Shockwave Medical HOME / CLINICIANS / CLINICAL EVIDENCE / CAD II USA / INTERNATIONAL Shockwave EU Post-Market Study Shows Strong Safety and Procedural Success Key Findings Disrupt CAD II Study confirms promising CAD I results and continues to demonstrate promising safety outcomes in more centers and more patients: Low rate of in-hospital MACE (5.8%) No perforations, slow flow, no-reflow or major (Type D-F) dissections IVL optimizes clinical outcomes in significantly calcified lesions 100% successful delivery of IVL 100% successful delivery of stents with high acute gain (1.7mm2) and low residual stenosis (8%) READ FULL PAPER Profs. Carlo Di Mario & Javier Escaned Discuss the DISRUPT CAD II Study at TCT19 After its presentation at TCT19 and simultaneous publication in Circulation: Cardiovascular Interventions, Profs. Carlo Di Mario & Javier Escaned discuss the key takeaways and implications on clinical practice for the DISRUPT CAD II Study, a post-market registry of coronary IVL in more patient and more centres than the first DISRUPT CAD I study. DISRUPT CAD II By The Numbers 120 Patients At 15 Sites 94 % Severe Ca++ 100 % IVL & Stent Delivery 0 % Major Dissections 0 % Perforations 0 % Slow/No Reflow Read the full DISRUPT CAD II study results in Circulation: Cardiovascular Interventions FULL STUDY RESULTS DISRUPT CAD II Study Leadership Prof. Jean Fajadet Co-Principal Investigator Clinique Pasteur Toulouse, France Prof. Carlo di Mario Co-Principal Investigator AOU Careggi SOD Interventistica Firenze, Italy Countries Included in DISRUPT CAD II SWEDEN DENMARK NETHERLANDS UNITED KINGDOM GERMANY BELGIUM FRANCE SPAIN ITALY Learn more about DISRUPT CAD II on ClinicalTrials.gov DISRUPT CAD II Study Design & Patient Characteristics Objective: A post-market study to assess the safety and performance of the Coronary IVL System with more patients in more centers Primary Safety Endpoint: In-hospital MACE (Cardiac death, MI or TVR) Secondary Performance Endpoints: Clinical and Angiographic Success Patient Characteristics Summary: 72 yo 32% DM 3.0mm RVD 60% diameter stenosis 26mm Ca++ length 72% Concentric/28% Eccentric Lesions 30% side branch involvement Stable angina, unstable angina or silent ischemia Heavily calcified, de novo coronary lesions RVD 2.5 – 4.0 mm, stenosis ≥50%, Lesion length ≤32 mm Strong Performance & Safety and Low Complications PERFORMANCE OUTCOMES RESULTS Clinical Success 94.2% (113) Angiographic Success 100% (120) Stent Delivery 100% (120) FINAL IN-STENT ANGIOGRAPHIC OUTCOMES (CORE LAB) RESULTS Residual diameter Stenosis, % 7.8% ± 7.1 Acute gain, mm 1.67 ± 0.49 Residual diameter stenosis <50% 100% (120) Residual diameter stenosis <30% 100% (120) Clinical success: ability of IVL to produce a residual diameter stenosis <50% after stenting with no evidence of in-hospital MACE SAFETY OUTCOMES RESULTS Final angiographic complications 0.0% (0/120) Dissections, type D- F 0.0% (0/120) Perforations 0.0% (0/120) Abrupt closure 0.0% (0/120) Slow flow 0.0% (0/120) No reflow 0.0% (0/120) Major adverse cardiac events in-hospital 5.8% (7/120) Cardiac death 0.0% (0/120) Non–Q-wave myocardial infarction 5.8% (7/120) Q-wave myocardial infarction 0.0% (0/120) Target vessel revascularization 0.0% (0/120) Major adverse cardiac events through 30 days* 7.6% (9/119) Cardiac death 0.8% (1/119) Non–Q-wave myocardial infarction 5.9% (7/119) Q-wave myocardial infarction 0.8% (1/119) Target vessel revascularization 0.8% (1/119) Stent thrombosis (definite or probable) 1.7% (2/119) *10 MACE in 9 subjects DISRUPT CAD II OCT SUB-STUDY RESULTS Calcium fracture, % 78.7% (37/47) Calcium fracture per lesion 3.4% ± 2.6 OCT Case Example Proximal LAD with side branch involvement Severe Ca++: >270° & >1mm thick Ca++ Fractures: Multiple locations (white arrows) Final Result: Full stent expansion Large acute gain A. Proximal vessel B. Maximum Calcification C. Distal vessel Read the full DISRUPT CAD II study results in circulation FULL STUDY RESULTS Ready to Make Waves with Shockwave IVL? 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