January 2026

This is a parallel, single-blind, randomized clinical trial assessing whether patients at high cardiac risk who underwent a liberal transfusion approach experienced a lower risk of post-operative death or ischemic events compared to those who underwent a restrictive transfusion approach in patients who underwent major vascular or general surgery operation and developed postoperative anemia.  Patients in the liberal transfusion group experienced a similar rate of the primary outcome compared to those in the restrictive transfusion group (9.1% versus 10.1%). However, patients undergoing a liberal transfusion approach experienced a lower rate of non-ischemic adverse cardiac events compared to those in the restrictive group (5.9% versus 9.9%, RR 0.59 [0.36 – 0.98]). 

Summary: This trial randomized 1,428 adults deemed to be at high cardiac risk who underwent major general or vascular surgery between February 2018 to March 2023 across 16 different Veterans Affairs Medical Centers in the United States to at a restrictive (transfusion triggered at <7 g/dL) versus liberal (transfusion triggered at <10 g/dL) post-operative transfusion strategy. Patients were considered to be at elevated cardiac risk if they had a history of ischemic heart disease, myocardial infarction, peripheral arterial disease, stroke, or transient ischemic attack. The primary outcome was either all-cause death or occurrence of a major ischemic event (myocardial infarction, open or percutaneous coronary revascularization, acute kidney failure, or ischemic stroke) within 90 days of randomization. While the primary outcome rate was similar between the two groups (liberal: 9.1% versus restrictive: 10.1%), those undergoing a liberal transfusion strategy did experience a lower rate of new cardiac arrhythmias, heart failure, or non-fatal cardiac arrest (5.9% versus 9.9%, RR 0.59 [0.36 – 0.98]). The rate of protocol deviations was low in both groups, with 9% of patients assigned to the liberal strategy not being transfused per a threshold of 10 g/dL and 4% of patients in the restrictive group transfused when hemoglobin was higher than the threshold of 7g/dL. This led the authors to conclude that a liveral transfusion strategy did not reduce 90-day death or major ischemic outcomes rates compared with a restrictive transfusion strategy.

There are some important limitations of the trial that should be noted. First, this was conducted Veterans Affairs Medical Centers so the population was largely male meaning that some of these conclusions may not apply to females. Additionally, the event rate for the trial was lower than expected which reduced the statistical power of the study. Finally, the trial had a disproportionate ratio of patients who underwent vascular (~90%) versus general surgery (~10%), as this may itself impact the time course and physiology of post-operative anemia. 

Bottom line: Patients undergoing a restrictive versus liberal transfusion strategy following major vascular or general surgery did not experience different rates of death or ischemic events, however those undergoing a liberal transfusion strategy did experience a lower rate of new cardiac arrhythmias, heart failure, or non-fatal cardiac arrest.

Parastomal hernias are common among patients undergoing radical cystectomy and ileal conduit diversion. This phase 3 randomized controlled trial investigated the impact of prophylactic mesh placement on radiographic parastomal hernia development within two years. Risk of parastomal hernia did not differ between the mesh vs. no mesh group (OR with mesh=1.78 [95% CI 0.89-3.55]) at two years, and there were no significant differences in complication rates between the two groups.

Summary: Parastomal hernias (PHs) occur in up to half of patients undergoing radical cystectomy (RC). Prophylactic mesh placement has been evaluated in colorectal surgery, with most studies showing resultant decrease in rate of PH. Prior studies evaluating prophylactic mesh placement in cystectomy patients have shown mixed results. The purpose of this study was to evaluate the impact of prophylactic mesh placement at the time of radical cystectomy and ileal conduit on risk of developing a radiographic PH. 

This was a randomized controlled study including patients with nonmetastatic urothelial carcinoma undergoing RC with formation of ileal conduit. Patients in the mesh cohort underwent placement of partially absorbable mesh in the sublay position at the time of RC. Patients were evaluated for PH clinically and radiographically for two years. Secondary endpoints included 90-day perioperative complications and stomal complications within the two-year follow-up period.

Eighty-eight patients were randomized to undergo prophylactic mesh placement and 90 randomized to undergo standard surgery. Ultimately, 59 were available for analysis from the mesh group and 58 in the control group. At two years, 32 (47%) patients in the mesh group and 23 (33%) in the control group had radiographic evidence of a PH, corresponding to OR of 1.78 (95% CI 0.89-3.55).  Effects of BMI (<30 vs. ≥30) and surgeon were adjusted for using Cochran-Mantel-Haenszel methods, which also did not yield a significant difference in risk of developing radiographic PH. There was no significant difference in Clavien-Dindo grade 2 to 5 complications (69% vs. 81%, p=0.11) or stomal complications (34% vs 33%, p>0.9) between the control and study groups. Furthermore, there were no reported mesh-related complications in the study group. 

This study is limited in its inclusion of all patients undergoing radical cystectomy, rather than patients at higher risk of developing a PH. While a prior exploratory study conducted by this group noted a 22% decrease in rate of PH, this was conducted in female patients with BMI >30. The present study did not include time to hernia development. Although most PHs develop within two years, longer-term follow-up with time-to-event analysis could clarify temporal trends in PH development. 

Bottom line: In this phase 3 randomized controlled trial, prophylactic mesh placement was not associated with reduced risk of developing parastomal hernia among patients undergoing cystectomy with ileal conduit formation. While this data does not support routine mesh placement, further work may evaluate benefit of prophylactic mesh placement specifically in higher-risk subgroups. 

CREST-2 is a randomized clinical trial consisting of two parallel observer-blinded studies. It evaluates intensive medical management alone versus intensive medical management plus revascularization for patients with high-grade (≥70%) asymptomatic carotid stenosis. The stenting trial showed a lower 4-year incidence of the primary composite outcome (periprocedural stroke or death plus subsequent ipsilateral ischemic stroke) with stenting (2.8%) compared to medical management alone (6.0%, p=0.02), while the endarterectomy trial found no significant difference (3.7% vs. 5.3%, p=0.24). These findings highlight the potential benefit of stenting in select patients but underscore the foundational role of optimized medical therapy in reducing stroke risk.

Summary: Treatment of high-grade asymptomatic carotid stenosis varies internationally, with many European countries restricting revascularization primarily to symptomatic or high-risk cases, while in the U.S., 75–80% of procedures are for asymptomatic patients. The CREST-1 trial (2004–2010) previously demonstrated that carotid endarterectomy (CEA) was superior to medical therapy alone in symptomatic patients and comparable to medical therapy in asymptomatic patients. However, advancements in medical management, stenting, and endarterectomy necessitated re-evaluation. The CREST-2 trial addresses this by conducting two parallel, multicenter, randomized, observer-blinded trials: one comparing intensive medical management alone to transfemoral carotid artery stenting (TF-CAS) plus medical management, and the other comparing medical management alone to CEA plus medical management.

Patients aged ≥35 years with ≥70% asymptomatic stenosis (confirmed by Doppler ultrasonography [peak systolic velocity ≥230 cm/s], CTA/MRA, or angiography) and no ipsilateral symptoms (within 180 days) were enrolled at 155 centers across five countries from December 2014 to 2025. Exclusions included prior disabling stroke, unstable angina, or atrial fibrillation requiring anticoagulation. Randomization was stratified by center and trial, with intention-to-treat analysis. Intensive medical management targeted systolic blood pressure <130 mm Hg after 2018, LDL cholesterol <70 mg/dL, and addressed other risk factors through health coaching. Follow-up included up to 4 year post-procedural assessments with annual Doppler and MRI/CT for suspected events. The primary outcome was a composite of periprocedural (0–44 days) stroke/death plus postprocedural ipsilateral ischemic stroke. 

A total of 2485 patients were randomized (1245 in stenting trial and 1240 in endarterectomy trial). 17–18% crossover from medical management to revascularization occurred due to new symptoms, clinical progression, or patient preference. In the stenting trial, the 4-year primary event rate was 6.0% (95% CI, 3.8–8.3) with medical management versus 2.8% (95% CI, 1.5–4.3) with stenting (p=0.02), driven by lower postprocedural ipsilateral strokes (annual rate 0.4% vs. 1.7%) despite periprocedural events (1.3% vs. 0%). In the endarterectomy trial, rates were 5.3% (95% CI, 3.3–7.4) versus 3.7% (95% CI, 2.1–5.5; p=0.24), with periprocedural strokes higher in CEA (1.5% vs. 0.5%). 

The Society for Vascular Surgery commentary (AbuRhama Dec 2025) critiqued CREST-2, and emphasized real-world data showing superior outcomes for CEA/TCAR. CREST-2 did not include transcarotid artery revascularization (TCAR), and interventionalists that performed TF-CAS for the study were subject to strict selection. Interventionalists for TF-CAS submitted cases for review with a 50% acceptance rate to the study, compared to surgeons for carotid endarterectomy which had a 90% acceptance rate and were required to have a documented <3% periprocedural stroke/death in 50 cases. There were also concerns regarding non-replicable medical management, as all study participants received health coaching, and after 2018, Alicorumab (PCSK9 inhibitor) was available to all participants free of cost (donation from the company). The study was able to achieve sustained risk factor control with >80% of participants meeting LDL targets by 12 months. Other limitations include 17–18% crossovers diluting differences between the parallel studies, predominantly White/U.S.-based cohort limiting generalizability, median 4-year follow-up (longer-term unknown), COVID-19 impacts on visits, low event rates reducing power, and exclusion of emerging and validated technologies like TCAR.

Bottom Line: CREST-2 supports selective TF-CAS in asymptomatic high-grade carotid stenosis patients with suitable anatomy and experienced operators but shows no clear benefit for CEA over intensive medical management alone. An individualized approach—considering patient risk, anatomy, and all modalities (including TCAR)—is essential, with further research needed on diverse populations, longer-term outcomes, and plaque features to refine guidelines and minimize perioperative risks.