Study: Link between IC revascularization and progression to CLTI established alongside rising rate of amputation

Vashisht Madabhushi (right) speaks at SAVS

PALM BEACH, Fla.—Revascularization of intermittent claudication (IC) patients is associated with an increased rate of progression to critical limb-threatening ischemia (CLTI)—as well as an increased rate of amputation.

Those were the main findings of a study presented in a scientific session at the Southern Association for Vascular Surgery (SAVS) annual meeting in Palm Beach, Florida (Jan. 8–11).

Delivered by Vashisht Madabhushi, MD, of the University of Kentucky in Lexington, Kentucky, attendees heard how the research had set out to determine if the rate of IC progression to CLTI— and amputation rates among patients initially diagnosed with the former—were influenced by treatment method.

“The most common symptomatic presentation of PAD [peripheral arterial disease] is [IC],” the researchers pointed out. “The natural progression of symptoms of IC is fairly low at 7–9% the first year and 2–3% each year thereafter, and IC portends an amputation rate of 1–3.3% at five years.”

Despite the proven benefits of mitigation by medical therapy, Madabhushi continued, a rapid growth in invasive treatment of IC has ensued.

The team’s single center, retrospective study reviewed the records of all patients who first had IC between November 2003 and April 2019, with the method defined as endovascular or open repair. Madabhushi et al stratified time to CLTI diagnosis and amputation by revascularization status.

Some 1,137 patients with IC were identified, with 109 excluded due to prior diagnosis of CLTI and 19 owing to revascularization prior to IC diagnosis, Madabhushi noted.

“There was no significant difference in age, smoking status or comorbidities between the two groups other than the revascularized group had a higher rate of COPD [chronic obstructive pulmonary disease] (15% vs. 23%; p<0.05),” Madabhushi continued. “After risk adjustment, there was a five-fold increase in the progression to CLTI in the revascularized IC group (6% vs. 35%; p<0.001) and amputation rates were nearly five times higher in the revascularized IC group (3% vs. 14%; p<0.001).”

Furthermore, a Cox multivariable regression analysis that included factors such as age, gender, body mass index, COPD and tobacco use, among others, identified revascularization of IC patients a significant risk factor on two fronts: the progression to CLTI with a hazard ratio (HR) of 6.25 (95% CI 4.01–9.73) and amputation (HR 6.16; 95% CI 2.83–13.42). Reflecting further on the findings, Madabhushi noted that further studies are needed to identify which—if any—IC patients benefit from revascularization procedures. “Given the results of this study, we believe that IC patients should be treated with SET [supervised exercise therapy] and BMT [best medical therapy],” Madabhushi et al concluded.

Discussant Malachi Sheahan III, chair in the division of vascular and endovascular surgery at the Louisiana State University Health Sciences Center in New Orleans, said he believed Madabhushi and colleagues were on the precipice of a landmark paper.

But he noted some unanswered questions— the chief of which involved selection bias, “where the patients who were selected for treatment were more likely to have more severe disease, and therefore at risk for progression.”

Sheahan also highlighted a need to return to the study charts to ascertain different treatment methods employed and their respective outcomes in order to identify any hazardous activity. “I think it would be very elucidating if you can determine if there is any difference in outcome based on the specialty of the treating provider,” he added.


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