Author + information
- Stefan C. Bertog1,
- Horst Sievert1,
- Mariusz Hochul2,
- Wojciech Wojakowski3,
- Jean Renkin4,
- Alexandre Persu5,
- Roland Schmieder6,
- Markus Van der Giet7,
- Maximilian De BuCourt8,
- Andreas Zirlik9,
- Petr Neuzil10,
- Nicole Haratani11,
- Helen Parise11,
- Tim Fischell11 and
- Felix Mahfoud12
- 1Cardiovascular Center, Frankfurt, Germany
- 2American Heart of Poland, Tychy, Poland
- 3Medical University of Silesia, Katowice, Poland
- 4Cliniques Universitaires, Brussels, Brussels, Belgium
- 5Université Catholique de Louvain, Brussels, Belgium
- 6Friedrich-Alexander University Erlangen-Nuremberg, Nuremberg, Germany
- 7Charite, Berlin, Germany
- 8Department of Radiology Charité - University Medicine, Berlin, Germany
- 9University Heart Center, Freiburg, Germany
- 10Homolka Hospital, Prague, Czech Republic
- 11Ablative Solutions Inc., Palo Alto, CA
- 12University Medical Center Homburg, Homburg, Germany
The Peregrine post-market study is a prospective, single-arm, open label, multicenter European trial evaluating the safety and performance of the Peregrine System™ Infusion Catheter (Ablative Solutions Inc., Palo Alto, CA, USA) to perform chemical (alcohol) renal denervation (cRDN) to treat resistant hypertension (rHTN).
The trial allows treatment of up to 120 subjects at up to 20 centers in Europe. Eligible subjects have rHTN. After confirmation of anatomical eligibility, subjects undergo bilateral cRDN with 0.6 mL of alcohol per renal artery using the Peregrine catheter. Major safety endpoints are assessed at 1 month. The major efficacy endpoint is the reduction of 24-hour mean systolic ambulatory blood pressure (SABP) at 6 months compared to baseline. It is anticipated that the first 30 subjects with 1-month ambulatory blood pressure measurement, and follow-up data through 3 and 6 months, will be presented.
All procedures (n=26) were technically successful. There were 2 minor renal artery dissections that resolved without intervention. There were 2 (9%) vascular access site complications without sequelae. There were no deaths, myocardial infarctions, strokes, transient ischemic attacks or renal events. Mean procedure time was 8±3 minutes/artery (n=50); mean contrast use 97±42 ml (n=26), and mean fluoroscopy time 11.0±11.0 minutes (n=26). At 1 month, mean systolic office blood pressure (SOBP) and SABP reductions were -27±20 mmHg (n=25; from 176±17 to 148±21 mmHg, p<0.001) and -13±13 mmHg (n=23; 153±15 to 140±18 mmHg, p<0.001), respectively. At 3 months, mean SOBP and SABP reductions were -22±26 mmHg (n=21; 177±18 to 155±24 mmHg, p=0.002) and -14±16mmHg (n=15; 154±15 to 140±19 mmHg, p=0.005), respectively. In 2 of 25 subjects (8%), antihypertensive medications were reduced at 1 and 3 months. In 1 subject, antihypertensive medications were increased at 6 months. This abstract serves as a promissory for updated data to be presented.
1) Alcohol-mediated RDN using the Peregrine catheter is feasible and safe and accompanied by a significant blood pressure reduction. 2) Additional data from larger randomized, double-blind, clinical trials will be needed to confirm these results.