News | November 15, 2010

Catheter Procedure no More Effective Than Drug Therapy in Preventing Strokes

November 15, 2010 - A catheter procedure that closes a hole in patients’ hearts appears to be no more effective than drug therapy in preventing recurrent strokes, according to trial results presented at the American Heart Association’s Scientific Sessions.

The CLOSURE I trial compared a catheter procedure plus medical therapy with medications alone to prevent new strokes in patients with unexplained stroke and a hole between the heart’s two upper chambers.

Researchers expected the trial to show the superiority of the STARFlex Septal Closure System followed by clopidogrel over drug therapies alone. Instead, results showed no statistically significant differences between the system and aspirin or warfarin therapy.

“It is possible the procedure has a slight benefit, but you would need thousands of patients to find it in a randomized trial,” said Anthony J. Furlan, M.D., lead investigator of the study and chairman of the neurology department at the Case Western Reserve University School of Medicine and University Hospitals Case Medical Center in Cleveland.

Strokes of unknown origin have several causes, including a patent foremen ovale (PFO), a hole between the heart’s two upper chambers. The hole is vital to fetal survival but normally closes after birth. In roughly 20 percent of adults, remnants of the hole remain, Furlan said. If a blood clot develops in a vein, passes through the hole and reaches the brain a stroke occurs.

No medical device is approved by the U.S. Food and Drug Administration for sealing PFOs. However, physicians use devices approved for closing other types of heart holes to seal the opening between the right and left atria, usually in hopes of preventing a stroke. The STARFlex Septal Closure System, attached to a catheter and threaded into the upper heart, applies a “clamshell”-type patch on both sides of the hole.

The study found a slight, but not statistically significant, decrease in the stroke rate for the PFO-treatment group.

Furlan said possible alternative explanations for the strokes and transient ischemic attacks (TIA) that occurred were found for the majority of patients in both groups.

“Based on the trial results, even though a patient has a PFO and a recurrent stroke, the hole may be totally coincidental to the second stroke,” Furlan said. “The undeniable message here is that too many of these holes are being closed with an off-label procedure, but that’s partly because we’ve never had a randomized trial to guide us.”

Related Content

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Cardiovascular Clinical Studies | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Cardiovascular Clinical Studies | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Cardiovascular Clinical Studies | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Cardiovascular Clinical Studies | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
stroke risk
News | Cardiovascular Clinical Studies | August 28, 2015
Most people assume strokes only happen to octogenarians, but recent evidence suggests that survivors of childhood can
Overlay Init