Genesis Nicolas W Shammas, MD, MS, FACC Research Director, MCRF - - PowerPoint PPT Presentation

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Highlights of Cardiology Research At Genesis

Nicolas W Shammas, MD, MS, FACC Research Director, MCRF Interventional Cardiologist, Cardiovascular Medicine, PC Genesis Heart Institute

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Bioabsorbable Stents

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Absorb BVS

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Bioresorbable Stents

BVS REVA Biotronik BIT Igaki-Tamai PLA Tyrosine- Policarbonate PAE-Salicylate Magnesium PLA

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BL 2Y

Resolved ISA

Non Discernible

Persistent ISA ISA incomplete stent apposition

Bioresorption and vessel wall integration are a reality.

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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

Why Degradable Stents?

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Study design

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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

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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.

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30d 6 mo 12 mo 24 mo 36 mo 48 mo 60 mo Clinical follow-up (*ECG) PRO follow-up

(PRO = patient reported outcomes)

A-III Cohort Objective Pivotal trial to support the US pre-market approval of Absorb BVS Randomized 2:1 ABSORB:XIENCE Primary Endpoint Target lesion failure at 1-year (composite of cardiac death, target vessel MI or ischemia driven-TLR) Treatment Up to two de novo lesions in different epicardial vessels. No planned overlap allowed Subjects and Location 2000 primary analysis subjects; US and Outside the US sites

ABSORB III – Randomized Subjects

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No ECG

*

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(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

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Study Design: Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention

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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

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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 ]

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• 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

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PCI over 90 Protocol (IIS supported by a Grant from Genesis Research Program)

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Characteristics

Gender - Male

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13.9 CAD - Yes

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63.3 Prior PCI - Yes

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23.9

Prior CABG - Yes

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18.7

Previous MI - Yes

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25.7

Prior Family Hx - Yes

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6.4

Renal Insufficiency - Yes

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Renal Failure -Yes

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6.4

PVD - Yes

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HTN - Yes

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80.7

CVD - Yes

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22.9

Hyperlipidemia - Yes

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COPD

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14.7

Cardiomyopathy - Yes

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7.3

Heart Failure - Yes

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30.3 Atrial fibrillation - Yes

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22 Tobacco Use - Past

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21.1 DM - Yes

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23.9 Dementia - Yes

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15.6

Valvular Disease - Yes

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18.3

Pacemaker - Yes

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Indications for Angiography

n Percent

None 54 50 Unstable Angina/NSTEMI 45 41.7 STEMI 7 6.5 Abnormal perfusion 2 1.9

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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

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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

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Ongoing Analysis

Died vs Lived: predictors of Mortality and MAE in- hospital and on follow-up Cath vs Conservative Rx Disposition after discharge Centurians?

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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

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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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Abstracts

Laham C, Jerin M, Shammas NW . 3-Dimensional Quantitative Coronary Angiography using Coronary Catheters as Objective Markers Reliably Unmasks Severe Occult Stenosis in Diffusely Diseased Vessels: New Results from the IQ-CATEGORIZE Lesions Study. Presented as a Late Breaking Clinical Trial by Laham at SCAI 2014 meeting, Las Vegas, May 28-21. Laham C, Jerin M, Shammas NW. 2-view quantitative coronary angiographic measurements corrected for reference vessel disease can predict lesion percent plaque area stenosis as reliably as IVUS. Presented at SCAI 2014 meeting, Las Vegas, May 28-21.Catheterization and Cardiovascular Interventions 2014;83 (Supplement):S96-97 (abstract B-054) 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. Presented at TCT 2013, San Francisco, October 27-Nov 1. J. Am Coll Cardiol. 2013; Vol. 62, Issue 18, Supplement 1, Page B163 Shammas NW, Gray W, Garcia L, Dave R, Meltser H, Kasper G. Preliminary results from the Jetstream navitus system Endovascular Therapy post- market (JET) registry. Presented at TCT 2013, San Francisco, October 27-Nov 1. J. Am Coll Cardiol. 2013; Vol. 62, Issue 18, Supplement 1, Page B163 Sarode K, Mohammad A, Hadidi OF, Thomas R, Das TM, Maduka J, Abu-Fadel M, Baig MS, Gigliotti O, Dieter R, TsaiTT, Ali MI, Klein A, Kumbhani DJ, Luna M, Shammas NW, Prasad A, Hastings JL, Addo T, Brilakis E, Banerjee S. Multicenter Registry for Peripheral Arterial Disease Interventions and Outcomes (XLPAD Registry). Presented at TCT 2013, San Francisco, October 27-Nov 1. J. Am. Coll. Cardiol. Vol. 62, Issue 18, Supplement 1, Pages B158-B159 Shammas NW, Gray W, Garcia L, Dave R, Meltser H, Kasper G. Preliminary results from the Jetstream navitus system Endovascular Therapy post- market (JET) registry. Presented at C3 2013, Orlando, Florida, June 19, 2013. J Invasive Cardiology, Shammas NW, Shammas GA. Preliminary results from the jetstream ISR registry in treating in-stent restenosis of femoropopliteal arteries. Abstract #4. Page 8, Proceedings of the 14th Annual New Cardiovascular Horizons Abstract book New Orleans, LA, June 5-7, 2013 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. Abstract #5. Page 9, Proceedings of the 14th Annual New Cardiovascular Horizons Abstract book New Orleans, LA, June 5-7, 2013 Shammas NW, Shammas GA, Nader E, Jerin M, Mrad L, Ehrecke N, Shammas WJ, Hafez A, Kelly R, Reynolds E. Outcomes of Patients Treated With The Paclitaxel- Versus The Everolimus -eluting Stents in a Consecutive Cohort of Patients at a Tertiary Medical Center. Presented at CRT 2013, Washington DC. J Am Coll Cardiol Intv. 2013;6(2_S):S16-S16 Shammas NW, Shammas GA, Jerin M. Age Differences in Long-Term Outcomes of Coronary Patients Treated with Drug Eluting Stents at a Tertiary Medical Center. Presented at CRT 2013, Washington DC. J Am Coll Cardiol Intv. 2013;6(2_S):S20-S21. Shammas NW, Shammas GA, Jerin M. Gender Differences in Long Term Outcomes of Coronary Patients Treated with Drug Eluting Stents at a Tertiary Medical Center. Presented at CRT 2013, Washington DC. J Am Coll Cardiol Intv. 2013;6(2_S):S20-S20 Shammas NW, Shammas GA, Hafez A, Kelley R, Reynolds E, Shammas AN. Safety and One-Year Revascularization Outcome of Excimer Laser Ablation Therapy in Treating In-Stent Restenosis of Femoropopliteal Arteries: A Retrospective Review from a Single Center. Presented at CRT 2013, Washington DC. J Am Coll Cardiol Intv. 2013;6(2_S):S29-S30 Shammas NW. Lam R, Mustapha J, Ellichman J, Aggarwala E, Rivera et al. Orbital Atherectomy and Balloon Angioplasty vs. Balloon Angioplasty Alone in Critical Limb Ischemia: Results of the CALCIUM 360 Trial. Abstracts and Late Breaking Trials at International Symposium on Endovascular Therapy 2013, Miami, Fl. Journal of Vascular and Interventional Radiology 2013: 145.e3 DOI: 10.1016/j.jvir.2010.04.029

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Book chapters

Shammas NW. Management of Chronic Venous Insufficiency. In: Bhatt Cardiovascular Interventions. A Companion to Braunwald’s Heart Disease, Elsevier Science, 2014 (In print) Toth PP, Shammas NW, Foreman B. Cardiovascular Medicine, in: Rakel Textbook of Family Medicine, Elsevier Science Health Science div, 2014 (in Print) Shammas NW. Treatment of subacute and chronic thrombotic

• cclusions of the lower extremity peripheral arteries: the role of

excimer laser. in Lasers in Cardiovascular Interventions (On Topaz, ed.) (in Print) Shammas NW, Padaria R, Coyne E. Pericarditis, Myocarditis and

• ther Cardiomyopathies. In Primary Care. Cardiovascular

Diseases Edited by Robert D. Sheeler) 2013 Mar;40(1):213-36

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Thank You for The Research Program at Genesis