1.
Drug-Coated Stents Versus Bare-Metal Stents in Academic Research Consortium-Defined High Bleeding Risk Patients
Marquis-Gravel G, Urban P, Copt S, Capodanno D, Pocock SJ, Sadozai Slama S, Stoll HP, Tanguay JF, Mehran R, Leon MB, et al
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology. 2020
Abstract
AIMS: To model the safety and effectiveness of drug-coated stents (DCS) vs. bare-metal stents (BMS) in high bleeding risk (HBR) patients according to the Academic Research Criteria (ARC) criteria. METHODS AND RESULTS Participants from the LEADERS FREE (LF) and LEADERS FREE (LFII) studies were pooled into one dataset. Participants were treated with 30 days of DAPT. The primary safety (composite of cardiac death, myocardial infarction, or stent thrombosis) and effectiveness (target-lesion revascularization) endpoints were compared between DCS and BMS in the subgroup of patients satisfying the ARC-HBR definition using propensity-score modelling. From the 3,635 participants included in the combined LF & LFII dataset, 2,898 (79.7%) satisfied the ARC-HBR criteria (DCS: 1,923; BMS: 975). The primary safety endpoint occurred in 184 (9.8%) and in 132 (13.8%) participants in the DCS and BMS groups, respectively (adjusted HR: 0.72; 95% CI: 0.57-0.91; p=0.006). The risk of the primary effectiveness endpoint was also significantly lower with DCS (6.2%) vs. BMS (8.8%) (adjusted HR: 0.70; 95% CI: 0.52-0.94; p=0.016). Safety and effectiveness of DCS vs. BMS were consistent according to ARC-HBR status (p interaction = 0.206 and 0.260, respectively). CONCLUSIONS DCS are safer and more effective than BMS in an ARC-defined HBR population.
2.
Comparison of Rates of Bleeding and Vascular Complications Before, During, and After Trial Enrollment in the SAFE-PCI Trial for Women
Rymer JA, Kaltenbach LA, Kochar A, Hess CN, Gilchrist IC, Messenger JC, Harrington RA, Jolly SS, Jacobs AK, Abbott JD, et al
Circulation. Cardiovascular interventions. 2019;12(5):e007086
Abstract
BACKGROUND SAFE-PCI for Women (Study of Access Site for Enhancement of PCI for Women), a randomized controlled trial comparing radial and femoral access in women undergoing cardiac catheterization or percutaneous coronary intervention (PCI), was terminated early for lower than expected event rates. Whether this was because of patient selection or better access site practice among trial patients is unknown. METHODS AND RESULTS SAFE-PCI was conducted within the National Cardiovascular Data Registry CathPCI registry. Using the National Cardiovascular Research Infrastructure Identification, PCI date, and age, patients enrolled in SAFE-PCI were compared with trial-eligible female CathPCI registry patients 1 year before, during, and 1 year after SAFE-PCI enrollment. Patient and procedure characteristics, predicted bleeding and mortality, and post-PCI bleeding were compared between groups. Enrolled SAFE-PCI patients and registry patients from the 3 time periods were linked to Centers for Medicare and Medicaid Services data to compare 30-day death and unplanned revascularization rates. At 54 SAFE-PCI sites, there were 496 SAFE-PCI trial patients with a PCI visit within the CathPCI registry. There were 24 958 registry patients from 1 year before and 1 year after SAFE-PCI enrollment and 15 904 trial-eligible registry patients during trial enrollment. Trial patients were younger, had lower predicted bleeding and mortality, and had lower rates of post-PCI bleeding within 72 hours compared with registry patients. Among 12 212 Centers for Medicare and Medicaid Services-linked patients, there were no significant differences in 30-day death and unplanned revascularization among the 4 groups. CONCLUSIONS Lower predicted risk of bleeding and mortality among SAFE-PCI trial patients compared with registry patients suggests that lower-risk patients were selectively enrolled for the trial. These data demonstrate how registry-based randomized trials may offer methods for enrollment feedback to curb selection bias in recruitment. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov . Unique identifier: NCT01406236.
3.
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
Abstract
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.