Reinterventions In Peripheral Arterial Disease: Claudication Versus Chronic Limb-Threatening Ischemia - A Retrospective Study And Review Of The Literature

ObjectivePatients with peripheral artery disease (PAD) present with claudication or chronic limb threatening ischemia (CLTI). CLTI patients have a more advanced stage of atherosclerosis and increased comorbidities compared to claudicants, and are at an elevated risk of major amputation and mortality after lower extremity revascularization (LER). However, the frequency of reinterventions for claudication and CLTI have not been compared. Our hypothesis is that patients with CLTI undergo more frequent reinterventions to prevent major amputation compared to patients with claudication. MethodsA single-center retrospective chart review of consecutive patients undergoing LER for PAD in 2013-2015 was performed. Patients were stratified based on indication for revascularization into claudication or CLTI. Patient characteristics, outcomes, and reinterventions were compared between the two groups. A comprehensive literature review in PubMed was also performed to summarize the findings from the literature with respect to reinterventions for patients undergoing LER for PAD. ResultsThere were 826 patients undergoing LER and 44% (N=361) had CLTI. Patients treated for CLTI were more likely to be smokers (p\u3c.001), have diabetes (p\u3c.001), chronic renal insufficiency (p\u3c.001), end stage renal disease (p\u3c.001), and cardiac disease (p\u3c.001). CLTI patients were less likely to be on optimal medical management as reflected by decreased rate of aspirin (p\u3c.001), ADP receptor/P2Y12 inhibitors (p\u3c.001), and statins (p\u3c.001) compared to patients with claudication. Patients with CLTI had significantly higher major amputation (3.7% vs .2%, P\u3c.001) and mortality (1.4% vs .2%, P=.092) at 30 days. At long-term follow up, patients with CLTI had higher rates of major amputation (15.5% vs 1.3%, P \u3c .001) and mortality (37.1% vs 18.1%, P \u3c .001) compared to patients with claudication. There was a significant difference in mean follow-up time between the two cohorts (claudication: 3.7 ± 1.5 years vs CLTI: 2.6 ± 1.8 years, P \u3c.001). There was no significant difference in the ipsilateral reintervention rate between the two groups (claudication: 39.6% vs CLTI: 42.7%, P=.37) or the mean number of ipsilateral reinterventions (claudication: 2.0± 1.6 vs CLTI: 2.0 ± 1.7). However, after adjusting for follow-up time, the mean number of reinterventions per year (frequency of reintervention) was significantly higher for CLTI patients compared to patients with claudication (1.4 ± 2.2 vs .6 ± 0.7 intervention per year, P \u3c.001). The literature review yielded 96 articles which met inclusion criteria including explicit report of reintervention rate in study cohorts composed of claudication and/or CLTI patients. Of those articles with large cohort size and similar follow-up as this study, reintervention rates ranged from 11% to 41.3% in those with claudication. In those with CLTI, the range was 11.6% to 61%. Only three articles specified reintervention frequency. Conclusion Patients undergoing LER for CLTI undergo more frequent reinterventions over time compared to patients treated for claudication. The current literature is limited to describing reintervention rates as percentage of patients undergoing any reintervention. Research on reinterventions after LER should include reporting of the frequency of reintervention adjusted for the follow up period

Adding colchicine to tocilizumab in hospitalized patients with severe COVID-19 pneumonia: An open-label randomized controlled trial

Introduction: Colchicine acts upstream in the cytokines cascade by inhibiting the nod-like receptor protein 3 (NLRP3) inflammasome while interleukin 6 (IL-6) receptor antagonists, such as tocilizumab, block the end result of the cytokines cascade. Hence, adding colchicine to tocilizumab with the aim of blocking the early and end products of the cytokines cascade, might reduce the risk of developing cytokine storm. Methods and analysis: We aim to conduct an open-label randomized controlled trial to evaluate the efficacy and safety of adding colchicine to tocilizumab among patients with severe COVID-19 pneumonia to reduce the rate of invasive mechanical ventilation and mortality. We will include patients with severe COVID-19 pneumonia who received tocilizumab according to our local guidelines. Enrolled patients will be then randomized in 1:1 to colchicine versus no colchicine. Patients will be followed up for 30 days. The primary outcome is the rate of invasive mechanical ventilation and will be determined using Cox proportional hazard model. Discussion: Given colchicine's ease of use, low cost, good safety profile, and having different anti-inflammatory mechanism of action than other IL-6 blockade, colchicine might serve as a potential anti-inflammatory agent among patients with severe COVID-19 pneumonia. This study will provide valuable insights on the use of colchicine in severe COVID-19 when added to IL-6 antagonists. Ethics and dissemination: The Medical Research Center and Institutional Review Board at Hamad Medical Corporation in Qatar approved the study protocol (MRC-01-21-299). Results of the analysis will be submitted for publication in a peer-reviewed journal. 2022 Lippincott Williams and Wilkins. All rights reserved.Scopu