Scholars@Duke
Shelly Sapp

Shelly Sapp

Biostatistician, Principal
Duke Clinical Research Institute
shelly.sapp@duke.edu
Duke Box 104785, DCRI - Ct Statistics, Durham, NC 27710
2400 Pratt Street, Box 3850, Durham, NC 27705

Scholarly Works

The Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure with Preserved Ejection Fraction (SPIRRIT-HFpEF): Rationale and design.

Journal article Eur J Heart Fail · November 2024 AIMS: Benefits of mineralocorticoid receptor antagonists (MRAs) in heart failure with preserved and mildly reduced ejection fraction (HFpEF/HFmrEF) have not been established. Conventional randomized controlled trials are complex and expensive. The Spironol ... Full text Link to item Cite

Biomarkers of erythropoiesis response to intravenous iron in a crossover pilot study in unexplained anemia of the elderly.

Journal article Hematology · December 2023 Anemia is common in older adults, but often unexplained. Previously, we conducted a randomized, controlled trial of intravenous (IV) iron sucrose to study its impact on the 6-minute walk test and hemoglobin in older adults with unexplained anemia and ferri ... Full text Link to item Cite

Effect of Torsemide vs Furosemide After Discharge on All-Cause Mortality in Patients Hospitalized With Heart Failure: The TRANSFORM-HF Randomized Clinical Trial.

Journal article JAMA · January 17, 2023 IMPORTANCE: Although furosemide is the most commonly used loop diuretic in patients with heart failure, some studies suggest a potential benefit for torsemide. OBJECTIVE: To determine whether torsemide results in decreased mortality compared with furosemid ... Full text Link to item Cite

Ascertaining Death Events in a Pragmatic Clinical Trial: Insights From the TRANSFORM-HF Trial.

Journal article J Card Fail · October 2022 BACKGROUND: Death ascertainment can be challenging for pragmatic clinical trials that limit site follow-up activities to usual clinical care. METHODS AND RESULTS: We used blinded aggregate data from the ongoing ToRsemide comparison with furoSemide FOR Mana ... Full text Link to item Cite

Pragmatic Design of Randomized Clinical Trials for Heart Failure: Rationale and Design of the TRANSFORM-HF Trial.

Journal article JACC Heart Fail · May 2021 Randomized clinical trials are the foundation of evidence-based medicine and central to practice guidelines and patient care decisions. Nonetheless, randomized trials in heart failure (HF) populations have become increasingly difficult to conduct and are f ... Full text Link to item Cite

Stroke in Patients With Peripheral Artery Disease.

Journal article Stroke · June 2019 Background and Purpose- Predictors of stroke and transient ischemic attack (TIA) in patients with peripheral artery disease (PAD) are poorly understood. The primary aims of this analysis were to (1) determine the incidence of ischemic/hemorrhagic stroke an ... Full text Open Access Link to item Cite

Ambulatory blood pressure in the dash diet trial: Effects of race and albuminuria.

Journal article J Clin Hypertens (Greenwich) · February 2018 We evaluated whether low-grade albuminuria or black race modulates ambulatory blood pressure (BP) or nocturnal BP response to the DASH diet. Among 202 adults enrolled in the DASH multicenter trial who were fed the DASH or control diet for 8 weeks, reductio ... Full text Link to item Cite

Short-term effects of the DASH diet in adults with moderate chronic kidney disease: a pilot feeding study.

Journal article Clin Kidney J · August 2016 BACKGROUND: Although the Dietary Approaches to Stop Hypertension (DASH) diet lowers blood pressure (BP) for adults with normal kidney function, evidence is lacking regarding its safety and efficacy in chronic kidney disease (CKD). We aimed to test the effe ... Full text Open Access Link to item Cite

A prospective randomized wait list control trial of intravenous iron sucrose in older adults with unexplained anemia and serum ferritin 20-200 ng/mL.

Journal article Blood Cells Mol Dis · December 2014 Anemia is common in older persons and is associated with substantial morbidity and mortality. One third of anemic older adults have unexplained anemia of the elderly (UAE). We carried out a randomized, wait list control trial in outpatients with UAE and se ... Full text Link to item Cite

Cardiovascular toxicity of epoetin-alfa in patients with chronic kidney disease.

Journal article Am J Nephrol · 2013 BACKGROUND: Recombinant erythropoietin has become a routine component of care of patients with chronic kidney disease reducing the need for blood transfusions but raising the risks for cardiovascular events. We undertook this secondary analysis of subjects ... Full text Link to item Cite

Effect of hemoglobin target on progression of kidney disease: a secondary analysis of the CHOIR (Correction of Hemoglobin and Outcomes in Renal Insufficiency) trial.

Journal article Am J Kidney Dis · September 2012 BACKGROUND: Conflicting relationships have been described between anemia correction using erythropoiesis-stimulating agents and progression of chronic kidney disease (CKD). This study was undertaken to examine the impact of target hemoglobin level on progr ... Full text Link to item Cite

Impact of higher hemoglobin targets on blood pressure and clinical outcomes: a secondary analysis of CHOIR.

Journal article Nephrol Dial Transplant · September 2012 BACKGROUND: Targeting a higher hemoglobin in patients with chronic kidney disease leads to adverse cardiovascular outcomes, yet the reasons remain unclear. Herein, we sought to determine whether changes in erythropoiesis-stimulating agent (ESA) dose and in ... Full text Link to item Cite

A secondary analysis of the CHOIR trial shows that comorbid conditions differentially affect outcomes during anemia treatment.

Journal article Kidney Int · February 2010 The CHOIR trial in anemic patients with chronic kidney disease compared epoetin-alfa treatment with low (11.3 g/l) and high (13.5 g/l) hemoglobin targets on the composite end point of death, hospitalization for heart failure, stroke, and myocardial infarct ... Full text Link to item Cite

Secondary analysis of the CHOIR trial epoetin-alpha dose and achieved hemoglobin outcomes.

Journal article Kidney Int · September 2008 Trials of anemia correction in chronic kidney disease have found either no benefit or detrimental outcomes of higher targets. We did a secondary analysis of patients with chronic kidney disease enrolled in the Correction of Hemoglobin in the Outcomes in Re ... Full text Link to item Cite

Anaemia of CKD--the CHOIR study revisited.

Journal article Nephrol Dial Transplant · July 2007 Full text Link to item Cite

Correction of anemia with epoetin alfa in chronic kidney disease.

Journal article N Engl J Med · November 16, 2006 BACKGROUND: Anemia, a common complication of chronic kidney disease, usually develops as a consequence of erythropoietin deficiency. Recombinant human erythropoietin (epoetin alfa) is indicated for the correction of anemia associated with this condition. H ... Full text Link to item Cite

Elevated creatine kinase-MB with normal creatine kinase predicts worse outcomes in patients with acute coronary syndromes: results from 4 large clinical trials.

Journal article Am Heart J · January 2006 BACKGROUND: The degree to which elevated creatine kinase (CK)-MB in the presence of normal CK is predictive of outcome is not well understood despite having been studied for decades. This analysis examined whether normal CK with elevated CK-MB in patients ... Full text Link to item Cite

Aspirin dose and six-month outcome after an acute coronary syndrome.

Journal article J Am Coll Cardiol · March 17, 2004 OBJECTIVES: This study was designed to compare the efficacy of low and intermediate aspirin doses in acute coronary syndromes. BACKGROUND: Little is known of the comparative efficacy of low and intermediate aspirin doses in this setting. METHODS: We compar ... Full text Link to item Cite

Triple antiplatelet therapy during percutaneous coronary intervention is associated with improved outcomes including one-year survival: results from the Do Tirofiban and ReoProGive Similar Efficacy Outcome Trial (TARGET).

Journal article Journal of the American College of Cardiology · October 2003 ObjectiveWe sought to examine if clopidogrel treatment initiated before coronary stenting improved clinical outcomes among patients receiving aspirin and a glycoprotein (GP) IIb/IIIa inhibitor.BackgroundAntiplatelet therapy plays a pivota ... Full text Cite

Prevalence of conventional risk factors in patients with coronary heart disease.

Journal article JAMA · August 2003 ContextIt is commonly suggested that more than 50% of patients with coronary heart disease (CHD) lack any of the conventional risk factors (cigarette smoking, diabetes, hyperlipidemia, and hypertension). This claim implies that other factors play ... Full text Cite

Mortality benefit of beta blockade in patients with acute coronary syndromes undergoing coronary intervention: pooled results from the Epic, Epilog, Epistent, Capture and Rapport Trials.

Journal article J Interv Cardiol · August 2003 The effects of beta blocker therapy in the settings of heart failure and coronary artery disease have been well described, although little data exist in patients presenting with acute coronary syndromes undergoing percutaneous coronary intervention. The cu ... Full text Link to item Cite

Use of antioxidant vitamins for the prevention of cardiovascular disease: meta-analysis of randomised trials.

Journal article Lancet (London, England) · June 2003 IntroductionOxidised LDL is thought to play an important part in the pathogenesis of atherosclerosis. Observational studies have associated alpha tocopherol (vitamin E), beta carotene, or both, with reductions in cardiovascular events, but not cli ... Full text Cite

Variability of area measurements obtained with different intravascular ultrasound catheter systems: Impact on clinical trials and a method for accurate calibration.

Journal article Journal of the American Society of Echocardiography : official publication of the American Society of Echocardiography · March 2003 BackgroundAtherosclerotic plaque burden is the major end point in ongoing progression trials. Intravascular ultrasound allows precise measurements of coronary artery dimensions. However, the variability of measurements among different catheter sys ... Full text Cite

Reduction in vascular access site bleeding in sequential abciximab coronary intervention trials.

Journal article Catheter Cardiovasc Interv · December 2002 We analyzed vascular access site bleeding from the EPIC, EPILOG, and EPISTENT trials to quantify the decrease in vascular bleeding complications in these three trials, especially those attributable to abciximab. The incidence of combined major and minor va ... Full text Link to item Cite

Multi-year follow-up of abciximab therapy in three randomized, placebo-controlled trials of percutaneous coronary revascularization.

Journal article Am J Med · July 2002 There is considerable evidence supporting the use of platelet glycoprotein IIb/IIIa inhibitors to reduce ischemic complications of percutaneous coronary revascularization. However, long-term follow-up has been limited. In three large-scale randomized trial ... Full text Link to item Cite

Glycoprotein IIb-IIIa inhibition with abciximab and postprocedural risk assessment: lessons from the evaluation of platelet IIb/IIIa inhibitor for stenting trial and implication for ad hoc use of glycoprotein IIb-IIIa antagonists.

Journal article Am Heart J · April 2002 BACKGROUND: Angiographic features of vessels in which stents have been deployed can be used to predict the risk of postprocedural ischemic events. The purpose of this study was to compare the effects of abciximab in patients with and without high-risk post ... Full text Link to item Cite

Attenuation of rebound ischemia after discontinuation of heparin therapy by glycoprotein IIb/IIIa inhibition with eptifibatide in patients with acute coronary syndromes: observations from the platelet IIb/IIIa in unstable angina: receptor suppression using integrilin therapy (PURSUIT) trial.

Journal article Circulation · December 4, 2001 Background- A reactivation of ischemia after the discontinuation of intravenous heparin in acute coronary syndromes has been described. The effect of glycoprotein IIb/IIIa blockade on heparin rebound is unknown. Methods and Results- Patients with acute cor ... Full text Link to item Cite

"Hot" unstable angina--is it worse than subacute unstable angina? Results from the GUARANTEE Registry.

Journal article J Thromb Thrombolysis · December 2001 BACKGROUND AND METHODS: Because time to presentation to the hospital affects time to treatment and is known to be important in acute myocardial infarction, we evaluated this variable in patients with unstable angina/non-ST segment elevation myocardial infa ... Full text Link to item Cite

Profile and prevalence of aspirin resistance in patients with cardiovascular disease.

Journal article The American journal of cardiology · August 2001 We determined the prevalence and clinical predictors of aspirin resistance by prospectively studying 325 patients with stable cardiovascular disease who were receiving aspirin (325 mg/day for > or =7 days) but no other antiplatelet agents. We also compared ... Full text Cite

Prognostic importance of concomitant heparin with eptifibatide in acute coronary syndromes. PURSUIT Investigators. Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrilin Therapy.

Journal article Am J Cardiol · March 1, 2001 Platelet glycoprotein IIb/IIIa inhibitors have been extensively studied in the treatment of patients with ischemic heart disease. Data regarding the use of these agents in the absence of concomitant intravenous heparin have been conflicting. We sought to d ... Full text Link to item Cite

Increased mortality with oral platelet glycoprotein IIb/IIIa antagonists: a meta-analysis of phase III multicenter randomized trials.

Journal article Circulation · January 2001 BackgroundNumerous clinical trials have established the benefits of intravenous glycoprotein IIb/IIIa inhibition in the management of coronary artery disease. In contrast, the recent large-scale, placebo-controlled, randomized trials of the oral g ... Full text Cite

Survival outcomes 1 year after reperfusion therapy with either alteplase or reteplase for acute myocardial infarction: results from the Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries (GUSTO) III Trial.

Journal article Circulation · October 10, 2000 BACKGROUND: New recombinant plasminogen activators have been developed to simulate the fibrinolytic action of the physiological serine protease tissue plasminogen activator (alteplase, t-PA), and have prolonged half-life features permitting bolus administr ... Full text Link to item Cite

Evaluation of the effects of aspirin combined with angiotensin-converting enzyme inhibitors in patients with coronary artery disease.

Journal article The American journal of medicine · October 2000 BackgroundSeveral studies have suggested that there may be an interaction between angiotensin-converting enzyme (ACE) inhibitors and aspirin in patients with congestive heart failure, such that their benefits are attenuated when used in combinatio ... Full text Cite

Abciximab and bleeding during coronary surgery: results from the EPILOG and EPISTENT trials. Improve Long-term Outcome with abciximab GP IIb/IIIa blockade. Evaluation of Platelet IIb/IIIa Inhibition in STENTing.

Journal article Ann Thorac Surg · August 2000 BACKGROUND: Abciximab during percutaneous coronary revascularization reduces ischemic complications, but concern exists regarding increased bleeding risk should emergency coronary surgical procedures be required. METHODS: Outcomes were assessed among 85 pa ... Full text Link to item Cite

Predictors of death and reinfarction at 30 days after primary angioplasty: the GUSTO IIb and RAPPORT trials.

Journal article Am Heart J · March 2000 BACKGROUND: Thirty-day death among recipients of fibrinolytic therapy for acute myocardial infarction (MI) is tightly correlated with easily obtainable key demographic and clinical parameters such as age, blood pressure, heart rate, and infarct location. S ... Full text Link to item Cite

Risk factors and outcomes after coronary reoperation in 739 elderly patients.

Journal article The Annals of thoracic surgery · February 2000 BackgroundAs second coronary artery bypass graft (CABG) operations are becoming more common in elderly patients, we conducted a retrospective analysis of risk factors for in-hospital and late outcome in patients aged 70 and over.MethodsWe ... Full text Cite

Glycoprotein IIb/IIIa inhibitors in acute coronary syndromes.

Journal article Cleve Clin J Med · February 2000 Glycoprotein (GP) IIb/IIIa inhibitors are potent antiplatelet agents and represent an exciting breakthrough in the treatment of acute coronary syndromes. However, their safety and cost-effectiveness require further investigation, and more information on ri ... Full text Link to item Cite

Outcomes at 1 year and economic implications of platelet glycoprotein IIb/IIIa blockade in patients undergoing coronary stenting: results from a multicentre randomised trial. EPISTENT Investigators. Evaluation of Platelet IIb/IIIa Inhibitor for Stenting.

Journal article Lancet · December 11, 1999 BACKGROUND: We assessed in a randomised trial the long-term outcomes for potent adjunctive antiplatelet therapy given at the time of coronary stenting. METHODS: In 63 hospitals in the USA and Canada, 2399 patients were randomly assigned stenting with abcix ... Full text Link to item Cite

Optimizing the percutaneous interventional outcomes for patients with diabetes mellitus: results of the EPISTENT (Evaluation of platelet IIb/IIIa inhibitor for stenting trial) diabetic substudy.

Journal article Circulation · December 1999 BackgroundStenting likely decreases the need for target-vessel revascularization procedures in diabetic patients compared with balloon angioplasty. However, the efficacy of stenting with platelet glycoprotein IIb/IIIa blockade has not yet been ass ... Full text Cite

Racial differences in the management of unstable angina: results from the multicenter GUARANTEE registry.

Journal article Am Heart J · December 1999 BACKGROUND: Prior studies, usually conducted with the use of insurance databases, have shown differences in the use of cardiac procedures between black patients and white patients hospitalized with various types of coronary artery disease. However, few dat ... Full text Link to item Cite

Differences between men and women in the management of unstable angina pectoris (The GUARANTEE Registry). The GUARANTEE Investigators.

Journal article Am J Cardiol · November 15, 1999 Few data are available in prospectively collected cohorts of patients with unstable angina pectoris or on the use of appropriate medications or interventions. Accordingly, we evaluated 2,948 consecutive patients with unstable angina admitted to 35 hospital ... Full text Link to item Cite

Complementary clinical benefits of coronary-artery stenting and blockade of platelet glycoprotein IIb/IIIa receptors. Evaluation of Platelet IIb/IIIa Inhibition in Stenting Investigators.

Journal article N Engl J Med · July 29, 1999 BACKGROUND: Inhibition of the platelet glycoprotein IIb/IIIa receptor with the monoclonal-antibody fragment abciximab reduces the acute ischemic complications associated with percutaneous coronary revascularization, whereas coronary-stent implantation redu ... Full text Link to item Cite

Racial differences in the management of unstable angina: Results from the multicenter GUARANTEE registry

Journal article American Heart Journal · 1999 Background: Prior studies, usually conducted with the use of insurance databases, have shown differences in the use of cardiac procedures between black patients and white patients hospitalized with various types of coronary artery disease. However, few dat ... Cite

Coronary stenting and use of abciximab.

Journal article Lancet (London, England) · October 1998 Full text Cite

Influence of insurance type on the use of procedures, medications and hospital outcome in patients with unstable angina: results from the GUARANTEE Registry. Global Unstable Angina Registry and Treatment Evaluation.

Journal article J Am Coll Cardiol · August 1998 OBJECTIVES: The purpose of this study was to investigate whether or not there is an association between managed care insurance and the delivery and outcome of care in patients presenting with unstable angina. BACKGROUND: The proportion of U.S. patients wit ... Full text Link to item Cite

Exercise performance and chronotropic response in heart failure patients with implantable left ventricular assist devices.

Journal article The American journal of cardiology · May 1998 During metabolic stress testing, 9 of 20 patients with left ventricular assist devices exhibited a lag in peak device rate by < or = 85% of peak native heart rate (group I), with peak device rates of 118 +/- 9 beats/min compared with group II, in which pea ... Full text Cite

Significance of mild transient release of creatine kinase-MB fraction after percutaneous coronary interventions.

Journal article Circulation · October 1996 BackgroundThe clinical significance of minor elevations in creatine kinase-myocardial band isoenzyme (CK-MB) after coronary interventions has not been systematically evaluated.Methods and resultsWe examined 4484 patients who underwent suc ... Full text Cite

Defining the appropriate threshold of creatine kinase elevation after percutaneous coronary interventions.

Journal article American heart journal · June 1996 The threshold of creatine kinase elevation after coronary interventions has been set at levels ranging in different studies from 2 to > 5 times the laboratory's upper limit of normal. This high variability is caused by the absence of any systematic evaluat ... Full text Cite

Surgical treatment of prosthetic valve endocarditis.

Journal article The Journal of thoracic and cardiovascular surgery · January 1996 From 1975 through 1992, we reoperated on 146 patients for the treatment of prosthetic valve endocarditis. Prosthetic valve endocarditis was considered to be early (< 1 year after operation) in 46 cases and active in 103 cases. The extent of the infection w ... Full text Cite

Clinical markers, management, and long-term follow-up of early ischemia after coronary artery bypass grafting.

Journal article The American journal of cardiology · November 1995 In summary, the occurrence of angina or myocardial infarction within 1 year after coronary bypass is associated with a high incidence of significant angiographic abnormalities. Early angiography is necessary to identify high-risk patients who could undergo ... Full text Cite

Effect of the implantable left ventricular assist device on neuroendocrine activation in heart failure.

Journal article Circulation · November 1995 BackgroundThe HeartMate left ventricular assist device has been successfully used as a bridge to cardiac transplantation. Because many patients exhibit marked clinical improvement in their heart failure after HeartMate implantation, we studied the ... Full text Cite

Percutaneous revascularization of ostial saphenous vein graft stenoses.

Journal article Journal of the American College of Cardiology · October 1995 ObjectivesThis study sought to evaluate the short-term results and long-term outcome of percutaneous revascularization of ostial saphenous vein graft stenoses in a large patient series.BackgroundPrevious studies have demonstrated that the ... Full text Cite

Regional variation across the United States in the management of acute myocardial infarction. GUSTO-1 Investigators. Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries.

Journal article N Engl J Med · August 31, 1995 BACKGROUND: Differences in the management of acute myocardial infarction have been reported among countries, but few studies have investigated this issue in regions of the United States. METHODS: We compared the management of acute myocardial infarction am ... Full text Link to item Cite

Long-term outcome of transient, uncomplicated in-laboratory coronary artery closure.

Journal article Circulation · June 1995 BackgroundSuccessful reversal of abrupt vessel closure without resultant major ischemic complications (death, Q-wave myocardial infarction, or coronary artery bypass graft surgery) is achieved in nearly half of all cases of abrupt vessel closure. ... Full text Cite

Prognosis of patients with left ventricular dysfunction, with and without viable myocardium after myocardial infarction. Relative efficacy of medical therapy and revascularization.

Journal article Circulation · December 1994 BackgroundThe uptake of F-18 deoxyglucose into dysfunction segments after myocardial infarction identifies metabolically active (FDG+) or inactive (FDG-) myocardium. Although patients with FDG+ segments have been found to be at risk for adverse ev ... Full text Cite

Gastroepiploic and inferior epigastric arteries for coronary artery bypass. Early results and evolving applications.

Conference Circulation · November 1994 BackgroundInternal thoracic artery (ITA) conduits are known to provide long-term patency and increased patient survival with low morbidity after coronary artery bypass grafting (CABG). Excellent clinical results with the ITA have stimulated intere ... Cite

Repair of insufficient bicuspid aortic valves.

Journal article The Annals of thoracic surgery · August 1994 A technique for the repair of bicuspid aortic valves that includes resection of the flail segment of the prolapsing leaflet, annuloplasty, and resection of the raphe, when present, has been reported. To assess the efficacy of this technique in the repair o ... Full text Cite

Directional coronary atherectomy in unstable angina.

Journal article Journal of the American College of Cardiology · July 1994 ObjectivesTo determine whether excision of complex, ulcerated plaque improves the risk of patients with unstable angina to the level of those with stable angina, the results of directional coronary atherectomy were compared in patients with these ... Full text Cite