Smoking: BEST-CLI trial points to protective effect against MALE in those undergoing open bypass over endovascular intervention

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Rohini Patel

An analysis of the BEST-CLI randomized controlled trial (RCT) found that smokers with chronic limb-threatening ischemia (CLTI) should be preferentially treated with open bypass over endovascular intervention.

Researchers from the University of California San Diego (UCSD) looked at BEST-CLI patients stratified into two groups related to smoking status—current smokers and non-smokers (a combination of never smokers and former smokers)—and discovered the paradox of the smokers’ effect: current smokers among those who underwent a bypass and those who received an endovascular procedure had better overall survival than non-smokers. However, the UCSD study revealed that the current smokers who got a bypass “had this protective effect against major adverse limb events (MALE) and we didn’t see that in the endovascular group,” presenting author Rohini Patel, MD, a general surgery resident at UCSD, tells Vascular Specialist after delivering results from the analysis at the 2024 Western Vascular Society (WVS) annual meeting in Colorado Springs, Colorado (Sept. 7–10).

Having previously looked at smoking in peripheral arterial disease (PAD) patients through the lens of the Vascular Quality Initiative (VQI) and finding that former smokers and never smokers had similar outcomes to one another, and that current smokers had worse outcomes than former smokers, the research team increasingly leant on the theory that, if they could get smokers to quit their habit, then they could have similar outcomes to people who never smoked.

“Our theory was that in patients who could have either an endovascular approach or an open approach—which is not every patient, but in the ones who could—that maybe we should really be doing an open approach in them first, because it tends to protect, at least in BEST-CLI, against major adverse limb events,” Patel explains.

The perennial mission to instigate smoking cessation, either though pharmacotherapy, counseling or regular physician interaction on the topic, remains important, Patel says, but “the reality is that a lot of these patients are going to continue smoking, so the thought is, knowing that information, what can we do? Is there something we can do that would maybe be better? That’s where our analysis has led us—to an open bypass as maybe a preferential treatment in these patients if they are still going to continue smoking.”

Looking ahead, Patel says BEST-CLI is laden with more nuanced data on smoking than the VQI, suggesting the trial might help yield further evidence around pack years and the extent of former smokers’ habits. Determining the optimal interval for smoking cessation is another potential area of future study, she adds.

Andrew Barleben

Andrew Barleben, MD, an associate professor of vascular and endovascular surgery at UCSD and senior author of the analysis, points to the unique vantage point brought by vascular surgery to this patient population.

“This helps us know a little bit more that vascular surgery provides a unique capability to do both open or endovascular surgery on these patients,” he says, “and that it emboldens our practitioners who help with care for these patients on the interventional side. To this end, they can—hopefully—easily get a venous ultrasound to see if there is an available vein for these patients, who may have difficulty quitting smoking or may intermittently quit smoking, and achieve better outcomes than if they just underwent endovascular intervention.”

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