Abstract

BACKGROUND In some randomized controlled trials (RCTs), transradial (TRA) compared with transfemoral access (TFA) was associated with lower mortality in coronary artery disease patients undergoing invasive management. We analyzed the effects of TRA versus TFA across multicenter RCTs and whether these associations are modified by patient or operator characteristics. METHODS We performed an individual patient data meta-analysis of multicenter RCTs comparing TRA versus TFA among patients undergoing coronary angiography with or without percutaneous coronary intervention (PCI) (PROSPERO; CRD42018109664). The primary outcome was all-cause mortality and the co-primary outcome was major bleeding at 30 days. The primary analysis was conducted by one-stage mixed-effects models based on the intention-to-treat cohort. The impact of access-site on mortality and major bleeding was further assessed by multivariable analysis. The relationship among access-site, bleeding, and mortality was investigated by natural effect model mediation analysis with multivariable adjustment. RESULTS A total of 21,600 patients (TRA=10,775 vs. TFA=10,825) from 7 RCTs were included. Median age was 63.9 years, 31.9% were female, 95% presented with acute coronary syndrome (ACS), and 75.2% underwent PCI. All-cause mortality (1.6% vs. 2.1%; HR 0.77, 95% CI 0.63-0.95, p=0.012) and major bleeding (1.5% vs. 2.7%; OR 0.55, 95% CI 0.45- 0.67, p<0.001) were lower with TRA. Subgroup analyses for mortality showed consistent results, except for baseline hemoglobin ((pinteraction)=0.033), indicating that the benefit of TRA was substantial in patients with significant anemia, while it was not significant in patients with milder or no baseline anemia. After adjustment, TRA remained associated with 24% and 51% relative risk reduction of all-cause mortality and major bleeding. A mediation analysis showed that the benefit of TRA on mortality was only partially driven by major bleeding prevention, and ancillary mechanisms are required to fully explain the causal association. CONCLUSIONS TRA is associated with lower all-cause mortality and major bleeding at 30 days, compared with TFA. The effect on mortality was driven by patients with anemia. The reduction in major bleeding only partially explains the mortality benefit.

Abstract

BACKGROUND Radial artery occlusion (RAO) is the most common complication following transradial approach (TRA) for cardiac catheterization. Our aim was to assess if decreasing radial hemostatic device (RHD) time reduces the risk of RAO among individuals receiving small sheath sizes with no adjunctive heparin. METHODS We randomized 450 individuals undergoing diagnostic cardiac catheterization via the TRA to 3 durations of RHD time: 10, 20 or 30 minutes. After this time period, the RHD was gradually released over 20 minutes. The primary efficacy endpoint was forearm hematoma grade ≥2 (5-10 cm) and the primary safety endpoint was RAO (as determined by Doppler ultrasound) one-hour post RHD removal (pre-discharge). RESULTS The mean age was 66 years and 64% were male. 5 French sheaths were used in all patients. Hematoma grade ≥2 occurred only in 1 patient in the 20 minutes groups (P=0.39). RAO occurred in 6.7% of patients in the 10 minute group, 10.7% in the 20 minute group and 6% in the 30 minute group (P=0.26). CONCLUSION Among patients receiving small caliber sheaths without adjunctive heparin, the incidence of forearm hematoma and RAO are low. Shorter durations of RHD time did not further reduce the risk of these complications. BRIEF SUMMARY We assessed if reducing radial hemostatic device (RHD) time decreases the risk of radial artery occlusion (RAO) in patients undergoing cardiac catheterization via the trasradial approach while small size sheaths and no heparin are used. We randomized 450 individuals into 3 durations of RHD time: 10, 20 or 30 minutes. The incidence of forearm hematoma and RAO were low and not different between groups.

Abstract

BACKGROUND The benefits and risks of blood transfusion in patients with acute myocardial infarction who are anemic or who experience bleeding are debated. We sought to study the association between blood transfusion and ischemic outcomes according to haemoglobin nadir and bleeding status in patients with NST-elevation myocardial infarction (NSTEMI). METHODS The TAO trial randomized patients with NSTEMI and coronary angiogram scheduled within 72h to heparin plus eptifibatide versus otamixaban. After exclusion of patients who underwent coronary artery bypass surgery, patients were categorized according to transfusion status considering transfusion as a time-varying covariate. The primary ischemic outcome was the composite of all-cause death or MI within 180 days of randomization. Subgroup analyses were performed according to pre-transfusion hemoglobin nadir and bleeding status. RESULTS 12,547 patients were enrolled. Among these, blood transfusion was used in 489 (3.9%) patients. Patients who received transfusion had a higher rate of death or MI (29.9% vs. 8.1%, p<0.01). This excess risk persisted after adjustment on GRACE score and nadir of hemoglobin (HR 3.36 95%CI 2.63-4.29 p<0.01). Subgroup analyses showed that blood transfusion was associated with a higher risk in patients without overt bleeding (adjusted HR 6.25 vs. 2.85; p-interaction 0.001) as well as in those with hemoglobin nadir > 9.0 g/dl (HR 4.01; p-interaction<0.0001). CONCLUSION In patients with NSTEMI, blood transfusion was associated with an overall increased risk of ischaemic events. However, this was mainly driven by patients without overt bleeding and those hemoglobin nadir > 9.0g/dl. This suggests possible harm of transfusion in those groups.