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Studies Clinical News
First US study to investigate the use of the EnligHTN renal denervation system for drug-resistant hypertension St Jude Medical has announced that the FDA has approved the initiation of the EnligHTN IV Renal Denervation Study, which, according to the company, is the first US trial using the EnligHTN multi-electrode renal denervation system to treat patients with drug- resistant hypertension. “Sub-optimal blood pressure control is the most common attributable risk for death worldwide,” said William B White, professor and chief of hypertension and clinical pharmacology in the Calhoun Cardiology Center at the University of Connecticut Health Center in Farmington, USA, and co-chair of the EnligHTN IV steering committee. “Despite the availability of several effective drugs, approximately 50% of patients have inadequately controlled blood pressure and 8% to 12% are considered resistant to these medications. Renal denervation therapy may be an important advancement for these patients.” William Gray,
interventional cardiologist at Columbia University Medical Center in New York City, USA, and co-chair of the EnligHTN IV steering committee stated, “The EnligHTN renal denervation system has shown tremendous promise in clinical studies outside the USA. We look forward to participating in this important study that has the real potential to change medical practice.” The EnligHTN
IV study, according to the company, is a randomised, single-blind, controlled, multicentre trial to investigate the safety and effectiveness of the EnligHTN renal denervation system in reducing systolic blood pressure when measured
in an office setting. The study is expected to enrol approximately 590 patients between the ages of 18 and 80 with an office systolic blood pressure of 160mmHg or greater, who are taking three or more antihypertensive medications including a diuretic. Study patients are expected to be enrolled at up to 80 sites in the USA and Canada. The EnligHTN multi-electrode renal denervation system received the CE mark and was launched in several markets,
according to a press release. The EnligHTN IV trial is being conducted under an investigational device exemption (IDE) from the FDA.
New registry data confirms safety of BioMatrix
studied, 5327 patients (96%) were followed up at 12-months. Only 239 (4.3%) were reported as experiencing a primary endpoint event. A very low rate of definite/ probable stent thrombosis was observed (0.6%), with most incidences occurring in the first month, while low rates of major bleeding continued out to 12 months, with an incidence of 1.6%. A broad range of inclusion criteria have ensured that
e-BioMatrix is a “real-
stents, together with a Biosensors-designed abluminal biodegradable polymer coating, which fully degrades into carbon dioxide and water after six to nine months as it releases Biolimus A9.
Enlightn
drug-eluting stent family in more than 5000 patients On the 21 May, at EuroPCR, Paris, France, new registry data confirmed that the BioMatrix drug-eluting stent family is safe over a 12-month period in a “real-world” population of 5559 patients. Initiated in March 2008, e-BioMatrix is a prospective, multicentre, observational registry. e-BioMatrix, according to a release, was designed to assess the reproducibility of the long term results from LEADERS, Biosensors’ randomised clinical trial, but in a broader range of centres representing “real world” patients. Data was pooled from two different registries: e-BioMatrix PMS, involving 1106 patients, and e-BioMatrix PMR, involving 4453 patients. The primary endpoint for the registry was MACE (a composite of cardiac death,
myocardial infarction and clinically-indicated target vessel revascularisation) at 12 months.
Of the 5559 patients
world” registry: Patients just had to be a minimum of 18 years old and have been treated with one of the BioMatrix family of drug-eluting stent (any size, any vessel). Multiple stents were allowed. There were no limitations on the number of treated lesions, vessels, or lesion length.
“The findings of this real-world registry are very important in helping us to learn more about the safety aspects of drug-eluting stents. The very low 12-month rate of definite and probable stent thrombosis confirm that stent thrombosis, while still associated with significant mortality, is no longer a frequent problem”, commented principle investigator Philip Urban, Hôpital de la Tour, Geneva, Switzerland. “Shorter dual antiplatelet therapy courses could be expected to be associated with a decreased incidence of major bleeding”.
The registry involved patients treated with either BioMatrix or BioMatrix Flex. Both drug-eluting stents incorporated Biolimus A9, a highly lipophilic anti-restenotic drug developed by Biosensors specifically for use with
First clinical research on the frequency and composition of embolic debris captured during TAVI published Claret Medical has announced the publication of an original manuscript by Nicolas Van Mieghem et al—“Histopathology of embolic debris captured during transcatheter aortic valve implantation [TAVI]”. The research was published ahead of print in Circulation on 7 May. The research is the result of collaboration between Erasmus Medical Center, Rotterdam, the Netherlands, and the
pathology team of Renu Virmani of the
Cardiovascular
Pathology Institute, Gaithersburg, USA. According to a
company release, this is the first time any research has reported the frequency and composition of debris captured in a series of patients who underwent TAVI combined with the use of the Claret Montage Dual Filter System. The results showed, from the 40 patient series, that there was visible debris in 75% of patients. Histological analysis of the captured debris was performed at Erasmus Medical Center as well as independently confirmed at the Cardiovascular Pathology Institute. The debris consisted of thrombotic, calcific and connective tissue. Overall, thrombotic material was found in 52% of patients and tissue fragments compatible with aortic valve or aortic wall origin in 52% of patients. The captured material varied in size from 0.15mm to 4.0mm. Differential analysis provided further insight into the origin of captured aortic debris, according to the results.
The samples captured were compared with histological samples of surgically removed valve leaflets. Virmani noted: “valve tissue consistent with aortic leaflets were captured in the filters in 27% of the patients with captured debris and either aortic valve or thrombotic material was captured in 75% of all patients undergoing TAVI. Therefore, it is important that we provide protection to patients undergoing TAVI.”
Speaking about the findings, Van Mieghem said, “During almost every TAVI procedure, significant debris is dislodged. The filter-based Montage 2 is the only way of capturing and getting this debris out of the body. One may wonder, how long until embolic protection is used in every TAVI procedure?” The Montage 2 Dual Filter System is CE marked, but is not available for sale in the USA.
Three- and six- month data for Surround Sound renal denervation system presented at EuroPCR Data from the WAVE I study, presented at a late-breaking trial session at EuroPCR (21-24 May, Paris, France), showed that patients treated with Kona Medical’s Surround Sound renal denervation system had no device- related serious adverse events, and experienced a 22mmHg drop in systolic blood pressure and a 9mmHg drop in diastolic blood pressure at three months (N=24) According to a
company press release, WAVE I is a first-in-man study evaluating the safety and efficacy of Kona Medical’s Surround Sound renal denervation system for the treatment of resistant hypertension. Unlike other renal denervation methods, which rely on a catheter emitting energy through the wall of the renal artery, Kona’s system delivers ultrasound energy to the nerves from outside the body. This targeted energy “surrounds” the artery and treats the
August 2013
nerves located in the vicinity of the vessel. The study showed that at three months, patients had no device-related serious adverse events and experienced a 22mmHg drop in systolic blood pressure and 9mmHg drop in diastolic blood pressure at three months (N=24). In those patients who had reached six months follow up (N=14) there was a 29mmHg drop in systolic blood pressure and 9mmHg drop in diastolic blood pressure. On average, study participants had a baseline blood pressure of 190mmHg systolic and 100mmHg diastolic and were taking an average of 4.5 anti-hypertension medications. Eleven of 14 participants (78%) reaching the six month efficacy endpoint had a clinically significant drop in systolic blood pressure of 10mmHg or more. Results from norepinephrine spillover studies indicate strong evidence of sympathetic denervation. There were no adverse findings in the subjects’ renal vasculature based on six-week angiogram (n=9) and 24 week MRI (n=14). Currently, the clinical sites are enrolling and treating participants in a follow-on study, WAVE II, which uses an optimised treatment protocol that reduces therapy delivery time from approximately 12 minutes per side (in WAVE I) to under three minutes. The study sponsor, Kona Medical, also has announced plans to initiate the WAVE III study, which will evaluate the safety and efficacy of a fully external (non- invasive) version of its ultrasound-based therapy. Study presenter Robert Whitbournm, of St. Vincent’s Hospital in Melbourne, Australia, said: The results from this initial study of external ultrasound for renal denervation are very promising. Blood pressure reduction in this very severe hypertensive cohort grows over time. We’ve also seen that the ultrasound energy leads to effective denervation without any discernible effect on the renal artery. While more studies
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