Slide 1: MASTER Trial Update & 6 Month Results
MASTER Trial Update & 6 Month Results Prof. Dr. Sigmund Silber FESC, FACC, FAHA Heart Center at the Isar, Munich, Germany on behalf of the MASTER study group
Slide 2: MGuard: Designed for Embolic Protection
MGUARD : DESIGNED FOR EMBOLIC PROTECTION DESIGN » Bare metal stent wrapped with an expandable 20µm MicroNet mesh » Polyethylene Terephthalate (PET) fiber » Pore size when deployed: 180 m » Pores are expandable for side branch access » Attached to proximal and distal edges of the stent ADVANTAGES »
Slide 3: MGuard & MGuard Prime Stent
MGUARD & MGUARD PRIME STENT MGuard MGuard Prime MATERIAL Stainless steel Cobalt chromium STRUT THICKNESS 100 m 80 m CROSSING PROFILE 1.1 - 1.3mm 1.0 - 1.2mm MICRONET MATERIAL PET FIBER DIAMETER 20 M
Slide 4: MASTER Trial Design
MASTER TRIAL DESIGN Primary Endpoint: complete ST - segment resolution at 60 - 90 min Secondary endpoints: TIMI flow, Myocardial Blush Grade, MACE (30d, 6m, 12m) Substudies: Cardiac MRI at 3 - 5 days (2x30 patients) Angiographic follow - up at 13 months (50 patients) 432 patients with STEMI pain < 1
Slide 5: Study Organization
STUDY ORGANIZATION PRINCIPAL INVESTIGATORS » Alexandre Abizaid » Dariusz Dudek » Sigmund Silber STUDY CHAIRMAN » Gregg Stone DATA ANALYSIS » CRF, New York CEC EVENT ADJUDICATION » CRC, Brazil ECG and MRI CORELAB » CRF, New York ANGIO CORELABS » CRC, Brazil » CRF, New York DSMB » 3 members, independe
Slide 6: Enrollment in Participating Countries
ENROLLMENT IN PARTICIPATING COUNTRIES Czech republic (19) Poland ( 166 ) Hungary ( 68 ) Germany ( 45 ) Brazil ( 14 ) South Africa ( 10 ) France (9) Israel ( 100 ) Ireland (2) July 22 , 2011 - May 29 , 2012 433 patients 50 sites, 9 countries
Slide 7: Top Enrolling Sites
TOP 12 ENROLLING SITES Prof. Bela Merkely Semmelweis University Hungary 37 Prof. Dariusz Dudek The University Hospital in Krakow Poland 33 Prof. Ran Kornowski Rabin Hospital Israel 31 Dr. Roman Wojdyła Krakow Center of Invasive Cardiology Poland 23 Dr. Dezső Apró State Hospital for Cardiology Balato
Slide 8: Main Inclusion / Exclusion Criteria
MAIN INCLUSION / EXCLUSION CRITERIA INCLUSION CRITERIA » Symptoms consistent with STEMI within 12 hours of symptom onset » ≥ 2 mm of ST - segment elevation in ≥2 contiguous leads » PCI of a single de novo lesion with RVD ≥ 3.0 to ≤ 4.0 mm » length ≤ 33 mm EXCLUSION CRITERIA » LBBB, paced rhythm, etc
Slide 9: Baseline Characteristics
BASELINE CHARACTERISTICS MGUARD (N= 217 ) CONTROL BMS / DES (N=216) Age (years) 60 [52, 68] 58 [51, 67] Male 75.1% 76.9% Hypertension 42.3% 47.4% Hyperlipidemia 27.4% 27.1% Diabetes mellitus 12.0% 18.1% Cigarette smoking 55.3% 46.8% Prior MI 3.7% 8.8% Prior PCI 3.7% 5.6% Symptoms to device, mins 207
Slide 10: Procedural Medications
PROCEDURAL MEDICATIONS MGUARD (N=217) CONTROL STENT BMS / DES (N=216) P Anti - platelet agents, peri - procedural Aspirin 98.6% 99.1% 1.0 ADP antagonists 95.4% 95.8% 0.82 Clopidogrel 72.9% 70.0% 0.51 Ticlopidine 0.5% 0.0% 1.0 Prasugrel 21.7% 20.8% 0.81 Ticagrelor 4.8% 9.2% 0.08 Anticoagulation, peri
Slide 11: Procedural Characteristics
PROCEDURAL CHARACTERISTICS MGUARD (N=217) CONTROL BMS / DES (N=216) P Aspiration performed 65.9% 67.1% 0.79 Balloon pre - dilatation performed 50.2% 44.9% 0.27 Direct stenting 12.0% 10.6% 0.66 > 1 stent implanted 99.5% 100.0% 1.0 Stent type MGuard 96.3%(*) 0.5% <0.0001 Bare metal stent 1.4% 59.7% <0
Slide 12: MGuard Superior in TIMI Flow
1.8 6.5 91.7 5.6 11.6 82.9 0 10 20 30 40 50 60 70 80 90 100 0/1 2 3 Percent (%) TIMI flow MGuard Control stent MGUARD SUPERIOR IN TIMI FLOW P= 0.006 P=0.01 Stone et. al, J Am Coll Cardiol . 2012 ; 60 : 1975 - 1984 .
Slide 13: MGuard Superior in ST Segment Resolution
MGUARD SUPERIOR IN ST SEGMENT RESOLUTION P= 0.005 P=0.008 PRIMARY ENDPOINT 16.7 25.5 57.8 17 38.3 44.7 0 10 20 30 40 50 60 Absent (≤30%) Partial (>30% - <70%) Complete (≥ 70 %) Percent (%) ST resolution MGuard Control stent Stone et. al, J Am Coll Cardiol . 2012 ; 60 : 1975 - 1984 .
Slide 14: Distal Embolization
DISTAL EMBOLIZATION 4.1 7.0 0.0 1.0 2.0 3.0 4.0 5.0 6.0 7.0 8.0 9.0 Distal Embolization Percent (%) MGuard Control stent P= 0.21 Stone et. al, J Am Coll Cardiol . 2012 ; 60 : 1975 - 1984 .
Slide 15: Cardiac MRI at 3-5 Days
CARDIAC MRI AT 3 - 5 DAYS MGUARD (N= 30 ) CONTROL BMS / DES (N=29) P Total LV myocardial mass, g 141 [117, 163] 147 [118, 174] 0.41 Infarct mass, g 17.1 [10.0, 30.0] 22.3 [15.7, 30.1] 0.27 Infarct mass (% total LV mass) 13.3 [7.9, 25.0] 16.6 [10.0, 22.6] 0.48 Total MVO, g 0.3 [0.0, 1.6] 1.0 [0.2, 2.
Slide 16: 30 Days Clinical Results
30 DAYS CLINICAL RESULTS* MGUARD (N= 217 ) CONTROL BMS / DES (N=216) P MACE 4 (1.8%) 5 (2.3%) 0.75 All cause mortality 0 (0.0%) 4 (1.9%) 0.06 Cardiac death 0 (0.0%) 4 (1.9%) 0.06 Reinfarction 3 (1.4%) 2 (0.9%) 1.00 TLR, ischemia - driven 4 (1.8%) 1 (0.5%) 0.37 TVR, ischemia - driven 5 (2.3%) 1 (0.5%
Slide 17: 6 Months Clinical Results
6 MONTHS CLINICAL RESULTS* MGUARD (N=217) CONTROL BMS / DES (N=216) P MACE 11 (5.2%) 7 (3.4%) 0.34 All cause mortality 1 (0.5%) 6 (2.8%) 0.06 Cardiac death 1 (0.5%) 5 (2.3%) 0.10 Reinfarction 3 (1.4%) 2 (0.9%) 0.66 TLR, ischemia - driven 10 (4.8%) 2 (1.0%) 0.02 TVR, ischemia - driven 13 (6.2%) 2 (1.
Slide 18: All Cause Mortality at 6 Months
ALL CAUSE MORTALITY AT 6 MONTHS Death - 6 months (%) 0 1 2 3 4 5 Time in Months 0 30 60 90 120 150 180 217 213 213 165 216 209 208 171 Number at risk: MGuard BMS/DES P= 0.056 HR: 0.16 [95% CI: 0.02, 1.36] 0.5% 2.8% MGuard BMS/DES Time in Days 2.8% 0.5%
Slide 19: Death and MI at 6 Months
DEATH AND MI AT 6 MONTHS DEATH/MI - 6 months (%) 0 1 2 3 4 5 Time in Months 0 30 60 90 120 150 180 217 211 211 163 216 208 207 170 Number at risk: MGuard BMS/DES P= 0.353 HR: 0.56 [95% CI: 0.16, 1.92] 1.9% 3.3% MGuard BMS/DES Time in Days
Slide 20: Conclusions
CONCLUSIONS CONCLUSIONS Among patients with STEMI undergoing emergent PCI, the MGuard embolic protection stent resulted in superior rates of epicardial coronary flow and complete ST - segment resolution. A positive trend toward reduced mortality is persistent even after 6. The 6 - month TLR rates in
Slide 21: Backup slides
Backup slides
Slide 22: Multivariable predictors of complete ST-segment resolution
Variables: age, male, BMI, hypertension, hyperlipidemia, diabetes, current smoking, congestive heart failure, prior angina, prior MI, prior PCI, randomized group Primary Endpoint: Complete ST - segment resolution Multivariable predictors OR (95%CI) P value MGuard vs. control 1.73 (1.14 - 2.62) 0.01
Slide 23: MACE at 6 Months
MACE AT 6 MONTHS MACE - 6 months (%) 0 2 4 6 8 10 Time in Months 0 30 60 90 120 150 180 217 209 207 159 216 208 208 171 Number at risk: MGuard BMS/DES P= 0.345 HR: 1.57 [95% CI: 0.61, 4.06] 5.2% 3.4% MGuard BMS/DES Time in Days