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Coronary Artery Disease: HELP
Articles by Sunil V. Rao
Based on 58 articles published since 2008
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Between 2008 and 2019, Sunil Rao wrote the following 58 articles about Coronary Artery Disease.
 
+ Citations + Abstracts
Pages: 1 · 2 · 3
1 Guideline SCAI expert consensus statement: 2016 best practices in the cardiac catheterization laboratory: (Endorsed by the cardiological society of india, and sociedad Latino Americana de Cardiologia intervencionista; Affirmation of value by the Canadian Association of interventional cardiology-Association canadienne de cardiologie d'intervention). 2016

Naidu, Srihari S / Aronow, Herbert D / Box, Lyndon C / Duffy, Peter L / Kolansky, Daniel M / Kupfer, Joel M / Latif, Faisal / Mulukutla, Suresh R / Rao, Sunil V / Swaminathan, Rajesh V / Blankenship, James C. ·Division of Cardiology, Winthrop University Hospital, Mineola, New York. ssnaidu@winthrop.org. · Warren Alpert Medical School of Brown University, Cardiovascular Institute, Providence, RI. · West Valley Medical Center, Caldwell, ID. · FirstHealth of the Carolinas, Pinehurst, NC. · Cardiovascular Medicine Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA. · University of Illinois School of Medicine-Peoria, Peoria, IL. · University of Oklahoma and VA Medical Center, Oklahoma City, OK. · University of Pittsburgh and VA Pittsburgh Healthcare System, Pittsburgh, PA. · Duke University Medical Center, Durham, NC. · Weill Cornell Medical College, New York-Presbyterian Hospital, Greenberg Division of Cardiology, New York, NY. · Geisinger Medical Center, Danville, PA. ·Catheter Cardiovasc Interv · Pubmed #27137680.

ABSTRACT: -- No abstract --

2 Guideline Management of platelet-directed pharmacotherapy in patients with atherosclerotic coronary artery disease undergoing elective endoscopic gastrointestinal procedures. 2009

Becker, Richard C / Scheiman, James / Dauerman, Harold L / Spencer, Frederick / Rao, Sunil / Sabatine, Marc / Johnson, David A / Chan, Frances / Abraham, Neena S / Quigley, Eamonn M M / Anonymous1490644 / Anonymous1500644. ·Duke University Medical Center, Duke Clinical Research Institute, Durham, NC 27705, USA. becke021@mc.duke.edu ·J Am Coll Cardiol · Pubmed #19942393.

ABSTRACT: The periprocedural management of patients with atherosclerotic coronary heart disease, including those who have heart disease and those who are undergoing percutaneous coronary intervention and stent placement who might require temporary interruption of platelet-directed pharmacotherapy for the purpose of an elective endoscopic gastrointestinal procedure, is a common clinical scenario in daily practice. Herein, we summarize the available information that can be employed for making management decisions and provide general guidance for risk assessment.

3 Editorial Complete Coronary Revascularization: The End Justifies the Means, as Long as Something Justifies the End. 2017

Rao, Sunil V. ·Duke Clinical Research Institute, Durham, North Carolina. Electronic address: sunil.rao@duke.edu. ·JACC Cardiovasc Interv · Pubmed #28728655.

ABSTRACT: -- No abstract --

4 Editorial Staying ahead of the curve. 2014

Rao, Sunil V / Cohen, Mauricio G. ·The Duke Clinical Research Institute, Durham, NC. Electronic address: sunil.rao@duke.edu. · University of Miami Miller School of Medicine, Miami, FL. ·Cardiovasc Revasc Med · Pubmed #24952683.

ABSTRACT: -- No abstract --

5 Editorial Isn't it about time we learned how to use blood transfusion in patients with ischemic heart disease? 2014

Rao, Sunil V / Sherwood, Matthew W. ·The Duke Clinical Research Institute, Durham, North Carolina. Electronic address: sunil.rao@duke.edu. · The Duke Clinical Research Institute, Durham, North Carolina. ·J Am Coll Cardiol · Pubmed #24361316.

ABSTRACT: -- No abstract --

6 Editorial Ischemia-driven revascularization: demonstrating and delivering a mature procedure in a mature way. 2013

Patel, Manesh R / Rao, Sunil V. · ·Circ Cardiovasc Qual Outcomes · Pubmed #23674312.

ABSTRACT: -- No abstract --

7 Editorial Evaluating the bite of the BARC. 2012

Rao, Sunil V / Mehran, Roxana. · ·Circulation · Pubmed #22344038.

ABSTRACT: -- No abstract --

8 Review Anemia and coronary artery disease: pathophysiology, prognosis, and treatment. 2018

Rymer, Jennifer A / Rao, Sunil V. ·Department of Medicine, Division of Cardiology, Duke University School of Medicine, Duke Clinical Research Institute, Durham, North Carolina, USA. ·Coron Artery Dis · Pubmed #29280914.

ABSTRACT: The mechanisms, pathophysiology, and treatment of anemia in coronary artery disease (CAD) are complex. The hemodynamic changes found in the acute anemic state may contribute to progressive arterial wall and left ventricular hypertrophy if the anemic state persists chronically. We will examine the evidence for anemia as an independent risk factor for CAD events and cardiovascular mortality after percutaneous coronary intervention. We will also investigate the thresholds for appropriate blood transfusion in patients with CAD, as well as the cardiovascular outcomes associated with the utilization of a liberal versus conservative blood transfusion strategy. Although there is evidence supporting the use of intravenous iron replacement in patients with congestive heart failure, we will demonstrate the lack of evidence for iron replacement in patients with CAD. Finally, we will examine the evidence for increased cardiovascular mortality and venous thromboembolic events with the use of erythropoietin-stimulating agents in patients with CAD.

9 Review Outcomes of Saphenous Vein Graft Intervention With and Without Embolic Protection Device: A Comprehensive Review and Meta-Analysis. 2017

Paul, Timir K / Bhatheja, Samit / Panchal, Hemang B / Zheng, Shimin / Banerjee, Subhash / Rao, Sunil V / Guzman, Luis / Beohar, Nirat / Zhao, David / Mehran, Roxana / Mukherjee, Debabrata. ·From the Division of Cardiology, Department of Internal Medicine (T.K.P., H.B.P.) and Department of Biostatistics and Epidemiology, College of Public Health (S.Z.), East Tennessee State University, Johnson City · The Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY (S.B., R.M.) · VA North Texas Health Care System, University of Texas Southwestern Medical Center at Dallas (S.B.) · The Duke Clinical Research Institute, Durham, NC (S.V.R.) · Virginia Commonwealth University, Richmond (L.G.) · Nirat Beohar, Columbia University Division of Cardiology at the Mount Sinai Medical Center, Miami Beach, FL (N.B.) · Wake Forest University, Winston-Salem, NC (D.Z.) · and Division of Cardiology, Department of Internal Medicine, Texas Tech University, El Paso (D.M.). ·Circ Cardiovasc Interv · Pubmed #29246912.

ABSTRACT: BACKGROUND: Current guidelines give a class I recommendation to use of embolic protection devices (EPD) for saphenous vein graft (SVG) intervention; however, studies have shown conflicting results. The objective of this meta-analysis is to compare all-cause mortality, major adverse cardiovascular events, myocardial infarction (MI), or target vessel revascularization in SVG intervention with and without EPD. METHODS AND RESULTS: Literature was searched through October 2016. Eight studies (n=52 893) comparing SVG intervention performed with EPD (n=11 506) and without EPD (n=41 387) were included. There was no significant difference in all-cause mortality (odds ratio [OR], 0.79; confidence interval [CI], 0.55-1.12; CONCLUSIONS: This study including 52 893 patients suggests no apparent benefit in routine use of EPD during SVG intervention in the contemporary real-world practice. Further randomized clinical trials are needed in current era to evaluate long-term outcomes in routine use of EPD, and meanwhile, current guideline recommendations on EPD use should be revisited.

10 Review Orbital atherectomy for the treatment of severely calcified coronary lesions: evidence, technique, and best practices. 2017

Shlofmitz, Evan / Martinsen, Brad J / Lee, Michael / Rao, Sunil V / Généreux, Philippe / Higgins, Joe / Chambers, Jeffrey W / Kirtane, Ajay J / Brilakis, Emmanouil S / Kandzari, David E / Sharma, Samin K / Shlofmitz, Richard. ·a Division of Cardiology , Columbia University Medical Center , New York , NY , USA. · b Cardiovascular Research Foundation , New York , NY , USA. · c Department of Clinical and Scientific Affairs , Cardiovascular Systems, Inc. , St. Paul , MN , USA. · d Division of Cardiology , UCLA Medical Center , Los Angeles , CA , USA. · e Duke Clinical Research Institute , Durham , NC , USA. · f Morristown Medical Center , Morristown , NJ , USA. · g Hôpital du Sacré-Coeur de Montréal , Université de Montréal , Montréal , Canada. · h Department of Engineering , Cardiovascular Systems, Inc ., St. Paul , MN , USA. · i Metropolitan Heart and Vascular Institute , Mercy Hospital , Minneapolis , MN , USA. · j Minneapolis Heart Institute , Abbott Northwestern Hospital , Minneapolis , MN , USA. · k Piedmont Heart Institute , Atlanta , GA , USA. · l Division of Cardiology , Mount Sinai Hospital , New York , NY , USA. · m Department of Cardiology , St. Francis Hospital-The Heart Center , Roslyn , NY , USA. ·Expert Rev Med Devices · Pubmed #28945162.

ABSTRACT: INTRODUCTION: The presence of severe coronary artery calcification is associated with higher rates of angiographic complications during percutaneous coronary intervention (PCI), as well as higher major adverse cardiac events compared with non-calcified lesions. Incorporating orbital atherectomy (OAS) for effective preparation of severely calcified lesions can help maximize the benefits of PCI by attaining maximal luminal gain (or stent expansion) and improve long-term outcomes (by reducing need for revascularization). Areas covered: In this manuscript, the prevalence, risk factors, and impact of coronary artery calcification on PCI are reviewed. Based on current data and experience, the authors review orbital atherectomy technique and best practices to optimize lesion preparation. Expert Commentary: The coronary OAS is the only device approved for use in the U.S. as a treatment for de novo, severely calcified coronary lesions to facilitate stent delivery. Advantages of the device include its ease of use and a mechanism of action that treats bi-directionally, allowing for continuous blood flow during treatment, minimizing heat damage, slow flow, and subsequent need for revascularization. The OAS technique tips reviewed in this article will help inform interventional cardiologists treating patients with severely calcified lesions.

11 Review Meta-Analysis of Randomized Controlled Trials of Percutaneous Coronary Intervention With Drug-Eluting Stents Versus Coronary Artery Bypass Grafting in Left Main Coronary Artery Disease. 2017

Garg, Aakash / Rao, Sunil V / Agrawal, Sahil / Theodoropoulos, Kleanthis / Mennuni, Marco / Sharma, Abhishek / Garg, Lohit / Ferrante, Giuseppe / Meelu, Omar A / Sargsyan, Davit / Reimers, Bernhard / Cohen, Marc / Kostis, John B / Stefanini, Giulio G. ·Department of Medicine, St. Peter's University Hospital, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey; Division of Cardiology, Cardiovascular Institute, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey. Electronic address: drgarg.aakash@gmail.com. · Division of Cardiology, Duke Clinical Research Institute, Durham, North Carolina. · Division of Cardiology, St. Luke's University Hospital, Bethlehem, Pennsylvania. · Department of Medicine, James J. Peters Veterans Affairs Medical Center, Bronx, New York. · Division of Cardiology, Cardio Center, Humanitas Research Hospital, Rozzano, Milan, Italy. · Department of Cardiovascular Medicine, State University of New York Downstate Medical Center, Brooklyn, New York. · Division of Cardiology, Lehigh Valley Hospital, Allentown, Pennsylvania. · Division of Cardiology, Mount Sinai Heart, Icahn School of Medicine at Mount Sinai Hospital, New York, New York. · Division of Cardiology, Cardiovascular Institute, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey. · Division of Cardiology, Newark Beth Israel Medical Center, Newark, New Jersey. · Division of Cardiology, Cardio Center, Humanitas Research Hospital, Rozzano, Milan, Italy; Department of Biomedical Sciences, Humanitas University, Rozzano, Milan, Italy. ·Am J Cardiol · Pubmed #28433215.

ABSTRACT: Few randomized controlled trials (RCTs) and observational studies had shown acceptable short-term efficacy and safety of percutaneous coronary intervention (PCI) with drug-eluting stents (DES) compared with coronary artery bypass grafting (CABG) in selected patients with left main coronary artery disease (LMCAD). We aimed to evaluate long-term outcomes of PCI using DES compared with CABG in patients with LMCAD. On November 1, 2016, we searched available databases for published RCTs directly comparing DES PCI with CABG in patients with LMCAD. Odds ratios (ORs) were used as the metric of choice for treatment effects using a random-effects model. I-squared index was used to assess heterogeneity across trials. Prespecified end points were all-cause mortality, cardiovascular mortality, myocardial infarction (MI), stroke, and repeat revascularization at maximal available follow-up. We identified 5 RCTs including a total of 4,595 patients, with a median follow-up of 60 months. The risk of all-cause mortality (OR 1.01; 95% confidence interval [CI] 0.76 to 1.34) and cardiovascular mortality (OR 1.02; 95% CI 0.73 to 1.42) were comparable between PCI with DES and CABG. Similarly, there were no statistically significant differences between PCI with DES and CABG for MI (OR 1.45; 95% CI 0.87 to 2.40) and stroke (OR 0.87; 95% CI 0.38 to 1.98). Conversely, repeat revascularization was significantly higher with PCI compared with CABG (OR 1.82; 95% CI 1.51 to 2.21). In conclusion, in patients with LMCAD, PCI with DES appears to be a viable alternative to CABG at long-term follow-up, with similar risks of ischemic adverse events (mortality, MI, and stroke) but a higher risk of repeat revascularization.

12 Review Polymer-Free Drug-Coated Coronary Stents in Patients with Stable Coronary Artery Disease at High Bleeding Risk. 2017

Panchal, Hemang B / Daggubati, Ramesh / Zhao, David / Rao, Sunil V / Paul, Timir. ·Division of Cardiology, Department of Internal Medicine, East Tennessee State University, 329 North State of Franklin Rd, Johnson City, TN, USA. · Division of Cardiology, Winthrop University Hospital, 259 First Street, Mineola, NY, 11501, USA. · Section on Cardiovascular Medicine, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC, 27157, USA. · Duke University Medical Center, Durham VA Medical Center, 508 Fulton Street (111A), Durham, NC, 27705, USA. · Department of Internal Medicine, Cardiovascular Research, East Tennessee State University, 329 North State of Franklin Rd, Johnson City, TN, USA. pault@etsu.edu. ·Curr Cardiol Rep · Pubmed #28185168.

ABSTRACT: PURPOSE OF REVIEW: Patients with stable coronary artery disease (CAD) and a high risk of bleeding are not ideal candidates for a polymer-based drug-eluting stent (DES) because it requires 6-12 months of dual antiplatelet therapy (DAPT) following percutaneous coronary intervention (PCI). The purpose of this review is to assess the angiographic and clinical outcomes of polymer-free drug-coated stents (PF-DCS) in stable CAD patients with a high bleeding risk. RECENT FINDINGS: Several randomized controlled trials (RCTs) have compared angiographic and clinical outcomes of PF-DCS with bare-metal stents (BMS), permanent polymer (PP)-DES, or biodegradable polymer (BP)-DES. However, none of these studies particularly recruited patients with stable CAD and a high risk of bleeding. Furthermore, there are limited data available on duration of DAPT following PF-DCS placement. PF-DCS has a better efficacy and similar safety as compared with BMS. PF-DCS with dual drug is noninferior to currently available PP-DES. Further RCTs are needed to assess the safety and efficacy of PF-DCS to BP-DES and PP-DES comparing shorter to standard durations of DAPT.

13 Review Meta-Analysis Comparing Complete Revascularization Versus Infarct-Related Only Strategies for Patients With ST-Segment Elevation Myocardial Infarction and Multivessel Coronary Artery Disease. 2016

Shah, Rahman / Berzingi, Chalak / Mumtaz, Mubashir / Jasper, John B / Goswami, Rohan / Morsy, Mohamed S / Ramanathan, Kodangudi B / Rao, Sunil V. ·Section of Cardiology, School of Medicine, University of Tennessee, Memphis, Tennessee; Veterans Affairs Medical Center, Memphis, Tennessee. Electronic address: Shahcardiology@yahoo.com. · West Virginia University Heart Institute, Morgantown, West Virginia. · Pinnacle Health, Wormleysburg, Pennsylvania. · Section of Cardiology, School of Medicine, University of Tennessee, Memphis, Tennessee. · Section of Cardiology, School of Medicine, University of Tennessee, Memphis, Tennessee; Veterans Affairs Medical Center, Memphis, Tennessee. · The Duke Clinical Research Institute, Durham, North Carolina. ·Am J Cardiol · Pubmed #27642115.

ABSTRACT: Several recent randomized controlled trials (RCTs) demonstrated better outcomes with multivessel complete revascularization (CR) than with infarct-related artery-only revascularization (IRA-OR) in patients with ST-segment elevation myocardial infarction. It is unclear whether CR should be performed during the index procedure (IP) at the time of primary percutaneous coronary intervention (PCI) or as a staged procedure (SP). Therefore, we performed a pairwise meta-analysis using a random-effects model and network meta-analysis using mixed-treatment comparison models to compare the efficacies of 3 revascularization strategies (IRA-OR, CR-IP, and CR-SP). Scientific databases and websites were searched to find RCTs. Data from 9 RCTs involving 2,176 patients were included. In mixed-comparison models, CR-IP decreased the risk of major adverse cardiac events (MACEs; odds ratio [OR] 0.36, 95% CI 0.25 to 0.54), recurrent myocardial infarction (MI; OR 0.50, 95% CI 0.24 to 0.91), revascularization (OR 0.24, 95% CI 0.15 to 0.38), and cardiovascular (CV) mortality (OR 0.44, 95% CI 0.20 to 0.87). However, only the rates of MACEs, MI, and CV mortality were lower with CR-SP than with IRA-OR. Similarly, in direct-comparison meta-analysis, the risk of MI was 66% lower with CR-IP than with IRA-OR, but this advantage was not seen with CR-SP. There were no differences in all-cause mortality between the 3 revascularization strategies. In conclusion, this meta-analysis shows that in patients with ST-segment elevation myocardial infarction and multivessel coronary artery disease, CR either during primary PCI or as an SP results in lower occurrences of MACE, revascularization, and CV mortality than IRA-OR. CR performed during primary PCI also results in lower rates of recurrent MI and seems the most efficacious revascularization strategy of the 3.

14 Review The choice of arterial access for percutaneous coronary intervention and its impact on outcome: An expert opinion perspective. 2015

Baker, Nevin C / Ansel, Gary M / Rao, Sunil V / Jolly, Sanjit S / Pichard, Augusto D / Steinberg, Daniel / Lipinski, Michael J / Escarcega, Ricardo O / Minha, Sa'ar / Lhermusier, Thibault / Magalhães, Marco A / Waksman, Ron. ·Division of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC. · OhioHealth Heart & Vascular Physicians, Columbus, OH. · Division of Cardiology, Duke University, Durham, NC. · Division of Cardiology, McMaster University, Ontario, Canada. · Division of Cardiology, Medical University of South Carolina, Charleston, SC. · Division of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC. Electronic address: ron.waksman@medstar.net. ·Am Heart J · Pubmed #26093860.

ABSTRACT: The prevention of major bleeding during percutaneous coronary intervention is one of the most widely discussed and often controversial topics within interventional cardiology. The choice of arterial access should be considered a mechanism for bleeding avoidance, and various strategies have been proposed to prevent or lower major bleeding and vascular complications with varying levels of strength. Herein, we review the current literature on arterial access as a bleeding avoidance strategy during percutaneous coronary intervention and its impact on outcome and provide a consensus opinion based on the strength of the evidence supporting various techniques.

15 Review Minimizing femoral artery access complications during percutaneous coronary intervention: a comprehensive review. 2014

Lee, Michael S / Applegate, Bob / Rao, Sunil V / Kirtane, Ajay J / Seto, Arnold / Stone, Gregg W. ·Division of Cardiology, UCLA Medical Center, Los Angeles, California. ·Catheter Cardiovasc Interv · Pubmed #24677734.

ABSTRACT: Major bleeding complications after percutaneous coronary intervention (PCI) increase patient morbidity, prolong the hospital stay and costs, and are associated with reduced survival. Transfemoral access is still preferred at many centers given its familiarity and ease of use and is necessary in cases where large bore access is needed. Multimodality imaging with fluoroscopy, ultrasonography, and angiography can facilitate proper puncture of the common femoral artery. A proper technique (which includes femoral artery puncture and vascular access site closure) associated with adequate pharmacotherapy (both during PCI and peri-procedural, for the treatment of the underlying coronary artery disease) has been shown to reduce the risk of bleeding and vascular complications associated with femoral artery access. Avoiding the use of arterial sheaths >6 French may further reduce the risk of bleeding. Data with vascular closure devices as a bleeding avoidance strategy are evolving but when used appropriately may further reduce the risk of bleeding and vascular access complications, and in this regard are synergistic with bivalirudin. Randomized trials to confirm these recommendations are needed.

16 Review Clinical outcomes after hybrid coronary revascularization versus coronary artery bypass surgery: a meta-analysis of 1,190 patients. 2014

Harskamp, Ralf E / Bagai, Akshay / Halkos, Michael E / Rao, Sunil V / Bachinsky, William B / Patel, Manesh R / de Winter, Robbert J / Peterson, Eric D / Alexander, John H / Lopes, Renato D. ·Duke Clinical Research Institute and Duke University Medical Center, Durham, NC; Academic Medical Center-University of Amsterdam, Amsterdam, The Netherlands. Electronic address: r.e.harskamp@gmail.com. · St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada. · Emory University School of Medicine, Atlanta, GA. · Duke Clinical Research Institute and Duke University Medical Center, Durham, NC. · Pinnacle Health Cardiovascular Institute, Harrisburg Hospital, Harrisburg, PA. · Academic Medical Center-University of Amsterdam, Amsterdam, The Netherlands. ·Am Heart J · Pubmed #24655709.

ABSTRACT: BACKGROUND: Hybrid coronary revascularization (HCR) represents a minimally invasive revascularization strategy in which the durability of the internal mammary artery to left anterior descending artery graft is combined with percutaneous coronary intervention to treat remaining lesions. We performed a systematic review and meta-analysis to compare clinical outcomes after HCR with conventional coronary artery bypass graft (CABG) surgery. METHODS: A comprehensive EMBASE and PUBMED search was performed for comparative studies evaluating in-hospital and 1-year death, myocardial infarction (MI), stroke, and repeat revascularization. RESULTS: Six observational studies (1 case control, 5 propensity adjusted) comprising 1,190 patients were included; 366 (30.8%) patients underwent HCR (185 staged and 181 concurrent), and 824 (69.2%) were treated with CABG (786 off-pump, 38 on-pump). Drug-eluting stents were used in 328 (89.6%) patients undergoing HCR. Hybrid coronary revascularization was associated with lower in-hospital need for blood transfusions, shorter length of stay, and faster return to work. No significant differences were found for the composite of death, MI, stroke, or repeat revascularization during hospitalization (odds ratio 0.63, 95% CI 0.25-1.58, P = .33) and at 1-year follow-up (odds ratio 0.49, 95% CI 0.20-1.24, P = .13). Comparisons of individual components showed no difference in all-cause mortality, MI, or stroke, but higher repeat revascularization among patients treated with HCR. CONCLUSIONS: Hybrid coronary revascularization is associated with lower morbidity and similar in-hospital and 1-year major adverse cerebrovascular or cardiac events rates, but greater requirement for repeat revascularization compared with CABG. Further exploration of this strategy with adequately powered randomized trials is warranted.

17 Review Radial versus femoral access. 2013

Rao, Sunil V / Turi, Zoltan G / Wong, S Chiu / Brener, Sorin J / Stone, Gregg W. · ·J Am Coll Cardiol · Pubmed #24135659.

ABSTRACT: -- No abstract --

18 Review Management of platelet-directed pharmacotherapy in patients with atherosclerotic coronary artery disease undergoing elective endoscopic gastrointestinal procedures. 2009

Becker, Richard C / Scheiman, James / Dauerman, Harold L / Spencer, Frederick / Rao, Sunil / Sabatine, Marc / Johnson, David A / Chan, Frances / Abraham, Neena S / Quigley, Eamonn M M / Anonymous270644. ·Duke University Medical Center, Duke Clinical Research Institute, Durham, North Carolina 27705, USA. becke021@mc.duke.edu ·Am J Gastroenterol · Pubmed #19935784.

ABSTRACT: The periprocedural management of patients with atherosclerotic coronary heart disease, including those who have heart disease and those who are undergoing percutaneous coronary intervention and stent placement who might require temporary interruption of platelet-directed pharmacotherapy for the purpose of an elective endoscopic gastrointestinal procedure, is a common clinical scenario in daily practice. Herein, we summarize the available information that can be employed for making management decisions and provide general guidance for risk assessment.

19 Clinical Trial Rationale and design of the randomized, double-blind trial testing INtraveNous and Oral administration of elinogrel, a selective and reversible P2Y(12)-receptor inhibitor, versus clopidogrel to eVAluate Tolerability and Efficacy in nonurgent Percutaneous Coronary Interventions patients (INNOVATE-PCI). 2010

Leonardi, Sergio / Rao, Sunil V / Harrington, Robert A / Bhatt, Deepak L / Gibson, C Michael / Roe, Matthew T / Kochman, Janusz / Huber, Kurt / Zeymer, Uwe / Madan, Mina / Gretler, Daniel D / McClure, Matthew W / Paynter, Gayle E / Thompson, Vivian / Welsh, Robert C. ·Duke Clinical Research Institute, Duke University Medical Center, Durham, NC 27705, USA. sergio.leonardi@duke.edu ·Am Heart J · Pubmed #20598974.

ABSTRACT: Despite current dual-antiplatelet therapy with aspirin and clopidogrel, adverse clinical events continue to occur during and after percutaneous coronary intervention (PCI). The failure of clopidogrel to provide optimal protection may be related to delayed onset of action, interpatient variability in its effect, and an insufficient level of platelet inhibition. Furthermore, the irreversible binding of clopidogrel to the P2Y(12) receptor for the life span of the platelet is associated with increased bleeding risk especially during urgent or emergency surgery. Novel antiplatelet agents are required to improve management of patients undergoing PCI. Elinogrel is a potent, direct-acting (ie, non-prodrug), selective, competitive, and reversible P2Y(12) inhibitor available in both intravenous and oral formulations. The INNOVATE-PCI study is a phase 2 randomized, double-blind, clopidogrel-controlled trial to evaluate the safety, tolerability, and preliminary efficacy of this novel antiplatelet agent in patients undergoing nonurgent PCI.

20 Clinical Trial Evaluation of a new heparin agent in percutaneous coronary intervention: results of the phase 2 evaluation of M118 IN pErcutaNeous Coronary intErvention (EMINENCE) Trial. 2010

Rao, Sunil V / Melloni, Chiara / Myles-Dimauro, Shelley / Broderick, Samuel / Kosinski, Andrzej S / Kleiman, Neal S / Dzavík, Vladimír / Tanguay, Jean Francois / Chandna, Harish / Gammon, Roger / Rivera, Ernesto / Alexander, John H / Fier, Ian / Roach, James / Becker, Richard C / Anonymous3890657. ·Duke Clinical Research Institute, Durham, NC, USA. sunil.rao@duke.edu ·Circulation · Pubmed #20368520.

ABSTRACT: BACKGROUND: Factor Xa and factor IIa (thrombin) play roles in thrombotic complications after percutaneous coronary intervention. M118 is a novel low-molecular-weight heparin that has been rationally designed to capture the desired attributes of unfractionated heparin (UFH) and low-molecular-weight heparin: Potent activity against factor Xa and IIa, predictable pharmacokinetics after both intravenous and subcutaneous administration, ability to be monitored by use of point-of-care coagulation assays, and reversibility with protamine sulfate. We performed a phase 2 randomized trial to evaluate the safety and feasibility of M118 in the setting of elective percutaneous coronary intervention. METHODS AND RESULTS: Overall, 503 patients undergoing elective percutaneous coronary intervention at 43 centers in the United States and Canada were randomized in an open-label fashion to 1 of 4 arms: UFH 70 U/kg, M118 50 IU/kg IV, M118 75 IU/kg IV, or M118 100 IU/kg IV. The primary outcome was the composite of death, myocardial infarction, repeat revascularization, stroke, thrombocytopenia, catheter thrombus, bailout use of glycoprotein IIb/IIIa inhibitor, or any bleeding through 30 days. The primary end point occurred in 31.1% of patients randomized to UFH and in 22.7%, 28.3%, and 30.1% of patients randomized to M118 50, 75, and 100 IU/kg, respectively. The primary analysis comparing the rates of the primary end points between the pooled M118 groups versus UFH demonstrated that M118 was noninferior to UFH at preventing percutaneous coronary intervention-related complications (28.4% pooled M118 arms versus 31.1% UFH). The adverse event profiles of M118 and UFH were comparable. CONCLUSIONS: This phase 2 randomized trial demonstrates that M118 is well tolerated and feasible to use as an anticoagulant in patients undergoing elective percutaneous coronary intervention and forms the basis for further investigation of this agent in ischemic heart disease. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00543400.

21 Article Lower Repeat Revascularization Rates Among Patients With Prior Coronary Artery Bypass Graft Surgery are Due to Lack of Adequate Target Vessels. 2018

Kumar, Anirudh / Wagener, John F / Wojdyla, Daniel / Jones, W Schuyler / Patel, Manesh R / Rao, Sunil V. ·Heart and Vascular Institute, Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH 44114 USA. Anirudh.Kumar23@icloud.com. ·J Invasive Cardiol · Pubmed #29138366.

ABSTRACT: BACKGROUND: Studies comparing percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) surgery in patients with multivessel coronary artery disease (CAD) have shown lower repeat revascularization rates in patients who undergo CABG. The reason remains unclear. METHODS: We identified patients with multivessel CAD who received CABG or PCI enrolled in the Duke Databank for Cardiovascular Disease (2003 to 2012). We compared the incidence of major adverse cardiovascular and cerebrovascular events (MACCE) between the two groups. Clinically performed follow-up angiograms for CABG patients were reviewed to determine adequacy of intervenable targets. RESULTS: A total of 1555 patients were included: 861 underwent PCI and 694 underwent CABG. Patients with index PCI were more often female, African-American, presented with ST-elevation myocardial infarction (MI), and had previous MI; they were less often diabetic and had less heart failure or proximal left anterior descending disease. The adjusted hazard ratio of MACCE for CABG vs PCI was 0.68 (95% confidence interval, 0.58-0.80; P<.001). The adjusted odds ratio for repeat revascularization for CABG vs PCI was 0.45 (95% confidence interval, 0.28-0.72; P<.001). Fifty-seven patients with index CABG were found to have ≥1 occluded graft on subsequent angiography without repeat revascularization; 48 patients (6.9%) had inadequate targets for intervention. CONCLUSION: Among patients with multivessel CAD, repeat revascularization rates are lower among CABG patients compared with PCI patients. However, a high proportion of CABG patients with occluded grafts on repeat angiography lack targets for repeat revascularization. This may partially explain the disparity in repeat revascularization rates and suggests that future comparison studies should additionally assess angiographic outcomes.

22 Article Comparison of Radial Access, Guided Femoral Access, and Non-Guided Femoral Access Among Women Undergoing Percutaneous Coronary Intervention. 2018

Koshy, Linda M / Aberle, Laura H / Krucoff, Mitchell W / Hess, Connie N / Mazzaferri, Ernest / Jolly, Sanjit S / Jacobs, Alice / Gibson, C Michael / Mehran, Roxana / Gilchrist, Ian C / Rao, Sunil V. ·Medical Education Program, Department of Medicine, Duke University Medical Center, DUMC Box 3182, Durham, NC 27710 USA. linda.koshy@duke.edu. ·J Invasive Cardiol · Pubmed #29035844.

ABSTRACT: OBJECTIVES: This study was conducted to determine the association between radial access, guided femoral access, and non-guided femoral access on postprocedural bleeding and vascular complications after percutaneous coronary intervention (PCI). BACKGROUND: Bleeding events and major vascular complications after PCI are associated with increased morbidity, mortality, and cost. While the radial approach has been shown to be superior to the femoral approach in reducing bleeding and vascular complications, whether the use of micropuncture, fluoroscopy, or ultrasound mitigates these differences is unknown. METHODS: We conducted a post hoc analysis of women in the SAFE-PCI for Women trial who underwent PCI and had the access method identified (n = 643). The primary endpoint of postprocedure bleeding or vascular complications occurring within 72 hours or at discharge was adjudicated by an independent clinical events committee and was compared based on three categories of access technique: radial, guided femoral (fluoroscopy, micropuncture, ultrasound), or non-guided femoral (none of the aforementioned). Differences between the groups were determined using multivariate logistic regression using radial access as the reference. RESULTS: Of the PCI population, 330 underwent radial access, 228 underwent guided femoral access, and 85 underwent non-guided femoral access. There was a statistically significant lower incidence of the primary endpoint with radial access vs non-guided femoral access; however, there was no significant difference between radial approach and femoral access guided by fluoroscopy, micropuncture, or ultrasound. CONCLUSIONS: This post hoc analysis demonstrates that while radial access is safer than non-guided femoral access, guided femoral access appears to be associated with similar bleeding events or vascular complications as radial access.

23 Article Rationale and design of the Drug-Eluting Stents vs Bare-Metal Stents in Saphenous Vein Graft Angioplasty (DIVA) Trial. 2017

Brilakis, Emmanouil S / Banerjee, Subhash / Edson, Robert / Shunk, Kendrick / Goldman, Steven / Holmes, David R / Bhatt, Deepak L / Rao, Sunil V / Smith, Mark W / Sather, Mike / Colling, Cindy / Kar, Biswajit / Nielsen, Lori / Conner, Todd / Wagner, Todd / Rangan, Bavana V / Ventura, Beverly / Lu, Ying / Holodniy, Mark / Shih, Mei-Chiung. ·VA North Texas Health Care System, Dallas. · Minneapolis Heart Institute, Minneapolis, Minnesota. · University of Texas Southwestern Medical School, Dallas. · VA Cooperative Studies Program Coordinating Center, Mountain View, California. · San Francisco VA Medical Center, San Francisco, California. · University of California, San Francisco. · University of Arizona Sarver Heart Center, Tucson. · Mayo Clinic, Rochester, Minnesota. · VA Boston Healthcare System, Boston, Massachusetts. · Brigham and Women's Hospital Heart and Vascular Center, Boston, Massachusetts. · Harvard Medical School, Boston, Massachusetts. · Durham VA Medical Center, Durham, North Carolina. · Duke University, Durham, North Carolina. · Truven Health Analytics, Ann Arbor, Michigan. · VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, New Mexico. · University of Texas Medical School, Houston. · Michael E. DeBakey VA Medical Center, Houston, Texas. · VA Health Economics Resource Center, Menlo Park, California. · Stanford University, Department of Surgery, Palo Alto, California. · Stanford University, Department of Biomedical Data Science, Palo Alto, California. · Stanford University, Department of Medicine, Palo Alto, California. ·Clin Cardiol · Pubmed #28841230.

ABSTRACT: VA Cooperative Studies Program #571 (DIVA) was designed to evaluate the efficacy of drug-eluting stents (DES) for reducing aortocoronary saphenous vein bypass graft (SVG) failure when compared with bare-metal stents (BMS) in participants undergoing stenting of de novo SVG lesions. Participants undergoing clinically indicated stenting of de novo SVG lesions were randomized in a 1:1 ratio to DES or BMS. Randomization was stratified by presence/absence of diabetes mellitus and the number of target SVG lesions (1 vs ≥2) within each participating site. At sites that did not routinely administer 12-months of dual antiplatelet therapy after SVG stenting participants without acute coronary syndromes received 1 month of open-label clopidogrel, followed by 11 months of clopidogrel for those assigned to DES and 11 months of placebo for those assigned to BMS. The primary endpoint was the 12-month incidence of target-vessel failure (defined as the composite of cardiac death, target-vessel myocardial infarction, or target-vessel revascularization). Secondary endpoints included the incidence of other clinical endpoints and the incremental cost-effectiveness of DES relative to BMS. Due to lower-than-anticipated target-vessel failure rates, target enrollment was increased from 519 to 762. The study had randomized 599 participants when recruitment ended in December 2015. The DIVA trial will provide clarity on the appropriate stent type for de novo SVG lesions.

24 Article Comparative Outcomes After Percutaneous Coronary Intervention Among Black and White Patients Treated at US Veterans Affairs Hospitals. 2017

Kobayashi, Taisei / Glorioso, Thomas J / Armstrong, Ehrin J / Maddox, Thomas M / Plomondon, Mary E / Grunwald, Gary K / Bradley, Steven M / Tsai, Thomas T / Waldo, Stephen W / Rao, Sunil V / Banerjee, Subhash / Nallamothu, Brahmajee K / Bhatt, Deepak L / Rene, A Garvey / Wilensky, Robert L / Groeneveld, Peter W / Giri, Jay. ·Corporal Michael J. Crescenz Veterans Affairs Medical Center, Philadelphia, Pennsylvania. · Penn Cardiovascular Outcomes, Quality, and Evaluation Research Center, Philadelphia, Pennsylvania. · Veterans Affairs Eastern Colorado Healthcare System, Denver. · University of Colorado School of Medicine, Aurora. · Colorado Cardiovascular Outcomes Research Consortium, Denver. · Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado Denver, Aurora. · Durham Veterans Affairs Medical Center, Durham, North Carolina. · Duke University, Durham, North Carolina. · Veterans Affairs North Texas Healthcare System, Dallas. · University of Texas Southwestern Medical Center, Dallas. · Ann Arbor Veterans Affairs Medical Center, Ann Arbor, Michigan. · University of Michigan, Ann Arbor. · Veterans Affairs Boston Healthcare System, Boston, Massachusetts. · Brigham and Women's Hospital Heart & Vascular Center, Boston, Massachusetts. · Harvard Medical School, Boston, Massachusetts. ·JAMA Cardiol · Pubmed #28724126.

ABSTRACT: Importance: Current comparative outcomes among black and white patients treated with percutaneous coronary intervention (PCI) in the Veterans Affairs (VA) health system are not known. Objective: To compare outcomes between black and white patients undergoing PCI in the VA health system. Design, Setting, and Participants: This study compared black and white patients who underwent PCI between October 1, 2007, and September 30, 2013, at 63 VA hospitals using data recorded in the VA Clinical Assessment, Reporting, and Tracking System for Cardiac Catheterization Laboratories (CART-CL) program. A generalized linear mixed model with a random intercept for site assessed the relative difference in odds of outcomes between black and white patients. The setting was integrated institutionalized hospital care. Excluded were all patients of other races or those with multiple listed races and those with missing data regarding race or the diagnostic cardiac catheterization. The dates of analysis were January 7, 2016, to April 17, 2017. Exposure: Percutaneous coronary intervention at a VA hospital. Main Outcomes and Measures: The primary outcome was 1-year mortality. Secondary outcomes were 30-day all-cause readmission rates, 30-day acute kidney injury, 30-day blood transfusion, and 1-year readmission rates for myocardial infarction. In addition, variations in procedural and postprocedural care were examined, including the use of intravascular ultrasound, optical coherence tomography, fractional flow reserve measurements, bare-metal stents, postprocedural medications, and radial access. Results: A total of 42 391 patients (13.3% black and 98.4% male; mean [SD] age, 65.2 [9.1] years) satisfied the inclusion and exclusion criteria. In unadjusted analyses, black patients had higher rates of 1-year mortality (7.1% vs 5.9%, P < .001) as well as secondary outcomes of 30-day acute kidney injury (20.8% vs 13.8%, P < .001), 30-day blood transfusion (3.4% vs 2.7%, P < .01), and 1-year readmission rates for myocardial infarction (3.3% vs 2.7%, P = .01) compared with white patients. After adjustment for demographics, comorbidities, and procedural characteristics, odds for 1-year mortality (odds ratio, 1.04; 95% CI, 0.90-1.19) were not different between black and white patients. There were also no differences in secondary outcomes with the exception of a higher rate of adjusted 30-day acute kidney injury (odds ratio, 1.22; 95% CI, 1.10-1.36). Conclusions and Relevance: While black patients had a higher rate of mortality than white patients in unadjusted analyses, race was not independently associated with 1-year mortality among patients undergoing PCI in VA hospitals.

25 Article Comparative Efficacy of Coronary Revascularization Procedures for Multivessel Coronary Artery Disease in Patients With Chronic Kidney Disease. 2017

Roberts, John K / Rao, Sunil V / Shaw, Linda K / Gallup, Dianne S / Marroquin, Oscar C / Patel, Uptal D. ·Division of Nephrology, Duke University Medical Center, Durham, North Carolina; Duke University School of Medicine, Durham, North Carolina. Electronic address: john.roberts@dm.duke.edu. · Duke University School of Medicine, Durham, North Carolina; Duke Clinical Research Institute, Durham, North Carolina. · Duke University School of Medicine, Durham, North Carolina. · Department of Medicine, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. · Division of Nephrology, Duke University Medical Center, Durham, North Carolina; Duke University School of Medicine, Durham, North Carolina; Duke Clinical Research Institute, Durham, North Carolina. ·Am J Cardiol · Pubmed #28318510.

ABSTRACT: Patients with chronic kidney disease (CKD) are at increased risk of cardiovascular disease and death, yet little data exist regarding the comparative efficacy of coronary revascularization procedures in CKD patients with multivessel disease. We created a cohort of 4,687 adults who underwent cardiac catheterization, had a serum creatinine value measured within 30 days, and had more than one vessel with ≥50% stenosis. We used Cox proportional hazard regression modeling weighted by the inverse probability of treatment to examine the association between 4 treatment strategies (medical management, percutaneous coronary intervention [PCI] with bare metal stent, PCI with drug-eluting stent, and coronary artery bypass grafting [CABG]) and mortality among patients across categories of estimated glomerular filtration rate; secondary outcome was a composite of mortality, myocardial infarction, or revascularization. Compared with medical management, CABG was associated with a reduced risk of death for patients of any nondialysis CKD severity (hazard ratio [HR] range 0.43 to 0.59). There were no significant mortality differences between CABG and PCI, except a decreased death risk in CABG-treated CKD patients (HR range 0.54 to 0.55). Compared with medical management and PCI, CABG was associated with a lower risk of death, myocardial infarction, or revascularization in nondialysis CKD patients (HR range 0.41 to 0.64). There were similar associations between decreased estimated glomerular filtration rate and increased mortality across all multivessel coronary artery disease patient treatment groups. When accounting for treatment propensity, surgical revascularization was associated with improved outcomes in patients of all CKD severities. A prospective randomized trial in CKD patients is required to confirm our findings.

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