Drug-Coated Balloon for the Treatment of Long-Segment Femoropopliteal Artery Disease: Pooled Analysis from the BIOLUX P-III SPAIN and BIOLUX P-III All-Comers Registry Long Lesion Subgroup.

PURPOSE: To investigate the clinical performance and safety of the Passeo-18 Lux drug-coated balloon (DCB) in complex femoropopliteal Trans-Atlantic Inter-Society Consensus (TASC) C and D lesions in an all-comers patient population. MATERIAL AND METHODS: Data from BIOLUX P-III SPAIN, a prospective, national, multicenter, postmarket all-comers registry conducted from 2017 to 2019, and a matching long lesion subgroup from the BIOLUX P-III All-Comers global registry conducted from 2014 to 2018 were pooled for analysis. The primary safety end point was freedom from major adverse events (MAEs) at 6 months, and the primary performance end point was freedom from clinically driven target lesion revascularization (fCD-TLR) at 12 months, both adjudicated by an independent clinical events committee. RESULTS: A total of 159 patients, of whom 32.7% had critical limb ischemia, were included in the Passeo-18 Lux long lesion cohort. The mean lesion length was 248.5 mm ± 71.6, and the majority were occluded (54.1%), calcified (87.4%), and of type TASC C (49.1%) or TASC D (50.9%). Freedom from MAEs was 90.6% (95% CI, 84.6-94.3) at 6 months and 83.9% (95% CI, 76.7-89.0) at 12 months. fCD-TLR was 84.4% (95% CI, 77.3-89.5) at 12 months. Freedom from target limb major amputation was 98.6% (95% CI, 94.6-99.7), and all-cause mortality was 5.3% (95% CI, 2.7-10.4) at 12 months. There were no device- or procedure-related deaths or amputations up to the 12-month follow-up. CONCLUSION: Passeo-18 Lux DCB is safe and effective for the treatment of long femoropopliteal lesions in a real-word setting.

Assessing the influence of the COVID-19 pandemic on the incidence, clinical presentation, and clindamycin resistance rates of Streptococcus pyogenes infections.

Objectives: Streptococcus pyogenes (group A Streptococcus [GAS]) is a prevalent cause of community-acquired bacterial infections, with invasive GAS (iGAS) infections presenting severe morbimortality. Clindamycin is generally used based on its antitoxin effect. This study investigates changes in iGAS incidence, clinical presentation, outcomes, and clindamycin resistance in an adult cohort. Methods: This is a retrospective analysis of S. pyogenes episodes from a tertiary adult hospital in Barcelona (Spain) between 2015 and 2023. The pre-pandemic period includes data from 2015-2019. The pandemic period, from 2020-2021, and post-pandemic period comprised 2022 to the first semester of 2023. Results: The global incidence of GAS infections in the pre-pandemic and post-pandemic periods were 2.62 and 2.92 cases per 10.000 hospital admissions, whereas for iGAS cases, they were 1.85 and 2.34. However, a transient decrease was observed during the pandemic period: 1.07 and 0.78 per 10.000 hospital admissions. There was a significant decrease in GAS and iGAS infections during the pandemic period compared with the pre-pandemic incidence (P <0.001 for GAS infections and P = 0.001 for iGAS cases) and the post-pandemic incidence (P = 0.032 for GAS infections and P = 0.037 for iGAS cases). The most common source of infection was skin and soft tissue infections with 264 (54%) cases. Skin and soft tissue infections and cases of necrotizing fasciitis increased during the pandemic. Clindamycin resistance occurred in 13.5% of isolations during the pre-pandemic and 17.5% in post-pandemic period (P = 0.05). Conclusions: Our study revealed a temporary reduction in iGAS infections, followed by resurgence in the post-pandemic period. The observed rise in clindamycin resistance emphasizes the importance of monitoring local resistance patterns for tailored treatment.