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4. Association of Health Status Scores With Cardiovascular and Limb Outcomes in Patients With Symptomatic Peripheral Artery Disease: Insights From the EUCLID (Examining Use of Ticagrelor in Symptomatic Peripheral Artery Disease) Trial

Author

Rymer, Jennifer A, Mulder, Hillary, Smolderen, Kim G, Hiatt, William R, Conte, Michael S, Berger, Jeffrey S, Norgren, Lars, Mahaffey, Kenneth W, Baumgartner, Iris, Fowkes, F Gerry, Katona, Brian G, Rockhold, Frank, Jones, W Schuyler, and Patel, Manesh R

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Clinical Trials and Supportive Activities, Cardiovascular, Clinical Research, Good Health and Well Being, Cardiovascular Diseases, Double-Blind Method, Female, Health Status Indicators, Humans, Lower Extremity, Male, Middle Aged, Outcome Assessment, Health Care, Peripheral Arterial Disease, Platelet Aggregation Inhibitors, Quality of Life, Surveys and Questionnaires, Symptom Assessment, Ticagrelor, Vascular Surgical Procedures, Visual Analog Scale, health status instruments, peripheral artery disease, quality of life, Cardiorespiratory Medicine and Haematology, Cardiovascular medicine and haematology
Abstract

Background There are limited data on health status instruments in patients with peripheral artery disease and cardiovascular and limb events. We evaluated the relationship between health status changes and cardiovascular and limb events. Methods and Results In an analysis of the EUCLID (Examining Use of Ticagrelor in Symptomatic Peripheral Artery Disease) trial, we examined the characteristics of 13 801 patients by tertile of health status instrument scores collected in the trial (EuroQol 5-Dimensions [EQ-5D], EQ visual analog scale [VAS], and peripheral artery questionnaire). We assessed the association between the baseline health status measurements and major adverse cardiovascular events, major adverse limb events, and lower-extremity revascularization procedures during trial follow-up and the association between 12-month health status change scores and subsequent end points during follow-up. There were 13 217 (95%) patients with EQ-5D scores, 13 533 (98%) with VAS scores, and 4431 (32%) with peripheral artery questionnaire scores. Patients in the lowest baseline EQ-5D tertile (0 to

Published
2020

6. Safety and Effectiveness of Paclitaxel Drug-Coated Devices in Peripheral Artery Revascularization: Insights From VOYAGER PAD

Author

Hess, Connie N., Patel, Manesh R., Bauersachs, Rupert M., Anand, Sonia S., Debus, E. Sebastian, Nehler, Mark R., Fanelli, Fabrizio, Yeh, Robert W., Secemsky, Eric A., Beckman, Joshua A., Mauri, Laura, Govsyeyev, Nicholas, Capell, Warren H., Brackin, Taylor, Berkowitz, Scott D., Muehlhofer, Eva, Haskell, Lloyd P., Hiatt, William R., and Bonaca, Marc P.

Published
2021
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12. Cardiovascular Safety Outcome Trials: A meeting report from the Cardiac Safety Research Consortium

Author

Sager, Philip T, Seltzer, Jonathan, Turner, J Rick, Anderson, Jeffrey L, Hiatt, William R, Kowey, Peter, Prochaska, Judith J, Stockbridge, Norman, and White, William B

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Heart Disease, Patient Safety, Cardiovascular, Good Health and Well Being, Cardiovascular Agents, Cardiovascular Diseases, Clinical Trials as Topic, Congresses as Topic, Drug Approval, Humans, United States, United States Food and Drug Administration, Cardiorespiratory Medicine and Haematology, Public Health and Health Services, Cardiovascular System & Hematology, Cardiovascular medicine and haematology
Abstract

This White Paper provides a summary of presentations and discussions at a Cardiovascular Safety Outcome Trials Think Tank cosponsored by the Cardiac Safety Research Consortium, the US Food and Drug Administration, and the American College of Cardiology, held at American College of Cardiology's Heart House, Washington, DC, on February 19, 2014. Studies to assess cardiovascular (CV) risk of a new drug are sometimes requested by regulators to resolve ambiguous safety signals seen during its development or among other members of its class. Think Tank participants thought that important considerations in undertaking such studies were as follows: (1) plausibility-how likely it is that a possible signal indicating risk is real, based on strength of evidence, and/or whether a plausible mechanism of action for potential CV harm has been identified; (2) relevance-what relative and absolute CV risk would need to be excluded to determine that the drug had an acceptable benefit-to-risk balance for its use in the intended patient population; and (3) how plausibility and relevance influence the timing and approach to further safety assessment.

Published
2015

13. Evaluation and Treatment of Patients With Lower Extremity Peripheral Artery Disease Consensus Definitions From Peripheral Academic Research Consortium (PARC)

Author

Patel, Manesh R, Conte, Michael S, Cutlip, Donald E, Dib, Nabil, Geraghty, Patrick, Gray, William, Hiatt, William R, Ho, Mami, Ikeda, Koji, Ikeno, Fumiaki, Jaff, Michael R, Jones, W Schuyler, Kawahara, Masayuki, Lookstein, Robert A, Mehran, Roxana, Misra, Sanjay, Norgren, Lars, Olin, Jeffrey W, Povsic, Thomas J, Rosenfield, Kenneth, Rundback, John, Shamoun, Fadi, Tcheng, James, Tsai, Thomas T, Suzuki, Yuka, Vranckx, Pascal, Wiechmann, Bret N, White, Christopher J, Yokoi, Hiroyoshi, and Krucoff, Mitchell W

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Clinical Trials and Supportive Activities, Angioplasty, Atherectomy, Blood Vessel Prosthesis, Constriction, Pathologic, Diagnostic Imaging, Endarterectomy, Humans, Lower Extremity, Patient Outcome Assessment, Peripheral Arterial Disease, Quality of Life, Severity of Illness Index, Stents, Walking, amputation, foot, intermittent claudication, leg, myocardial infarction, stroke, myocardial infarction, Cardiorespiratory Medicine and Haematology, Public Health and Health Services, Cardiovascular System & Hematology, Cardiovascular medicine and haematology
Abstract

The lack of consistent definitions and nomenclature across clinical trials of novel devices, drugs, or biologics poses a significant barrier to accrual of knowledge in and across peripheral artery disease therapies and technologies. Recognizing this problem, the Peripheral Academic Research Consortium, together with the U.S. Food and Drug Administration and the Japanese Pharmaceuticals and Medical Devices Agency, has developed a series of pragmatic consensus definitions for patients being treated for peripheral artery disease affecting the lower extremities. These consensus definitions include the clinical presentation, anatomic depiction, interventional outcomes, surrogate imaging and physiological follow-up, and clinical outcomes of patients with lower-extremity peripheral artery disease. Consistent application of these definitions in clinical trials evaluating novel revascularization technologies should result in more efficient regulatory evaluation and best practice guidelines to inform clinical decisions in patients with lower extremity peripheral artery disease.

Published
2015

14. Clinical Trials in Peripheral Vascular Disease

Author

Subherwal, Sumeet, Patel, Manesh R, Chiswell, Karen, Tidemann-Miller, Beth A, Jones, W Schuyler, Conte, Michael S, White, Christopher J, Bhatt, Deepak L, Laird, John R, Hiatt, William R, Tasneem, Asba, and Califf, Robert M

Subjects
Prevention, Clinical Trials and Supportive Activities, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Cardiovascular, Amputation, Clinical Trials as Topic, Databases, Factual, Device Approval, Double-Blind Method, Geographic Mapping, Health Services Accessibility, Humans, Internet, Patient Selection, Peripheral Arterial Disease, Peripheral Vascular Diseases, Placebos, Research Design, Research Support as Topic, Stroke, United States, Venous Insufficiency, clinical trials as topic, peripheral vascular diseases, prevention and control, registries, Amputation, Surgical, Cardiorespiratory Medicine and Haematology, Clinical Sciences, Public Health and Health Services, Cardiovascular System & Hematology
Abstract

BackgroundTremendous advances have occurred in therapies for peripheral vascular disease (PVD); until recently, however, it has not been possible to examine the entire clinical trial portfolio of studies for the treatment of PVD (both arterial and venous disease).Methods and resultsWe examined interventional trials registered in ClinicalTrials.gov from October 2007 through September 2010 (n=40,970) and identified 676 (1.7%) PVD trials (n=493 arterial only, n=170 venous only, n=13 both arterial and venous). Most arterial studies investigated lower-extremity peripheral artery disease and acute stroke (35% and 24%, respectively), whereas most venous studies examined deep vein thrombosis/pulmonary embolus prevention (42%) or venous ulceration (25%). A placebo-controlled trial design was used in 27% of the PVD trials, and 4% of the PVD trials excluded patients >65 years of age. Enrollment in at least 1 US site decreased from 51% of trials in 2007 to 41% in 2010. Compared with noncardiology disciplines, PVD trials were more likely to be double-blinded, to investigate the use of devices and procedures, and to have industry sponsorship and assumed funding source, and they were less likely to investigate drug and behavioral therapies. Geographic access to PVD clinical trials within the United States is limited to primarily large metropolitan areas.ConclusionsPVD studies represent a small group of trials registered in ClinicalTrials.gov, despite the high prevalence of vascular disease in the general population. This low number, compounded by the decreasing number of PVD trials in the United States, is concerning and may limit the ability to inform current clinical practice of patients with PVD.

Published
2014

15. Effect of Rivaroxaban and Aspirin in Patients With Peripheral Artery Disease Undergoing Surgical Revascularization: Insights From the VOYAGER PAD Trial

Author

Debus, E. Sebastian, Nehler, Mark R., Govsyeyev, Nicholas, Bauersachs, Rupert M., Anand, Sonia S., Patel, Manesh R., Fanelli, Fabrizio, Capell, Warren H., Brackin, Taylor, Hinterreiter, Franz, Krievins, Dainis, Nault, Patrice, Piffaretti, Gabriele, Svetlikov, Alexei, Jaeger, Nicole, Hess, Connie N., Sillesen, Henrik H., Conte, Michael, Mills, Joseph, Muehlhofer, Eva, Haskell, Lloyd P., Berkowitz, Scott D., Hiatt, William R., and Bonaca, Marc P.

Published
2021
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25. Application of Adaptive Design and Decision Making to a Phase II Trial of a Phosphodiesterase Inhibitor for the Treatment of Intermittent Claudication

Author

Lewis, Roger J, Connor, Jason T, Teerlink, John R, Murphy, James R, Cooper, Leslie T, Hiatt, William R, and Brass, Eric P

Abstract

Abstract Background Claudication secondary to peripheral artery disease (PAD) is associated with substantial functional impairment. Phosphodiesterase (PDE) inhibitors have been shown to increase walking performance in these patients. K-134 is a selective PDE 3 inhibitor being developed as a potential treatment for claudication. The use of K-134, as with other PDE 3 inhibitors, in patients with PAD raises important safety and tolerability concerns, including the induction of cardiac ischemia, tachycardia, and hypotension. We describe the design, oversight, and implementation of an adaptive, phase II, dose-finding trial evaluating K-134 for the treatment of stable, intermittent claudication. Methods The study design was a double-blind, multi-dose (25 mg, 50 mg, and 100 mg of K-134), randomized trial with both placebo and active comparator arms conducted in the United States and Russia. The primary objective of the study was to compare the highest tolerable dose of K-134 versus placebo using peak walking time after 26 weeks of therapy as the primary outcome. Study visits with intensive safety assessments were included early in the study period to provide data for adaptive decision making. The trial used an adaptive, dose-finding strategy to efficiently identify the highest dose(s) most likely to be safe and well tolerated, based on the side effect profiles observed within the trial, so that less promising doses could be abandoned. Protocol specified criteria for safety and tolerability endpoints were used and modeled prior to the adaptive decision making. The maximum target sample size was 85 subjects in each of the retained treatment arms. Results When 199 subjects had been randomized and 28-day data were available from 143, the Data Monitoring Committee (DMC) recommended termination of the lowest dose (25 mg) treatment arm. Safety evaluations performed during 14- and 28-day visits which included in-clinic dosing and assessments at peak drug concentrations provided core data for the DMC review. At the time of review, no subject in any of the five treatment arms (placebo, three K-134-containing arms, and cilostazol) had met pre-specified definitions for resting tachycardia or ischemic changes on exercise ECG. If, instead of dropping the 25-mg K-134 treatment arm, all arms had been continued to full enrollment, then approximately 43 additional research subjects would have been required to complete the trial. Conclusions In this phase II, dose-finding trial of K-134 in the treatment of stable intermittent claudication, no concerning safety signals were seen at interim analysis, allowing the discontinuation of the lowest-dose-containing arm and the retention of the two highest-dose-containing arms. The adaptive design facilitated safe and efficient evaluation of K-134 in this high-risk cardiovascular population. Trial registration ClinicalTrials.gov: NCT00783081

Published
2011

26. Rivaroxaban and Aspirin in Peripheral Artery Disease Lower Extremity Revascularization: Impact of Concomitant Clopidogrel on Efficacy and Safety

Author

Hiatt, William R., Bonaca, Marc P., Patel, Manesh R., Nehler, Mark R., Debus, Eike Sebastian, Anand, Sonia S., Capell, Warren H., Brackin, Taylor, Jaeger, Nicole, Hess, Connie N., Pap, Akos F., Berkowitz, Scott D., Muehlhofer, Eva, Haskell, Lloyd, Brasil, David, Madaric, Juraj, Sillesen, Henrik, Szalay, David, and Bauersachs, Rupert

Published
2020
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30. Abstract 15943: Health Status and Quality of Life With Early Invasive and Non-invasive Treatment Strategies for Patients With Claudication

Author

Angraal, Suveen, Hejjaji, Vittal, Tang, Yuanyuan, Derbas, Laith, Patel, Manesh R, Heyligers, Jan, White, Christopher J, Tutein Nolthenius, Rudolf, Mena-hurtado, Carlos, Aronow, Herbert D, Moneta, Gregory L, Hiatt, William R, Fitridge, Robert, Soukas, Peter A, Abbott, Jinnette D, Spertus, John, and Smolderen, Kim G

Published
2020
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33. Abstract 13474: Rivaroxaban Reduces Major Cardiovascular and Limb Events in Patients With the High-risk Triad of Chronic Kidney Disease, Peripheral Artery Disease and Recent Lower Extremity Revascularization: Insights From VOYAGER PAD

Author

Hsia, Judith A, Anand, Sonia, Nehler, Mark R, Bauersachs, Rupert, Patel, Manesh R, Debus, Sebastian, Hess, Connie N, Capell, Warren, Diao, Lihong, Berkowitz, Scott D, Muehlhofer, Eva, Haskell, Lloyd P, Hiatt, William R, and Bonaca, Marc P

Published
2020
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46. Rivaroxaban Plus Aspirin for Extended Thromboprophylaxis in Acutely Ill Medical Patients: Insights from the MARINER Trial

Author

Spyropoulos, Alex C., additional, Goldin, Mark, additional, Ageno, Walter, additional, Albers, Gregory W., additional, Elliott, C. Gregory, additional, Hiatt, William R., additional, Halperin, Jonathan L., additional, Maynard, Gregory, additional, Steg, P. Gabriel, additional, Weitz, Jeffrey I., additional, Spiro, Theodore E., additional, Lu, Wentao, additional, Marsigliano, Jessica, additional, Raskob, Gary E., additional, and Barnathan, Elliot S., additional

Published
2022
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