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
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.
A Randomized Trial Comparing Short versus Prolonged Hemostasis with Rescue Recanalization by Ipsilateral Ulnar Artery Compression: Impact on Radial Artery Occlusion-The RESCUE-RAO Trial
Ognerubov DV, Sedaghat A, Provatorov SI, Tereshchenko AS, Bertrand OF, Bernat I, Arutyunyan GK, Pogorelova OA, Tripoten MI, Balakhonova TV, et al
Journal of interventional cardiology. 2020;2020:7928961
BACKGROUND Despite the enormous benefits of radial access, this route is associated with a risk of radial artery occlusion (RAO). OBJECTIVE We compared the incidence of RAO in patients undergoing transradial coronary angiography and intervention after short versus prolonged hemostasis protocol. Also we assessed the efficacy of rescue 1-hour ipsilateral ulnar artery compression if RAO was observed after hemostasis. Material and Methods. Patients referred for elective transradial coronary procedures were eligible. After 6 F radial sheath removal, patients were randomized to short (3 hours) (n = 495) or prolonged (8 hours) (n = 503) hemostasis and a simple bandage was placed over the puncture site. After hemostasis was completed, oximetry plethysmography was used to assess the patency of the radial artery. RESULTS One thousand patients were randomized. Baseline characteristics were similar between both groups with average age 61.4 ± 9.4 years (71% male) and PCI performed on half of the patients. The RAO rate immediately after hemostasis was 3.2% in the short hemostasis group and 10.1% in the prolonged group (p < 0.001). Rescue recanalization was successful only in the short group in 56.2% (11/19); at hospital discharge, RAO rates were 1.4% in the short group and 10.1% in the prolonged group (p < 0.001). CONCLUSION Shorter hemostasis was associated with significantly less RAO compared to prolonged hemostasis. Rescue radial artery recanalization was effective in > 50%, but only in the short hemostasis group.
Comparison of a new slender 6 french sheath with a standard 5 french sheath for transradial coronary angiography and intervention: a randomized multicenter trial the RAP and BEAT (Radial Artery Patency and Bleeding, Efficacy, Adverse evenT) Trial
Aminian A, Saito S, Takahashi A, Bernat I, Jobe RL, Kajiya T, Gilchrist IC, Louvard Y, Kiemeneij F, Van Royen N, et al
Eurointervention : Journal of Europcr in Collaboration With the Working Group on Interventional Cardiology of the European Society of Cardiology. 2017;13((5):):e549-e556
AIMS: The 6 French(Fr) Glidesheath Slender (GSS6Fr, Terumo, Japan) is a recently developed thin-walled radial sheath with an outer diameter (OD) that is smaller than the OD of standard 6Fr sheaths. The effect of this introducer sheath on radial artery occlusion (RAO) is unknown. METHODS AND RESULTS We conducted a randomized, multicenter, non-inferiority trial comparing the GSS6Fr against the standard 5Fr Glidesheath (GS5Fr, Terumo, Japan) in patients undergoing TR coronary angiography and/or intervention. Patients in each group were subsequently randomized to undergo patent hemostasis or the institutional hemostasis protocol. The primary endpoint was the occurrence of RAO at discharge. A total of 1926 patients were randomized in 12 centers. The incidence of RAO was 3.47% with GSS6Fr compared with 1.74% with GS5Fr (risk difference 1.73%, 95% CI 0.51-2.95%; Pnon inferiority=0.150). Patients randomized to patent hemostasis had similar rate of RAO compared with institutional hemostasis (2.61% vs 2.61%, P=1). There was no difference with regard to all secondary end-points, including vascular access-site complication, local bleeding and spasm. CONCLUSIONS In this large multicenter randomized trial, the GSS6Fr was associated with a low event rate for the primary end-point (RAO) although non-inferiority to the GS5Fr was not met, due to a lower than expected rate of RAO in the GS5Fr group. As compared to institutional hemostasis, the use of patent hemostasis was not associated with a reduced rate of RAO.