醫 學 新 知 (I) 35 11.74 mm Hg 2. 50% 3. SYMPLICITY HTN-III study 26% 4. 5. SYMPLICITY HTN-I SYMPLICITY HTN-II SYMPLICITY HTN-III 6 A controlled trial of

34 醫 學 新 知 (I) 針 對 頑 固 性 高 血 壓 之 腎 動 脈 交 感 神 經 阻 斷 術 控 制 研 究 編 譯 : 王 宇 澄 中 國 醫 藥 大 學 附 設 醫 院 心 臟 內 科 2:1 6 24 70% 535 14.13±23.93 mm Hg 11.74±25.94 mm Hg ( p <0.001) -2.39 mm Hg (95% 6.89 2.12 5 mm Hg p 0.26) 24 6.75±15.11 mm Hg 4.79±17.25 mm Hg 1.96 mm Hg (95% 4.97 1.06 2 mm Hg p 0.98) SYMPLICITY HTN-1 SYMPLICITY HTN-2 trials : 1. : A.SYMPLICITY HTN-1 study B.SYMPLICITY HTN-2 study

醫 學 新 知 (I) 35 11.74 mm Hg 2. 50% 3. SYMPLICITY HTN-III study 26% 4. 5. SYMPLICITY HTN-I SYMPLICITY HTN-II SYMPLICITY HTN-III 6 A controlled trial of renal denervation for resistant hypertension. Bhatt DL, et al. for the SYMPLICITY HTN-3 Investigators. N Engl J Med 2014; 370:1454-1457 BACKGROUND: Prior unblinded studies have suggested that catheter-based renal-artery denervation reduces blood pressure in patients withresistant hypertension. METHODS: We designed a prospective, single-blind, randomized, sham-controlled trial. Patients with severe resistant hypertension were randomly assigned in a 2:1 ratio to undergo renal denervation or a sham procedure. Before

36 醫 學 新 知 (I) randomization, patients were receiving a stable antihypertensive regimen involving maximally tolerated doses of at least three drugs, including a diuretic. The primary efficacy end point was the change in office systolic blood pressure at 6 months; a secondary efficacy end point was the change in mean 24-hour ambulatory systolic blood pressure. The primary safety end point was a composite of death, end-stage renal disease, embolic events resulting in end-organ damage, renovascular complications, or hypertensive crisis at 1 month or new renalartery stenosis of more than 70% at 6 months. RESULTS: A total of 535 patients underwent randomization. The mean (±SD) change in systolic blood pressure at 6 months was -14.13±23.93 mm Hg in the denervation group as compared with -11.74±25.94 mm Hg in the shamprocedure group (P<0.001 for both comparisons of the change from baseline), for a difference of -2.39 mm Hg (95% confidence interval [CI], -6.89 to 2.12; P=0.26 for superiority with a margin of 5 mm Hg). The change in 24-hour ambulatory systolic blood pressure was -6.75±15.11 mm Hg in the denervation group and -4.79±17.25 mm Hg in the sham-procedure group, for a difference of -1.96 mm Hg (95% CI, -4.97 to 1.06; P=0.98 for superiority with a margin of 2 mm Hg). There were no significant differences in safety between the two groups. CONCLUSIONS: This blinded trial did not show a significant reduction of systolic blood pressure in patients with resistant hypertension 6 months afterrenal-artery denervation as compared with a sham control. (Funded by Medtronic; SYMPLICITY HTN-3 ClinicalTrials.gov number, NCT01418261.).

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