Highlights of Cardiology Research At Genesis · Grant from Genesis Research Program) Characteristics Gender - Male 109 36 13.9 CAD - Yes 109 69 63.3 Prior PCI - Yes 109 26 23.9 Prior

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

3

Absorb BVS

Bioresorbable Stents

BVS

REVA

Biotronik

BIT

Igaki-Tamai PLA

Tyrosine-

Policarbonate

PAE-Salicylate

Magnesium

PLA

BL 2Y

Resolved ISA

Non Discernible

Persistent

ISA ISA incomplete

stent apposition

Bioresorption and vessel wall integration are a reality.

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?

Study design

7

ABSORB IIIRandomized 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

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

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 ObjectivePivotal trial to support the US pre-market approval of Absorb BVS Randomized 2:1 ABSORB:XIENCE

Primary EndpointTarget lesion failure at 1-year (composite of cardiac death, target vessel MI or ischemia driven-TLR)

TreatmentUp 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

9

No ECG

*

(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 109 36 13.9

CAD - Yes 109 69 63.3

Prior PCI - Yes 109 26 23.9

Prior CABG - Yes 107 20 18.7

Previous MI - Yes 109 28 25.7

Prior Family Hx - Yes 109 7 6.4

Renal Insufficiency - Yes 109 36 33

Renal Failure -Yes 109 7 6.4

PVD - Yes 109 12 11

HTN - Yes 109 88 80.7

CVD - Yes 109 25 22.9

Hyperlipidemia - Yes 109 49 45

COPD 109 16 14.7

Cardiomyopathy - Yes 109 8 7.3

Heart Failure - Yes 109 33 30.3

Atrial fibrillation - Yes 109 24 22

Tobacco Use - Past 109 23 21.1

DM - Yes 109 26 23.9

Dementia - Yes 109 17 15.6

Valvular Disease - Yes 109 20 18.3

Pacemaker - Yes 109 12 11

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 FemoropoplitealArtery: Mechanical, Biological and Procedural Factors. Int J Angiol 2013:22:1-8

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, KumbhaniDJ, 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

Book chaptersShammas 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

occlusions 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

other Cardiomyopathies. In Primary Care. Cardiovascular

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

Thank You for The Research Program at Genesis