Early peripheral vascular intervention (PVI) for claudication is associated with higher rates of progression to chronic limb-threatening ischemia (CLTI) and major adverse limb events (MALE) compared with conservative medical management, according to data presented at the 2026 annual winter meeting of the Vascular and Endovascular Surgery Society (VESS) in Olympic Valley, California (Feb. 2-8).
The study analyzed 100% fee-for-service Medicare data to compare outcomes among patients with claudication who underwent early intervention versus those managed initially with conservative therapy. Investigators focused on the risk of conversion to CLTI and MALE, including reintervention, major amputation, and need for open bypass.
“What makes this study unique is that we used a target trial emulation methodology,” said Caitlin Hicks, MD, associate professor of surgery at Johns Hopkins Medicine and senior author on the study. “There’s a lot of selection bias that goes into which patients may or may not receive interventions, especially when using big data without a lot of granularity. Target trial emulation is supposed to emulate a randomized controlled trial.”
Using a technique known as clone censor weighting, patients were statistically assigned to each treatment pathway. This allowed investigators to estimate the probability of outcomes under different management strategies. “You can’t get rid of all bias,” said Hicks. “But this methodology is supposed to minimize the bias to the full extent possible and allowable by the data.”
The study included 562,561 patients with a new diagnosis of claudication, of which 14,216 underwent an early PVI. Findings showed that the cumulative conversion to CLTI and MALE incidence was higher among patients treated with early PVI. Early PVI was also associated with a persistently increased risk of CLTI and MALE.
“I’ve been a strong proponent of medical therapy first for patients with claudication,” said Hicks. “These results reinforce that. It really provides additional evidence that intervening early on claudication is ill-informed. There are obviously exceptions to the rule at all times, but for most patients, they should be managed in a conservative style prior to considering invasive intervention.”
Hicks said discussing the increased risks of CLTI and MALE with patients is critical when deciding treatment. “When patients come in with claudication, most come in wanting an intervention,” she said. “When I talk to them, I say ‘Does it bother you so much to the point you are willing to have an intervention and increase the risk you may lose your leg?’ When you put it in that framing, most patients say no.”
This highlights the importance of shared decision-making and how clinicians need to be more open with patients. “Everything we do comes with a risk-benefit profile,” said Hicks. “It’s all about maximizing the benefit side. There are never no risks. It really is about framing questions in a way that patients can understand that we can improve things now, but there may be consequences long-term. And for each patient, their values are different. You need to be able to phrase it in that way so they can make an informed decision.”
One of the strengths of the analysis is that it provides data to support these conversations, said Hicks. “A lot of us are very short-sighted when we treat patients,” she said. “We think ‘I can make your symptoms better right now.’ But these data suggest on a longer time horizon — this was a three-year study — that we ultimately may be doing a disservice to patients.”
Although the study provides more evidence about the potential harms of early PVI, Hicks said she isn’t sure the data will have an immediate impact on clinical practice. “Clinicians that manage patients with claudication conservatively will use these data to say ‘I knew I was right. Let’s keep doing it,’” she said. “Clinicians that manage non-conservatively, their reasons are usually more that. They think ‘We can provide immediate relief to patients.’ This study doesn’t resolve that.”
Chen Dun, PhD, MHS, a research associate in biomedical informatics and data sciences at Johns Hopkins School of Medicine and first author on the study, said the findings support current guidelines for treating new claudication patients, which recommend starting with medical management and exercise.
“This study validated the safety of ‘watch and wait,’” said Dun. “Clinicians often face pressure to ‘do’ something quickly to help patients relieve symptoms. Our study provides rigorous evidence showing that delaying intervention and doing more conservative therapy is safe and beneficial in the long term. I hope this study can shift the conversation from ‘why wait’ to ‘why rush.’”
