ASSOCIATED WITH LESS REINTERVENTION THAN STENTING IN FIRST SIX MONTHS–STUDY REINTERVENTION

By Bryan Kay

A DURABILITY STUDY THAT LOOKS at reintervention risk among patients treated with carotid endarterectomy (CEA) versus carotid artery stenting (CAS) procedures established that CEA demonstrated the lowest risk up to six months after surgery. A subgroup analysis between stenting procedures—transfemoral stenting versus transcarotid artery revascularization (TCAR)—further showed the latter stenting modality was superior after six months.

The data are to be delivered during Plenary Session 2 today (9:45–11 a.m.) in Potomac A/B by first author Shaunak Adkar, MD, a vascular surgery resident at Stanford Medicine in Stanford, California.

The point was to understand the as-yet lesser-understood nature of procedural durability, explains senior author Jordan R. Stern, MD, clinical associate professor of vascular surgery at Stanford, in an interview with VS@VAM ahead of this year’s meeting. “We don’t really know about the durability of each of the procedures,” he says.

The study team used the Vascular Quality Initiative (VQI), matching it to Medicare claims via the Vascular Implant Surveillance and Implantation Network (VISION) database.

They identified patients who had primary carotid revascularization from December 2016 to December 2019. The primary outcome was ipsilateral reintervention, while secondary outcomes included stroke and mortality. After propensity match-

Depression

ing, patients who underwent CEA and CAS were compared within six months following the index procedure, and from six months to three years separately. A separate propensity-matched analysis was then performed to compare transfemoral stenting and TCAR.

“Like many endovascular procedures, we had a presumption that reintervention may be significantly higher among stenting-type procedures versus endarterectomy—analogous to lower-extremity or aortic work,” explains Stern.

“When we looked at reintervention, which was what we were primarily interested in, we found a difference between endarterectomy and all stenting. CEA was superior up to six months, but that was not maintained in the long run. Over time, the reintervention rates merge and it’s no longer statistically significant.

“In terms of TCAR versus transfemoral stenting, I had the presumption that things would be equal,” Stern continues. “A stent is a stent, and, once you get through the perioperative risk of transfemoral stenting, I thought that, probably in the long run, the stents would be equally durable.

“But, actually, we did not find that—we found that TCAR was associated with a lower risk of reintervention than transfemoral stenting. That was after six months. So CEA is better than all stents within six months, and TCAR is better than transfemoral stenting after six months.”

The data were based on some 27,944 patients undergoing CEA (n=21,256) or CAS (n=6,688). After propensity matching, 4,705 patients were compared in each group.

They showed an increased risk of reintervention within six months for CAS, with a hazard ratio (HR) of 1.97 (confidence interval [CI] 1.11–3.50; p<0.05), but not beyond (HR: 1.08; CI: 0.62-1.89; p=0.79).

For Stern, the findings paint a broad picture, between well-defined perioperative outcomes and reintervention risk.

“For me personally, transfemoral stenting has been relegated to a secondary procedure because of the perioperative stroke risk,” he says.

“I think, then, that when I’m looking at durability, if reinterventions are lower with CEA within the first six months, that would probably push me towards CEA even more than I already am. The finding of TCAR being lower than transfemoral stenting I think provides more evidence that TCAR is a superior procedure in most ways compared to transfemoral stenting.”

Ultimately, says Stern, “what we really want to know is what is good for patients long-term.”

To that end, further analyses carried out by the research team uncovered additional findings set to be elaborated upon during the VAM talk today.

“In the unmatched set, transfemoral stenting was an independent predictor of reintervention,” Stern reveals. “And we did an additional analysis of TCAR versus CEA, since those seem to be the superior modalities, and did not find a difference.”

Back on the core analysis, presenting author Adkar, on behalf of Stern and colleagues is set to tell VAM 2023: “CEA portends a lower risk of reintervention than CAS, particularly within the first six months after intervention. We also confirm prior data suggesting lower rates of ipsilateral stroke and death with CEA compared to CAS.

“On subgroup analysis of stenting modalities, TCAR had a lower rate of reintervention than transfemoral stenting. CEA appears to be the most durable carotid revascularization strategy, with TCAR being more durable among stenting procedures.”

Carotid revascularization capable of improving mood in depressed patients with carotid atherosclerosis

Aprospective study has demonstrated that carotid intervention can improve mood in depressed patients with advanced carotid disease, in addition to enabling cognitive improvements irrespective of baseline depression.

These findings are set to be presented during today’s Plenary Session 1: William J. von Liebig Forum by Bahaa Succar, MD, a postdoctoral research fellow at the University of Arizona in Tucson (8:23–8:34 a.m)

Speaking to VS@VAM, Succar said: “This study provides valuable information regarding the use of carotid interventions, particularly for patients with asymptomatic carotid artery stenosis. Since stroke and mortality rates are relatively low for carotid interventions and best medical therapy, mood and cognitive assessments could offer an additional perspective to help clinicians tailor the treatment approach when counselling a patient.”

Outlining the backdrop to their work, the researchers note that the impact carotid interventions may have on neurocognitive function in patients with advanced carotid atherosclerosis has not yet been fully elucidated. In addition, little is currently known about the impact carotid interventions can have on mood.

As such, they set out to investigate this phenomenon in a “well-defined cohort of patients”, prospectively recruiting a total of 158 people undergoing carotid revascularization. Screening for depression was performed preoperatively, and at one, six and 12 months post-intervention using the long form of the geriatric depression scale (GDS) questionnaire. The cohort was divided into ‘depressed’ and ‘non-depressed’ based on preoperative GDS scores >9 and ≤9, respectively. Patients also received other neuropsychometric tests to assess memory and executive function concurrently at the designated timepoints—with scores being adjusted against age and education to generate scaled comparisons.

Succar is set to report the following results at VAM 2023: At baseline, depression (GDS >9) was observed in 49 subjects (31%), whereas 109 (69%) were not depressed (GDS score ≤9), and the average preoperative GDS scores were 15 and 4 in the depressed and non-depressed groups, respectively. A “significant improvement” in average GDS scores was observed within the depressed group at one month (13), six months (13.2) and one year (11.6) post-intervention compared to preoperatively, whereas the non-depressed group had similar postoperative GDS scores at all timepoints compared to baseline.

“Improvements in mood are only among those who had baseline depression,” the researchers conclude. “Further studies with larger sample sizes are warranted to investigate the association between depression, carotid disease, and carotid intervention.”—Jamie Bell

BASE REVASCULARIZATION STRATEGY ON EFFECTIVENESS IN RESTORING ADEQUATE AND DURABLE LIMB PERFUSION, BEST-CLI SUBANALYSIS ADVISES

The results of a subanalysis of the BEST-CLI trial found that patients with chronic limb-threatening ischemia (CLTI) who were deemed suitable for open lower-extremity bypass surgery “have similar periprocedural complications following either open or endovascular revascularization.”

By Jocelyn Hudson

infarction, stroke and death— non-serious (non-SAE) and serious adverse events (SAE) 30 days after revascularization. The investigators share that they used a per-protocol analysis, which in this case was intervention received without crossover.

30-DAY mortality

The finding led researchers to assert that choice of revascularization strategy should be based primarily on effectiveness in restoring adequate and durable limb perfusion.

Submitting and presenting author Jeffrey J. Siracuse, MD, of the Boston University School of Medicine in Boston, is due to present the results of this study during the first of today’s two SVS-VESS (Vascular and Endovascular Surgery Society) Scientific Sessions (1:30–3 p.m.) in Potomac C.

In the abstract for their study, Siracuse et al note that perioperative morbidity is a “major deciding factor” for choosing a revasculariza- tion method for CLTI. It was the objective in this study, they communicate, to assess systemic perioperative complications in the BEST-CLI trial.

By way of context, the authors write that the BEST-CLI trial was a prospective randomized trial comparing open and endovascular revascularization strategies. They detail that there were two cohorts, with cohort 1 including patients with adequate single-segment great saphenous vein (SSGSV) and cohort 2, those without SSGSV.

Data from the trial were analyzed for major adverse cardiovascular events (MACE)— defined as a composite of myocardial

Siracuse and colleagues relay that there were 1,367 (662 open, 705 endovascular) patients in cohort 1 and 379 (188 open, 191 endovascular) in cohort 2 who met their inclusion criteria. Sharing the results in their study abstract, the authors report that 30-day mortality was low—1.5% in cohort 1 (open 1.8%; endovascular 1.3%) and 1.3% in cohort 2 (2.7% open; 0% endovascular).

They add that the rate of MACE in cohort 1 was 4.98% for open vs. 3.3% for endovascular (p=0.12) and in cohort 2 was 4.3% for open and 1.6% for endovascular (p=0.16). The authors specify that on multivariate analysis, there was no difference in 30-day mortality MACE for open vs. endovascular for either cohort 1 (hazard ratio [HR] 1.49, 95% confidence interval [CI] 0.85–2.62, p=0.17) or cohort 2 (HR 2.25, 95% CI 0.49–10.4, p=0.3).

Acute renal failure was found to be similar by intervention, Siracuse et al state, detailing that the rates in cohort 1 were 3.6% for open vs. 2.1% endovascular (HR 1.6, 95% CI 0.85–3.12, p=0.14) and cohort 2, 4.2% vs. 1.6% (HR 2.86, 95% CI 0.75–10.8, p=0.12). In addition, they note that venous thromboembolism (VTE) rates were low, with cohort 1 at 0.7% (open 0.9%; endovascular 0.4%) and cohort 2 at 0.3% (open 0.5%; endovascular 0%).

Other results from the study include the fact that patients with non-SAE in cohort 1 were 23.4% for open and 17.9% for endovascular (p=0.06), and in cohort 2 were 21.8% for open and 19.9% for endovascular (p=0.71). Furthermore, the investigators share that patients with SAE in cohort 1 were 35.3% for open and 31.6% for endovascular (p=0.57), and cohort 2 were for 25.5% open and 23.6% endovascular (p=0.72). Siracuse and colleagues detail that the most common etiologies for nonSAE and SAE were infectious, procedural complications, and related to underlying peripheral vascular disease.