This column alerts SIR members to abstracts that may have an impact on their practice and how they converse with referring clinicians. If you would like to suggest abstracts you feel should be included, email us at gandhi@baptisthealth.net or suvranu.ganguli@bmc.org.
The key takeaways accompanying each abstract were generated using human-assisted AI.
A vein bypass first versus a best endovascular treatment first revascularisation strategy for patients with chronic limb threatening ischaemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal revascularisation procedure to restore limb perfusion (BASIL-2): An open-label, randomised, multicentre, phase 3 trial
Lancet. 2023 May 27;401(10390):1798–1809.
Bradbury AW, Moakes CA, Popplewell M, Meecham L, Bate GR, Kelly L, Chetter I, Diamantopolous A, Ganeshan A, Hall J, Hobbs S, Houlind K, Jarrett H, Lockyer S, Malmstedt J, Patel JV, Patel S, Rashid ST, Saratzis A, Slinn G, Scott DJA, Zayed H, Deeks JJ
Methods: Bypass versus Angioplasty for Severe Ischemia of the Leg (BASIL)-2 was an open-label, pragmatic, multicenter, phase 3, randomized trial done at 41 vascular surgery units in the United Kingdom (n=39), Sweden (n=1) and Denmark (n=1). Eligible patients were those who presented to hospital-based vascular surgery units with chronic limb-threatening ischemia due to atherosclerotic disease and who required an infrapopliteal, with or without an additional more proximal infrainguinal, revascularization procedure to restore limb perfusion. Participants were randomly assigned (1:1) to receive either vein bypass (vein bypass group) or best endovascular treatment (best endovascular treatment group) as their first revascularization procedure through a secure online randomization system. Participants were excluded if they had ischemic pain or tissue loss considered not to be primarily due to atherosclerotic peripheral artery disease. Most vein bypasses used the great saphenous vein and originated from the common or superficial femoral arteries. Most endovascular interventions comprised plain balloon angioplasty with selective use of plain or drug-eluting stents. Participants were followed up for a minimum of 2 years. Data were collected locally at participating centers. In England, Wales and Sweden, centralized databases were used to collect information on amputations and deaths. Data were analyzed centrally at the Birmingham Clinical Trials Unit. The primary outcome was amputation-free survival defined as time to first major (above the ankle) amputation or death from any cause measured in the intention-to-treat population. Safety was assessed by monitoring serious adverse events up to 30-days after first revascularization. The trial is registered with the ISRCTN registry, ISRCTN27728689.
Conclusion: In the BASIL-2 trial, a best endovascular treatment first revascularization strategy was associated with a better amputation-free survival, which was largely driven by fewer deaths in the best endovascular treatment group. These data suggest that more patients with chronic limb-threatening ischemia who required an infrapopliteal, with or without an additional more proximal infrainguinal, revascularization procedure to restore limb perfusion should be considered for a best endovascular treatment first revascularization strategy.
Key takeaways:
- The objective of the BASIL-2 trial was to compare two treatment strategies for chronic limb-threatening ischemia caused by atherosclerotic disease in the leg. The two treatment strategies were vein bypass and best endovascular treatment (plain balloon angioplasty with selective use of stents).
- The primary outcome of the study was amputation-free survival, defined as the time it took for participants to experience either a major amputation (above the ankle) or death from any cause. The study found that the best endovascular treatment strategy was associated with better amputation-free survival, largely driven by fewer deaths in the best endovascular treatment group.
- Based on the study's findings, the authors suggest that a best endovascular treatment first revascularization strategy should be considered for more patients with chronic limb-threatening ischemia who required infrapopliteal (below the knee) revascularization procedures to restore blood flow to the limb. This indicates that the endovascular approach may offer better outcomes in these patients compared to vein bypass as the first-line treatment option.
Prevalence and predictors of cardiogenic shock in intermediate-risk pulmonary embolism: Insights from the FLASH registry
JACC Cardiovasc Interv. 2023 Apr 24;16(8):958–972. doi: 10.1016/j.jcin.2023.02.004.
Bangalor S, Horowitz JM, Beam D, Jaber WA, Khandhar S, Toma C, Weinberg MD, Mina B
Background: Patients with acute pulmonary embolism (PE) and hypotension (high-risk PE) have high mortality. Cardiogenic shock can also occur in nonhypotensive or normotensive patients (intermediate-risk PE) but is less well characterized.
Objectives: The authors sought to evaluate the prevalence and predictors of normotensive shock in intermediate-risk PE.
Methods: Intermediate-risk PE patients in the FLASH (FlowTriever All-Comer Registry for Patient Safety and Hemodynamics) registry undergoing mechanical thrombectomy with the FlowTriever System (Inari Medical) were included. The prevalence of normotensive shock (systolic blood pressure ≥90 mm Hg but cardiac index ≤2.2 L/min/m2) was assessed. A composite shock score consisting of markers of right ventricular function and ischemia (elevated troponin, elevated B-type natriuretic peptide, moderately/severely reduced right ventricular function), central thrombus burden (saddle PE), potential additional embolization (concomitant deep vein thrombosis), and cardiovascular compensation (tachycardia) was prespecified and assessed for its ability to identify normotensive shock patients.
Results: Over one-third of intermediate-risk PE patients in FLASH (131/384, 34.1%) were in normotensive shock. The normotensive shock prevalence was 0% in patients with a composite shock score of 0 and 58.3% in those with a score of 6 (highest score). A score of 6 was a significant predictor of normotensive shock (odds ratio: 5.84; 95% CI: 2.00–17.04). Patients showed significant on-table improvements in hemodynamics post-thrombectomy, including normalization of the cardiac index in 30.5% of normotensive shock patients. Right ventricular size, function, dyspnea, and quality of life significantly improved at the 30-day follow-up.
Conclusions: Although hemodynamically stable, over one-third of intermediate-risk FLASH patients were in normotensive shock with a depressed cardiac index. A composite shock score effectively further risk stratified these patients. Mechanical thrombectomy improved hemodynamics and functional outcomes at the 30-day follow-up.
Key takeaways:
- More than one-third (34.1%) of intermediate-risk pulmonary embolism (PE) patients in the FLASH registry experienced normotensive shock (depressed cardiac index) despite having a systolic blood pressure ≥90 mm Hg.
- A composite shock score, considering various factors like right ventricular function, thrombus burden, and cardiovascular compensation, effectively predicted the likelihood of normotensive shock.
- Mechanical thrombectomy with the FlowTriever System showed significant improvements in hemodynamics and functional outcomes for normotensive shock patients, with 30.5% experiencing a normalization of the cardiac index, and improvements in right ventricular size, function, dyspnea, and quality of life at the 30-day follow-up.
Retrieval of renal function after renal artery stenting improves event-free survival in a subgroup analysis of the Cardiovascular Outcomes in Renal Atherosclerotic Lesions trial
J Vasc Surg. 2023 Jun;77(6):1685-1692.e2.
Modrall JG, Zhu H, Prasad T, Moe O, Dworkin LD, Cutlip DE, Murphy TP, Cooper CJ, Toto R
Objective: The Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL) trial, a multicenter randomized controlled trial with 947 patients, concluded that there was no benefit of renal artery stenting (RAS) over medical therapy. However, patients with chronic kidney disease (CKD) were not analyzed separately in the CORAL trial. CKD is a risk factor for cardiovascular and renal morbidity. We hypothesized that improved renal function after RAS would be associated with increased long-term survival and a lower risk of cardiovascular and renal events in patients with CKD.
Methods: This post hoc analysis of the CORAL trial included 842 patients with CKD stages 2 to 4 at baseline who were randomized to optimal medical therapy alone (OMT; n = 432) or RAS plus OMT (RAS + OMT; n = 410). Patients were categorized as responders or nonresponders based on the change in the estimated glomerular filtration rate (eGFR) from baseline to last follow-up (median, 3.6 years; interquartile range, 2.6–4.6 years). Responders were defined by a 20% or greater increase in eGFR from baseline; all others were designated as nonresponders. Event-free survival was defined as freedom from death and multiple cardiovascular and renal complications. Event-free survival was analyzed using the Kaplan-Meier method and log-rank test. Multivariable Cox proportional hazards regression analysis was used to identify independent predictors of event-free survival.
Results: The RAS + OMT group had a higher proportion of patients with improved renal function (≥20% increase in eGFR over baseline), compared with the OMT group (25.6% vs 17.1%; P = .003). However, event-free survival was no different for the two cohorts (P = .18 by the log-rank test). Multivariable Cox proportional hazards regression analysis identified four variables that independently correlated with event-free survival for the stented cohort. Higher preoperative eGFR (hazard ratio, 0.98; 95% confidence interval [CI], 0.96-0.99; P = .002) and being a responder to stenting (hazard ratio, 0.49; 95% CI, 0.26–0.95; P = .033) increased event-free survival, whereas a history of congestive heart failure (hazard ratio, 2.52; 95% CI, 1.46-4.35; P < .001) and a higher preoperative systolic BP (hazard ratio, 1.02; 95% CI, 1.01–1.03; P = .002) decreased event-free survival. Within the stented group, 105 of 410 patients (25.6%) were responders. Event-free survival was superior for responders, compared with nonresponders (P = .009 by log-rank test). The only independent preoperative negative predictor of improved renal function after stenting was diabetes (odds ratio, 0.37; 95% CI, 0.16–0.84; P = .017), which decreased the probability of improved renal function after RAS + OMT. A subset of patients (23.4%) after RAS had worsened renal function, but OMT alone produced an equivalent incidence of worsened renal function. An increased urine albumin/creatinine ratio was an independent predictor of worsened renal function after RAS.
Conclusions: CORAL participants who demonstrated improved kidney function after RAS + OMT demonstrated improved event-free survival. This finding reinforces the need for predictors of outcome to guide patient selection for RAS.
Key takeaways:
- This post hoc analysis of the CORAL trial focused on CKD patients (stages 2 to 4) receiving either optimal medical therapy (OMT) or renal artery stenting (RAS) + OMT. The goal was to assess the association between improved renal function and long-term survival.
- Patients in the RAS + OMT group with improved renal function (≥20% increase in eGFR) demonstrated better event-free survival compared to nonresponders.
- Higher preoperative eGFR and being a responder to stenting independently correlated with improved event-free survival. Diabetes was identified as a negative predictor of renal function improvement after RAS + OMT. The study underscores the need for outcome predictors to guide patient selection for RAS.
Carbon dioxide angiography during peripheral vascular interventions is associated with decreased cardiac and renal complications in patients with chronic kidney disease
J Vasc Surg. 2023 Jul;78(1):201–208. doi: 10.1016/j.jvs.2023.03.029. Epub 2023 Mar 21.
Lee S, Ali S, Cardella J, Turner J, Guzman RJ, Dardik A, Ochoa Chaar CI.
Objective: Patients with chronic kidney disease (CKD) who undergo peripheral vascular interventions (PVI) with iodinated contrast are at higher risk of post-contrast acute kidney injury (PC-AKI). Carbon dioxide (CO2) angiography can reduce iodinated contrast volume usage in this patient population, but its impact on PC-AKI has not been studied. We hypothesize that CO2 angiography is associated with a decrease in PC-AKI in patients with advanced CKD.
Methods: The Vascular Quality Initiative PVI dataset from 2010 to 2021 was reviewed. Only patients with advanced CKD (estimated glomular filtration rate <45 ml/min/1.73 m2) treated for peripheral arterial disease were included. Propensity matching and multivariate logistic regression based on demographics, comorbidities, CKD stage, and indications were used to compare the outcomes of patients treated with and without CO2.
Results: There were 20,706 PVIs performed in patients with advanced CKD, and only 22% utilized CO2 angiography. Compared with patients treated without CO2, patients who underwent CO2 angiography were younger and less likely to be women or White, and more likely to have poor renal function, diabetes, cardiac comorbidities, and present with tissue loss. Propensity matching yielded well-matched groups with 4472 patients in each group. The procedural details after matching demonstrated 50% reduction in the volume of contrast used (32±33 vs 65±48 mL; P < .01). PVI with CO2 angiography was associated with lower rates of PC-AKI (3.9% vs 4.8%; P = .03) and cardiac complications (2.1% vs 2.9%; P = .03) without a significant difference in technical failure or major/minor amputations. Low contrast volumes (≤50 mL for CKD3, ≤20 mL for CKD4, and ≤9 mL for CKD5) are associated with reduced risk of PC-AKI (hazard ratio, 0.59; P < .01).
Conclusions: CO2 angiography reduces iodinated contrast volume usage during PVI and is associated with decreased cardiac complications and PC-AKI. CO2 angiography is underutilized and should be considered for patients with advanced CKD who require endovascular therapy.
Key takeaways:
- Using CO2 angiography during vascular interventions for advanced CKD patients reduces iodinated contrast volume by 50%, leading to fewer cases of postcontrast acute kidney injury (PC-AKI) and cardiac complications.
- Patients treated with CO2 angiography have a lower risk of PC-AKI (3.9% vs. 4.8%) and cardiac complications (2.1% vs. 2.9%) compared to traditional techniques.
- CO2 angiography is underused despite its advantages. It should be considered more often for endovascular therapy in advanced CKD cases to enhance outcomes and decrease risks.
