Non-invasive cardiac assessment in high risk patients (The GROUND study): rationale, objectives and design of a multi-center randomized controlled clinical trial

Background: Peripheral arterial disease (PAD) is a common disease associated with a considerably increased risk of future cardiovascular events and most of these patients will die from coronary artery disease (CAD). Screening for silent CAD has become an option with recent non-invasive developments in CT (computed tomography)-angiography and MR (magnetic resonance) stress testing. Screening in combination with more aggressive treatment may improve prognosis. Therefore we propose to study whether a cardiac imaging algorithm, using non-invasive imaging techniques followed by treatment will reduce the risk of cardiovascular disease in PAD patients free from cardiac symptoms. Design: The GROUND study is designed as a prospective, multi-center, randomized clinical trial. Patients with peripheral arterial disease, but without symptomatic cardiac disease will be asked to participate. All patients receive a proper risk factor management before randomization. Half of the recruited patients will enter the 'control group' and only undergo CT calcium scoring. The other half of the recruited patients (index group) will undergo the non invasive cardiac imaging algorithm followed by evidence-based treatment. First, patients are submitted to CT calcium scoring and CT angiography. Patients with a left main (or equivalent) coronary artery stenosis of > 50% on CT will be referred to a cardiologist without further imaging. All other patients in this group will undergo dobutamine stress magnetic resonance (DSMR) testing. Patients with a DSMR positive for ischemia will also be referred to a cardiologist. These patients are candidates for conventional coronary angiography and cardiac interventions (coronary artery bypass grafting (CABG) or percutaneous cardiac interventions (PCI)), if indicated. All participants of the trial will enter a 5 year follow up period for the occurrence of cardiovascular events. Sequential interim analysis will take place. Based on sample size calculations about 1200 patients are needed to detect a 24% reduction in primary outcome. Implications: The GROUND study will provide insight into the question whether non-invasive cardiac imaging reduces the risk of cardiovascular events in patients with peripheral arterial disease, but without symptoms of coronary artery disease. Trial registration: Clinicaltrials.gov NCT0018911

Cost-effectiveness of conventional and endovascular repair of abdominal aortic aneurysms: results of a randomized trial.

Contains fulltext : 53719.pdf (publisher's version ) (Closed access)BACKGROUND: Two randomized trials have shown similar mid-term outcomes for survival and quality of life after endovascular and conventional open repair of abdominal aortic aneurysms (AAA). With reduced hospital and intensive care stay, endovascular repair has been hypothesized to be more efficient than open repair. The Dutch Randomized Endovascular Aneurysm Management (DREAM) trial was undertaken to assess the balance of costs and effects of endovascular vs open aneurysm repair. METHODS: We conducted a multicenter, randomized trial comparing endovascular repair with open repair in 351 patients with an AAA and studied costs, cost-effectiveness, and clinical outcome 1 year after surgery. In addition to clinical outcome, costs and quality of life were recorded up to 1 year in 170 patients in the endovascular repair group and in 170 in the open repair group. Incremental cost-effectiveness ratios were estimated for cost per life-year, event-free life-year, and quality adjusted life-year (QALY) gained. Uncertainty regarding these outcomes was assessed using bootstrapping. RESULTS: Patients in the endovascular repair group experienced 0.72 QALY vs 0.73 in the open repair group (absolute difference, 0.01; 95% confidence interval [CI], -0.038 to 0.058). Endovascular repair was associated with additional euro 4293 direct costs (euro 18,179 vs euro 13.886; 95% CI, euro 2,770 to euro 5,830). Most of the bootstrap estimates indicated that endovascular repair resulted in slightly longer overall and event-free survival associated with respective incremental cost-effectiveness ratios of euro76,100 and euro 171,500 per year gained. Open repair appeared the dominant strategy in costs per QALY. CONCLUSION: Presently, routine use of endovascular repair in patients also eligible for open repair does not result in a QALY gain at 1 year postoperatively, provides only a marginal overall survival benefit, and is associated with a substantial, if not prohibitive, increase in costs