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One-Year Follow-Up of Vascular Intervention Trials Disrupted by the COVID-19 Pandemic: A Use-Case landscape
Jennifer A Rymer1, Ajay J Kirtane2, Andrew Farb3
1Duke University School of Medicine, Durham, NC, United States of America; Duke Clinical Research Institute, Durham, NC, United States of America.
Insights
Most cardiovascular clinical trials interrupted by the COVID-19 pandemic resumed enrollment within a year. Trials in early enrollment stages or unable to adapt to virtual visits faced greater disruption. Further analysis is needed for vascular intervention trials.
Area of Science:
- Cardiovascular clinical research
- Medical device trials
- Pandemic impact on healthcare
Background:
- The COVID-19 pandemic significantly disrupted global cardiovascular clinical research operations.
- The long-term effects on study progress and decision-making remain under-described.
Purpose of the Study:
- To assess the operational status and decision-making processes of cardiovascular trials one year after pandemic-related interruptions.
- To describe the impact of COVID-19 on peripheral artery disease (PAD) and coronary artery disease (CAD) intervention trials.
Main Methods:
- A task force analyzed 17 device trials (9 CAD, 8 PAD) for use-case scenarios.
- Data included publicly available criteria, endpoints, and study designs, supplemented by trial leadership input.
- Trials were categorized by enrollment status at interruption and geographic distribution.
Main Results:
- Seventeen multicenter trials (15 industry-sponsored, 2 government-sponsored) participated.
- At one year, most trials had resumed enrollment, despite ongoing pandemic activity.
- Trials interrupted early in enrollment or lacking virtual capabilities experienced more significant delays.
Conclusions:
- The majority of cardiovascular trials resumed enrollment one year post-COVID-19 interruption.
- Early-stage trials and those unable to adopt virtual methods were most affected.
- Further research is necessary to fully understand the impact on vascular intervention trials.
Introduction:
The COVID-19 pandemic had an unprecedented impact on cardiovascular clinical research. The decision-making and state of study operations in cardiovascular trials 1-year after interruption has not been previously described.
Methods:
In the spring of 2020, we created a pandemic impact task force to develop a landscape of use case scenarios from 17 device trials of peripheral artery disease (PAD) and coronary artery disease (CAD) interventions. In conjunction with publicly available (clinictrials.gov) study inclusion criteria, primary endpoints and study design, information was shared for this use-case landscape by trial leadership and data owners.
Results:
A total of 17 actively enrolling trials (9 CAD and 8 PAD) volunteered to populate the use case landscape. All 17 were multicenter studies (12 in North America and 5 international). Fifteen studies were industry-sponsored, of which 13 were FDA approved IDEs, one was PCORI-sponsored and two were sponsored by the NIH. Enrollment targets ranged from 150 to 9000 pts. At the time of interruption, 5 trials were <20 % enrolled, 9 trials were 50-80 % enrolled and 3 trials were >80 % enrolled. At 1 year, the majority of studies were continuing to enroll in the context of more sporadic but ongoing pandemic activity.
Conclusions:
At 1 year from the first surge interruptions, most trials had resumed enrollment. Trials most heavily interrupted were trials early in enrollment and those trials not able to pivot to virtual patient and site visits. Further work is needed to determine the overall impact on vascular intervention trials disrupted during the COVID-19 pandemic.
