Slide 1: The MASTER Trial: Evaluation of a PET Micronet Mesh Covered Stent (MGuard) in STEMI
The MASTER Trial A Prospective , Randomized, Multicenter Evaluation of a PET Micronet Mesh Covered Stent (MGuard) in STEMI Gregg W. Stone, MD Columbia University Medical Center NewYork - Presbyterian Hospital Cardiovascular Research Foundation
Slide 2: Disclosure Statement of Financial Interest
Disclosure Statement of Financial Interest • Consulting Fees/Honoraria • Abbott Vascular, Boston Scientific, Medtronic, InspireMD, Atrium Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Fina
Slide 3: Background
Background • Suboptimal myocardial reperfusion after PCI in STEMI is common, and results in increased infarct size and mortality • The MGuard Embolic Protection Stent (EPS) s a novel thin - strut metallic stent with a PET micronet covering designed to trap and exclude thrombus and friable atheromato
Slide 4: The MGuard and MGuard Prime Embolic Protection Stent (EPS)
The MGuard and MGuard Prime Embolic Protection Stent (EPS) *InspireMD, Tel Aviv, Israel; ** Polyethyleneterephthalate MGuard MGuard Prime Metallic frame 316L stainless steel L605 cobalt chromium Strut width 100 µm 80 µm Crossing profile 1.1 – 1.3 mm 1.0 – 1.2 mm Shaft dimensions 0.65 – 0.86 mm 0.65
Slide 5: Thrombus Entrapment by the MGuard in STEMI
Thrombus Entrapment by the MGuard in STEMI Jain AK and Rothman MT. JACC 2011;58;e39 Pre Post aspiration Residual thrombus
Slide 6: Thrombus Entrapment by the MGuard in STEMI
Thrombus Entrapment by the MGuard in STEMI Jain AK and Rothman MT. JACC 2011;58;e39 Thrombus trapped behind mesh Post MGuard Mesh
Slide 7: The MASTER Trial design
M GUARD for A cute ST E levation R eperfusion The MASTER Trial STEMI with symptom onset within 12 hours at 432 pts at 50 sites in 9 countries Substudies: Cardiac MRI : 60 pts (30 pts in each arm) at 3 - 5 days Angio FU: 5 0 pts in MGuard arm at 13 months Follow - up: 30 days, 6 months, 1 year Primar
Slide 8: Principal Inclusion Criteria
Principal 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 and length ≤ 33 mm (capable of being covered by a single study stent)
Slide 9: Principal Exclusion Criteria
Principal E xclusion Criteria • LBBB, paced rhythm, etc. • Prior PCI within 6 months or prior CABG anytime • LVEF ≤20%, cardiogenic shock or CPR • ≥50% left main stenosis present • Infarct lesion ostial or bifurcation with ≥ 2.0 mm sidebranch • T arget vessel or infarct lesion excessively tortuous,
Slide 10: Primary Endpoint and Power
Primary Endpoint and Power • Primary endpoint: Complete ST - segment resolution (STR), defined as ≥70 % reduction in the summed 12 - lead extent of ST - segment elevation from the baseline to the post - procedure (60 - 90’) ECG as determined by a blinded, independent electrocardiographic core labora
Slide 11: Study Organization
Study Organization Principal investigators: Alexandre Abizaid, Dariusz Dudek, Sigmund Silber Study chairman: Gregg W. Stone Executive committee: GW Stone , A Abizaid , D Dudek , S Silber, C Lotan, MB Leon, E Bar, E Yaacoby, M Ivenshitz Data monitoring: K CRI, Poland; MedPass Int, France; CRC, Brazil
Slide 12: Top Enrolling Sites
Top 12 Enrolling Sites 1. Bela Merkely, Semmelweis University, Budapest, Hungary 37 2. Dariusz Dudek, University Hospital in Krakow, Krakow, Poland 33 3 . Ran Kornowski, Rabin Medical Center, Petach Tiqva , Israel 31 4. Roman Wojdyła, Krakow Center of Invasive Cardiology, Electrotherapy and Angiolog
Slide 13: Baseline Characteristics
Baseline Characteristics MGuard stent (n=217) Control stent (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 14: Procedural Medications
Procedural Medications MGuard stent (n=217) Control stent (n=216) P value 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 Anticoa
Slide 15: Procedures
Procedures *191 MGuard, 26 MGuard Prime **Marginally higher in the MGuard group MGuard stent (n=217) Control stent (n=216) P value 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 > 2 stent
Slide 16: Device Success
Device Success Device success: < 50% final residual stenosis using only the randomized stent Lesion success: < 50% final residual stenosis using any percutaneous method Angiographic success: < 50% final residual stenosis and final TIMI 3 flow 95.9 95.9 100 91.7 91.7 100 99.1 99.5 82.9 82.4 0 25 50 7
Slide 17: Procedural Results
Procedural Results MGuard stent (n=217) Control stent (n=216) P value TIMI flow = 3 91.7% 82.9% 0.006 TIMI flow = 2 6.5% 11.6% 0.06 TIMI flow = 0/1 1.8% 5.6% 0.01 Corrected TIMI frame count 17 [12, 23] 18 [13,22] 0.23 Myocardial blush = 2/3 83.9% 84.7% 0.81 IPTE 21.7% 22.3% 0.87 RVD, mm 3.20 [2.90,
Slide 18: Primary Endpoint: Complete ST-segment resolution
Primary Endpoint: Complete ST - segment resolution MGuard (n=204) Control (n=206) 44.7% 38.3% 17.0% 57.8% 25.5% 16.7% Difference [95%CI] = 13.2% [3.1, 23.3 ] P=0.008
Slide 19: Primary Endpoint: Multivariable predictors
Primary Endpoint: Complete ST - segment resolution Multivariable predictors Variables: age , male , BMI, hypertension, hyperlipidemia, diabetes, current smoking, congestive heart failure, prior angina, prior MI, prior PCI, randomized group OR (95%CI) P value MGuard vs. control 1.73 (1.14 - 2.62 ) 0.
Slide 20: Complete STR: Subgroup Analysis
Complete STR: Subgroup Analysis Group MGuard Control RR [95% CI] Control Better MGuard Better P (Int) 0.81 Relative Risk (95% CI) 0.1 10 0.64 1 Male 80/163 (49.1%) 64/166 (38.6%) 1.27 [0.99, 1.63] Sex Female 38/54 (70.4%) 29/50 (58.0%) 1.21 [0.91, 1.63] 0.92 < 65 years 78/149 (52.3%) 63/154 (40.9%)
Slide 21: Clinical Events at 30 Days
Clinical Events at 30 Days MGuard stent (n=217) Control stent (n=214) P value MACE 4 (1.8%) 5 (2.3%) 0.75 – Cardiac mortality* 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 6 (2.8%) 1 (0.5%) 0.12 Stent thrombosis,
Slide 22: MRI Substudy Results
3 - 5 Day MRI Substudy Results MGuard stent (n=30) Control stent (n=29) P value Total LV myocardial mass, gms 141 [117, 163] 147 [118, 174] 0.41 Infarct mass, grams 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, grams 0.3 [0
Slide 23: Limitations
Limitations • Single - blind only • Underpowered for infarct size and clinical events, and subgroup analyses should be considered hypothesis - generating. • More experience with the MGuard Prime in STEMI is required • Long - term clinical and angiographic follow - up is ongoing • Discordance between
Slide 24: Conclusions and Implications
Conclusions and Implications • Among pts with acute STEMI undergoing emergent PCI, the MGuard micronet mesh covered stent compared to conventional metallic stents resulted in superior rates of epicardial coronary flow and complete STR • A larger randomized trial is warranted to verify these findings
Slide 25: The MASTER Trial: JACC publication
The MASTER Trial JACC image Stone GW et al. J Am Coll Cardiol 2012;