BACKGROUND: During transradial (TR) access, it remains unclear whether differences in baseline patients characteristics and hemostasis care impact the rate of radial artery occlusion (RAO). We sought to compare the rate of RAO after TR access with the 6 French(Fr) Glidesheath Slender (GSS6Fr, Terumo, Japan) or a standard 5 Fr sheath in Japanese and non-Japanese patients. METHODS AND RESULTS: The Radial Artery Patency and Bleeding, Efficacy, Adverse evenT (RAP and BEAT) trial randomized 1,836 patients undergoing TR coronary angiography and/or interventions to receive the GSS6Fr or the standard 5 Fr Glidesheath (GS5Fr, Terumo, Japan). Out of this study population, 1,087 were Japanese patients and 751 non-Japanese patients. The overall incidence of RAO was significantly higher in Japanese patients (3.6% vs. 1.2%, P = 0.002). Use of GSS6Fr was associated with higher rates of RAO than GS5Fr in Japanese patients (5% vs. 2.2%, P = 0.02) and with similar RAO rates in non-Japanese patients (1.3 vs. 1.1%, P = 1). The mean hemostasis time was significantly longer in Japanese patients (378 ± 253 vs. 159 ± 136 min, P < 0.001) and more Japanese patients had a hemostasis time of more than 6 hr (16.2% vs. 4.9%, P < 0.0001). Longer hemostasis time was an independent predictor of RAO (OR per additional hour 1.070, 95% CI 1.008-1.136, P = 0.03). CONCLUSIONS: Use of GSS6Fr was associated with a higher rate of RAO than a standard 5 Fr sheath in Japanese patients but not in non-Japanese patients. Whether improvement in post-procedural care and reduced hemostasis time could impact the incidence of RAO in Japanese patients should be further assessed.

• MeSH
• arteria radialis diagnostické zobrazování   patofyziologie   MeSH
• arteriální okluzní nemoci diagnostické zobrazování   etnologie   patofyziologie   MeSH
• Asijci * MeSH
• časové faktory MeSH
• design vybavení MeSH
• hemostáza * MeSH
• incidence MeSH
• jednoduchá slepá metoda MeSH
• koronární angiografie škodlivé účinky   přístrojové vybavení   MeSH
• koronární angioplastika škodlivé účinky   přístrojové vybavení   MeSH
• krvácení etnologie   MeSH
• lidé středního věku MeSH
• lidé MeSH
• nemoci koronárních tepen diagnostické zobrazování   etnologie   patofyziologie   terapie   MeSH
• periferní katetrizace škodlivé účinky   přístrojové vybavení   MeSH
• prospektivní studie MeSH
• průchodnost cév * MeSH
• rizikové faktory MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• srdeční katétry * MeSH
• výsledek terapie MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• randomizované kontrolované studie MeSH
• srovnávací studie MeSH
• Geografické názvy
• Japonsko MeSH
• Spojené státy americké MeSH

BACKGROUND: Transradial access (TRA) has become the default access method for coronary diagnostic and interventional procedures. As compared to transfemoral access, TRA has been shown to be safer, cost-effective and more patient-friendly. Radial artery occlusion (RAO) represents the most frequent complication of TRA, and precludes future coronary procedures through the radial artery, the use of the radial artery as a conduit for coronary artery bypass grafting or as arteriovenous fistula for patients on hemodialysis. Recently, distal radial access (DRA) has emerged as a promising alternative to TRA, yielding potential for minimizing the risk of RAO. However, an international multicenter randomized comparison between DRA, and conventional TRA with respect to the rate of RAO is still lacking. TRIAL DESIGN: DISCO RADIAL is a prospective, multicenter, open-label, randomized, controlled, superiority trial. A total of 1300 eligible patients will be randomly allocated to undergo coronary angiography and/or percutaneous coronary intervention (PCI) through DRA or TRA using the 6 Fr Glidesheath Slender sheath introducer. Extended experience with both TRA and DRA is required for operators' eligibility and optimal evidence-based best practice to reduce RAO systematically implemented by protocol. The primary endpoint is the incidence of forearm RAO assessed by vascular ultrasound at discharge. Several important secondary endpoints will also be assessed, including access-site cross-over, hemostasis time, and access-site related complications. SUMMARY: The DISCO RADIAL trial will provide the first large-scale multicenter randomized evidence comparing DRA to TRA in patients scheduled for coronary angiography or PCI with respect to the incidence of RAO at discharge.

• MeSH
• arteria radialis MeSH
• arteriální okluzní nemoci * MeSH
• koronární angiografie metody   MeSH
• koronární angioplastika * metody   MeSH
• lidé MeSH
• prospektivní studie MeSH
• výsledek terapie MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH

Transradial access (TRA) is increasingly used worldwide for percutaneous interventional procedures and associated with lower bleeding and vascular complications than transfemoral artery access. Radial artery occlusion (RAO) is the most frequent post-procedural complication of TRA, restricting the use of the same radial artery for future procedures and as a conduit for coronary artery bypass graft. The authors review recent advances in the prevention of RAO following percutaneous TRA diagnostic or interventional procedures. Based on the available data, the authors provide easily applicable and effective recommendations to prevent periprocedural RAO and maximize the chances of access in case of repeat catheterization or coronary artery bypass grafting surgery.

• MeSH
• angiografie * škodlivé účinky   MeSH
• arteria femoralis * diagnostické zobrazování   patofyziologie   MeSH
• arteriální okluzní nemoci diagnostické zobrazování   etiologie   patofyziologie   prevence a kontrola   MeSH
• benchmarking MeSH
• hodnocení rizik MeSH
• konsensus MeSH
• lidé MeSH
• ochranné faktory MeSH
• periferní katetrizace * škodlivé účinky   MeSH
• průchodnost cév MeSH
• rizikové faktory MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• přehledy MeSH
• směrnice pro lékařskou praxi MeSH

BACKGROUND: Results from the Distal vs Conventional Radial Access (DISCO RADIAL) trial confirmed distal radial access (DRA) as a valid alternative to conventional transradial access, with equally low rates of radial artery occlusion (RAO), yet higher crossovers but shorter hemostasis. OBJECTIVES: The purpose of the study was to investigate whether patient anthropometric measures influence the effect of randomized access on key secondary outcomes. METHODS: DISCO RADIAL was an international, multicenter, randomized controlled trial in which patients with indications for percutaneous coronary procedure using a 6-F Slender sheath were randomized to DRA (n = 650) or transradial access (n = 657) implementing best practices to reduce RAO. The primary endpoint of the trial was incidence of forearm RAO, which was extremely uncommon. Secondary endpoints, including sheath insertion time, radial artery spasm, crossover (failure to obtain access through assigned access site), hemostasis time, and access site complications, were the focus of the current analysis. Regression models (linear for continuous and logistic for binary outcomes) were used to determine whether anthropometric measures (weight, height, body mass index, and body surface area) influenced the effect of randomized access on outcomes. RESULTS: Across tertiles of weight, height, body mass index, and body surface area, both before and after adjustment for sex and age, the main effect of vascular access on radial artery spasm, crossover, hemostasis time, and access site complications remained, with no significant interaction effect. CONCLUSIONS: The results of this exploratory analysis are consistent with the main findings of the trial and support the use of DRA in all patients, regardless of anthropometric measures.

• Publikační typ
• časopisecké články MeSH

BACKGROUND: In some randomized clinical trials, transradial access (TRA) compared with transfemoral access (TFA) was associated with lower mortality in patients with coronary artery disease undergoing invasive management. We analyzed the effects of TRA versus TFA across multicenter randomized clinical trials and whether these associations are modified by patient or procedural characteristics. METHODS: We performed an individual patient data meta-analysis of multicenter randomized clinical trials comparing TRA with TFA among patients undergoing coronary angiography with or without percutaneous coronary intervention. The primary outcome was all-cause mortality and the co-primary outcome was major bleeding at 30 days. The primary analysis was conducted by 1-stage mixed-effects models on the basis of the intention-to-treat cohort. The effect of access site on mortality and major bleeding was assessed further 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 (10 775 TRA, 10 825 TFA) from 7 randomized clinical trials were included. The median age was 63.9 years, 31.9% were women, 95% presented with acute coronary syndrome, and 75.2% underwent percutaneous coronary intervention. All-cause mortality (1.6% versus 2.1%; hazard ratio, 0.77 [95% CI, 0.63-0.95]; P=0.012) and major bleeding (1.5% versus 2.7%; odds ratio, 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 level (Pinteraction=0.003), indicating that the benefit of TRA was substantial in patients with moderate or severe anemia, whereas 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, respectively. 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. REGISTRATION: URL: https://www.crd.york.ac.uk/prospero; Unique identifier: CRD42018109664.

• MeSH
• arteria femoralis diagnostické zobrazování   MeSH
• arteria radialis MeSH
• koronární angiografie * škodlivé účinky   MeSH
• koronární angioplastika * škodlivé účinky   MeSH
• krvácení etiologie   MeSH
• lidé středního věku MeSH
• lidé MeSH
• multicentrické studie jako téma MeSH
• randomizované kontrolované studie jako téma MeSH
• rizikové faktory MeSH
• výsledek terapie MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• metaanalýza MeSH

BACKGROUND: Currently, transradial access (TRA) is the recommended access for coronary procedures because of increased safety, with radial artery occlusion (RAO) being its most frequent complication, which will increasingly affect patients undergoing multiple procedures during their lifetimes. Recently, distal radial access (DRA) has emerged as a promising alternative access to minimize RAO risk. A large-scale, international, randomized trial comparing RAO with TRA and DRA is lacking. OBJECTIVES: The aim of this study was to assess the superiority of DRA compared with conventional TRA with respect to forearm RAO. METHODS: DISCO RADIAL (Distal vs Conventional Radial Access) was an international, multicenter, randomized controlled trial in which patients with indications for percutaneous coronary procedure using a 6-F Slender sheath were randomized to DRA or TRA with systematic implementation of best practices to reduce RAO. The primary endpoint was the incidence of forearm RAO assessed by vascular ultrasound at discharge. Secondary endpoints include crossover, hemostasis time, and access site-related complications. RESULTS: Overall, 657 patients underwent TRA, and 650 patients underwent DRA. Forearm RAO did not differ between groups (0.91% vs 0.31%; P = 0.29). Patent hemostasis was achieved in 94.4% of TRA patients. Crossover rates were higher with DRA (3.5% vs 7.4%; P = 0.002), and median hemostasis time was shorter (180 vs 153 minutes; P < 0.001). Radial artery spasm occurred more with DRA (2.7% vs 5.4%; P = 0.015). Overall bleeding events and vascular complications did not differ between groups. CONCLUSIONS: With the implementation of a rigorous hemostasis protocol, DRA and TRA have equally low RAO rates. DRA is associated with a higher crossover rate but a shorter hemostasis time.

• MeSH
• arteria radialis diagnostické zobrazování   MeSH
• arteriální okluzní nemoci * MeSH
• koronární angiografie škodlivé účinky   metody   MeSH
• koronární angioplastika * škodlivé účinky   metody   MeSH
• lidé MeSH
• periferní katetrizace * škodlivé účinky   metody   MeSH
• výsledek terapie MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH