Recurrent Events in Cardiovascular Trials: JACC State-of-the-Art Review

J Gregson, GW Stone, DL Bhatt, M Packer… - Journal of the American …, 2023 - jacc.org
Many randomized trials in cardiovascular disease have repeat nonfatal events (such as
hospitalizations) occurring during patient follow-up; yet, it remains common practice to have …

Effect of dapagliflozin on total heart failure events in patients with heart failure with mildly reduced or preserved ejection fraction: a prespecified analysis of the …

PS Jhund, BL Claggett, A Talebi, JH Butt… - JAMA …, 2023 - jamanetwork.com
Importance In the Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved
Ejection Fraction Heart Failure (DELIVER) trial, dapagliflozin reduced the risk of time to first …

Advancing Transthyretin Amyloidosis Drug Development in an Evolving Treatment Landscape: Amyloidosis Forum Meeting Proceedings

MS Maurer, P Soman, A Hernandez, P Garcia-Pavia… - Advances in …, 2024 - Springer
Conclusion Given rapid evolution of natural history in ATTR amyloidosis, the utility of
historical control data is limited. Leveraging contemporary real-world data is essential for …

Use of Win Statistics to Analyze Outcomes in the DAPA-HF and DELIVER Trials

T Kondo, SB Gasparyan, PS Jhund… - NEJM …, 2023 - evidence.nejm.org
Background The primary end point in most heart failure (HF) trials is a composite of time to a
first worsening HF event or cardiovascular death. Prevention of recurrent events and …

Recurrent revascularization at 10 years after percutaneous treatment of drug-eluting stent restenosis

T Koch, T Lenz, T Rheude, S Cassese, M Kazazi… - Cardiovascular …, 2024 - jacc.org
Background Treatment of patients with recurrence of in-stent restenosis (ISR) remains
particularly challenging, with data and guideline recommendations for repeat percutaneous …

Cost Effectiveness of Dapagliflozin for Heart Failure Across the Spectrum of Ejection Fraction: An Economic Evaluation Based on Pooled, Individual Participant Data …

AS Bhatt, M Vaduganathan, BL Claggett… - Journal of the …, 2024 - Am Heart Assoc
Background The sodium glucose cotransporter‐2 inhibitors are guideline‐recommended to
treat heart failure across the spectrum of left ventricular ejection fraction; however, economic …

Rationale and design of PURE, a randomized controlled trial to evaluate Peritoneal Ultrafiltration with PolyCore™ in Refractory Congestive Heart Failure

E Gronda, M Gallieni, G Pacileo, G Capasso… - Kidney and Blood …, 2024 - karger.com
Abstract Introduction: Peritoneal Ultrafiltration (PUF) has been proposed as an additional
therapeutic option for Refractory Congestive Heart Failure (RCHF) patients. Despite …

[HTML][HTML] The Imperative to Enhance Cost-Effectiveness for Cardiovascular Therapeutic Development

MH Davidson, A Hsieh, MR Dicklin, KC Maki - JACC: Basic to Translational …, 2024 - Elsevier
Cardiovascular disease (CVD) is the leading cause of mortality worldwide. Therapeutic
agents, such as those that lower low-density lipoprotein cholesterol, have been a critical …

Simulation‐based sample size calculations of marginal proportional means models for recurrent events with competing risks

JF Furberg, PK Andersen, T Scheike… - Pharmaceutical …, 2024 - Wiley Online Library
In randomised controlled trials, the outcome of interest could be recurrent events, such as
hospitalisations for heart failure. If mortality rates are non‐negligible, both recurrent events …

Analysis of composite time-to-event endpoints in cardiovascular outcome trials

R Marceau West, G Golm, DV Mehrotra - Clinical Trials, 2024 - journals.sagepub.com
Composite time-to-event endpoints are commonly used in cardiovascular outcome trials. For
example, the IMPROVE-IT trial comparing ezetimibe+ simvastatin to placebo+ simvastatin in …