Two studies published Nov. 10 in JACC: Cardiovascular Interventions examine current treatment options, outcomes and trends for peripheral vascular interventions (PVIs). First, three-year results of the SELUTION SFA JAPAN prospective single-arm study demonstrated the durability, safety and efficacy of a sirolimus drug-coated balloon (DCB) for femoropopliteal disease. Second, results of a retrospective cohort study revealed that ambulatory surgical centers (ASCs) and outpatient-based laboratories (OBLs) have become more common than hospital-based clinical settings for chronic limb-threatening ischemia (CLTI) revascularization among Medicare beneficiaries and are associated with improved outcomes.

In the SELUTION SFA JAPAN study, Yoshimitsu Soga, MD, PhD, FACC, et al., analyzed data from 134 patients (mean age, 74 years; 19% women; 60% had diabetes) at 13 Japanese centers undergoing endovascular treatment of femoropopliteal lesions with the SELUTION drug-eluting balloon. One-year results demonstrated a promising 88% primary patency rate.

The 36-month results showed a primary patency rate of 82%, and freedom from clinically driven target lesion revascularization (TLR) was 94%. The rate of major adverse events was 14%, comprising eight clinically driven TLRs and 11 all-cause deaths (unrelated to the device or procedure). Findings also revealed marked improvements in Rutherford class and ankle-brachial index (ABI) that were sustained through 36 months (e.g., median ABI improved from 0.72 to 0.97).

In an accompanying editorial, Bernardo Cortese, MD, and Marco Frazzetto, MD, write that "sirolimus DCBs appear to be a valuable and promising alternative to paclitaxel DCBs" in this patient population; however, "confirmation in larger trials across a wider spectrum of disease complexity remains necessary before claiming that we have found the new kid on the block."

In the second study, Joseph M. Kim, MD, Eric A. Secemsky, MD, MSc, FACC, et al., used Medicare fee-for-service claims data from 2016-2023 to analyze national trends including 925,905 beneficiaries aged ≥66 years undergoing lower extremity PVI for CLTI.

Results showed that of 133,175 patients, the proportion of 820,381 total revascularizations performed in ASC/OBLs increased to 47% by 2023. More Black patients (18%) and dual-eligible beneficiaries (30%) but fewer rural patients (2% vs. 4%) were treated in ASC/OBLs, and more patients with gangrene and complex comorbidities were treated in hospital inpatient settings.

Over a median 657-day follow-up, the primary endpoint, a composite of all-cause mortality or major amputation, occurred in 57% of patients: 53% died and 11% had major amputations.

Notably, ASC/OBLs saw a lower risk of the primary outcome compared with hospital-based outpatient (hazard ratio [HR], 0.93; 95% CI, 0.92-0.94) and inpatient settings (HR, 0.47; 95% CI, 0.45-0.49), but a higher incidence of repeat revascularization.

Kim and colleagues write that the improved outcomes associated with ASC/OBLs "suggest appropriate patient selection has supported the migration of PVI to ambulatory environments."

Indeed, in an accompanying editorial, Ido Weinberg, MD, MSc, FACC, and Offer Galili, MD, note that "the investigators' technical rigor and judicious interpretation elevate the conversation from 'where' to revascularize to 'how' to deliver ambulatory CLTI care safely, measurably, and equitably as volumes continue to grow, even while acknowledging that for the sickest patients, hospitals will remain indispensable."