Similar BP reductions after renal denervation across high-risk subgroups and ASCVD risk scores
Renal Denervation in High-Risk Patients With Hypertension
Introduction and methods
Short-term safety and efficacy of renal denervation (RDN) therapy for patients with uncontrolled hypertension and relatively few comorbidities have recently been verified in three separate sham-controlled trials [1-3]. However, it has remained unclear whether comorbidities associated with increased sympathetic activity or overall higher CV risk affect the BP-lowering response of RDN. It is also unknown whether the durability of the BP-lowering effect of RDN is limited in patients with such comorbidities .
The Global proSpective registrY for syMPathetic renaL denervatIon in seleCted IndicatIons Through 3 Years Registry (GSR) trial evaluated short- and long-term BP reduction, clinical events, and adverse event (AE) rates in patients who received RDN . In this ongoing, international single-arm trial, patients (n=2652) with uncontrolled hypertension and/or conditions associated with sympathetic nervous system activation are followed up to 3 years after RDN. In the GSR trial, uncontrolled hypertension was defined as BP above recommended levels (regardless of therapy) according to published local guidelines at the time of enrollment. Patients with sympathetic nervous system activation included those with diabetes, congestive HF, CKD, obstructive sleep apnea, or arrhythmias.
The present post-hoc analysis of the GSR trial evaluated whether RDN was effective and durable in patients with varying comorbidities and baseline CV risk. SBP changes over time were analyzed for various high-risk subgroups, including elderly patients (age ≥65 years) (n=1059), patients with AF (n=317), T2DM (n=978), severe treatment resistant hypertension (office SBP >150 mm Hg despite prescription of 3 antihypertensive medications) (n=1822), CKD (estimated GFR <60 ml/min/1.73 m2) (n=609), and isolated systolic hypertension (ISH) (baseline office SBP ≥140 mm Hg and diastolic BP <90 mm Hg) (n=995). Comparisons were made to patients aged <65 years and to patients who did not meet these clinical criteria. Change in SBP was also analyzed stratified by baseline atherosclerosis cardiovascular disease (ASCVD) risk score (<10%, ≥10 to <20% and ≥20% risk score) . Finally, AE’s at 3 years were analyzed in the various high-risk subgroups and for patients with different baseline ASCVD risk scores.
- Measured at 3 years, reduction in 24-h SBP was -8.9±20.1 mm Hg (95%CI: -10.7 to -7.1) for the overall cohort, -10.4±21 (95%CI: -12.7 to -8.0) for resistant hypertension, -8.7±17.4 (95%CI: -11.1 to -6.2) in patients age ≥65 years, -10.2±17.9 (95%CI: -12.7 to -7.7) for T2DM, -8.6±18.7 (95%CI: -11.2 to -6.0) for ISH, -10.1±20.3 (95%CI: -13.8 to -6.3) for CKD, and -10.1±19.1 (95%CI: -14.5 to -5.4) for AF (P <0.0001 compared with baseline for all).
- Similar decreases in office and 24-h SBP were seen between subgroups (age <65 vs. age ≥65 years, ISH vs. no ISH, AF vs. no AF, T2DM vs. no T2DM). Reductions were sustained to 3 years follow-up.
- For differing baseline ASCVD risk scores, change in BP after 6, 12, 24, and 36 months showed similar reductions in office and 24-h SBP.
- Individuals with highest baseline ASCVD risk scores (≥20%) had higher 3-year rates of death (8.4%, P <0.001), CV death (4.5%, P=0.002), and hospitalization for new-onset heart failure (5.3%, P=0.03) or AF (6.3%, P=0.003) compared with those with lower baseline ASCVD risk scores (<10% and ≥10 to <20%).
- AEs at 3 years were similar between subgroups, although with exceptions: for patients with T2DM vs. without T2DM, there was a higher rate of MI (4% vs. 1.6%, P=0.002), end-stage renal disease (2.8% vs. 1.0%, P=0.005), and elevated creatinine levels (2.4% vs. 0.8%, P=0.007). Death and CV death rates at 3 years were higher for patients aged ≥65 years vs. patients aged <65 years (death: 9.2% vs. 3.1%, P <0.001; CV death: 4.6% vs. 1.7%, P <0.001) and for patients with T2DM vs. without T2DM (death: 7.1% vs. 4.5%, P=0.02; CV death: 4% vs. 2%, P=0.01). Patients with AF vs. without AF had higher rates of death (9.2% vs. 3.1%, P <0.001). Patients with ISH had a higher rate of CV death than patients without ISH (4.0% vs. 2.2%, P=0.04).
Reductions in 24-h SBP after RDN were similar in patients with varying high-risk comorbidities. Similar office and 24-h SBP reductions were seen in patients with differing ASCVD risk scores. BP reductions with RDN were durable across subgroups since they were sustained to 3 years. Clinical events after RDN increased with increasing ASCVD risk score.
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