Endo-First Strategy Matches Surgery in Select CLI Patients: Retrospective Data

(UPDATED) Patients with critical limb ischemia (CLI) deemed to be good candidates for endovascular intervention fare as well with this treatment as do surgically treated patients, real-world numbers from California hospitals suggest.

What the observational analysis does not do, Jonathan H. Lin, MD (University of California Davis Medical Center, Sacramento), and colleagues stress, is directly compare endovascular therapy and open surgery. This comparison, they note in their paper published online today in Circulation: Cardiovascular Quality and Outcomes, is at the heart of the ongoing BEST-CLI trial, which is enrolling individuals who are candidates for either procedure.

The current study used administrative data that lacked details on anatomy and disease severity, Lin told TCTMD. Another thing it didn’t address is whether variations across geography and physician subspecialty might have influenced the choice of treatment.

That said, in today’s practice, “vascular surgeons and other interventionalists who do peripheral revascularizations often will choose endovascular first. The data currently suggest that [this strategy] is at least a reasonable option and that at least we’re not producing inferior results,” Lin commented.

“Critical limb ischemia is a devastating disease for patients. It’s resource-intensive and ultimately it takes a collaboration [among] a multidisciplinary team: the interventionalist, the nursing staff, patient education, and additional medical support from endocrinologists and primary care doctors,” he said, adding that “revascularization is only one portion of the puzzle.”

Treatment decisions, Lin advised, should be individualized and informed by patient preference.

Commenting on the paper for TCTMD, Mehdi Shishehbor, DO, PhD (University Hospitals Cleveland Medical Center, OH), agreed that “it continues to support that the endovascular-first approach may be reasonable . . . in the majority of patients.”

That said, the study leaves many questions unanswered when it comes to information on which interventions were performed and how, he observed. In particular, the years covered—2005 to 2013—represent an era of endovascular therapy when balloon angioplasty and bare-metal stents predominated. Today’s treatments might perform even better, Shishehbor suggested.

Amputation-Free Survival and Reintervention

Here, the researchers looked at data from nonfederal hospitals in California on more than 200,000 patients with lower-extremity ulcers and PAD who underwent revascularization between 2005 and 2013. Within this group, 16,800 CLI patients (59% men) had either open surgery (36%) or endovascular intervention (64%) as their initial treatment.

Nearly half of patients in the cohort were white, while one-quarter were Hispanic, 10% were black, and 6% were Asian. White patients were more likely to have open surgery; in contrast, Hispanic patients were more apt to first undergo endovascular intervention.

Patients in the endo-first group were significantly younger than those who underwent surgery (mean 70 vs 72 years) and they were more likely to have comorbid renal failure (36% vs 24%), CAD (34% vs 32%), congestive heart failure (19% vs 15%), and diabetes (65% vs 58%).

Major amputation occurred in 30% of the endo-first group and 34% in the surgery-first group at a median time of 4.7 and 2.8 months after treatment, respectively. Rates of repeat revascularization were 38% and 34% after endovascular versus surgical intervention, occurring at a median of 4.0 and 7.8 months. Mortality rates were 29% and 27%, respectively, with median times to death of 22 and 16 months for the endovascular and surgical groups.

In an attempt to account for imbalances in comorbidity burden and other baseline differences, Lin et al performed inverse propensity weighting as well as adjustments for patients’ ability to manage their disease and for hospitals’ revascularization experience. Open surgery was linked to worse amputation-free survival (HR 1.16; 95% CI 1.13-1.20), which the researchers say is “perhaps due to increased severity of wounds at the time of presentation.”

Endovascular treatment, on the other hand, was linked to higher risk of reintervention (HR 1.19; 95% CI 1.14-1.23). There was no difference in mortality between the two groups.

“Patients with CLI have multiple comorbidities, and choosing the initial treatment requires a customized therapeutic approach that balances patient factors with technical and anatomic limitations,” the researchers note in their paper.

Importantly, the suboptimal rates of primary patency merit attention, they stress. “While we continue to strive for improvements in endovascular technologies, we have not made much progress in the past 20 years with the development of new surgical conduits or adjuncts to improve bypass patency. As a vascular community, more work needs to focus on improved patency of surgical bypasses as well. This is especially important as there are many patients who are not candidates for endovascular therapy due to anatomic limitations as well as many patients who do not have good single segment venous conduits.”

Shishehbor said that despite the study not being randomized, “they have a good database in California [with] a large sample size.”

What leapt out to him most is that so few patients—2%—were self-pay. One theory about why CLI patients tend to fare worse than others with PAD is that they “usually come from a lower socioeconomic class, and one of the arguments has been that the differential in outcome may be related to insurance issues,” Shishehbor explained. But in this data set, this wasn’t the case.

Also noteworthy is that even in the open-surgery group, one-third of patients needed another round of revascularization, he pointed out.

But Shishehbor was not convinced that bigger wounds could account for the greater likelihood of major amputation after surgical revascularization, since the paper reported no data to back this up. Most patients who undergo surgery, on the flip side, tend to “have good targets and good autologous veins” that would be expected to result in better outcomes, he countered. So it’s unclear why there was an imbalance for this outcome.