Vascular Medicine Research

The core investigators have deep knowledge in using novel statistical methods to perform comparative analyses of safety and effectiveness of peripheral devices in observational data.

Safety Assessment of Femoropopliteal Endovascular Treatment with Paclitaxel-coated Devices

The SAFE-PAD study aims to evaluate the long-term safety of paclitaxel-coated devices compared with non-paclitaxel-coated devices for femoropopliteal artery revascularization among a broad, real-world population of Medicare beneficiaries with peripheral artery disease. This multi-year analysis represents an ongoing mechanism to evaluate the safety of paclitaxel-coated devices in real world practice. Project completion is expected in 2024. Watch the video of Eric Secemsky, MD, explaining the latest results.

Comparison of Unibody and Non-Unibody Endografts for Abdominal Aortic Aneurysm Repair

The SAFE-AAA study was designed with the Food & Drug Administration to provide a longitudinal assessment of the safety of unibody aortic stent grafts, as these specific stent grafts have raised concerns about higher risk of adverse events compared to other commercially available stent grafts. This retrospective cohort study evaluated whether unibody aortic stent grafts are non-inferior (NI) to non-unibody stent grafts with respect to the composite primary outcome of aortic reintervention, rupture and mortality among Medicare beneficiaries. Findings from these studies contributed to label changes for this device and are now published in Circulation.

 

A major focus of the program is to establish real-world evidence of the epidemiology of vascular disorders and the interplay with the healthcare system. Recent investigation has also focused on the implementation of patient-reported outcome measures (PROMS) to guide treatment decisions and evaluate response to therapy.

Shared Decision-Making to Improve the Health Status of Patients with Claudication: Developing and Implementing Strategies to Individualize Treatment Decisions

This project, led by Eric Secemsky, MD, involves the development and validation of a prediction tool for patients with claudication focused on patient-reported outcomes measures. Incorporating these tools with educational material and patient and clinician input, the goal is to design, implement, and prospectively evaluate a personalized shared decision making aid for treatment decisions in peripheral artery disease (PAD).

Socioeconomic and Racial Disparities in the Treatment of Peripheral Artery Disease

This study, led by Anna Krawisz, MD, used Medicare fee-for-service data to evaluate incidence and outcomes of peripheral endovascular intervention (PVI). Results published in Circulation showed that black adults had substantially higher population-level PVI incidence and were significantly more likely to experience adverse events after PVI than white adults.

Temporal Trends and Practice Variation in the Use of Intravascular Ultrasound During Peripheral Vascular Procedures

This multi-year collaboration with Philips intends to better characterize how IVUS is being used in the US among Medicare beneficiaries undergoing peripheral vascular intervention (PVI) (arterial and venous) in multiple clinical settings (inpatient, outpatient, and office-based labs). In addition, it aims to examine variation in use among physician operators, both as a group and among different clinical settings.

Elective Ascending Aortic Aneurysm Repair Outcomes

This project, led by Brett Carroll, MD, reviewed outcomes following elective ascending aortic repair to determine risk factors for adverse events, and evaluate difference by institutional surgical volume. The study utilized the Nationwide Readmissions Database and the results are now published in Heart. 

Vascular Medicine Research is deeply involved in clinical trials related to cardiovascular disease, in particular device trials for the management of peripheral artery disease, hypertension and pulmonary embolism.

Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature

The ELEGANCE Registry, sponsored by Boston Scientific is collecting data from patients treated with commercially available BSC drug-eluting devices marketed for treatment of lesions located in the peripheral vasculature. A goal of the study is to include populations not previously represented in peripheral vascular disease trials, with a mandate that greater than 40% of participants are either women or underrepresented minorities. For more information please see the trial’s posting on clinicaltrials.gov.

SPYRAL AFFIRM: Global Study of Renal Denervation in Subjects with Uncontrolled Hypertension

The SPYRAL AFFIRM Study aims to evaluate long-term safety, efficacy and durability of the Spyral system for renal denervation in patients with hypertension. BIDMC is one of several national recruiting sites, and the only active site in Massachusetts. For more information please see the trial’s posting on the clinicaltrials.gov website. 

The basic/translational thrombosis and coagulation research program, run by Alec Schmaier, MD, PhD, focuses on endothelial dysfunction that predisposes to thrombosis. In collaboration with the Division of Hemostasis and Thrombosis, Dr. Schmaier’s laboratory is using cellular and animal models and state-of-the-art intravital microscopy to understand novel mechanisms of thrombotic disease and investigate therapeutic interventions.

• Black Adults Treated for Common Arterial Disease Are at Greater Risk of Amputation and Death Than White Adults, Researchers Show
• Researchers Find No Increased Risk of Death with Drug-Coated Devices Used for Lower Extremity Revascularization
• BIDMC Research Guides FDA Action on Common Medical Device

• Quality of Life Improvement After PVI | VDM (hmpgloballearningnetwork.com)
• Quality improvement initiative cuts use of triple therapy after PCI (healio.com)
• Peripheral vascular interventions for PAD (interventionalnews.com)
• CLD | Global Consensus and Real-World Data Supporting Peripheral IVUS-Guided Revascularization (Podcast) (hmpgloballearningnetwork.com)

Brett Carroll, MD, is the Director of the Section of Vascular Medicine and an Assistant Professor of Medicine at Harvard Medical School. He directs the BIDMC pulmonary embolism response team, is the medical director of the BIDMC Aortic Center, and director of lymphatic medicine. His research interests include venous thromboembolism, aortic disease, and lymphedema. He utilizes large administrative datasets to evaluate vascular diseases.

Research Profile

Anna Krawisz, MD, is a cardiologist at BIDMC, an Instructor in Medicine at Harvard Medical School, and a member of the Smith Center for Outcomes Research in Cardiology. Her research focuses on the use of large, real-world datasets to answer important questions in vascular disease and develop strategies for the improvement of patient care with a particular focus on disparities. She has studied the use of large databases to study race, sex, and wealth-based disparities in vascular disease outcomes, the use of claims data to evaluate the safety and efficacy of peripheral vascular interventions, the use of registry data to compare outcomes in carotid artery interventions, and the construction of novel model systems in which to study disease processes.

Research Profile

Alec Schmaier, MD, PhD, is a member of the Section of Vascular Medicine and Instructor of Medicine at Harvard Medical School. Dr. Schmaier’s research focuses on the interplay of endothelial cell biology and thrombosis and how they predispose to cardiovascular disease. Specific projects include endothelial membrane alterations that promote coagulation on the vessel wall, regulation of the Tie2-angiopoietin pathway for therapeutic intervention in vascular disease, platelet-derived vascular mediators, and mechanisms of endothelial dysfunction and thrombosis in COVID-19.

Research Profile

Eric A. Secemsky, MD, MSc, is the Director of Vascular Intervention in the CardioVascular Institute at Beth Israel Deaconess Medical Center and Director of Vascular Research at the Smith Center for Outcomes Research in Cardiology. He is also an Assistant Professor of Medicine at Harvard Medical School. Dr. Secemsky's research focuses on the comparative effectiveness of coronary and vascular therapies, with an emphasis on the use of novel statistical methods. He also examines outcomes related to cardiovascular disorders and the use of risk prediction models to individualize treatment strategies. Dr. Secemsky's clinical expertise is in vascular medicine, vascular intervention, and interventional cardiology.

Research Profile