The SPARTACUS Trial: Controversies and Unresolved Issues

Abstract

Adrenal vein sampling (AVS) is considered the gold standard for the differential diagnosis in patients with primary aldosteronism (PA). The distinction between unilateral and bilateral disease dictates the targeted therapeutic approach with surgery for aldosterone producing adenomas and medical therapy for patients with bilateral hyperplasia. Thereby, this diagnostic step is crucial in clinical care. As AVS is an invasive, not well standardized procedure that is restricted to few specialized centers, several attempts have been made to simplify diagnostic algorithms. In this clinical scenario, the recently published SPARTACUS trial aimed at answering the question whether AVS in fact is superior for differential diagnosis in comparison to imaging of the adrenal glands. In this multicenter study, patients were randomized to be treated according to AVS results or based on abdominal imaging only. Clinical outcome in both patient groups after one year was reported as not different. While the study results found broad interest, it also stirred considerable controversies. This review provides an overview on the different views regarding the outline of the SPARTACUS trial and the interpretation of its results.

MANAGEMENT OF ENDOCRINE DISEASE: Diagnosis and management of primary aldosteronism: the Endocrine Society guideline 2016 revisited

“…Additional secondary endpoints, such as health-related quality of life or biochemical remission (80% vs 89%, P = 0.25), were not different. Details of the study and perceived weaknesses in its design and methodology have been discussed in an unprecedented and ongoing flood of commentaries (50,51,52,53) splitting the community into those who were for or against AVS. The emotions arising from the study are in part due to the trial highlighting that a sophisticated procedure such as AVS is not 100% accurate, having a failure rate of approximately 5% (48), and that CT-based management might be better than previously thought.…”

Radiation exposure of adrenal vein sampling: a German Multicenter Study

“…Furthermore, there is not only an ongoing debate regarding the use of AVS itself ( 13 , 14 , 15 ), but also its superiority in comparison to adrenal CT scan in terms of clinical outcome ( 9 , 16 ). However, the SPARTACUS-trial raised controversial discussions itself due to its study design and patient selection ( 15 , 17 ). The clinical usefulness of more recent approaches to replace AVS by molecular imaging is yet to be defined within clinical trials ( 18 , 19 ).…”

Hormone and Metabolic Research: 50 Years of Research

“…Within the last couple of years, a special focus was given to endocrine tumors, e. g. of the neuroendocrine system including pituitary tumors and pheochromocytoma / paraganglioma. In addition, three issues were published on primary hyperaldosteronism focusing on the genetic cause of the disease as well as diagnostic and therapeutic options [2][3][4][5][6][7][8][9][10][11][12][13][14][15].…”