Highlights of Cardiology Research At Genesis Nicolas W Shammas, MD, MS, FACC Research Director, MCRF Interventional Cardiologist, Cardiovascular Medicine, PC Genesis Heart Institute
Bioabsorbable Stents
Absorb BVS 3
Bioresorbable Stents Igaki-Tamai PLA PLA BVS Tyrosine- REVA Policarbonate BIT PAE-Salicylate Magnesium Biotronik
Bioresorption and vessel wall integration are a reality. BL 2Y Persistent Resolved ISA ISA incomplete ISA stent apposition Non Discernible
Why Degradable Stents? Why Degradable Stents? Decrease late adverse events – Late thrombosis – Hypersensitivity reactions (chronic inflammation) – Stent fractures Does not restrict arterial remodeling Permits non-invasive imaging of artery Permits bypass surgery in future
Study design ABSORB III Randomized 2:1 (BVS : XIENCE) N ~2250 Primary EP: 1 yr TLF Non-inferiority of BVS vs. XIENCE TLF=Cardiac death, Non fatal MI attributable to target vessel or TLR 7
General Inclusion Subject must have evidence of myocardial ischemia (e.g., stable or unstable angina, post-infarct angina or silent ischemia, as identified by chest pain or functional studies such as a stress test), suitable for elective PCI. Subjects with stable angina or silent ischemia and < 70% diameter stenosis must have objectives sign of ischemia as determined by one of the following, echocardiogram, nuclear scan, ambulatory ECG or stress ECG). In the absence of noninvasive ischemia, fractional flow reserve (FFR) must be done and indicative of ischemia. 8
ABSORB III – Randomized Subjects No ECG Clinical follow-up (*ECG) * 30d 6 mo 12 mo 24 mo 36 mo 48 mo 60 mo PRO follow-up (PRO = patient reported outcomes) Pivotal trial to support the US pre-market approval of Absorb BVS A-III Cohort Objective Randomized 2:1 ABSORB:XIENCE Target lesion failure at 1-year (composite of cardiac death, target vessel MI or Primary Endpoint ischemia driven-TLR) Up to two de novo lesions in different epicardial vessels. No planned overlap Treatment allowed Subjects and Location 2000 primary analysis subjects; US and Outside the US sites 9
( Apex ) Multicenter, Randomized, Active- Controlled Efficacy And Safety Study Comparing Extended Duration Betrixaban With Standard Of Care Enoxaparin For The Prevention Of Venous Thromboembolism In Acute Medically Ill Patients
Study Design: Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Arms Assigned Intervention Experimental: Betrixaban Drug: Betrixaban Betrixaban 80 mg PO QD for 35 day + 7 days. Enoxaparin Placebo: Once daily, 6-14 days Active Comparator: Enoxaparin Drug: Enoxaparin Enoxaparin 40 mg SC QD for 10 4 days. Betrixaban Placebo: once daily, 35 days
Primary Outcome Measures: Composite of VTE (DVT and/or PE) and VTE Death [ Time Frame: Occurrence of any of the events through the Day 35 visit ] Secondary Outcome Measures: Number of patients with symptomatic VTE [ Time Frame: The occurrence through the Day 35 visit ]
• Inclusion Criteria: men and non-pregnant, non-breastfeeding women anticipated to be severely immobilized for at least 24 hours after randomization hospitalized with one of the following – congestive heart failure – acute respiratory failure, – acute infection without septic shock, – acute rheumatic disorders – acute ischemic stroke with lower extremity hemiparesis or hemi paralysis • Exclusion Criteria: a condition requiring prolonged anticoagulation or anti-platelets active bleeding or at high risk of bleeding contraindication to anticoagulant therapy general conditions in which subjects are not suitable to participate in the study
PCI over 90 Protocol (IIS supported by a Grant from Genesis Research Program)
Characteristics Gender - Male 13.9 109 36 CAD - Yes 63.3 109 69 Prior PCI - Yes 23.9 109 26 Prior CABG - Yes 18.7 107 20 Previous MI - Yes 25.7 109 28 Prior Family Hx - Yes 6.4 109 7 33 Renal Insufficiency - Yes 109 36 Renal Failure -Yes 6.4 109 7 PVD - Yes 11 109 12 80.7 HTN - Yes 109 88 CVD - Yes 22.9 109 25 Hyperlipidemia - Yes 45 109 49 COPD 14.7 109 16 Cardiomyopathy - Yes 7.3 109 8 Heart Failure - Yes 30.3 109 33 Atrial fibrillation - Yes 22 109 24 Tobacco Use - Past 21.1 109 23 DM - Yes 23.9 109 26 Dementia - Yes 15.6 109 17 Valvular Disease - Yes 18.3 109 20 Pacemaker - Yes 11 109 12
Indications for Angiography n Percent None 54 50 Unstable Angina/NSTEMI 45 41.7 STEMI 7 6.5 Abnormal perfusion 2 1.9
Procedural/Angiographic Selected Data N Mean SD EF (Cath and Echo) 77 46.4 13.8 Total Lesion Length per patient 50 63.9 42 Number of Denovo Lesions per patient 50 2.5 2.1 Door to balloon time for STEMI 5 57.2 28.2 Pre-lesion severity 149 85.5 13.2 Syntax 41 23.2 14.5
n Percent PCI Complications None 43 72.9 pRBC's transfusion/anemia 4 6.8 renal failure/ renal insufficency 5 8.5 major bleeding 1 1.7 pseudoaneurysm 2 3.4 cardiac tamponade 1 1.7 arrythmia 1 1.7 pericardial effusion 1 1.7 dissection and thrombus of CFA 1 1.7
Ongoing Analysis Died vs Lived: predictors of Mortality and MAE in- hospital and on follow-up Cath vs Conservative Rx Disposition after discharge Centurians?
Publications since last Research Conference Shammas NW , Hauber W. How to Implement an Office-Based Vein Program. J Invasive Cardiol 2014 (In Print) Banerjee S, Sarode K, Das T, Hadidi O, Thomas R, Vinas A, Garg P, Mohammad A, Baig MS, Shammas NW, Brilakis ES. Crossing of Infrainguinal Peripheral Arterial Chronic Total Occlusion with VianceT Blunt Microdissection Catheter. J Invasive Cardiol;2014 (In print) Banerjee S, Sarode K, Das T, Hadidi O, Thomas R, Vinas A, Garg P, Mohammad A, Baig MS, Shammas NW, Brilakis ES. Endovascular Treatment of Infrainguinal Peripheral Arterial Chronic Total Occlusions with the TruePath Device: Featured Case Series, Device Features, Handling and Procedural Outcomes. J Endovasc Ther 2014; 21(2):281-8 Roberts D, Niazi K, Miller W, Krishnan P, Gammon R, Schreiber T, Shammas NW and Clair D. Effective Endovascular Treatment of Calcified Femoropopliteal Disease with Plaque Excision Atherectomy and Distal Embolic Protection Catheterization and Cardiovascular Interventions 2014; 2014 Jan 9. doi: 10.1002/ccd.25384. [Epub ahead of print] Shammas NW , Shammas GA , Jerin M. Differences in Patients’ Selection and Outcomes of SilverHawk Atherectomy versus Laser Atherectomy in Treating In-Stent Restenosis of the Femoropopliteal Arteries: A Retrospective Analysis from a Single Center. J Endovasc Ther 2013; 20(6):844-52. doi: 10.1583/13-4411R.1. Shammas NW . Jetstream atherectomy for treating iatrogenic occlusion of stented common femoral artery following deployment of Angioseal closure device. J Invasive Cardiol, 2013; 25(9):475-7 Shammas NW , Shammas GA, Nader E, Jerin M, Mrad L, Ehrecke N, Shammas WJ, Voelliger CM, Hafez A, Kelly R, Reynolds E. Outcomes of Patients Treated with the Everolimus- Versus the Paclitaxel -Eluting Stents in a Consecutive Cohort of Patients at a Tertiary Medical Center . Int J Angiol 2013;22:165-170 Shammas NW , Shammas GA, Sharis P, Jerin M. Age differences in long term outcomes of coronary patients treated with drug eluting stents at a tertiary medical center. Journal of Aging Research, Article ID 471026, 4 pages. http://dx.doi.org/10.1155/2013/471026
Continued-Publications Shammas NW . JETSTREAM atherectomy: a review of technique, tips and tricks in treating the femoropopliteal lesions. Int J Angiol 2014 (In Print) Shammas NW . Role of Distal Protection in Percutaneous Renal Intervention for Atherosclerotic Renovascular Disease. Vascular Disease Management, 2013:10(12):E254-E258 De Borst GJ, Shammas NW. The search for reliable markers for increased carotid artery stenting – induced cerebral embolism J Endovasc Ther 2013; 20(5):695-698 Shammas NW . Editorial: Optimizing strategy in peripheral vascular interventions: the role of JETSTREAM atherectomy. J Invasive Cardiol 2013; 25 (Supplement B):2B Shammas NW. Addressing challenges in the treatment of infrainguinal arterial disease: an endovascular specialist’s perspective. J Invasive Cardiol 2013; 25 (Supplement B):3B-6B Shammas NW. Local delivery of thrombolysis using the Clearway irrigating balloon catheter in acute limb ischemia. J Endovasc Ther. 2013; 20: 427-30 Shammas NW, Padaria R, Coyne E. Pericarditis, myocarditis, and other cardiomyopathies. Prim Care 2013 Mar;40(1):213-36. Shammas NW. An Overview of Optimal Endovascular Strategy in Treating the Femoropopliteal Artery: Mechanical, Biological and Procedural Factors. Int J Angiol 2013:22:1-8
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