29
Highlights of Cardiovscular Research At Genesis/MCRF/CVM Nicolas W Shammas, MD, MS, FACC, FSCAI, FICA Research Director, Midwest Cardiovascular Research Foundation Interventional Cardiologist, Cardiovascular Medicine, PC Genesis Heart Institute

Highlights of Cardiovscular Research At Genesis/MCRF/CVM Nicolas W Shammas, MD, MS, FACC, FSCAI, FICA Research Director, Midwest Cardiovascular Research

Embed Size (px)

Citation preview

Page 1: Highlights of Cardiovscular Research At Genesis/MCRF/CVM Nicolas W Shammas, MD, MS, FACC, FSCAI, FICA Research Director, Midwest Cardiovascular Research

Highlights of Cardiovscular Research At Genesis/MCRF/CVM

Nicolas W Shammas, MD, MS, FACC, FSCAI, FICA

Research Director, Midwest Cardiovascular Research Foundation

Interventional Cardiologist, Cardiovascular Medicine, PC

Genesis Heart Institute

Page 2: Highlights of Cardiovscular Research At Genesis/MCRF/CVM Nicolas W Shammas, MD, MS, FACC, FSCAI, FICA Research Director, Midwest Cardiovascular Research

Conflict of Interest

Research grants or subsidies for MCRF-based research projects (to the Midwest Cardiovascular Research Foundation)All research grants and support are sent directly to MCRF. Significant Grants for investigator initiated studies have been received from Boston Scientific, Possis, Edwards, the Medicines Co, ev3, Schering-Plough, Fox-Hollow, Spectranetics, Atrium, Gilead, Medtronic, Genesis Foundation, CSI, BayerEducational grants/ philanthropist support from industry (to the Midwest Cardiovascular Research Foundation)Abbott Vascular, AGA Medical, Astellas Pharmaceuticals, AstraZeneca, Boehringer-Ingelheim, Boston Scientific, Cordis Vascular, Daiichi Sankyo, ev3, Gilead Sciences, IDEV Technologies, Lilly USA, Pfizer, BMS, The Medicines Company, Medtronic Cardiovascular, Spectranetics, St. Jude Medical, Takeda Pharmaceuticals, Terumo Medical, and Zoll Lifevest.ConsultantCSI, Medicines Company, Covidien/ev3, NAMSA, Boston ScientificTrainerCovidien. RF ablation procedureBoston Scientific. JetStream AtherectomyCSI. Orbital atherectomyStocks, Options, InvestmentsDr Shammas has no commercial, proprietary or financial interest in any pharmaceutical or device companies or their products and has no intention in doing so in the near future.

Page 3: Highlights of Cardiovscular Research At Genesis/MCRF/CVM Nicolas W Shammas, MD, MS, FACC, FSCAI, FICA Research Director, Midwest Cardiovascular Research

Cardiovascular Research in QC, Iowa

Page 4: Highlights of Cardiovscular Research At Genesis/MCRF/CVM Nicolas W Shammas, MD, MS, FACC, FSCAI, FICA Research Director, Midwest Cardiovascular Research

Key Findings Since January of 2015

• In a Randomized, double-blind crossover study (Therapeutics and Clinical Risk Management 2015)

– Ranolazine in patients with ischemic cardiomyopathy on optimal medical therapy including 2 anti-anginals was safe and resulted in significant reduction in anginal attacks

Page 5: Highlights of Cardiovscular Research At Genesis/MCRF/CVM Nicolas W Shammas, MD, MS, FACC, FSCAI, FICA Research Director, Midwest Cardiovascular Research

Key Findings Since January of 2015Excimer laser atherectomy for treatment of femoropopliteal in-stent restenosis: initial results from the EXCITE ISR trial . JACC InterventionLaser ablation to restenotic tissue was superior to POBA in reducing the chance for target lesion revascularization

Product-Limit Survival Estimates

Days

FR

EE

DO

ME

FR

OM

TLR

Page 6: Highlights of Cardiovscular Research At Genesis/MCRF/CVM Nicolas W Shammas, MD, MS, FACC, FSCAI, FICA Research Director, Midwest Cardiovascular Research

Key Findings Since January of 2015Excellence in Peripheral Arterial Disease Registry (xl-PAD)

1.Define for the first time the incidence of acute stent thrombosis in PPI2.Define the differences in strategy between using a specialized crossing device vs balloon and wires for chronic total occlusion3.Evaluating different practices in dual antiplatelet management post percutaneous intervention4.Evaluating outcomes between a stent vs a no stent strategy in peripheral arterial interventions

Page 7: Highlights of Cardiovscular Research At Genesis/MCRF/CVM Nicolas W Shammas, MD, MS, FACC, FSCAI, FICA Research Director, Midwest Cardiovascular Research

Key Findings since January 2015

PCI and a higher SBP on admission appear to be an independent predictor of long-term survival in patients over the age of 90 years admitted with an ACS at a tertiary medical center.

Predictors of Long-Term Survival of Acute Coronary Syndrome Patients Over 90 Years of Age Admitted to a Tertiary Care Center

Page 8: Highlights of Cardiovscular Research At Genesis/MCRF/CVM Nicolas W Shammas, MD, MS, FACC, FSCAI, FICA Research Director, Midwest Cardiovascular Research

Key Findings Since January of 2015Number of Runs Using the JetStream Navitus Atherectomy Device to Achieve Optimal Tissue Debulking of in-Stent Restenosis in a Porcine Stent/Balloon Injury Overstretch Model ( In print in JEVT 2015)Define for the first time the optimal number of runs using the Jetstream atherectomy device to be 2 BD and 2 BU to obtain best debulking within a stent

Page 9: Highlights of Cardiovscular Research At Genesis/MCRF/CVM Nicolas W Shammas, MD, MS, FACC, FSCAI, FICA Research Director, Midwest Cardiovascular Research

JetStream ISR Feasibility Study

• DESIGN: Prospective, feasibility registry at 2 centers, evaluating JetStream XC atherectomy (JS) in treating Femoropopliteal in-stent restenosis (FP ISR)

• OBJECTIVE: To evaluate efficacy and safety of JS with adjunctive PTA (JS+PTA) and assess stent-device interaction using Angiographic Core Lab adjudication

• PRINCIPAL INVESTIGATOR Nicolas W Shammas, MD, MS• SUBINVESTIGATOR Subhash Banerjee, MD• Angiographic Core Laboratory Beth Israel Deaconess Med Ctr Jeffrey Popma, MD

29 patients (32 limbs) enrolled at 2 clinical sites between October 2012 and August

2014 in the United States

32 limbs crossed intraluminally/JS+PTA

Stent Integrity evaluation per core lab (n=24)

Primary Safety endpoint and TLR

(n=27 pts; n=29 limbs)

Primary Efficacy/Safety

endpoints at 1 mo (n=32)

1 patient died (2 limbs)1 patient withdrew (1 limb)

Page 10: Highlights of Cardiovscular Research At Genesis/MCRF/CVM Nicolas W Shammas, MD, MS, FACC, FSCAI, FICA Research Director, Midwest Cardiovascular Research

JetStream XC

Cutter size: JETSTREAM®XC - 2.1mm/3.0mm 120 cm

Vessel size 3.5-5 mmBD 3.5-4.0 mmBD/BU 4.0-5.0 mm

- 2.4mm/3.4mm 135 cm Vessel size > 5.0 mm

Page 11: Highlights of Cardiovscular Research At Genesis/MCRF/CVM Nicolas W Shammas, MD, MS, FACC, FSCAI, FICA Research Director, Midwest Cardiovascular Research

Primary Endpoints

Primary Efficacy Endpoint• Acute Procedural Success

• Less or equal 30% residual narrowing With no serious adverse events• Acute Device Success (secondary endpoint)(Less or equal 50% residual narrowing after JS alone)

Primary Safety Endpoint• Major Adverse Events :

• In-hospital: Treated DE, Perforation, Major Bleeding, death, amputation, acute closure, access complication, Acute renal failure, adverse stent-device interaction (fracture/deformity)

• 30 days and 6 months: Death, unplanned amputation, freedom from clinically driven TLR (recurrence of symptoms with abnormal ABI or confirmed loss of patency angiographically >50% lesion ), Stent deformity and fracture (6 months)

Page 12: Highlights of Cardiovscular Research At Genesis/MCRF/CVM Nicolas W Shammas, MD, MS, FACC, FSCAI, FICA Research Director, Midwest Cardiovascular Research

Inclusion and Exclusion Criteria

• Inclusion Criteria

• Femoropopliteal lesions with in-stent restenosis of > 50%

• Rutherford-Becker category of 1-5

• One patent infrapopliteal distal runoff

• Vessel Diameter of > 5 mm

• No lesion length limit• Exclusion Criteria

• Not able to give informed consent

• Unable to take antiplatelet drugs post procedure

• Cr > 2.5 mg per dl

• Planned surgical or endovascular procedure within 15 days of the index procedure

• Displaced stent fractures

Page 13: Highlights of Cardiovscular Research At Genesis/MCRF/CVM Nicolas W Shammas, MD, MS, FACC, FSCAI, FICA Research Director, Midwest Cardiovascular Research

Clinical and Angiographic Variables

Demographic and Clinical

Angiographic

Age (mean) yrs 69.9 Treated length mm 19.5 ± 12.9Male 37.9 % Lesion Diam. mm 5.3 ± 0.8Hyperlipidemia 82.8 % Run-off vessels 1.8 ± 0.9Diabetes 41.4 % Stenosis Severity % 79.6 ± 16.3Hypertension 89.7 % Stenosis post JS % 45 ± 15.5Current smoking 41.4 % Stenosis post PTA % 20 ± 10.7Prior index lesion ISR 66.0 % TASC C/D 62.5 %Prior PCI 48.3 % Blades Up run time min 2.5 ± 1.6

Rutherford Category Blades Down run time min 2.9 ± 1.80 6.3 % Treatment Interval min 5.1 ± 3.33 65.6 % JS XC 2.4 78.1 %4 12.5 % JS XC 2.1 21.9 %5 15.6% Mean Volume Aspirate ml 230

On Aspirin 90.6 % Lesions > 30 cm/CTO 25 %/25%On ADP-receptor antagonist 75 % Stent Fracture 1&2 3/24 (12.5%)

Page 14: Highlights of Cardiovscular Research At Genesis/MCRF/CVM Nicolas W Shammas, MD, MS, FACC, FSCAI, FICA Research Director, Midwest Cardiovascular Research

Intraprocedural Outcomes/ComplicationsDevice Success 75.9 %

Residual Stenosis <30%(post adjunctive balloon)

100%

Procedural Success (no SAE) 90.6 %

Stenting post JS/PTA 9.4%

Bail out stenting (2/32) 6.3%

Treated Distal Embolization 9.4%

No Filter 6.3 %

Spider Filter 3.1%

Nav-6 Filter 0%

New Stent Fracture or Deformities (Core Lab)(n=24)

0%

No Abrupt Closure, acute thrombosis, perforation, major bleeding

Page 15: Highlights of Cardiovscular Research At Genesis/MCRF/CVM Nicolas W Shammas, MD, MS, FACC, FSCAI, FICA Research Director, Midwest Cardiovascular Research

Baseline Post Jetstream Post Angioplasty

JetStream ISR patient: Baseline, postJS and post adjunctive balloon angioplasty

Page 16: Highlights of Cardiovscular Research At Genesis/MCRF/CVM Nicolas W Shammas, MD, MS, FACC, FSCAI, FICA Research Director, Midwest Cardiovascular Research

Primary Safety endpoint: 30 d and 6 months

TLR/TVR 30 days 0 %

Death 30 days 0 %

Amputation 30 days 0 %

Death 6 months (non vascular) 3.4 %

Freedom from TLR 6 mo (not including intraprocedural bail out stenting as TLR)

86.2 %

Freedom from TLR 6 mo (including intraprocedural bail out stenting as TLR)

79.3 %

Patency 6 mo 72 %New Stent Fracture or Deformities (Core Lab) at 6 mo (n=24) 0 %

Amputation 6 mo 0 %

Page 17: Highlights of Cardiovscular Research At Genesis/MCRF/CVM Nicolas W Shammas, MD, MS, FACC, FSCAI, FICA Research Director, Midwest Cardiovascular Research

Freedom from TLR (censored)

Page 18: Highlights of Cardiovscular Research At Genesis/MCRF/CVM Nicolas W Shammas, MD, MS, FACC, FSCAI, FICA Research Director, Midwest Cardiovascular Research

ABI and Rutherford Becker Category

Baseline 6 monthsBaseline ABI 0.7 ± 0.3 6-month ABI 0.8 ± 0.2

(p=0.039)Rutherford Category

Rutherford Category(p=0.035)

0 6.3 % 0 14.3 %1 & 2 0% 1 & 2 35.8 %

3 65.6 % 3 35.7 %4 12.5 % 4 3.6 %5 15.6% 5 10.7 %

Page 19: Highlights of Cardiovscular Research At Genesis/MCRF/CVM Nicolas W Shammas, MD, MS, FACC, FSCAI, FICA Research Director, Midwest Cardiovascular Research

Atherectomy for FP ISR: TLR* at 6 mo and 1 yr

*TLR does not include bail out stenting Liistro F. DEBATE-ISR. J Endovasc Ther. 2014;21:1-8; Krankenberg. FAIR Trial. LINC 2014; Dippel EJ. EXCITE ISR JACC Cardiovasc Interv. 2015;8 (1 Pt A):92-101; Shammas NW. SilverHawk in in-stent restenosis Cardiovasc Revasc Med. 2012;13:341-4 ; Shammas NW Excimer laser in in-stent restenosis Cardiovasc Revasc Med. 2012;13:341-4 ; Schmidt A. PATENT. J Endovasc Ther. 2014;21:52-60; Dake MD. Zilver PTX randomized study results. Circ Cardiovasc Interv. 2011;4:495-504; Stabile E. J Am Coll Cardiol. 2012;60:1739-42; Zeller T. JACC Cardiovasc Interv. 2013;6:274-81.

Atherectomy in FP ISR DCB/DCS in FP ISR

Page 20: Highlights of Cardiovscular Research At Genesis/MCRF/CVM Nicolas W Shammas, MD, MS, FACC, FSCAI, FICA Research Director, Midwest Cardiovascular Research

Conclusions

• JS atherectomy is effective and safe in this feasibility prospective registry in treating FP ISR:

• In long lesions averaging 19.5 cm in length, CTO 25%• With high procedural (100% < 30% residual) and device success (75.9% <

50% residual)• No stent-device interaction by adjudicated Angiographic Core Lab (even in

Class 1 and 2 fractures and stent overlap)• TLR rates in the same range as published literature for laser

• JS atherectomy for FP ISR is off label and this data needs to be validated in a larger prospective trial

• Combining atherectomy with DCB in treating FP ISR may be promising and is currently being investigated

Page 21: Highlights of Cardiovscular Research At Genesis/MCRF/CVM Nicolas W Shammas, MD, MS, FACC, FSCAI, FICA Research Director, Midwest Cardiovascular Research

Animal Data + Feasibility Pilot study Study=?

1.4 Mil dollars grant to finish this project in a multicenter (14 sites) study that will be under an IDE.

Stay tuned for the results !!!

Page 22: Highlights of Cardiovscular Research At Genesis/MCRF/CVM Nicolas W Shammas, MD, MS, FACC, FSCAI, FICA Research Director, Midwest Cardiovascular Research

Manuscripts 2015 (n=12)

• Shammas NW, Shammas GA, Keyes K, Duske S, Kelly R, Jerin M. Ranolazine versus placebo in patients with ischemic cardiomyopathy and persistent chest pain or dyspnea despite optimal medical and revascularization therapy: a pilot randomized, double-blind crossover study. Therapeutics and Clinical Risk Management 2015;11:469-74. doi: 10.2147/TCRM.S82288. eCollection 2015.

• Shammas NW, Aasen N, Bailey L, Budrewicz J, Farago T, Jarvis G. Number of Runs Using the JetStream Navitus Atherectomy Device to Achieve Optimal Tissue Debulking of in-Stent Restenosis in a Porcine Stent/Balloon Injury Overstretch Model (In print, JEVT)

• Banerjee S, Sarode K, Mohammad A, Gigliotti O, Baig S, Tsai S, Shammas NW, Prasad A, Abu-Fadel M, Klein A, Armstrong E, Brilakis E. Peripheral Artery Stent Thrombosis: Report from the Excellence in Peripheral Artery Disease (XLPAD) Registry (in Print in Circulation Intervention)

• Banerjee S, Pershwitz G, Sarode K, Mohammad A, Abu-Fadel M, Baig M, Tsai S, Little BB, Gigliotti O, Klein A, Addo T, Luna M, Shammas NW, Prasad A, Brilakis E. Multicenter Registry for Peripheral Arterial Disease Interventions and Outcomes (XLPAD Registry) (submitted)

• Banerjee S, Sarode K, Patel A, Mohammad A, Parikh R, Armstrong EJ, Tsai S, Shammas NW, Brilakis ES. Comparative Assessment of Guidewire and Microcatheter versus Crossing Device-Based Strategy to Traverse Infrainguinal Peripheral Artery Chronic Total Occlusions 2015 May 18. pii: 1526602815587707. [Epub ahead of print]

• Sarode K, Mohammad A, Das S, Vinas A, Banerjee A, Klein A, Armstrong EJ, Shammas NW, Brilakis ES, Banerjee S. Comparison of Dual Antiplatelet Therapy Durations after Endovascular Revascularization of Infrainguinal Arteries. Ann Vasc Surgery (In Print)

• Dippel EJ, Makam P, Kovach R, George JC, Patlola R, Metzger DC, Mena-Hurtado C, Beasley R, Soukas P, Colon-Hernandez PJ, Stark MA, Walker C; EXCITE ISR Investigators.(Dr Shammas listed as a collaborator) . Randomized controlled study of excimer laser atherectomy for treatment of femoropopliteal in-stent restenosis: initial results from the EXCITE ISR trial (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis). JACC Cardiovasc Interv. 2015;8(1 Pt A):92-101. doi: 10.1016/j.jcin.2014.09.009. Epub 2014 Dec 10.

Page 23: Highlights of Cardiovscular Research At Genesis/MCRF/CVM Nicolas W Shammas, MD, MS, FACC, FSCAI, FICA Research Director, Midwest Cardiovascular Research

Manuscripts-continued• Banerjee S, Pershwitz G, Sarode K, Mohammad A, Abu-Fadel MS, Baig MS, Tsai S, Little BB,

Gigliotti OS, Soto-Cora E, Foteh MI, Rodriguez G, Klein A, Addo T, Luna M, Shammas NW, Prasad A, Brilakis E. Stent and Non-stent Based Outcomes of Infrainguinal Peripheral Artery Interventions From the Multicenter XLPAD Registry. J Invasive Cardiol. 2015;27(1):14-8

• Shammas NW, Banerjee S. Should we Routinely Stent the Femoropopliteal Artery? An Interventionalist’s Perspective. J Invasive Cardiol 2015; (In print)

• Banerjee A, Shammas NW, Brilakis ES, Banerjee S. Antiplatelet therapy in lower extremity peripheral arterial interventions (submitted)

• Shammas NW. Treating Subacute Thrombus in Peripheral Arterial Disease: the Effectiveness of Ultrasound-Accelerated Lysis. J Endovasc Ther;2015;22:96-98

• Shammas NW, Shammas GA, Jerin M, Shanks C, Dvorak A, Serrano P, Harb C, Voelliger CM. Predictors of Long-Term Survival of Acute Coronary Syndrome Patients Over 90 Years of Age Admitted to a Tertiary Care Center. J Am Geriatrics Society 2015;(In print)

Collaborative work with over 25 institutions in the United States

Page 24: Highlights of Cardiovscular Research At Genesis/MCRF/CVM Nicolas W Shammas, MD, MS, FACC, FSCAI, FICA Research Director, Midwest Cardiovascular Research

Abstracts 2015 (n=17)• Laham C, Chandra M, Kettlekamp R, Shammas NW. OUTSIDE START Cilostazol Bridge Study: 8-year experience with

Outpatient Cilostazol Bridging in High Stent Thrombosis Risk Paclitaxel Drug Eluting Stents in Patients having Surgery during the Proven at Risk Period. Presented at SCAI 2015, San Diego May 6-9, 2015 as a Late Breaking Clinical Trial Slides: http://clinicaltrialresults.org/Slides/SCAI2015/Laham_OUTSIDE-START.pdf

• Shammas NW, Sarode K, Mohammad A, Master R, Shammas AN, Ali MI, Gigliotti OS, Armstrong EJ, Brilakis ES, Banerjee S. Indications for use and outcomes with the Jetstream atherectomy device from the XLPAD registry. Presented at SCAI 2015, San Diego May 6-9, 2015. Catheterization and Cardiovascular Interventions 2015. Abstracts 082, S51

• Esparza MI, Sarode K, Mohammed A, Spelber D, Klein A, Dieter RS, Shammas NW, Ali MI, Luna M, Addo T, Abu-Fadel M, Brilakis E, Banerjee S, Tsai S, Gigliotti OS, Baig M, Armstrong EJ, Sethi S, Prasad P. Incidence, Predictors, Management, and Prevention of Distal Embolization During Endovascular Therapy for Infrainguinal Peripheral Arterial Disease. Presented at SCAI 2015, San Diego May 6-9, 2015. Catheterization and Cardiovascular Interventions 2015. Abstracts O-04, S44

• Laham C, Chandra M, Shammas NW. Cilostazol Bridging in Patients with Drug Eluting Stents Undergoing Surgical Interventions and Requiring Interruption of Dual Antiplatelet Therapy. Presented at SCAI 2015, San Diego May 6-9, 2015. Catheterization and Cardiovascular Interventions 2015. Abstracts O-04, S44

• Banerjee S, Sarode K, Mohammad A, Gigliotti O, Luna M, Addo T, Baig M, Tsai S, Shammas NW, Prasad A, Abu-Fadel M, Klein A, Brilakis E. Experience Treating In-Stent Restenosis Lesions from a Multicenter Registry. Presented at American College of Cardiology Scientific Sessions, San Diego, CA, March 2015. JACC 2015;65(10S): A1845

• Sarode K, Mohammad A, Gigliotti O, Luna M, Addo T, Baig M, Tsai S, Shammas NW, Prasad A, Abu-Fadel, M, Klein A, Brilakis E, Banerjee S. Zilver PTX Drug-Coated Peripheral Artery Stent Use in a U.S. Multicenter Registry. Presented at American College of Cardiology Scientific Sessions, San Diego, CA, March 2015. JACC 2015;65(10S): A1811

• Banerjee S, Sarode K, Mohammad A, Gigliotti O, Luna M, Addo T, Baig M, Tsai S, Shammas NW, Prasad A, Abu-Fadel M, Klein A, Brilakis E. Peripheral Artery Stent Thrombosis: Report from the Excellence in Peripheral Artery Disease (XLPAD) Registry. Presented at American College of Cardiology Scientific Sessions, San Diego, CA, March 2015. JACC 2015;65(10S): A1696

• Shammas NW, Shammas GA, Park H, Banerjee S, Mohammad A, Jerin M. Safety and in-Hospital Outcomes of JetStream Atherectomy in Treating In-Stent Restenosis of Femoropopliteal Arteries. Presented at American College of Cardiology Scientific Sessions, San Diego, CA, March 2015. JACC 2015;65(10S): A1812

• Prasad A, Sarode K, Mohammad A, Brilakis E, Gigliotti O, Luna M, Addo T, Baig M, Shammas NW, Abu-Fadel M, Ortiz-Lopez C, Spelber D, Esparza M, Tsai S, Banerjee S. Contrast media use during endovascular therapy for infrainguinal peripheral arterial disease: Insights from the multicenter xl-PAD registry. JACC 2015;65(10S): A1745

Page 25: Highlights of Cardiovscular Research At Genesis/MCRF/CVM Nicolas W Shammas, MD, MS, FACC, FSCAI, FICA Research Director, Midwest Cardiovascular Research

• Shammas NW, Shammas GA, Banerjee S, Popma JJ, Mohammad A, Jerin M. Six-Month revascularization outcome of JetStream Atherectomy in treating in-stent restenosis of femoropopliteal arteries: Results of the JetStream-ISR Study. Presented at CRT, Washington DC, February 2015. . JACC: Cardiovascular Interventions 2015;8 (Suppl S): S3

• Laham C, Chandra M, Shammas NW. Cilostazol Bridging in Patients with Drug Eluting Stents Undergoing Surgical Interventions and Requiring Interruption of Dual Antiplatelet Therapy. Presented at CRT, Washington DC, February 2015. JACC: Cardiovascular Interventions 2015;8 (Suppl S): S2

• Shammas NW, Aasen N, Bailey L, Budrewicz J, Farago T, Jarvis G Optimal Number of Runs Using the JetStream Navitus Device to Achieve Maximum Tissue Debulking of in-Stent Restenosis in a Porcine Stent/Balloon Injury Overstretch Model. Presented at CRT, Washington DC, February 2015. JACC: Cardiovascular Interventions 2015;8 (Suppl S): S35

• Shammas NW, Aasen N, Bailey L, Budrewicz J, Farago T, Jarvis G Minimal Plaque Surface Area and Minimal Luminal Area Needed for Effective Atherectomy using the JetStream Navitus in Treating In-Stent Restenosis of Femoral Artery in a Porcine Model. Presented at CRT, Washington DC, February 2015. JACC: Cardiovascular Interventions 2015;8 (Suppl S): S34

• Shammas NW, Aasen N, Bailey L, Budrewicz J, Farago T, Jarvis G. Intravascular Ultrasound Assessment of the Optimal Number of Runs Using the JetStream Navitus Device to Achieve Maximum Tissue Debulking in Femoral Artery in-Stent Restenosis Porcine Model. Presented at CRT, Washington DC, February 2015. JACC: Cardiovascular Interventions 2015;8 (Suppl S): S35

• Shammas NW, Gray W, Garcia L, Amin A, Dave R, Mehta M, Davis T, Chang K, Bernardo N for the JET investigators. Procedural Success and in-hospital Outcomes in Treating Femoropopliteal Arteries with the JetStream Navitus System in the post-Market JET Registry. Presented at CRT, Washington DC, February 2015. JACC: Cardiovascular Interventions 2015;8 (Suppl S): S35

• Shammas NW, Shammas GA, Robken J, Harris T, Madison A, Dinklenburg C, Shammas AN, Harb C, Jerin M. Acute Procedural Success and One-Year Outcome of Patients Treated for Coronary Chronic Total Occlusion Early in the Experience of a Single Operator at a Tertiary Medical Center. Presented at Cardiovascular Revascularization Therapies, Washington DC, February 2015

• Shammas NW, Shammas GA, Robken J, Harris T, Madison A, Dinklenburg C, Shammas AN, Harb C, Jerin M. The Learning Curve in Treating Coronary Chronic Total Occlusion Early in the Experience of an Operator at a Tertiary Medical Center.Presented at Cardiovascular Revascularization Therapies, Washington DC, February 2015

Abstracts Continued

Page 26: Highlights of Cardiovscular Research At Genesis/MCRF/CVM Nicolas W Shammas, MD, MS, FACC, FSCAI, FICA Research Director, Midwest Cardiovascular Research

Book chapters 2015 (n=3)

• Shammas NW. Management of Chronic Venous Insufficiency. In: Bhatt Endovascular Interventions. A Companion to Braunwald’s Heart Disease, Elsevier Science, 2015 (In print)

• Toth PP, Shammas NW, Foreman B. Cardiovascular Medicine, in: Rakel Textbook of Family Medicine, Elsevier Science Health Science div, 2015

• 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.) 2015 (in Print)

Page 27: Highlights of Cardiovscular Research At Genesis/MCRF/CVM Nicolas W Shammas, MD, MS, FACC, FSCAI, FICA Research Director, Midwest Cardiovascular Research

New Clinical Trials 2015 (n=9)

• SPIRE 1. PHASE 3 MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED,PLACEBO-CONTROLLED, PARALLEL GROUP EVALUATION OF THE EFFICACY, SAFETY, AND TOLERABILITY OF BOCOCIZUMAB (PF-04950615), IN REDUCING THE OCCURRENCE OF MAJOR CARDIOVASCULAR EVENTS IN HIGH RISK SUBJECTS (Principal Investigator, MCRF, Shammas NW, 2015)

• SPIRE 2. PHASE 3 MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED,PLACEBO-CONTROLLED, PARALLEL GROUP EVALUATION OF THE EFFICACY, SAFETY, AND TOLERABILITY OF BOCOCIZUMAB (PF-04950615), IN REDUCING THE OCCURRENCE OF MAJOR CARDIOVASCULAR EVENTS IN HIGH RISK SUBJECTS. (Principal Investigator, MCRF, Shammas NW, 2015)

• SAFE-DCB Registry. A Prospective, Multicenter, Single Arm, Real-World Registry Assessing the Clinical Use of the Lutonix 035 Drug Coated Balloon (DCB) Catheter in Arteries of the Superficial Femoral Artery (SFA) and Popliteal Artery (PA) (Principal Investigator, MCRF, Shammas NW, 2015)

• ASPIRE trial. Antiplatelet Strategy for Peripheral Arterial Interventions for Revascularization of Lower Extremities (Sub-investigator, MCRF, Shammas NW, 2015)

• THEMIS trial. A Study Comparing Cardiovascular Effects of Ticagrelor versus Placebo in Patients With Type 2 Diabetes Mellitus (Principal Investigator, MCRF, Shammas NW, 2015)

• LIBERTY 360°: Prospective, Observational, Multi-Center Clinical Study to Evaluate Acute and Long Term Clinical and Economic Outcomes of Endovascular Device Intervention in Patients with Distal Outflow Peripheral Arterial Disease (PAD) (Principal Investigator, MCRF, Shammas NW, 2015)

• DART Registry. Diagnosing Adverse Drug Reactions Registry. (Principal Investigator, MCRF, Shammas NW, 2015)

• COMPASS – Cardiovascular Outcomes for People Using Anticoagulation Strategies (Principal Investigator, MCRF, Shammas NW, 2015)

• Bolster (iliac stent trial. PI Dippel, 2015)

Page 28: Highlights of Cardiovscular Research At Genesis/MCRF/CVM Nicolas W Shammas, MD, MS, FACC, FSCAI, FICA Research Director, Midwest Cardiovascular Research

Summary for the first 6 months of 2015• Manuscripts: 12

• Abstracts: 17

• Book chapters: 3

Clinical trials: 9

32 publications in 6 months (~1.3 publications/week)

Journals

JEVT

JACC Interv

JACC

JIC

CCI

Ann Vasc Surgery

Therapeutics and Clinical Risk Management

Circulation Intervention

J Am Geriatrics Society

Page 29: Highlights of Cardiovscular Research At Genesis/MCRF/CVM Nicolas W Shammas, MD, MS, FACC, FSCAI, FICA Research Director, Midwest Cardiovascular Research