Medical Student Research Fellowship for Summer 2010

Mentor: Subhash Banerjee, MD
Department: Cardiology, Veterans Hospital, Dallas
Room number: 5B-674
Mail Code: 111a
Phone number: 214-857-1608
E-mail: subhash.banerjee@utsouthwestern.edu
Project title: Study of Optimal Clopidogrel Duration post-Drug Eluting Coronary Stent Implants

Human subjects IRB approved project number (where applicable):
08-048 VA IRB

Project Type: patient-based research

Brief Description of Project:

ClinicalTrials.gov Identifier: NCT00781573

Although the optimal duration of clopidogrel (an anti-platelet agent) therapy has been established after bare metal stent implantation in the blood vessels of the heart, there is lack of consensus regarding the optimal duration of therapy after implantation of a drug eluting stents (DES). Current American College of Cardiology guidelines recommend clopidogrel use for at least one year in the absence of contraindications after DES implantation, while recognizing that the optimal duration remains unknown. While an extended clopidogrel therapy (that is beyond the current 1 year recommendation) may increase bleeding complication, it may reduce the rates of adverse cardiovascular events like heart attacks and repeat revascularization procedures. A clinical trial which randomizes patients with an uneventful one year course after a DES implantation, to an additional year of clopidogrel and aspirin therapy versus aspirin alone, will be able to answer the important question about the role of extended (2y) dual anti-platelet therapy with clopidogrel and aspirin after DES implants. The investigators hypothesize that clopidogrel discontinuation at 1 year post-DES implantation is associated with an increase in cardiovascular events during the one year of follow-up period.

Student's Role in Project: Cyril has been involved with the project since the design and initiation phase. His specific role now will include (not limited to):
1. Data collection form completion
2. Preparation of outcome tables for DSMB review
3. Preparation of abstract
4. Experience with statistical analysis

Previous Research Activities or Publications with Medical Students:
Cardiovascular Outcomes with Concomitant Use of Clopidogrel and Proton Pump Inhibitors post-PCI. Abstract Cardiovascular Revascularization Therapy, Washington DC 2009

Comparison of the impact of short (<1 year) and long-term (> or =1 year) clopidogrel use following percutaneous coronary intervention on mortality. Am J Cardiol. 2008 Nov 1;102(9):1159-62. Epub 2008 Sep 11.

Drug-eluting stents in saphenous vein graft interventions: a systematic review.
Brilakis ES, Saeed B, Banerjee S.
EuroIntervention. 2010 Jan;5(6):722-30.

Closure of a coexisting ostium secundum atrial septal defect and patent foramen ovale using a single Amplatzer patent foramen ovale occluder device.
Luna M, Banerjee S, Brilakis ES.
Cardiovasc Revasc Med. 2010 Jan-Mar;11(1):63-6.

Clinical presentation and angiographic characteristics of saphenous vein graft failure after stenting: insights from the SOS (stenting of saphenous vein grafts) trial.
Lichtenwalter C, de Lemos JA, Roesle M, Obel O, Holper EM, Haagen D, Saeed B, Iturbe JM, Shunk K, Bissett JK, Sachdeva R, Voudris VV, Karyofillis P, Kar B, Rossen J, Fasseas P, Berger P, Banerjee S, Brilakis ES.

Prior coronary artery bypass graft surgery patients undergoing diagnostic coronary angiography have multiple uncontrolled coronary artery disease risk factors and high risk for cardiovascular events.
Boatman DM, Saeed B, Varghese I, Peters CT, Daye J, Haider A, Roesle M, Banerjee S, Brilakis ES.

Subclavian artery intervention with vertebral embolic protection.
Michael TT, Banerjee S, Brilakis E.
Catheter Cardiovasc Interv. 2009 Jul 1;74(1):22-5.

Perioperative risk of patients undergoing noncardiac surgery after coronary artery bypass surgery.
Daye J, Boatman D, Peters C, Varghese I, Haider A, Roesle M, Jessen ME, Dimaio JM, Banerjee S, Brilakis ES.
J Investig Med. 2008 Aug;56(6):878-81.