Key result
Renal denervation cuts MACE by ~24% vs. sham control alongside significant BP reductions.
Why the study?
Catheter-based renal denervation (RDN) demonstrated significant ambulatory BP reductions in sham-controlled trials of resistant hypertension, but whether these hemodynamic gains translate into long-term hard cardiovascular outcomes beyond 12 months had not been pooled.
Does catheter-based renal denervation reduce MACE and 24-hour ambulatory systolic blood pressure compared to sham control in patients with confirmed resistant hypertension?
Meta-Analysis (n=5,892)
Sham-controlled
Randomized sham-controlled trials
Does catheter-based renal denervation reduce MACE and 24-hour ambulatory systolic blood pressure compared to sham control in patients with confirmed resistant hypertension?
In pooled sham-controlled trials of resistant hypertension, catheter-based renal denervation produces durable blood pressure reduction that translates into significant reductions in MACE and stroke over a median of 28 months.
Answers are grounded in this paper and cite their sources.
Renal denervation may lower MACE in resistant hypertension; challenges consensus by extending sham-controlled BP reductions to hard outcomes.
Background: Resistant hypertension (RH) — uncontrolled BP on ≥3 maximally dosed agents including a diuretic — affects 12-15% of hypertensive adults and carries disproportionate MACE risk. Catheter-based renal denervation (RDN) has re-emerged after sham-controlled trials demonstrated significant ambulatory BP reductions. Whether these hemodynamic gains translate into long-term hard cardiovascular outcomes has not been pooled. This is the first meta-analysis restricted to sham-controlled RDN trials reporting MACE data beyond 12 months. Methods: Following PRISMA 2020, we searched MEDLINE, Embase, Cochrane CENTRAL, and ClinicalTrials.gov through March 2025. Eligible studies were randomized sham-controlled trials of RDN in confirmed RH with ≥12-month follow-up and MACE reporting. Primary outcomes: MACE (CV death, non-fatal MI, non-fatal stroke) and 24-hour ambulatory systolic BP (ASBP) reduction. Secondary outcomes included antihypertensive pill burden, renal function, and procedural safety. Pooled MDs and RRs used random-effects models; ASBP-MACE dose-response assessed by meta-regression. Results: Sixteen sham-controlled trials (n=5,892; baseline ASBP 165.4 ± 14.2 mmHg; median follow-up 28 months) were included. RDN significantly reduced 24-hour ASBP (MD –8.7 mmHg, 95% CI –11.2 to –6.2; p<0.0001; I 2 =31%). MACE was significantly lower with RDN (RR 0.76, 95% CI 0.64-0.90; p=0.002); stroke was reduced by 34% (RR 0.66, 95% CI 0.49-0.88; p=0.005). Meta-regression confirmed a significant ASBP-MACE dose-response (β=–0.021; p=0.003). Antihypertensive burden decreased by 0.8 agents (p<0.0001). Procedural serious adverse events occurred in 1.2%. Conclusions: Renal denervation produces durable BP reduction that translates into significant MACE and stroke reduction in sham-controlled trials. The ASBP-MACE dose-response confirms hemodynamic mediation of cardiovascular benefit. Current AHA resistant hypertension guidelines do not include RDN as a therapeutic option; this sham-controlled pooled evidence base supports formal guideline consideration as an adjunctive strategy in true RH. An adequately powered, outcomes-primary RDN trial is now the logical next step.
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Krishnan et al. (2026) conducted a meta-analysis in Resistant hypertension (n=5,892). Catheter-based renal denervation (RDN) vs. Sham control / Optimal medical therapy was evaluated on Major adverse cardiovascular events (MACE: CV death, non-fatal MI, non-fatal stroke) and 24-hour ambulatory systolic BP (ASBP) reduction (RR 0.76, 95% CI 0.64-0.90, p=0.002). Renal denervation significantly reduced MACE (RR 0.76; 95% CI 0.64-0.90; p=0.002) and 24-hour ambulatory systolic BP (MD -8.7 mmHg; p<0.0001) compared with sham control.
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