Adrenal vein sampling versus CT scan to determine treatment in primary aldosteronism: an outcome-based randomised diagnostic trial
Adrenal vein sampling versus CT scan to determine treatment in primary aldosteronism: an outcome-based randomised diagnostic trial
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DOI：
10.1016/s2213-8587(16)30100-0
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发表时间：
2016-09-01
影响因子：
44.5
通讯作者：
Deinum, Jaap
中科院分区：
文献类型：
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作者：
Dekkers, Tanja;Prejbisz, Aleksander;Deinum, Jaap
背景单侧醛固酮分泌腺瘤或双侧肾上腺增生是原发性醛固酮增多症的病因，通常通过肾上腺CT或肾上腺静脉取样（AVS）来区分。CT或AVS是否代表最好的诊断方法尚不清楚。我们的目的是比较基于ct的治疗和基于av的治疗原发性醛固酮增多症患者的结果。方法在一项随机对照试验中，我们随机分配醛固酮增多症患者接受肾上腺CT或AVS检查，以确定醛固酮分泌腺瘤（随后的治疗包括肾上腺切除术）或双侧肾上腺增生（随后的治疗包括矿化皮质激素受体拮抗剂）的存在。主要终点是在意向诊断人群中随访1年后获得目标血压的药物治疗强度。药物治疗强度以每日限定剂量表示。主要次要终点包括接受肾上腺切除术患者的生化结局、健康相关生活质量、成本-效果和不良事件。该试验已在ClinicalTrials.gov注册，注册号为NCT01096654。我们在2010年7月6日至2013年5月30日期间招募了200名患者。在184名完成随访的患者中，92名接受了基于ct的治疗（46名肾上腺切除术和46名矿皮质激素受体拮抗剂），92名接受了基于av的治疗（46名肾上腺切除术和46名矿皮质激素受体拮抗剂）。我们发现基于ct治疗和基于avs治疗的患者控制血压所需的降压药物强度无差异（每日定义剂量中位数3.0 [IQR 1.0-5.0] vs 3.0 [1.1-5.9], p=0.52；药物中位数2 [IQR 1-3] vs 2 [1-3]， p=0.87）。分别有39例（42%）和41例（45%）患者达到目标血压（p=0.82）。在次要终点，我们发现基于ct和基于av的治疗在健康相关生活质量方面没有差异（RAND-36身体评分中位数为52.7 [IQR 43.9-56.8] vs 53.2 [44.0-56.8], p=0.83； RAND-36心理评分中位数为49.8 [43.1-54.6]vs 52.7 [44.9-55.5], p=0.17）。生化方面，37例（80%）基于ct的肾上腺切除术患者和41例（89%）基于av的肾上腺切除术患者的高醛固酮增多症得到缓解（p=0.25）。在质量调整生命年（QALYs）中，AVS组的优势平均差异为0.05 (95% CI -0.04至0.13)，与每位患者（sic）2285的平均医疗保健费用显著增加（95% CI 1323-3248）相关。在每个QALY的支付意愿值为3万的情况下，与CT相比，AVS在原发性醛固酮增多症患者的诊断检查中有效利用医疗资源的概率小于0.2。基于ct和基于av治疗的不良事件组间无差异（159个事件，其中9个严重，187个事件，其中12个严重）。解释随访1年后，基于CT或AVS的原发性醛固酮增多症治疗在降压药强度或临床获益方面无显著差异。这一发现挑战了目前对所有原发性醛固酮增多症患者进行AVS的建议。
Background The distinction between unilateral aldosterone-producing adenoma or bilateral adrenal hyperplasia as causes of primary aldosteronism is usually made by adrenal CT or by adrenal vein sampling (AVS). Whether CT or AVS represents the best test for diagnosis remains unknown. We aimed to compare the outcome of CT-based management with AVS-based management for patients with primary aldosteronism.Methods In a randomised controlled trial, we randomly assigned patients with aldosteronism to undergo either adrenal CT or AVS to determine the presence of aldosterone-producing adenoma (with subsequent treatment consisting of adrenalectomy) or bilateral adrenal hyperplasia (subsequent treatment with mineralocorticoid receptor antagonists). The primary endpoint was the intensity of drug treatment for obtaining target blood pressure after 1 year of follow-up, in the intention-to-diagnose population. Intensity of drug treatment was expressed as daily defined doses. Key secondary endpoints included biochemical outcome in patients who received adrenalectomy, health-related quality of life, cost-effectiveness, and adverse events. This trial is registered with ClinicalTrials.gov, number NCT01096654.Findings We recruited 200 patients between July 6, 2010, and May 30, 2013. Of the 184 patients that completed follow-up, 92 received CT-based treatment (46 adrenalectomy and 46 mineralocorticoid receptor antagonist) and 92 received AVS-based treatment (46 adrenalectomy and 46 mineralocorticoid receptor antagonist). We found no differences in the intensity of antihypertensive medication required to control blood pressure between patients with CT-based treatment and those with AVS-based treatment (median daily defined doses 3.0 [IQR 1.0-5.0] vs 3.0 [1.1-5.9], p=0.52; median number of drugs 2 [IQR 1-3] vs 2 [1-3], p=0.87). Target blood pressure was reached in 39 (42%) patients and 41 (45%) patients, respectively (p=0.82). On secondary endpoints we found no differences in health-related quality of life (median RAND-36 physical scores 52.7 [IQR 43.9-56.8] vs 53.2 [44.0-56.8], p=0.83; RAND-36 mental scores 49.8 [43.1-54.6] vs 52.7 [44.9-55.5], p=0.17) for CT-based and AVS-based treatment. Biochemically, 37 (80%) of patients with CT-based adrenalectomy and 41 (89%) of those with AVS-based adrenalectomy had resolved hyperaldosteronism (p=0.25). A non-significant mean difference of 0.05 (95% CI -0.04 to 0.13) in quality-adjusted life-years (QALYs) was found to the advantage of the AVS group, associated with a significant increase in mean health-care costs of (sic)2285 per patient (95% CI 1323-3248). At a willingness-to-pay value of (sic)30 000 per QALY, the probability that AVS compared with CT constitutes an efficient use of health-care resources in the diagnostic work-up of patients with primary aldosteronism is less than 0.2. There was no difference in adverse events between groups (159 events of which nine were serious vs 187 events of which 12 were serious) for CT-based and AVS-based treatment.Interpretation Treatment of primary aldosteronism based on CT or AVS did not show significant differences in intensity of antihypertensive medication or clinical benefits for patients after 1 year of follow-up. This finding challenges the current recommendation to perform AVS in all patients with primary aldosteronism.