A McMaster researcher is leading international trials focused on helping people on every continent access comprehensive follow-up care after heart surgery.
The goal is to collect data from the most diverse study population possible so the results can benefit people all over the world who need specialized cardiac care, says Emilie Belley-Côté, a scientist at the Population Health Research Institute (PHRI) and associate professor of medicine at McMaster University.
“There are some patients in our trials who live in remote areas or face financial burdens that mean they are getting their blood levels tested much less frequently than what is recommended,” said Belley-Côté.
“Some patients need to travel for hours to get a blood test, and we need to know how they’re impacted just as much as those patients who have easy access to health care.”
Spanning dozens of sites across the world, the LIMIT and DANCE trials are initiatives from PHRI that build on McMaster’s global reputation as the birthplace of evidence-based medicine.
Both trials focus on enhancing patient management after cardiac surgery, each using a different anticoagulation or blood thinning strategy, said Belley-Côté, who is associate deputy director at PHRI, a joint institute of McMaster University and Hamilton Health Sciences.
The purpose of LIMIT is to determine if a lower level of blood thinning for patients with mechanical heart valves will result in less bleeding and ultimately prevent strokes and clotting in those patients, who are typically under the age of 60 and are expected to need this kind of treatment for decades.
While there have been smaller studies that have suggested the lower level is safe and effective, Belley-Côté said LIMIT is broadening its scope and aiming to enroll 2,625 patients across North and South America, Europe, Africa, Asia, and Australia.
“We will really have a global reach, so the results will be more generalizable, both in terms of different patient profiles and different types of valves that weren’t included in previous trials.”
Belley-Côté says the goal of research conducted through PHRI is to reflect the diversity of patients around the world so the evidence they collect is beneficial to as many people as possible.
DANCE is examining the impact of blood thinners on patients in the crucial three-month period after they’ve had cardiac surgery. Specifically, it is comparing the safety of a newer type of blood thinner called direct oral anticoagulants (DOACs) with the tried-and-true warfarin, which doesn’t interact well with many commonly used medications and certain foods that contain vitamin K.
Warfarin also requires patients to get their blood tested regularly, which is an added strain when they’re in recovery, explained Belley-Côté. The more modern blood thinner medications are convenient because they only require one dose, but there’s one significant downside that requires further study: “We don’t have good reversal agents for these drugs, so if the patients start bleeding or experience a complication that requires an operation, there’s no good way to reverse the effect of the blood thinner.”
That’s where DANCE enters the picture, with a goal of recruiting 3,500 patients across as many countries as possible.
Coordinating these enormous clinical trials on a global scale isn’t an easy feat, especially given the complexity of dealing with many different regulatory bodies and health–care systems. It’s a challenge that PHRI research coordinator Pyper Olver said is one of the most rewarding aspects of her job.
“There are a lot of moving pieces and important operational factors and considerations that we need to take into account that require a lot of flexibility and creativity,” said Olver, who is pursuing her master’s in Health Research Methodology while managing the logistics of these trials.
Pyper Olver (right) is a research coordinator at PHRI and has a crucial role managing the logistics of the LIMIT and DANCE studies. She’s also pursuing her master’s in Health Research Methodology, with Belley-Côté as her thesis supervisor.
“Fortunately, McMaster has a good reputation for doing this kind of work internationally. We have a culture of collaboration that helps us foster these strong relationships with researcher teams and investigators from around the world.”
Olver’s background is a prime example of the interdisciplinarity at the core of research at McMaster. Her undergraduate studies were in the Faculty of Science, where she developed an interest in clinical research through an eight-month co-op placement and later became familiar with the work underway at PHRI.
“That was my first real exposure to the field, and it helped me fully conceptualize the work involved in gathering the evidence that shapes healthcare decisions,” said Olver. “The more I became involved, the more I wanted to understand the rationale for the decisions that were being made behind the scenes and the methods that were being used to address these research questions.”
With Belley-Côté as her thesis supervisor, Olver said she feels empowered to stay curious and continue asking questions – a mindset that she said is prevalent among the research ecosystem at McMaster and PHRI.
That curiosity is also what attracted Belley-Côté to McMaster, along with the breadth of knowledge and expertise in cardiovascular medicine and research that has built the foundation for her work.
“I continue to collaborate with my mentors here at McMaster, reviewing the progress of these studies regularly,” said Belley-Côté. “McMaster is really a very special environment in that way, bringing world experts together in a friendly way and having them work together to have a positive global impact.”