Capturing the Big Picture in DCB studies

 

Studies of drug-coated balloons in the lower extremities need to evolve to take a more nuanced look at outcomes, in part by incorporating more patient-centric endpoints, says a leading global expert on DCBs.

Dr. Marianne Brodmann of the University of Ganz, Austria, and a frequent principal investigator on endovascular trials, makes the case Saturday morning that it cannot be assumed that all DCBs are equally effective – though current trial and registry evidence, with their limited efficacy endpoints, make this somewhat hard to see.

“We have to step away from the philosophy we had in the past that a mechanical device like a balloon is a balloon, and therefore the same as any other balloon. When you add a drug, you have to prove the drug is working,” Dr. Brodmann said.

DCB’s right now “use different concepts of how to bring the drug onto the balloon, how much drug, and different excipients or coatings. We have different technical features that get the drug from the balloon into the vessel wall. We absolutely need a better sense of how this is working for each DCB – each one has to prove its efficacy.”

Dr. Brodmann said that investigators need to look beyond the usual measures, such as late lumen loss, which prove only that the drug is working in the vessel – and toward outcomes that better reflect a patient’s real-world quality of life after the intervention.

“The first time you have a DCB or other technology, you’re really proving efficacy just in terms of treating the stenosis or the occlusion,” she said. “But for the larger RCTs or the registries, you have to not just prove efficacy, you have to go into other endpoints, and that’s something we have to change when we look at these devices,” she said.

“For example, take a patient with intermittent claudication. If you keep that patient mobile and he’s able to walk and do regular daily activity, that’s one of the things we should look at in the future when we design trials and registries. Because if this patient, after the intervention, is able to resume his daily exercise routine and activities without feeling limited, he is also going to be reducing his cardiovascular morbidity and mortality,” Dr. Brodmann said.

Similarly, future studies should take a closer look at re-intervention as an outcome measure. “One of the most important things we can do for our patients is not have to bring them back into the cath lab,” Dr. Brodmann said. “It may not carry the same risk as surgery, but each endovascular procedure you perform still has risks – bleeding at the puncture site, allergic reactions to contrast media. Reducing the patient’s likelihood of going back is another quality-of-life improvement.”

Right now, “quality of life measures are insufficiently captured” in randomized controlled trials (RTCs). “There’s only one DCB trial that’s looked at it. But its increasingly being discussed in expert circles that it’s more and more necessary to focus on quality of life, and to expand our endpoints. We may find we do see something good for our patients beyond the endpoints we have right now,” Dr. Brodmann said.

To understand the full efficacy picture with DCBs, Dr. Brodmann said, it’s important to look both at registry and RCT evidence. “The large RCTs we have establish proof of efficacy but then I would highlight the manufacturer registries, because these registries represent the real-world scenarios you see when you treat patients with a DCB.”

Session 99: New Developments in the Treatment of Diseases of the Lower Extremities
Grand Ballroom East, 3rd Floor
Differences and Similarities in all the DCB Registries and RCTs: All DCBs and All Studies Are Not Equal
Saturday 7:58 .m. – 8:03 a.m.

 

Studies of drug-coated balloons in the lower extremities need to evolve to take a more nuanced look at outcomes, in part by incorporating more patient-centric endpoints, says a leading global expert on DCBs.

Dr. Marianne Brodmann of the University of Ganz, Austria, and a frequent principal investigator on endovascular trials, makes the case Saturday morning that it cannot be assumed that all DCBs are equally effective – though current trial and registry evidence, with their limited efficacy endpoints, make this somewhat hard to see.

“We have to step away from the philosophy we had in the past that a mechanical device like a balloon is a balloon, and therefore the same as any other balloon. When you add a drug, you have to prove the drug is working,” Dr. Brodmann said.

DCB’s right now “use different concepts of how to bring the drug onto the balloon, how much drug, and different excipients or coatings. We have different technical features that get the drug from the balloon into the vessel wall. We absolutely need a better sense of how this is working for each DCB – each one has to prove its efficacy.”

Dr. Brodmann said that investigators need to look beyond the usual measures, such as late lumen loss, which prove only that the drug is working in the vessel – and toward outcomes that better reflect a patient’s real-world quality of life after the intervention.

“The first time you have a DCB or other technology, you’re really proving efficacy just in terms of treating the stenosis or the occlusion,” she said. “But for the larger RCTs or the registries, you have to not just prove efficacy, you have to go into other endpoints, and that’s something we have to change when we look at these devices,” she said.

“For example, take a patient with intermittent claudication. If you keep that patient mobile and he’s able to walk and do regular daily activity, that’s one of the things we should look at in the future when we design trials and registries. Because if this patient, after the intervention, is able to resume his daily exercise routine and activities without feeling limited, he is also going to be reducing his cardiovascular morbidity and mortality,” Dr. Brodmann said.

Similarly, future studies should take a closer look at re-intervention as an outcome measure. “One of the most important things we can do for our patients is not have to bring them back into the cath lab,” Dr. Brodmann said. “It may not carry the same risk as surgery, but each endovascular procedure you perform still has risks – bleeding at the puncture site, allergic reactions to contrast media. Reducing the patient’s likelihood of going back is another quality-of-life improvement.”

Right now, “quality of life measures are insufficiently captured” in randomized controlled trials (RTCs). “There’s only one DCB trial that’s looked at it. But its increasingly being discussed in expert circles that it’s more and more necessary to focus on quality of life, and to expand our endpoints. We may find we do see something good for our patients beyond the endpoints we have right now,” Dr. Brodmann said.

To understand the full efficacy picture with DCBs, Dr. Brodmann said, it’s important to look both at registry and RCT evidence. “The large RCTs we have establish proof of efficacy but then I would highlight the manufacturer registries, because these registries represent the real-world scenarios you see when you treat patients with a DCB.”

Session 99: New Developments in the Treatment of Diseases of the Lower Extremities
Grand Ballroom East, 3rd Floor
Differences and Similarities in all the DCB Registries and RCTs: All DCBs and All Studies Are Not Equal
Saturday 7:58 .m. – 8:03 a.m.

 

Studies of drug-coated balloons in the lower extremities need to evolve to take a more nuanced look at outcomes, in part by incorporating more patient-centric endpoints, says a leading global expert on DCBs.

Dr. Marianne Brodmann of the University of Ganz, Austria, and a frequent principal investigator on endovascular trials, makes the case Saturday morning that it cannot be assumed that all DCBs are equally effective – though current trial and registry evidence, with their limited efficacy endpoints, make this somewhat hard to see.

“We have to step away from the philosophy we had in the past that a mechanical device like a balloon is a balloon, and therefore the same as any other balloon. When you add a drug, you have to prove the drug is working,” Dr. Brodmann said.

DCB’s right now “use different concepts of how to bring the drug onto the balloon, how much drug, and different excipients or coatings. We have different technical features that get the drug from the balloon into the vessel wall. We absolutely need a better sense of how this is working for each DCB – each one has to prove its efficacy.”

Dr. Brodmann said that investigators need to look beyond the usual measures, such as late lumen loss, which prove only that the drug is working in the vessel – and toward outcomes that better reflect a patient’s real-world quality of life after the intervention.

“The first time you have a DCB or other technology, you’re really proving efficacy just in terms of treating the stenosis or the occlusion,” she said. “But for the larger RCTs or the registries, you have to not just prove efficacy, you have to go into other endpoints, and that’s something we have to change when we look at these devices,” she said.

“For example, take a patient with intermittent claudication. If you keep that patient mobile and he’s able to walk and do regular daily activity, that’s one of the things we should look at in the future when we design trials and registries. Because if this patient, after the intervention, is able to resume his daily exercise routine and activities without feeling limited, he is also going to be reducing his cardiovascular morbidity and mortality,” Dr. Brodmann said.

Similarly, future studies should take a closer look at re-intervention as an outcome measure. “One of the most important things we can do for our patients is not have to bring them back into the cath lab,” Dr. Brodmann said. “It may not carry the same risk as surgery, but each endovascular procedure you perform still has risks – bleeding at the puncture site, allergic reactions to contrast media. Reducing the patient’s likelihood of going back is another quality-of-life improvement.”

Right now, “quality of life measures are insufficiently captured” in randomized controlled trials (RTCs). “There’s only one DCB trial that’s looked at it. But its increasingly being discussed in expert circles that it’s more and more necessary to focus on quality of life, and to expand our endpoints. We may find we do see something good for our patients beyond the endpoints we have right now,” Dr. Brodmann said.

To understand the full efficacy picture with DCBs, Dr. Brodmann said, it’s important to look both at registry and RCT evidence. “The large RCTs we have establish proof of efficacy but then I would highlight the manufacturer registries, because these registries represent the real-world scenarios you see when you treat patients with a DCB.”

Session 99: New Developments in the Treatment of Diseases of the Lower Extremities
Grand Ballroom East, 3rd Floor
Differences and Similarities in all the DCB Registries and RCTs: All DCBs and All Studies Are Not Equal
Saturday 7:58 .m. – 8:03 a.m.