BACKGROUND: The effectiveness and safety of drug-coated balloon (DCB) have been extensively studied in the treatment of de novo small-vessel coronary lesions. Proper lesion preparation is essential prior to performing DC...BACKGROUND: The effectiveness and safety of drug-coated balloon (DCB) have been extensively studied in the treatment of de novo small-vessel coronary lesions. Proper lesion preparation is essential prior to performing DCB angioplasty; however, the optimal approach for intravascular ultrasound (IVUS)-guided lesion preparation remains unclear. The safety and efficacy of IVUS-guided DCB treatment for de novo small-vessel coronary lesions continue to be uncertain. To address these gaps, this trial has been designed to evaluate the efficacy and safety of IVUS-guided DCB angioplasty for de novo small-vessel coronary lesions. Additionally, the trial seeks to establish optimal critical values for IVUS-derived lumen parameters (such as minimum lumen area, plaque burden, and the length and thickness of dissection) prior to the use of DCB for de novo small-vessel coronary lesions. METHODS AND DESIGN: This trial is designed to test the hypothesis that IVUS-guided DCB results in a lower rate of major adverse cardiac events (MACE) for de novo small-vessel coronary lesions. It is a prospective, multicenter, randomized controlled study involving 998 patients indicated for PCI with de novo coronary lesions suitable for DCB treatment. Participants will be randomly allocated in a 1:1 ratio to either the research group (IVUS-guided group) or the control group (angiography-guided group). The primary endpoint is defined as the incidence of MACE (comprising cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization) at the 12-month follow-up. Secondary endpoints include clinical outcomes such as all-cause mortality, any myocardial infarction, or ischemia-driven target vessel revascularization at the 12-month follow-up. Additionally, periprocedural outcomes, including the angiographic success rate, clinical procedural success rate, and target vessel drug-eluting stent implantation rate, will also be assessed. CONCLUSIONS: This clinical trial aims to provide evidence on whether IVUS-guided DCB reduces the incidence of MACE in de novo small-vessel coronary lesions. TRIAL REGISTRATION: ChiCTR2300073877, URL: https://www.chictr.org.cn/indexEN.html.
BACKGROUND: Severe aortic stenosis (AS) induces a disproportional pressure gradient across the aortic valve causing increased left ventricular (LV) afterload. Transcatheter Aortic Valve Replacement (TAVR) aims to immedia...BACKGROUND: Severe aortic stenosis (AS) induces a disproportional pressure gradient across the aortic valve causing increased left ventricular (LV) afterload. Transcatheter Aortic Valve Replacement (TAVR) aims to immediately alleviate the aortic pressure gradient and thereby changing LV cardiac mechanics. The aim was to describe by in-vivo assessment of LV pressure-volume (PV) relationships how TAVR acutely affects LV cardiac mechanics. METHODS: In this prospective observational study in patients with severe AS, LV cardiac mechanics were evaluated with an LV conductance catheter before and after TAVR. The effects of transcatheter valve design, pre and postdilatation, use of rapid pacing (≥180 bpm) and LV ejection fraction (EF) were specifically addressed. RESULTS: In-vivo LV PV reconstructions were obtained in 61 patients. Stroke work (SW) and pressure volume area (PVA) were significantly lower following TAVR (decrease from median [25th-75th percentile] of 10,935.6 [6877.5-13490.8] to 6,878.0 [4,870.8-8,613.8] mmHg/mL, P < .001 and from 17,831.5 [12,414.9-22,416.8] to 11,024.9 [8364.7-14705.0] mmHg/mL, P < .001, respectively) with stable SW/PVA ratios. Overall, end-systolic and end-diastolic pressures and volumes were significantly lower after TAVR. Arterial Elastance, as an index for LV afterload also decreased (2.66 [2.01-3.87]-1.96 [1.25-2.72] mmHg/mL, P < .001). LV contractility declined as illustrated by a reduction in End-systolic Elastance (2.22 [1.50-3.10]-1.58 [1.08-2.43] mmHg/mL, P < .001). The trends in changing LV cardiac mechanics were similar for balloon- and self-expanding valves and were not affected by pre/post dilatation, rapid pacing or LV EF. CONCLUSIONS: TAVR for severe AS resulted in immediate LV unloading, lower myocardial metabolic demand and impaired contractility. TRIAL REGISTRATION: This observational study was registered at URL: https://www. CLINICALTRIALS: gov with unique identifier: NCT06204783.
RATIONALE: Left ventricular (LV) thrombus is a consequence of systolic dysfunction and is associated with an increased risk of stroke and systemic embolism. Anticoagulation with warfarin has been the standard of care. Ho...RATIONALE: Left ventricular (LV) thrombus is a consequence of systolic dysfunction and is associated with an increased risk of stroke and systemic embolism. Anticoagulation with warfarin has been the standard of care. However, following the widespread adoption of direct oral anticoagulants (DOACs) in other settings, these are increasingly used to treat LV thrombus, despite limited randomized data to support equivalent outcomes and safety. PRIMARY HYPOTHESIS: We hypothesize that DOACs will be noninferior to warfarin in the resolution of LV thrombus, without the occurrence of cardiovascular death, stroke, systemic embolism or major bleeding at 3-months. DESIGN: The REsolution of LEft VENTricular thrombus (RELEVENT) trial (ACTRN12618001254280) will test the noninferiority of DOACs compared to warfarin. This prospective trial will randomize 216 patients with best-available imaging confirmed LV thrombus, at a 1:1 ratio to either warfarin or a DOAC, for a duration of 12 to 14 weeks. Any DOAC approved for stroke prevention in atrial fibrillation may be used, according to local preference. The primary endpoint will be the resolution of the thrombus, without the occurrence of cardiovascular death, stroke, systemic embolism or major bleeding at 3-month follow-up. Secondary and other endpoints of interest include components of the primary outcome, changes to thrombus diameter, days alive and out of hospital, disability free survival and quality of life. Patients will be followed up for 3 years to obtain data on long-term management and outcomes. SITES: Recruitment to the RELEVENT trial is underway in 16 centers in New Zealand and Australia. CONCLUSIONS: The RELEVENT trial will help clarify whether DOACs are noninferior to warfarin in the early treatment of LV thrombus. It will also generate important insights into the long-term management and outcomes for patients.
Montalescot G, Bolognese L, Bartus S
… +21 more, Cequier-Fillat A, Thiele H, Mach F, Jukema JW, Ferrari E, Souteyrand G, Bouleti C, Range G, Chioccioli M, Picchi A, Batias-Moreau L, Esposito G, Braik N, Redjimi N, Duband B, Guedeney P, Zeitouni M, Brochard K, Silvain J, Vicaut E, AMUNDSEN investigators of the ACTION Study Group
RATIONALE: PCSK9 inhibitors are currently recommended as third-line therapy for post-myocardial infarction (MI) patients, added to high-dose statin, ezetimibe, and potentially bempedoic acid when the LDL-C target of <55...RATIONALE: PCSK9 inhibitors are currently recommended as third-line therapy for post-myocardial infarction (MI) patients, added to high-dose statin, ezetimibe, and potentially bempedoic acid when the LDL-C target of <55 mg/dL is not achieved. These guideline-driven indications result in delayed initiation of PCSK9 inhibitors, potentially missing the opportunity for benefit during the acute phase. Recent studies have demonstrated that early PCSK9 inhibition promotes anti-inflammatory effects and plaque stabilization, suggesting a potential role early in MI management. METHODS: The AMUNDSEN trial is a randomized, international, phase IV study using a PROBE (Prospective Randomized Open, Blinded Endpoint) design to evaluate the effects of early PCSK9 inhibition in high-risk acute MI patients undergoing percutaneous coronary intervention (PCI). A total of 2,166 patients were enrolled, including those with ST-elevation MI undergoing primary PCI and those with non-ST-elevation MI with an indication for PCI, all presenting with at least 1 high-risk clinical characteristic. Patients were randomized to receive either immediate evolocumab prior to PCI alongside standard care or standard care alone. The primary objective is to achieve both a ≥ 50% reduction in LDL-C from baseline and a target LDL-C < 55 mg/dL at 12 months. The main clinical objective is to assess the composite of all-cause death or unplanned hospitalization for a cardiovascular (CV) reason at 12 months. CURRENT STATUS: Enrollment and randomization are complete. Lipid and clinical follow-up are ongoing. Results from this study will clarify the lipid-lowering efficacy and clinical impact of early evolocumab initiation in the acute MI setting. CONCLUSION: The AMUNDSEN trial will provide critical insights into the potential benefits of early PCSK9 inhibition in high-risk MI patients undergoing PCI. CLINICAL TRIAL REGISTRATION: NCT (clinicaltrials.gov): 04951856 - EUCT number: 2024-518195-31-00.
Mahmoudi M, Nicholas Z, Jabbour RJ
… +12 more, Shambrook J, Abbas A, Browne T, Hinton J, Antoniades C, Mamas M, Leipsic J, Rogers C, Koo BK, Al-Lamee R, Kontopantelis E, Curzen N
BACKGROUND: Up to 50% of patients presenting with ST-elevation myocardial infarction (STEMI) have multivessel coronary artery disease (CAD). Randomized trials suggest that complete revascularization improves outcomes, bu...BACKGROUND: Up to 50% of patients presenting with ST-elevation myocardial infarction (STEMI) have multivessel coronary artery disease (CAD). Randomized trials suggest that complete revascularization improves outcomes, but the mechanism and identification of patients who benefit remain unclear. This study aims to assess the association between blood and coronary imaging biomarkers and clinical events, to identify patient-, vessel-, and lesion-specific risk in STEMI patients with bystander disease. METHOD: PICNIC is a multicenter, international, prospective, observational study enrolling 320 patients with STEMI and multivessel CAD undergoing primary PCI of the culprit vessel without complete revascularization. Participants will undergo blood sampling for inflammatory markers and coronary CT angiography (CTCA) to assess: (1) plaque burden and morphology, (2) artificial intelligence-enabled fractional flow reserve derived from CTCA (FFR) analysis of plaque and hemodynamic features, and (3) fat attenuation index (FAI) to evaluate perivascular inflammation. The primary analysis will evaluate the association between a composite 24-month clinical endpoint (including all-cause mortality, myocardial infarction, ischemia-driven revascularization as first layer and cardiac arrest, heart failure, stroke, and ventricular tachyarrhythmia (second layer)) and: (1) serum inflammatory markers, and (2) anatomical and physiological characteristics of non-infarct-related arteries (NIRA) assessed by CTCA, FFR, and FAI. Statistical and machine learning methods will be applied to determine which combinations of clinical, imaging, and biomarker data best predict patient-, vessel-, and lesion-specific risk. CONCLUSION: PICNIC will characterize the anatomical, physiological, and inflammatory features of NIRA lesions in STEMI patients treated with culprit-only PCI in order to develop an AI-based risk prediction model. If such a model is successful it could be used to inform personalized revascularization strategies.
BACKGROUND: The MISSION Act of 2018 expanded veterans' access to necessary care at non-Veterans Affairs (VA) facilities. The policy is intended to improve access to timely, high-quality care-particularly for specialized...BACKGROUND: The MISSION Act of 2018 expanded veterans' access to necessary care at non-Veterans Affairs (VA) facilities. The policy is intended to improve access to timely, high-quality care-particularly for specialized procedures like transcatheter aortic valve replacement (TAVR). However, veterans' preferences regarding specialty care in the community vs within the VA system remain unexplored. METHODS: This cross-sectional quality improvement study surveyed veterans at an urban VA heart center who received referrals to community hospitals between 2018 and 2023 for structural heart disease care. The 14-item survey evaluated satisfaction across 3 key domains-communication, quality, and care coordination-along with overall satisfaction with community and VA care, and preferences for future care delivery settings. RESULTS: Of 47 veterans who completed the survey, most (78.7%) preferred receiving care at a VA hospital (P < .0001). Veterans reported high satisfaction with both community (mean score 9.15/10) and VA-based care (9.19/10; P = .876). While 64% preferred the VA for future cardiovascular care, this trend did not reach statistical significance (P = .079). In contrast, 78.7% preferred the VA for general healthcare (P < .001). Satisfaction with community care was most strongly associated with staff competence (r = 0.839) and feeling their concerns were heard (r = 0.818). VA satisfaction correlated most strongly with care coordination (r = 0.789) and clear follow-up instructions (r = 0.729). Transportation challenges were reported by 17% of respondents and were significantly associated with preference for community care for general health (P < .001). CONCLUSIONS: Veterans referred for cardiovascular procedures through the MISSION Act reported high satisfaction across settings but expressed a clear preference for VA-based care for general healthcare. These findings suggest that while community care is a valuable tool for improving access, investments in VA-based services remain critical to meeting veteran expectations and preserving care quality.
BACKGROUND: There is a high burden of hospitalizations and deaths annually due to heart failure (HF) in the United States despite effective medical therapy and rural areas may be disproportionately affected. We sought to...BACKGROUND: There is a high burden of hospitalizations and deaths annually due to heart failure (HF) in the United States despite effective medical therapy and rural areas may be disproportionately affected. We sought to compare guideline-directed medical therapy (GDMT) utilization between rural and non-rural Veterans with HF with reduced ejection fraction (HFrEF). METHODS: We performed a cross sectional cohort study of Veterans with HFrEF (LVEF ≤ 40%) on January 1, 2022. The VA is an integrated health system with reduced financial barriers, which has a high proportion of rural patients. We compared the frequency of medication fills among rural and non-rural Veterans for renin-angiotensin system inhibitors (RASi), beta-blockers (BB), mineralocorticoid receptor antagonists (MRA) and sodium glucose co-transporter 2 inhibitors (SGLT2i). We used a continuous version of the 4-pillar score (C4P) to assess medical therapy intensity. We used multivariable logistic regression to identify patient characteristics associated with a high C4P score. RESULTS: Of 65,025 Veterans with HFrEF, 23,728 (36.5%) resided in a rural location, defined as RUCA (Rural-Urban Commuting Areas) code of greater than 1.1. Compared with non-rural, rural Veterans were more frequently White (82.5% vs 63.9%, P < .01) and had a higher burden of comorbidities. Rural Veterans had longer drive times to primary (32 vs 15 minutes, P < .01) and specialty (74 vs 36 minutes, P < .01) care and were less likely to receive VA Cardiology care (44.4% vs 55.8%, P < .01) or care at a high-complexity (level 1a) VA facility (36.4% vs 50.4%, P < .01). Rural Veterans were less frequently prescribed >50% target dose of RASi (19.9% vs 20.2%, P < .01) and BBs (30.9% vs 32.2%, P < .03) and less frequently prescribed SGLT2i (16.3% vs 18.9%, P < .01) and MRA (27.8% vs 28.6%, P < .03) therapy. Rural Veterans were significantly less likely to have a C4P score in the highest decile (OR 0.94, CI: 0.90-0.99) compared with non-rural Veterans. CONCLUSION: Rural Veterans with HFrEF were slightly less likely be prescribed comprehensive GDMT. This small difference may be related to gaps in access to VA cardiology and high-complexity facilities. Novel interventions and quality initiatives are needed to decrease disparities in HFrEF care for rural Veterans.
BACKGROUND: International practice guidelines recommend the more rapid European Society of Cardiology (ESC) 0/1h-algorithm for the triage of patients with suspected myocardial infarction (MI) as the preferred option and...BACKGROUND: International practice guidelines recommend the more rapid European Society of Cardiology (ESC) 0/1h-algorithm for the triage of patients with suspected myocardial infarction (MI) as the preferred option and consider the ESC 0/3h-algorithm as an alternative. However, many centers worldwide have not yet adopted the ESC 0/1h-algorithm in clinical practice due to uncertainty which approach best balances safety and efficacy. METHODS: PRESC1SE-MI (PRospective Evaluation of the European Society of Cardiology 0/1h-algorithm`s Safety and Efficacy for Triage of Patients with Suspected Myocardial Infarction) is an international, investigator-initiated multicenter, stepped-wedge, cluster randomized controlled trial. At least 52,156 consecutive adult patients with nontraumatic acute chest discomfort and suspected MI presenting to the Emergency Department (ED) will be enrolled. Sites still using the ESC 0/3h-algorithm as standard-of-care will be randomized to implement the more rapid ESC 0/1h-algorithm at an early or late implementation step. During the validation phase, participating sites continue to use the ESC 0/3h-algorithm. The co-primary outcomes are a composite of type 1 MI or all-cause death at 30 days (safety), and the length of stay in the ED (efficacy). The trial is designed to show noninferiority for safety and superiority for efficacy, with a power of at least 90%. CONCLUSIONS: PRESC1SE-MI is the largest international multicenter trial to date evaluating the safety and the efficacy of the implementation of the more rapid ESC 0/1h-algorithm at late adopting centers across multiple countries and healthcare systems. Its findings have the potential to improve patient care and reduce healthcare costs. TRIAL REGISTRATION: https://clinicaltrials.gov/study/NCT05649384.
BACKGROUND: Unfractionated heparin is routinely used during transcatheter aortic valve implantation (TAVI) to reduce catheter thrombosis and thromboembolism. Protamine reverses the effect of heparin and may lower bleedin...BACKGROUND: Unfractionated heparin is routinely used during transcatheter aortic valve implantation (TAVI) to reduce catheter thrombosis and thromboembolism. Protamine reverses the effect of heparin and may lower bleeding risk, but it can also trigger severe allergic reactions. Robust data on the safety and efficacy of routine protamine administration after TAVI is lacking. METHODS: The ``routine versus selective protamine administration to reduce bleeding complications after transcatheter aortic valve implantation (POPular ACE TAVI)'' is an investigator-initiated, multicenter, double-blind, placebo-controlled, randomized clinical trial. A total of 1000 patients will be randomized 1:1 to routine versus selective protamine administration, stratified by study site and antithrombotic therapy. Primary and secondary outcomes are defined according to the Valve Academic Research Consortium-3 (VARC-3) criteria. The primary outcome is a composite of all-cause mortality and clinically relevant bleeding (type 1-4) within 30 days after TAVI. Ranked secondary outcomes include clinically relevant bleeding; major, life-threatening or fatal bleeding (type 2-4); major vascular complications; cardiovascular mortality; and all-cause mortality. Safety outcomes include anaphylaxis and thromboembolic events defined as the composite of myocardial infarction, ischemic stroke, transient ischemic attack, or noncerebral distal embolization. Recruitment began in November 2023 and will continue until 1,000 patients are randomized. The trial will end after 30‑day follow‑up of the last patient. CONCLUSION: The POPular ACE TAVI trial (NCT05774691) will evaluate whether routine protamine administration reduces all-cause mortality or clinically relevant bleeding after TAVI compared with selective use. TRIAL REGISTRATION: clinicaltrials.gov. Unique identifier NCT05774691.
BACKGROUND: Patients undergoing transcatheter aortic valve implantation (TAVI) frequently experience life-threatening ischemic and bleeding complications. However, management of antithrombotic therapy after TAVI in patie...BACKGROUND: Patients undergoing transcatheter aortic valve implantation (TAVI) frequently experience life-threatening ischemic and bleeding complications. However, management of antithrombotic therapy after TAVI in patients without oral anticoagulation (OAC), particularly in patients with high burden for subsequent ischemic events, has limited evidence from randomized controlled trials. METHODS: The REAC TAVI2 trial is a prospective, multicenter, open-label, phase III randomized trial (NCT05283356). A total of 1206 patients undergoing TAVI with high ischemic risk (defined as concomitant coronary artery disease, diabetes mellitus or peripheral vascular disease) will be randomized in a 1:1 ratio to single antiplatelet therapy with aspirin (100 mg once daily) or low-dose ticagrelor (60 mg twice daily). The primary endpoint is the incidence of a net adverse clinical event (NACE) at 1-year after TAVI. NACE is defined as a composite of all-cause mortality, cerebrovascular events, myocardial infarction, progressive angina leading to emergency evaluation, rehospitalization or new coronary angiogram, clinical valve thrombosis, acute limb ischemia leading to hospitalization, and type 2, 3, or 5 bleeding. The secondary endpoint is the incidence of subclinical valve thrombosis detected by hypo-attenuated leaflet thickening and reduced leaflet motion at 3 and 12 months post-TAVI assessed by 4-dimensional computed tomography. SUMMARY: In patients undergoing TAVI without an indication for OAC, there is a need for antiplatelet therapy that provides protection against ischemic events without increasing bleeding, particularly in the subset of patients at heightened risk of ischemic events. The REAC-TAVI 2 is a randomized multicenter clinical trial designed to study the effect of single antiplatelet therapy with aspirin compared to low-dose ticagrelor on a composite outcome of all-cause mortality, ischemic, and bleeding events after TAVI.
BACKGROUND: Excess dietary sodium intake is a major contributor to hypertension (HTN) and cardiovascular disease in the U.S., yet most Americans exceed recommended sodium intake levels. Despite the established benefits o...BACKGROUND: Excess dietary sodium intake is a major contributor to hypertension (HTN) and cardiovascular disease in the U.S., yet most Americans exceed recommended sodium intake levels. Despite the established benefits of sodium reduction, behavioral adherence remains a challenge. Just-in-time adaptive interventions (JITAIs) provide a novel mobile health (mHealth) strategy to support low-sodium choices in real-time at restaurants and grocery stores. METHODS: LowSalt4Life 2 is a 6-month randomized controlled trial evaluating a mobile application-based sodium-focused JITAI among adults with HTN. In phase one, participants were randomized 1:1 to either the LowSalt4Life app with JITAI (App+JITAI) or the app alone. At 2 months, the App+JITAI group was re-randomized to either continue with the standard JITAI or receive a personalized JITAI (pJITAI) informed by reinforcement learning based on prior engagement. The primary outcome was change in systolic blood pressure (SBP) at 2 months. Secondary outcomes included changes in BP medication, dietary sodium intake, and engagement metrics. RESULTS: As of October 2025, 410 participants had been enrolled and completed follow-up. The trial's final results are anticipated in Spring 2025. Primary analysis focuses on the change in SBP between the App+JITAI and App-only groups, as well as the added value of personalization in the second study phase. CONCLUSIONS: LowSalt4Life 2 tests a scalable, context-aware digital intervention designed to reduce dietary sodium and improve BP management. By personalizing engagement based on user behavior, this study seeks to advance mHealth strategies for HTN self-management and inform future interventions targeting dietary behaviors in real-world settings.
BACKGROUND: Previous studies have reported that obesity-related metabolic abnormalities (eg, diabetes and hypertension) lead to myocardial dysfunction and adverse cardiac remodeling. However, it is unclear whether such c...BACKGROUND: Previous studies have reported that obesity-related metabolic abnormalities (eg, diabetes and hypertension) lead to myocardial dysfunction and adverse cardiac remodeling. However, it is unclear whether such cardiac remodeling is from obesity or obesity-related metabolic abnormalities. We hypothesize that overweight and obesity are associated with adverse cardiac remodeling independent of associated metabolic abnormalities. METHODS: We evaluated 6,639 participants from the Framingham Heart Study who underwent echocardiography and had no prevalent cardiovascular disease. Individuals were classified into 6 obesity sub-phenotypes based on metabolic health (metabolically healthy or metabolically unhealthy) and body mass index (normal weight, overweight, or obese). Obesity subphenotypes were related to echocardiographic measures using multivariable regression analyses. RESULTS: Mean age was 49 years and 55% were women. Overweight and obesity were consistently associated with adverse cardiac remodeling in both metabolic healthy and unhealthy participants. Among metabolically healthy participants, compared to the normal weight group (referent), overweight and obesity were significantly associated with increased left ventricular mass (11.6 and 21.4 gm), left atrium end-systolic dimension (0.27 and 0.48 cm), global longitudinal strain (0.82 and 1.06%), and the ratio of early diastolic trans-mitral flow velocity to early diastolic mitral annulus velocity (0.35 and 0.87) (all P < .001). Additionally, obesity was significantly associated with mitral annular plane systolic excursion (0.08 cm, P < .001) and relative wall thickness (0.01, P = .001) compared to the normal weight referent group. CONCLUSIONS: Increasing body weight was associated with adverse cardiac remodeling regardless of metabolic health status, which suggests that obesity may directly increase the risk of adverse cardiac remodeling.
RATIONALE: Distal radial access (DRA) has emerged as a promising alternative to conventional transradial access (TRA) for coronary angiography and percutaneous coronary intervention (PCI). However, existing randomized ev...RATIONALE: Distal radial access (DRA) has emerged as a promising alternative to conventional transradial access (TRA) for coronary angiography and percutaneous coronary intervention (PCI). However, existing randomized evidence on DRA primarily involves low-risk patients undergoing diagnostic angiography or noncomplex PCI using ≤6 French (Fr) introducer sheaths. The clinical benefits of DRA among patients undergoing PCI for complex coronary lesions using large-bore guide catheters remain therefore uncertain. DESIGN: DISCO COMPLEX is an investigator-initiated, prospective, multicenter, international, open-label, randomized, controlled trial with a blinded outcome assessment and superiority design. The trial will compare in a 1:1 ratio large-bore DRA versus conventional TRA using a 7-Fr introducer sheath in 708 patients undergoing PCI for complex coronary lesions (chronic total occlusions, left main disease, heavily calcified lesions, or complex bifurcations) with a 7-Fr guide catheter. The primary hypothesis is that large-bore DRA is superior to conventional TRA with respect to the incidence of forearm radial artery occlusion (RAO) assessed by Doppler ultrasound at hospital discharge. The prespecified DISCOPHILE COMPLEX hand function substudy is a noninferiority trial evaluating whether large-bore DRA is not inferior to conventional TRA with respect to change in full-Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire score from baseline to 12 months in participants of the DISCO COMPLEX trial. ENROLMENT STATUS: The trial aims to recruit a total of 708 patients from 10 to 15 participating centers across Europe. The first patient was enrolled on August 31, 2023. As of August 20, 2025, 385 patients have been included. CONCLUSION: DISCO COMPLEX is the first randomized clinical trial designed to test the superiority of large-bore DRA over conventional TRA in reducing RAO rates among patients undergoing complex PCI with 7-Fr guide catheters. TRIAL REGISTRATION: Clinicaltrials.gov: Identifier, NCT05490238.
Ye L, Girouard MP, Go AS
… +18 more, Liu JY, Parikh RV, Tan TC, Lee ES, Sun G, Halaseh R, Bhatt AS, Pravoverov L, Zheng S, Svetlichnaya J, Fitzpatrick JK, Avula HR, Lee KK, Adatya S, Ouyang D, Goyal P, Sandhu AT, Ambrosy AP
BACKGROUND: Chronic kidney disease (CKD) is a major risk factor for heart failure (HF). However, the burden of worsening HF (WHF) events among adults with mild-to-moderate CKD has not been well described. OBJECTIVES: Thi...BACKGROUND: Chronic kidney disease (CKD) is a major risk factor for heart failure (HF). However, the burden of worsening HF (WHF) events among adults with mild-to-moderate CKD has not been well described. OBJECTIVES: This study assessed the burden of WHF in a contemporary cohort of adults with mild-to-moderate CKD. METHODS: We identified adults with mild-to-moderate CKD (eGFR 30-59 mL/min/1.73m² or eGFR ≥60 mL/min/1.73m² with albuminuria) within a large, integrated healthcare delivery system from 2012 to 2021. Outcomes included hospitalizations, emergency department visits, and outpatient encounters for WHF, stratified by HF status and level of CKD. RESULTS: Among 375,495 adults with mild-to-moderate CKD, mean age was 64 ± 16 years, 54% were women, mean eGFR was 76 ± 26 mL/min/1.73m², and 6.5% had prior known HF. CKD stages G1A2 (31.6%), G2A2 (24.9%), and G3aA1 (25.1%) were most prevalent. Rates (95% CI) per 100 person-years for WHF events were 1.85 (1.83-1.87) for hospitalizations, 0.85 (0.84-0.86) for emergency department visits, and 0.83 (0.81-0.84) for outpatient encounters, resulting in a cumulative rate of 2.42 (2.40-2.44). Event rates were higher at lower eGFR and higher albuminuria levels. CONCLUSIONS: WHF is a common source of morbidity in adults with earlier stage CKD, and particularly high in those with lower eGFR and greater albuminuria. These findings underscore the importance of implementing available and emerging cardioprotective and renoprotective therapies in this high-risk population.