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: The COVID-19 pandemic adversely affected health care systems. Patients in need of transcatheter aortic valve replacement (TAVR) are especially susceptible to treatment delays. OBJECTIVES: This study sought to evaluate the impact of the COVID-19 pandemic on global TAVR activity. METHODS: This international registry reported monthly TAVR case volume in participating institutions prior to and during the COVID-19 pandemic (January 2018 to December 2021). Hospital-level information on public vs private, urban vs rural, and TAVR volume was collected, as was country-level information on socioeconomic status, COVID-19 incidence, and governmental public health responses. RESULTS: We included 130 centers from 61 countries, including 65,980 TAVR procedures. The first and second pandemic waves were associated with a significant reduction of 15% (P < 0.001) and 7% (P < 0.001) in monthly TAVR case volume, respectively, compared with the prepandemic period. The third pandemic wave was not associated with reduced TAVR activity. A greater reduction in TAVR activity was observed in Africa (-52%; P = 0.001), Central-South America (-33%; P < 0.001), and Asia (-29%; P < 0.001). Private hospitals (P = 0.005), urban areas (P = 0.011), low-volume centers (P = 0.002), countries with lower development (P < 0.001) and economic status (P < 0.001), higher COVID-19 incidence (P < 0.001), and more stringent public health restrictions (P < 0.001) experienced a greater reduction in TAVR activity. CONCLUSIONS: TAVR procedural volume declined substantially during the first and second waves of the COVID-19 pandemic, especially in Africa, Central-South America, and Asia. National socioeconomic status, COVID-19 incidence, and public health responses were associated with treatment delays. This information should inform public health policy in case of future global health crises.
- MeSH
- aortální chlopeň diagnostické zobrazování chirurgie MeSH
- aortální stenóza * diagnostické zobrazování chirurgie epidemiologie MeSH
- COVID-19 * epidemiologie MeSH
- lidé MeSH
- pandemie MeSH
- registrace MeSH
- rizikové faktory MeSH
- transkatetrální implantace aortální chlopně * škodlivé účinky metody MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- 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
