1.
Impact on Mortality and Major Bleeding of Radial Versus Femoral Artery Access for Coronary Angiography or Percutaneous Coronary Intervention: a Meta-analysis of Individual Patient Data from Seven Multicenter Randomized Clinical Trials
Gargiulo G, Giacoppo D, Jolly SS, Cairns J, Le May M, Bernat I, Romagnoli E, Rao SV, van Leeuwen MAH, Mehta SR, et al
Circulation. 2022
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.
2.
A multicenter randomized controlled trial to assess the feasibility of testing modified ultrafiltration as a blood conservation technology in cardiac surgery
Boodhwani M, Hamilton A, de Varennes B, Mesana T, Williams K, Wells GA, Nathan H, Dupuis JY, Babaev A, Wells P, et al
The Journal of Thoracic and Cardiovascular Surgery. 2010;139((3):):701-6.
-
-
Free full text
-
Abstract
OBJECTIVES Modified ultrafiltration is a technique after cardiopulmonary bypass whereby blood withdrawn from the aortic cannula is passed across a semipermeable membrane to hemoconcentrate. Unblinded trials have suggested that modified ultrafiltration is efficacious for blood conservation. The objective of this trial was to assess the feasibility of a model testing modified ultrafiltration in which all members of the surgical team were blinded to the intervention. METHODS Patients (<65kg) undergoing procedures involving cardiopulmonary bypass were randomized to undergo either modified ultrafiltration (n=29) or sham (circulation without an interposed filter, n=36) for 15 minutes. The circuit was shielded from all members of the team except the perfusionist. A questionnaire was administered to determine the blinding success. RESULTS Modified ultrafiltration resulted in a removal of 1000+/-251mL of fluid and a reduction in the pump balance (1025+/-807 vs 1804+/-838; P < . 001) with an increase in hemoglobin immediately after intervention (increase of 7. 7+/-8. 8g/L in modified ultrafiltration vs 3. 8+/-5. 1g/L in sham; P=. 04). Introduction or increase in dose of vasopressors was more frequent in the modified ultrafiltration group (52% vs 28%; P=. 048). Differences in red cell transfusion rates between groups did not reach statistical significance (P=. 59). Blinding was successful for the anesthetist (blinding index 0. 13 [95% confidence interval, 0. 11-0. 38] and the intensivist (blinding index, 0. 09 [95% confidence interval, 0. 14-0. 31]) but not for the surgeon (blinding index, 0. 24 [95% confidence interval, 0. 05-0. 42]). The compliance rate for the transfusion protocol was greater than 90%. CONCLUSIONS Modified ultrafiltration was effective for hemoconcentration after cardiopulmonary bypass in patients of low body weight, but it is associated with an increased need for vasopressor support. The anesthetist and intensivist were successfully blinded to the intervention.
