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although previous investigations of the procedure have had conflicting results.
Renal sympathetic denervation (RSD) was associated with statistically significant reductions in blood pressure assessed by 24-hour ambulatory, daytime ambulatory, and office measurements in the analysis of six trials including a total of 977 participants.
However, the benefit was particularly pronounced in more recent randomized trials that had few patients with isolated systolic hypertension, had highly experienced operators; used more complete techniques of radiofrequency ablation, used novel approaches such as endovascular renal denervation, and used efficacy endpoints such as clinical outcomes, according to investigator Partha Sardar, MD, of Brown University, Providence, R.I., and his colleagues.
“Altogether, the present study affirms the safety and efficacy of renal denervation for blood pressure reduction, and highlights the importance of incorporating the previously described modifications in trial design,” wrote Dr. Sardar and his coauthors. The report is in the Journal of the American College of Cardiology.
While initial trials of catheter-based denervation of renal arteries were positive, three blinded randomized, controlled trials showed no difference in blood pressure between the procedure and a sham procedure, the investigators said. Those findings led to several small, sham-controlled trials that incorporated the aforementioned changes.
For the six trials combined in the meta-analysis, reductions in 24-hour ambulatory systolic blood pressure were significantly lower for RSD, with a weighted mean difference of –3.65 mm Hg (P less than .001), Dr. Sardar and his colleagues reported.
For the earlier trials, the average reductions in 24-hour ambulatory systolic and diastolic blood pressure were 2.23 and 0.66 for RSD and sham patients, respectively.
By contrast, in the second-generation trials, those blood pressure reductions were 4.85 for RSD and 2.98 mm Hg for sham, they said in the report, adding that the reduction in daytime ambulatory systolic blood pressure with RSD was significantly greater for the second-generation studies.
The second-generation studies excluded patients with isolated systolic hypertension, based in part on observations that RSD has a more pronounced impact on blood pressure with combined systolic and diastolic hypertension, according to the authors.
Moreover, the second-generation studies required that very experienced operators perform the procedures, incorporated advanced catheter and ablation techniques, less often used modified medication regimens, and set ambulatory blood pressure as the primary end point, they added.
“These results should inform the design and powering of larger, pivotal trials to evaluate the long-term efficacy and safety of RSD in patients with uncontrolled and resistant hypertension,” Dr. Sardar and his coauthors said.
Dr. Sardar reported no relevant financial disclosures, as did most of the coauthors. Three coauthors provided disclosures related to Regado Biosciences, Abbott Vascular, Amgen, Bristol-Myers Squibb, Lilly, Medtronic, and ReCor Medical, among others.
SOURCE: Sardar P et al. J Am Coll Cardiol. 2019;73(13):1633-42.
While questions remain about the future of renal sympathetic denervation for treatment of hypertension, the present meta-analysis provides “interesting” findings that confirm a benefit of the procedure, particularly in the more recent randomized trials, editorialists said.
“The evidence is now there to conclude that RSD does lower blood pressure in hypertensive patients,” Sverre E. Kjeldsen, MD, PhD, Fadl E.M. Fadl Elmula, MD, PhD, and Alexandre Persu, MD, PhD, wrote in their editorial. That conclusion makes sense in light of knowledge that sympathetic overactivity is a known contributor to hypertension pathogenesis.
Although the blood pressure benefits of RSD in the second-generation trials still seem “relatively modest” and equate roughly to the effect of one antihypertensive drug, the aggregate results mask a wide variation in individual patient response, with up to 30% of patients experiencing dramatic improvements after the procedure, they said.
Accordingly, one key research priority is to figure out what patient characteristics might be used to single out patients who are extreme responders to the therapy.
That kind of optimized patient selection, in tandem with technical improvements in the procedure, they said, may help break the “glass ceiling” in blood pressure reduction reported in randomized trials to date.
“Research on RSD still has good days to come, and patients may eventually benefit from this research effort,” Dr. Kjeldsen, Dr. Fadl Elmula, and Dr. Persu concluded.
Dr. Kjeldsen and Dr. Fadl Elmula are at Oslo University Hospital, Ullevaal, and the University of Oslo; Dr. Persu is at the Université Catholique de Louvain, Brussels. The comments summarize an editorial accompanying the article by Sardar et al. (J Am Coll Cardiol. 2019. doi: 10.1016/j.jacc.2019.02.008). Dr. Kjeldsen reported disclosures related to Merck KGaA, Merck Sharp and Dohme, Sanofi, and Takeda.
While questions remain about the future of renal sympathetic denervation for treatment of hypertension, the present meta-analysis provides “interesting” findings that confirm a benefit of the procedure, particularly in the more recent randomized trials, editorialists said.
“The evidence is now there to conclude that RSD does lower blood pressure in hypertensive patients,” Sverre E. Kjeldsen, MD, PhD, Fadl E.M. Fadl Elmula, MD, PhD, and Alexandre Persu, MD, PhD, wrote in their editorial. That conclusion makes sense in light of knowledge that sympathetic overactivity is a known contributor to hypertension pathogenesis.
Although the blood pressure benefits of RSD in the second-generation trials still seem “relatively modest” and equate roughly to the effect of one antihypertensive drug, the aggregate results mask a wide variation in individual patient response, with up to 30% of patients experiencing dramatic improvements after the procedure, they said.
Accordingly, one key research priority is to figure out what patient characteristics might be used to single out patients who are extreme responders to the therapy.
That kind of optimized patient selection, in tandem with technical improvements in the procedure, they said, may help break the “glass ceiling” in blood pressure reduction reported in randomized trials to date.
“Research on RSD still has good days to come, and patients may eventually benefit from this research effort,” Dr. Kjeldsen, Dr. Fadl Elmula, and Dr. Persu concluded.
Dr. Kjeldsen and Dr. Fadl Elmula are at Oslo University Hospital, Ullevaal, and the University of Oslo; Dr. Persu is at the Université Catholique de Louvain, Brussels. The comments summarize an editorial accompanying the article by Sardar et al. (J Am Coll Cardiol. 2019. doi: 10.1016/j.jacc.2019.02.008). Dr. Kjeldsen reported disclosures related to Merck KGaA, Merck Sharp and Dohme, Sanofi, and Takeda.
While questions remain about the future of renal sympathetic denervation for treatment of hypertension, the present meta-analysis provides “interesting” findings that confirm a benefit of the procedure, particularly in the more recent randomized trials, editorialists said.
“The evidence is now there to conclude that RSD does lower blood pressure in hypertensive patients,” Sverre E. Kjeldsen, MD, PhD, Fadl E.M. Fadl Elmula, MD, PhD, and Alexandre Persu, MD, PhD, wrote in their editorial. That conclusion makes sense in light of knowledge that sympathetic overactivity is a known contributor to hypertension pathogenesis.
Although the blood pressure benefits of RSD in the second-generation trials still seem “relatively modest” and equate roughly to the effect of one antihypertensive drug, the aggregate results mask a wide variation in individual patient response, with up to 30% of patients experiencing dramatic improvements after the procedure, they said.
Accordingly, one key research priority is to figure out what patient characteristics might be used to single out patients who are extreme responders to the therapy.
That kind of optimized patient selection, in tandem with technical improvements in the procedure, they said, may help break the “glass ceiling” in blood pressure reduction reported in randomized trials to date.
“Research on RSD still has good days to come, and patients may eventually benefit from this research effort,” Dr. Kjeldsen, Dr. Fadl Elmula, and Dr. Persu concluded.
Dr. Kjeldsen and Dr. Fadl Elmula are at Oslo University Hospital, Ullevaal, and the University of Oslo; Dr. Persu is at the Université Catholique de Louvain, Brussels. The comments summarize an editorial accompanying the article by Sardar et al. (J Am Coll Cardiol. 2019. doi: 10.1016/j.jacc.2019.02.008). Dr. Kjeldsen reported disclosures related to Merck KGaA, Merck Sharp and Dohme, Sanofi, and Takeda.
although previous investigations of the procedure have had conflicting results.
Renal sympathetic denervation (RSD) was associated with statistically significant reductions in blood pressure assessed by 24-hour ambulatory, daytime ambulatory, and office measurements in the analysis of six trials including a total of 977 participants.
However, the benefit was particularly pronounced in more recent randomized trials that had few patients with isolated systolic hypertension, had highly experienced operators; used more complete techniques of radiofrequency ablation, used novel approaches such as endovascular renal denervation, and used efficacy endpoints such as clinical outcomes, according to investigator Partha Sardar, MD, of Brown University, Providence, R.I., and his colleagues.
“Altogether, the present study affirms the safety and efficacy of renal denervation for blood pressure reduction, and highlights the importance of incorporating the previously described modifications in trial design,” wrote Dr. Sardar and his coauthors. The report is in the Journal of the American College of Cardiology.
While initial trials of catheter-based denervation of renal arteries were positive, three blinded randomized, controlled trials showed no difference in blood pressure between the procedure and a sham procedure, the investigators said. Those findings led to several small, sham-controlled trials that incorporated the aforementioned changes.
For the six trials combined in the meta-analysis, reductions in 24-hour ambulatory systolic blood pressure were significantly lower for RSD, with a weighted mean difference of –3.65 mm Hg (P less than .001), Dr. Sardar and his colleagues reported.
For the earlier trials, the average reductions in 24-hour ambulatory systolic and diastolic blood pressure were 2.23 and 0.66 for RSD and sham patients, respectively.
By contrast, in the second-generation trials, those blood pressure reductions were 4.85 for RSD and 2.98 mm Hg for sham, they said in the report, adding that the reduction in daytime ambulatory systolic blood pressure with RSD was significantly greater for the second-generation studies.
The second-generation studies excluded patients with isolated systolic hypertension, based in part on observations that RSD has a more pronounced impact on blood pressure with combined systolic and diastolic hypertension, according to the authors.
Moreover, the second-generation studies required that very experienced operators perform the procedures, incorporated advanced catheter and ablation techniques, less often used modified medication regimens, and set ambulatory blood pressure as the primary end point, they added.
“These results should inform the design and powering of larger, pivotal trials to evaluate the long-term efficacy and safety of RSD in patients with uncontrolled and resistant hypertension,” Dr. Sardar and his coauthors said.
Dr. Sardar reported no relevant financial disclosures, as did most of the coauthors. Three coauthors provided disclosures related to Regado Biosciences, Abbott Vascular, Amgen, Bristol-Myers Squibb, Lilly, Medtronic, and ReCor Medical, among others.
SOURCE: Sardar P et al. J Am Coll Cardiol. 2019;73(13):1633-42.
although previous investigations of the procedure have had conflicting results.
Renal sympathetic denervation (RSD) was associated with statistically significant reductions in blood pressure assessed by 24-hour ambulatory, daytime ambulatory, and office measurements in the analysis of six trials including a total of 977 participants.
However, the benefit was particularly pronounced in more recent randomized trials that had few patients with isolated systolic hypertension, had highly experienced operators; used more complete techniques of radiofrequency ablation, used novel approaches such as endovascular renal denervation, and used efficacy endpoints such as clinical outcomes, according to investigator Partha Sardar, MD, of Brown University, Providence, R.I., and his colleagues.
“Altogether, the present study affirms the safety and efficacy of renal denervation for blood pressure reduction, and highlights the importance of incorporating the previously described modifications in trial design,” wrote Dr. Sardar and his coauthors. The report is in the Journal of the American College of Cardiology.
While initial trials of catheter-based denervation of renal arteries were positive, three blinded randomized, controlled trials showed no difference in blood pressure between the procedure and a sham procedure, the investigators said. Those findings led to several small, sham-controlled trials that incorporated the aforementioned changes.
For the six trials combined in the meta-analysis, reductions in 24-hour ambulatory systolic blood pressure were significantly lower for RSD, with a weighted mean difference of –3.65 mm Hg (P less than .001), Dr. Sardar and his colleagues reported.
For the earlier trials, the average reductions in 24-hour ambulatory systolic and diastolic blood pressure were 2.23 and 0.66 for RSD and sham patients, respectively.
By contrast, in the second-generation trials, those blood pressure reductions were 4.85 for RSD and 2.98 mm Hg for sham, they said in the report, adding that the reduction in daytime ambulatory systolic blood pressure with RSD was significantly greater for the second-generation studies.
The second-generation studies excluded patients with isolated systolic hypertension, based in part on observations that RSD has a more pronounced impact on blood pressure with combined systolic and diastolic hypertension, according to the authors.
Moreover, the second-generation studies required that very experienced operators perform the procedures, incorporated advanced catheter and ablation techniques, less often used modified medication regimens, and set ambulatory blood pressure as the primary end point, they added.
“These results should inform the design and powering of larger, pivotal trials to evaluate the long-term efficacy and safety of RSD in patients with uncontrolled and resistant hypertension,” Dr. Sardar and his coauthors said.
Dr. Sardar reported no relevant financial disclosures, as did most of the coauthors. Three coauthors provided disclosures related to Regado Biosciences, Abbott Vascular, Amgen, Bristol-Myers Squibb, Lilly, Medtronic, and ReCor Medical, among others.
SOURCE: Sardar P et al. J Am Coll Cardiol. 2019;73(13):1633-42.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Key clinical point: Renal sympathetic denervation significantly reduced blood pressure in randomized, sham-controlled trials.
Major finding: In second-generation trials of renal sympathetic denervation for hypertension therapy, 24-hour ambulatory blood pressure reductions were 4.85 for RSD and 2.98 mm Hg for sham.
Study details: Renal sympathetic denervation for treating hypertension was tested in six randomized, sham-controlled trials of 24-hour ambulatory, daytime ambulatory, and blood pressure office measurements including a total of 977 participants.
Disclosures: Dr. Sardar reported no relevant financial disclosures, as did most of the coauthors. Three coauthors provided disclosures related to Regado Biosciences, Abbott Vascular, Amgen, Bristol-Myers Squibb, Lilly, Medtronic, and ReCor Medical, among others.
Source: Sardar P et al. J Am Coll Cardiol. 2019;73(13):1633-42.