The Clinical Evaluation of the Medtronic AVE Driver Coronary Stent System A prospective, multicenter, non randomized study to evaluate the safety and efficacy of the Medtronic AVE Driver Coronary Stent System in subjects with de novo and restenotic lesions of native coronary arteries. Principal Investigator: Michael H. Sketch Jr., MD, FACC Duke University Medical Center
Sites Enrolling in Driver Registry Investigator Site Name Location Michael Ball, MD* St. Vincent Hospital Indianapolis, IN Dean Kereiakes, MD* Barry Rutherford, MD* Michael H. Sketch Jr., MD* Robert C. Stoler, MD* Stephen Yakubov, MD Greg Braden, MD* Rakesh Prashad, MD* Jeffrey Chambers, MD* Thomas McGarry, MD* Magdi Ghali, MD* Lowell Satler, MD* Patrik Zetterlund, MD* Joseph Fredi, MD A. Charles Rabinowitz, MD James O Toole, MD Peter J. Counihan, MD* D. Scott Gantt, DO Michael Ring, MD Stylianos Papadakos, MD R. David Fish, MD* Jeffrey S. Garrett, MD* Timothy Byrne, DO* The Christ Hospital St. Luke s Hospital Duke University Medical Center Baylor University Medical Center Riverside Methodist Hospital Forsyth Medical Center Ocala Regional Medical Center Mercy Hospital OU Medical Center-Presbyterian Towers Mercy Medical Center Washington Hospital Center Salinas Valley Memorial Hospital St. Thomas Hospital Methodist Hospital UPMC Shadyside Hospital UPMC Presbyterian Hospital Scott & White Memorial Hospital Sacred Heart Medical Center NY Hospital Queens St. Luke s Episcopal Hospital The Western Pennsylvania Hospital Good Samaritan Regional Medical Center Cincinnati, OH Kansas City, MO Durham, NC Dallas, TX Columbus, OH Winston-Salem, NC Ocala, FL Coon Rapids, MN Oklahoma City, OK Des Moines, IA Washington, DC Salinas, CA Nashville, TN San Antonio, TX Pittsburgh, PA Pittsburgh, PA Temple, TX Spokane, WA Flushing, NY Houston, TX Pittsburgh, PA Phoenix, AZ * These sites enrolled patients in angiographic subset N=101 patients.
Methodology Study population: Patients with symptomatic ischemic heart disease due to stenotic lesions of the native coronary arteries that are amenable to percutaneous stenting de novo or restenotic target lesion Lesion length <30 mm in length Target vessel reference diameter >3.0 mm and <4.0 mm Driver stent sizes used: 3.0, 3.5 and 4.0 mm diameter stents in 9, 12 and 18 mm lengths Enrollment: 298 subjects at 23 sites in the United States
Endpoints Primary: MACE at 180 days defined as a composite of death, Q-wave and non-q-wave MI, emergent bypass surgery, or target lesion revascularization (repeat PTCA or CABG) Secondary: TVF in-hospital, at 14 days, 30 days, 180 days, and 270 days Acute success Clinically driven TLR at 180 and 270 days Binary angiographic restenosis at 180 days Late loss at 180 days Ischemic, bleeding and vascular complications
Patient Demographics Number of patients 298 Age (yr) 62.6 ±10.8 Male 68.1% Risk Factors Diabetes 27.6% Hypertension on Rx 68.4% Current smoker 28.8% Family history of CAD 49.1% Hyperlipidemia on Rx 75.9%
Patient Demographics Cardiac History Prior MI 28.1% History of PTCA 23.0% History of CABG 6.0% Cardiac Status/Angina Class Stable 31.2% Unstable 47.0% Angina Class CCS III or IV 55.3% LV Ejection Fraction (mean) 55.9 ± 9.8%
Baseline Angiography Major Coronary Arteries >50% Stenosed Single 66.8% Double 22.8% Triple 10.4% Target Lesion Vessel LAD 45.4% LCX 19.4% RCA 34.5% Left Main 0.7%
Baseline Angiography ACC/AHA Lesion Class A 14.8% B1 34.2% B2 (or higher) 45.4% C 5.6% Target Lesion Morphology Calcification (moderate to severe) 14.1% Eccentric lesion 41.2% Thrombus 1.1% Angulation >45 degrees 7.0%
Procedure Characteristics % of Patients Implanted with: 1 stent 82.9% 2 stents 16.4% 3 stents 0.67% Number of stents/lesion (mean) 1.18 Lesion length (mm) 11.04 ±4.25
Safety Results Incidence of MACE In-hospital 180 days 270 days Death 0.0% 0.7%* 1.3%* Q-wave MI 0.0% 0.0% 0.0% Non-Q-wave MI 1.7% 1.7% 1.7% TLR 0.0% 3.4% 7.0% Combined MACE 1.7% 5.7% 10.1% TVR 0.0% 4.4% 8.1% TVF (TVR + MI + cardiac death) 1.7% 6.7% 9.7% Stent thrombosis 0.0% 0.0% 0.0% *deaths were non-cardiac
Safety Results 180 days by Diabetic Status N=215 pts N=82 pts Incidence of MACE to 180 days Diabetic Non-Diabetic Death 0.5%* 1.2%* Q-wave MI 0.0% 0.0% Non-Q-wave MI 1.9% 1.2% emergent CABG 0.0% 0.0% TLR 3.3% 3.7% Combined MACE 5.6% 6.1% TVR 4.2% 4.9% TVF (TVR + MI + cardiac death) 6.1% 6.1% Stent thrombosis 0.0% 0.0% *deaths were non-cardiac
Safety Results 270 days by Diabetic Status N=215 pts N=82 pts Incidence of MACE to 270 days Diabetic Non-Diabetic Death 0.9%* 2.4%* Q-wave MI 0.0% 0.0% Non-Q-wave MI 1.9% 1.2% emergent CABG 0.0% 0.0% TLR 5.6% 11.0% Combined MACE 8.4% 14.6% TVR 6.5% 12.2% TVF (TVR + MI + cardiac death) 8.4% 13.4% Stent thrombosis 0.0% 0.0% *deaths were non-cardiac
Efficacy Results Device success 100% (298/298) Lesion success 100% (298/298) Procedure success 98.3% (293/298) Kaplan-Meier estimates at: 180 days 270 days MACE-free at 270 days 93.9% 87.7% TLR-free at 270 days 96.2% 91.2% TVR-free at 270 days 95.2% 90.0% TVF-free at 270 days 92.8% 88.3%
Restenosis Risk Factors Diabetes 27.6% Reference Vessel Diameter 3.07 ± 0.47 mm Lesion Length 11.04 ± 4.25 mm
Criteria Angiographic Results (QCA) Reference vessel diameter (mm) In-lesion minimum lumen diameter (mm) In-lesion diameter stenosis (%) In-stent minimum lumen diameter (mm) In-stent diameter stenosis (%) In-lesion acute gain (mm) In-stent acute gain (mm) In-lesion late loss (mm) In-lesion loss index ratio (mm/mm) In-stent late loss (mm) In-stent loss index ratio (mm/mm) Binary restenosis in stent (%) Binary restenosis in lesion (%) Pre-procedure 3.07 ± 0.47 1.01 ± 0.38 67.1 ± 11.1 Postprocedure 3.01 ± 0.48 2.55 ± 0.50 15.0 ± 11.4 2.90 ± 0.41 3.0 ± 10.5 1.55 ± 0.51 1.93 ± 0.44 180-day 3.02 ± 0.48 1.93 ± 0.58 36.1 ± 15.0 1.99 ± 0.62 34.2 ± 16.3 0.62 ± 0.56 0.38 ± 0.37 0.94 ± 0.54 0.49 ± 0.29 In lesion defined as measurements within the stented segment plus 5 mm proximal and distal to the stent margins. 15.7 15.7