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Recruitment rates for Crohn's disease and ulcerative colitis clinical trials continue to decrease annually. The inability to reach recruitment targets and complete trials has serious implications for stakeholders in the inflammatory bowel disease (IBD) community. Action is required to ensure patients with an unmet medical need have access to new therapies to improve the management of their IBD.Identify challenges contributing to recruitment decline in IBD clinical trials and propose potential solutions.PubMed and Google were used to identify literature, regulatory guidelines and conference proceedings related to IBD clinical trials and related concepts. Data on IBD clinical trials conducted between 1989 and 2020 were extracted from the Trialtrove database.Key aspects that may improve recruitment rates were identified. An increasingly patient-centric approach should be taken to study design including improvements to the readability of key trial documentation and inclusion of patient representatives in trial planning. Placebo is unappealing to patients; approaches including platform trials should be explored to minimise placebo exposure. Non-invasive imaging, biomarkers and novel digital endpoints should continue to be examined to reduce the burden on patients. Reducing the administrative burden associated with trials via the use of electronic signatures, for example, may benefit study sites and investigators. Changes implemented to IBD trials during the COVID-19 pandemic provided examples of how trial conduct can be rapidly and constructively adapted.To improve recruitment in Crohn's disease and ulcerative colitis trials, the IBD community should address a broad range of issues related to clinical trial conduct.

OBJECTIVES To determine the prognostic impact of anemia in patients randomized to bivalirudin or unfractionated heparin (UFH) during transcatheter aortic valve replacement (TAVR). BACKGROUND Whether the periprocedural use of bivalirudin as compared with UFH in anemic patients undergoing TAVR has an impact on outcomes remains unknown. METHODS The BRAVO-3 trial compared the use of bivalirudin versus UFH in 802 high risk patients undergoing transfemoral TAVR for severe symptomatic aortic stenosis. Patients were stratified according to the presence (defined as hemoglobin levels

Objectives This study sought to investigate the clinical outcomes of patients with and without peripheral artery disease (PAD) in the BRAVO‐3 trial with respect to the effect of bivalirudin versus unfractionated heparin (UFH). Background PAD is found frequently in patients undergoing transcatheter aortic valve replacement (TAVR) and is reported to confer an increased risk of adverse events. It is unknown whether patients with and without PAD may demonstrate a differential response to bivalirudin versus UFH. Methods BRAVO‐3 was a randomized multicenter trial comparing transfemoral TAVR with bivalirudin versus UFH (31 centers, n = 802). Major adverse cardiovascular events (MACE) were a composite of 30‐day death, myocardial infarction, or cerebrovascular accidents (CVA). Net adverse cardiovascular events (NACE) were a composite of major bleeding or MACE. Results The total cohort included 119 patients with PAD. Vascular complications occurred significantly more frequently in patients with PAD both in‐hospital (25.2 vs. 16.7%; OR 1.68) and at 30 days (29.4 vs. 17.3%; OR 1.99). No significant differences were observed regarding mortality, NACE, MACE, major bleeding or CVA with bivalirudin versus UFH among patients with or without PAD. In patients with PAD, bivalirudin was associated with an increased risk of minor vascular complications at 30 days. Conclusions Patients with PAD undergoing transfemoral TAVR did not exhibit an increased risk of any major adverse events, according to the procedural anticoagulant randomization. However, patients treated with Bivalirudin had significantly higher rates of minor vascular complications.

Background: Selection of valve and procedural anticoagulant type may impact bleeding and vascular complications in transfemoral transcatheter aortic valve replacement (TAVR). We sought to compare outcomes by valve [balloon expandable (BE) or non-BE] and anticoagulant [bivalirudin vs. unfractionated heparin (UFH)] type from the BRAVO-3 trial. Methods: BRAVO-3 was a randomized multicenter trial included 500 BE-TAVR and 282 non-BE TAVR patients, randomized to bivalirudin vs. UFH. Selection of valve type was at the discretion of the operator and randomization was stratified according to device type. Total follow up was to 30 days. We examined the incidence of Bleeding Academic Research Consortium (BARC) type ≥3b bleeding, major vascular complications and all ischemic outcomes at 30-days. Outcomes were adjusted using logistic regression analysis. Results: Of the trial cohort treated, 63.9% were treated with BE valves (n=251 bivalirudin vs. n=249 UFH) and 36.1% with non-BE valves (n=140 bivalirudin vs. n=142 UFH). Patients treated with non-BE valves were older, with higher euroSCORE I. At 30 days, there were non-significant differences between the two valve types with a trend for higher adjusted risk of all-cause mortality (HR 2.07, 95% CI 0.91-4.70, p = 0.084) and major vascular complications (HR 1.78, 95% CI 0.97-3.26, p = 0.062) with non-BE compared to BE valves. A significant interaction was observed between valve and anticoagulant type, with lower risk of major vascular complications with bivalirudin compared to UFH in non-BE TAVR (p-interaction = 0.039). Conclusions: Majority of patients in the BRAVO 3 trial received BE valves. At 30-days, there were non-significant differences with a tendency for greater death and major vascular complications with non-BE vs. BE valves. A significant interaction was observed between valve type and procedural anticoagulant for lower risk of major vascular complications with bivalirudin versus UFH in non-BE TAVR. This article is protected by copyright. All rights reserved.

Background: Prior studies have suggested that patients with atrial fibrillation (AF) undergoing transcatheter aortic valve replacement (TAVR) are at higher risk for adverse cardiovascular events. Whether procedural bivalirudin compared to unfractionated heparin (UFH) has a beneficial effect on early outcomes in these patients is unknown. We examined for the effect of baseline or new-onset AF within 30 days of TAVR and explored for the effect of bivalirudin vs. UFH by AF status, on 30-day outcomes from the BRAVO 3 trial. Methods: The BRAVO-3 trial multicenter randomized trial included 802 patients undergoing transfemoral TAVR randomized to bivalirudin or UFH. We compared AF and no-AF groups and examined for 30-day Bleeding Academic Research Consortium (BARC) type ≥3b bleeding, major vascular complications and all ischemic endpoints. Adjusted outcomes were analyzed using logistic regression methods. Results: Of the study population, 41.4% (n=332) patients had baseline or new-onset AF within 30 days of TAVR, whereas 58.6% (n= 470) had no AF. Patients with AF had greater prevalence of renal dysfunction, lower left ventricular ejection fraction and higher euroSCORE I compared to their counterparts without AF. Among AF and no-AF patients, there were no significant baseline differences between bivalirudin and UFH groups. At 30 days the incidence of death (6.0% vs. 4.5%, p = 0.324) and stroke (3.9% vs. 2.6%, p = 0.274) was similar in AF vs. no-AF patients. However, new-onset AF (n=38) was associated with significantly greater crude risk of 30-day stroke compared to no AF (HR 4.49, 95% CI 1.37-14.67). Regardless of AF status, there were no differences in 30-day death (p-int = 0.652) or stroke (p-int= 0.066) by anticoagulation type. Conclusions: Prior or new-onset AF within 30 days of transfemoral TAVR is noted in more than one-third of patients. Despite greater baseline comorbidities than non-AF patients, AF was not associated with greater risk of adjusted 30-day outcomes. In the BRAVO 3 trial, early outcomes were similar regardless of anticoagulant strategy in each group. This article is protected by copyright. All rights reserved.