-dilatation is optional in simple lesions More data needed to assess direct technique in complex lesions The direct approach with Stellarex DCB is safe Robust cadence of clinical studies with pre-dil in progress Currently underway: ILLUMENATE EU RCT, ILLUMENATE PK, ILLUMENATE Pivotal (US IDE Study), and ILLUMENATE Global Registry

15 ILLUMENATE FIH Direct DCB Cohort 12-Month Results Stephan Duda Berlin Study Investigators: H. Schröder (PI), B. Lux, F. Rücker, M. Martorana, D. Meyer, H. Hartmann, S. Duda