DISRUPT CAD. Todd J. Brinton, MD Clinical Associate Professor of Medicine Adjunct Professor of Bioengineering Stanford University
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1 DISRUPT CAD A multicenter, prospective, single-arm study of percutaneous Lithoplasty prior to stent implantation in heavily calcified coronary lesions Todd J. Brinton, MD Clinical Associate Professor of Medicine Adjunct Professor of Bioengineering Stanford University
2 Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Grant/Research Support Consulting Fees/Honoraria Affiliation/Financial Relationship Major Stock Shareholder/Equity Royalty Income Ownership/Founder Intellectual Property Rights Other Financial Benefit None Company Shockwave Medical, Inc., Kona Medical, Inc., Qool Therapeutics Kona Medical, Inc., Qool Therapeutics, ELS None Shockwave Medical, Inc., BioParadox, Inc. None None
3 Prevalence Prevalence Impact of Age on Vascular Calcification A 100% B 100% 90% 90% 80% 70% 60% 50% 40% 30% 20% All Coronary-Aorta-Iliac Carotid-Aorta-Iliac Carotid-Coronary Aorta-Iliac Coronary Carotid None 80% 70% 60% 50% 40% 30% 20% All Coronary-Aorta-Iliac Carotid-Aorta-Iliac Carotid-Coronary Aorta-Iliac Coronary Carotid None 10% 10% 0% < >70 Age Prevalence of calcium per vascular pattern in women 0% < >70 Age Prevalence of calcium per vascular pattern in men >70 years, all have calcium in at least 1 vascular bed and 2/3 in all arterial beds Allison et. al Arterioscler Thromb Vasc Biol. 2004;24:
4 Challenges of Treating Calcified Coronary Lesions HORIZONS-AMI and ACUITY CORONARY CALCIUM: 1 Yr Outcomes 6855 Patients Enrolled None/Mild Moderate Severe p = % 15.3% p = 0.22 p = % p = % 4.2% 2.8% p = % 2.8% 1.8% 9.4% 7.3% 7.6% 8.2% 8.7% 6.0% Death Cardiac Death MI TLR MACE Généreux P; Ischemic outcomes after coronary intervention of calcified vessels. J Am Coll Cardiol 2014;63:
5 Challenges of Treating Calcified Coronary Lesions Increased Coronary Calcification Higher pressure to dilate effectively Higher number of dissections Decreased stent expansion More complications Poor outcomes Mintz et al. J Am Coll Cardiol 2014;64(2): Fitzgerald et al. Circulation 1992;86: Potkin et al. J Am Coll Cardiol 1992;20: Kovach et al. J Am Coll Cardiol 1993;22: Mintz et al. Circulation 1995;92: Von Birgelen et al. Am J Cardiol 2003;92:5-10
6 Currently Approved Devices Traditional Balloons Compliant Non-Compliant Specialty Balloons AngioSculpt Scoring Balloon Atherectomy Rotational : Rotoblator Orbital : CSI
7 Insight: Lithotripsy Lithoplasty Dispersive, non focused lithotripsy Dose dependent result Circumferential mechanical energy distribution 25 years of safety data in kidney stone treatment Focused acoustic pulse waves Point of Maximum Energy Density Target Unfocused acoustic pulse waves
8 Lithoplasty Lesion modification using lithotripsy in a balloon Tissue-selective: Hard on hard tissue, Soft on soft tissue Lithotripsy waves travel outside balloon Designed to disrupt both superficial, deep calcium Designed to normalize vessel wall compliance prior to controlled, low pressure dilatation Effective lesion expansion with minimized impact to healthy tissue Front-line balloon-based Rapid Exchange.014 platform The Shockwave Medical Coronary Lithoplasty System is investigational and is not available for sale.
9 Lithoplasty The Shockwave Medical Coronary Lithoplasty System is investigational and is not available for sale.
10 Baseline Active Lithoplasty Lithoplasty Final The Shockwave Medical Coronary Lithoplasty System is investigational and is not available for sale.
11 Investigational device Lithotripsy delivery Nominal pressure Rated burst pressure 4 atm 6 atm 10 atm guidewire compatible 138 cm working length 6F sheath compatibility Balloon Sizes Diameter Length 2.5 mm 12 mm 2.75 mm 12 mm 3.0 mm 12 mm 3.25 mm 12 mm 3.5 mm 12 mm 3.75 mm 12 mm 4.0 mm 12 mm The Shockwave Medical Coronary Lithoplasty System is investigational and is not available for sale.
12 Disrupt CAD Study Design Stable angina, unstable angina or silent ischemia Moderate and severely calcified, de novo coronary lesions RVD mm, stenosis 50%, Lesion length 32 mm 60 patients enrolled 31 subject OCT sub-study 30 day & 6 months follow-up Core Angiographic & OCT Labs (Yale University & CRF) Objective: To assess the safety and performance of the Shockwave Medical Coronary Rx Lithoplasty System Primary Safety Endpoint: MACE within 30 days defined as: Cardiac death, MI or TVR Primary Performance Endpoint: Clinical Success defined as residual stenosis (<50%) after stenting with no evidence of in-hospital MACE.
13 Investigational Sites 60 patients enrollment completed in Sep 2016 Investigator Site Enrollment Jean Fajadet, MD (PI) Clinic Pasteur, France 10 Carlo Di Mario, MD (Co-PI) Ian Meredith, MD Jonathan Hill, MD Nicolas Van Mieghem, MD Robert Whitbourn, MD Matthias Götberg, MD Royal Brompton, England Monash Health, Australia King s College, England Erasmus, Netherlands St Vincent s, Australia Skane University Hospital, Sweden
14 DISRUPT CAD Baseline Characteristics Medical History N= 60 Age 72.1 (9.6) Male gender 80.0%(48) Diabetes 30.0% (18) Hypertension 80.0% (48) Hyperlipidemia 80.0% (48) Myocardial Infarction 40.0% (24) Prior CABG 23.3% (14) Stroke/TIA 13.3% (8) Current Smoker 15.0% (9) Renal insufficiency 10.0% (6) 60% 50% 40% 30% 20% 10% 0% 48% 32% 17% 3% Class I Class II Class III Class IV Angina Classification
15 Pre-procedure Angiographic Findings core lab adjudicated Pre-Procedure N=60 RVD (mm) 3.0 ± 0.5 MLD (mm) 0.9 ± 0.4 % Diameter stenosis 68.1 ± 13.1 Lesion length (mm) 20.3 ± 10.5 Calcified length (mm) 22.3 ± 12.5 Calcification Moderate 13.3% (8) Severe 80.0% (48) Lesion Assessment Concentric 78.3% (47) Eccentric 21.7% (13) Side branch involvement 28.3% (17)
16 Procedural Characteristics Procedural Time N= 60 Lithoplasty Time (min) 6.4 Fluoroscopy time (min) 32.3 Total procedure time (min) 92.9 * 1.5mm PTCA balloon was allowed to facilitate OCT imaging catheter Procedural Details N= 60 Pre-dilatation > 1.5mm PTCA * 15% (9) Number of Lithoplasty balloons 2.0 Number of pulses 88 Mean Lithoplasty pressure (atm) 6.0 Avg. Number of stents 1.4 Post-dilatation 86.7% (52)
17 Safety Outcomes Procedural Angiographic Complications Freedom from 30-day MACE: 95% Dissection Final N = 60 None 100% (60) A to C 0.0% D to F 0.0% Perforation 0.0% Abrupt Closure 0.0% Slow flow 0.0% No reflow 0.0% 0% 5% Cardiac Death Non-Q-Wave MI 0% 0% 5% Q-Wave MI TVR Cumulative MACE Angiographic core lab adjudicated CEC adjudicated
18 Primary Performance Outcomes N= 60 Clinical Success 95.0% (57) Device Success 98.3% (59) Facilitated Stent Delivery 100% (60) Clinical success defined as residual stenosis <50% after stenting with no evidence of in-hospital MACE. Device success defined as successful device delivery and Lithoplasty treatment at the target lesion.
19 Cumulative Frequency % Performance Outcomes % Diameter Stenosis Cumulative Frequency Distribution 68.1% % 30 Pre Final Pre Final MLD (mm) 0.9 ± ± 0.5 Acute Gain (mm) NA 1.7 ± Min Lumen Diameter Pre-Procedure Final Angiography
20 Case 1 Baseline Post Lithoplasty Final 2.4mm RVD 80.3% stenosis 7.6mm length 2.75 and 3.0mm Lithoplasty 4.7% stenosis Acute gain 2.1 Stent length 18.3mm The Shockwave Medical Coronary Lithoplasty System is investigational and is not available for sale.
21 Case 2 Baseline Post Lithoplasty Final 3.6mm RVD 87.6% stenosis 37.5mm length 4.0mm Lithoplasty 4.0% stenosis Acute gain 3.1 Stent length 40.5mm The Shockwave Medical Coronary Lithoplasty System is investigational and is not available for sale.
22 Mechanism of Lithoplasty Calcium Calcium Fracture Calcium Angle: 327 Pre-Procedure Calcium Final The Shockwave Medical Coronary Lithoplasty System is investigational and is not available for sale.
23 OCT Case Review Example 1 Example 2 Example 3 Preprocedure Lumen Area: 6.00mm 2 Lumen Area: 2.98mm 2 Lumen Area: 4.12mm 2 Post- Lithoplasty Lumen Area: 7.69mm 2 Lumen Area: 6.34mm 2 Lumen Area: 6.40mm 2 Post Stent Final Lumen Area: 9.79mm 2 Stent Area: 8.55mm 2 Lumen Area: 8.15mm 2 Lumen Area: 8.99mm 2 Stent Area: 7.44mm 2 Stent Area: 8.16mm 2
24 OCT Summary Pre Final Minimum lumen area (mm 2 ) 2.2 ± ± 2.0 Area stenosis (%) 66 ± ± 20 Acute gain (mm 2 ) 3.7±1.5 Calcium Measurements Maximum Ca angle (degree) 229 ± 93 Maximum Ca thickness (mm) 0.97 ± 0.25 Calcium Angle: 327 Quadrants of Ca Fracture / Lesion 34 The Shockwave Medical Coronary Lithoplasty System is investigational and is not available for sale.
25 Pre Procedure OCT Tertile Analysis By Calcium Burden Lowest Tertile Middle Tertile Highest Tertile P-value Minimum lumen area (mm 2 ) Area stenosis (%) Maximum Ca angle (º) <0.001 Ca length (mm) <0.001 Final Stent area (mm 2 ) Complete Ca fracture, % 22% 55% 78% Acute gain (mm 2 ) The Shockwave Medical Coronary Lithoplasty System is investigational and is not available for sale.
26 Conclusions The Disrupt CAD Study successfully enrolled a population with complex, calcified, obstructive coronary disease. The Lithoplasty balloon-based therapy resulted in 98% device success and facilitated100% stent delivery. The study demonstrated a low MACE rate of 5.0% with minimal vascular complications. Core lab angiographic analysis demonstrated high acute gain and low residual stenosis. OCT sub-study showed clear evidence of circumferential calcium fracture as the mechanism for vessel dilatation prior to stent placement. OCT sub-study demonstrated high luminal acute gain independent of the degree of calcification in this hard to treat population. The Shockwave Medical Coronary Lithoplasty System is investigational and is not available for sale.
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