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: 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
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
BACKGROUND: Radial artery occlusion (RAO) may occur posttransradial intervention and limits the radial artery as a future access site, thus precluding its use as an arterial conduit. In this study, we investigate the incidence and factors influencing the RAO in the current literature. METHODS AND RESULTS: We searched MEDLINE and EMBASE for studies of RAO in transradial access. Relevant studies were identified and data were extracted. Data were synthesized by meta-analysis, quantitative pooling, graphical representation, or by narrative synthesis. A total of 66 studies with 31 345 participants were included in the analysis. Incident RAO ranged between <1% and 33% and varied with timing of assessment of radial artery patency (incidence of RAO within 24 hours was 7.7%, which decreased to 5.5% at >1 week follow-up). The most efficacious measure in reducing RAO was higher dose of heparin, because lower doses of heparin were associated with increased RAO (risk ratio 0.36, 95% CI 0.17-0.76), whereas shorter compression times also reduced RAO (risk ratio 0.28, 95% CI 0.05-1.50). Several factors were found to be associated with RAO including age, sex, sheath size, and diameter of radial artery, but these factors were not consistent across all studies. CONCLUSIONS: RAO is a common complication of transradial access. Maintenance of radial patency should be an integral part of all procedures undertaken through the radial approach. High-dose heparin along with shorter compression times and patent hemostasis is recommended in reducing RAO.
- MeSH
- antikoagulancia aplikace a dávkování MeSH
- arteria radialis patofyziologie MeSH
- arteriální okluzní nemoci diagnóza epidemiologie patofyziologie prevence a kontrola MeSH
- heparin aplikace a dávkování MeSH
- incidence MeSH
- lidé středního věku MeSH
- lidé MeSH
- odds ratio MeSH
- periferní katetrizace škodlivé účinky MeSH
- punkce MeSH
- rizikové faktory MeSH
- rozdělení chí kvadrát MeSH
- senioři MeSH
- vazokonstrikce * MeSH
- vztah mezi dávkou a účinkem léčiva MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- metaanalýza MeSH
- přehledy MeSH
