![]() These patients were older, had more severe vascular symptoms, higher bleeding risk, and worse prognosis than trial participants.Īspirin External applicability Generalisability Peripheral arterial disease Rivaroxaban VOYAGER PAD trial.Ĭopyright © 2021 The Author(s). "VOYAGER eligible" patients experienced a higher cumulative incidence of most endpoints than patients enrolled in the control arm of the VOYAGER PAD trial.Īmong patients in routine clinical practice, 27.1% were eligible for the VOYAGER PAD trial. Rates of secondary endpoints were also consistently lower for patients who did not meet the inclusion criteria (predominantly due to central aorto-iliac procedures) and highest for "VOYAGER excluded" patients. For the primary safety outcome of thrombolysis in myocardial infarction (TIMI) major bleeding, rates were 2.24, 3.76, and 1.17, respectively. The three year rate of the primary efficacy outcome was 10.08 per 100 person years among the "VOYAGER eligible", 16.32 among "VOYAGER excluded", and 6.98 among the "VOYAGER not included". The main reasons for exclusion were atrial fibrillation (32.3%), poorly regulated hypertension (20.6%), requirement for long term dual antiplatelet therapy (10.9%), cytochrome P450 inhibitors or inducers (9.7%), and renal failure (9.3%). According to GlobalData, Phase I drugs for Neuroendocrine Tumors have a 74 phase transition success rate (PTSR) indication benchmark for progressing into Phase II. Of those not included, 30.7% had at least one exclusion criterion ("VOYAGER excluded"), and an additional 42.3% did not fulfil the inclusion criteria ("VOYAGER not included"). Voyager-V1 is under clinical development by Vyriad and currently in Phase I for Neuroendocrine Tumors. Trial inclusion and exclusion criteria were applied, and the three year cumulative incidence of primary and secondary trial outcomes was estimated.Īltogether, 27.1% of patients with PAD in the DVR were "VOYAGER eligible". In total, 32 911 patients who underwent lower extremity revascularisation for symptomatic peripheral arterial disease (PAD) in the DVR (2000-2016) were identified. This study described the proportion of patients eligible for VOYAGER PAD within the nationwide Danish Vascular Registry (DVR), reasons for ineligibility, and outcomes according to eligibility. However, patients enrolled in the trial may not reflect patients encountered in daily clinical practice. In the VOYAGER PAD trial, rivaroxaban 2.5 mg plus aspirin significantly reduced the primary composite efficacy outcome of acute limb ischaemia, major amputation, myocardial infarction, ischaemic stroke, or cardiovascular death compared with aspirin alone.
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