Ressource pédagogique : Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Debate : What relevant endpoints in autonomic nerve modulation therapy trials? What kind/level of evidence? Targets to meet for approval (FDA, and in EU, beyond CE mark) and reimbursement

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Title : Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Debate : What relevant endpoints in autonomic nerve modulation therapy trials? What kind/level of evidence? Targets to meet for approval (FDA, and in EU, beyond CE mark) and reimbursement Investigator viewpoint: George BAKRIS, Chicago, USA - Ileana PIÑA, New York, USA Regulatory viewpoint: Andrew FARB, FDA, USA Industry viewpoint: Rob KIEVAL, CVRx, USA - Kenneth STEIN, Boston Scientific, USA Abstract : What are relevant endpoints in autonomic nerve modulation therapy trials? What kind/level of evidence? Targets to meet for approval and reimbursement What kind of evidence is needed and the level is somewhat clear. Obviously, data from prospective randomized trials such as SYMPLICITY HTN-1, 2 and 3 is level 1 evidence.  Additionally, there are two domains of answers: a). adequate response relative to a clinical endpoint of interest, and b). adequate relative to mechanism of either efferent and/ or afferent neurologic activity reduction. Ideally, both should be demonstrated, as the demonstration of either one of these does not assume the other has been proven. Obviously, efferent nerve measures, the “gold standard” being reduction of renal noradrenaline (NA) spillover or less accepted alternative would be alterations of renal vein renin production or angiotensin II. Direct measurements of renal sympathetic nerve activity are also possible. Afferent nerve measures are more complicated as reductions of MSNA and total body NA spillover can each be a consequence of reduced afferent nerve conduction and/or reduced ANGII influence on hypothalamic efferent activity. To meet approval clear evidence of blood pressure reduction of at least 10?15 mmHg needs to be achieved and sustained for at least six months. Follow-up of up to three years shows persistence of effect. Frankly, if the procedure provides a high likelihood of achieving a blood pressure target of

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