Feature | November 08, 2012

PFO Closure May Improve Outcomes Over Medical Therapy in Cryptogenic Stroke

Results of the RESPECT trial using the Amplatzer device presented at TCT 2012

Amplatzer Structural Heart Occulder Closure Device RESPECT Clinical Trial

November 8, 2012 — A clinical trial indicates that using an investigational medical device to close a PFO, or “hole in the heart,” may be superior to medical management alone in the prevention of a repeated stroke. Results of the RESPECT trial were presented at the 24th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation (CRF).

A PFO (patent foramen ovale) is a flap-like opening between the left and right upper chambers of the heart, which typically fuses shut after birth. In approximately one in four people, the opening does not fuse shut, and in some cases, a blood clot may pass through the PFO and potentially travel to the brain, causing an ischemic stroke. It is estimated that PFO rates are three times higher in the patient population with cryptogenic stroke, or stroke without an overt source. However, to date, no randomized clinical trial has demonstrated superiority of PFO closure over standard medical therapy for secondary stroke prevention, despite there being observational data suggesting a possible benefit.

To see a video of this presentation, click here.

RESPECT was a prospective, randomized, multicenter trial designed to evaluate whether PFO closure with the Amplazter PFO Occluder is superior to the current standard medical treatment in the prevention of recurrent stroke. Made of wire mesh, the investigational device is inserted into the PFO through a catheter to seal the passageway between the left and right atria.

A total of 980 patients were enrolled over eight years. Patients diagnosed with a cryptogenic stroke and PFO (age 18-60) were randomized to either the investigational device group or the medical therapy group within 270 days of the stroke. Forty-nine percent of the patients had a large stroke as the qualifying stroke event. The average age in the study was 46, and patients were otherwise generally healthy.

Statistics from the RESPECT trial:

  • Two-year events rates were low in both the device and medically treated groups
    • 1.6 percent vs. 3 percent, respectively
    • All primary events were non-fatal, recurrent ischemic strokes
  • The clinical risk reduction of stroke using the device ranged from 46.6 percent to 72.7 percent compared to medical management alone, depending on the analysis population being assessed
    • Among the intent-to-treat analysis population, this reduction achieved borderline statistical significance
    • In per-protocol and as-treated analyses, the reductions were statistically significant
  • Serious adverse event rates did not differ between the device and medical groups
    • 23 percent vs. 21.6 percent, respectively
  • Medical therapy included one of four regimens:
    • Warfarin (25.2 percent)
    • Aspirin (46.5 percent)
    • Clopidogrel (14 percent)
    • Aspirin combined with dipyridamole (8.1 percent)
    • Aspirin combined with clopidogrel (6.3 percent)
  • The total incidence of atrial fibrillation was not significantly different between the device and medical group
    • 3 percent vs. 1.5 percent, respectively
  • No device-related thrombus, erosion or embolization was observed
  • There were no study-related deaths

“In patients between 18 and 60 years old with cryptogenic ischemic stroke and PFO, the totality of evidence from RESPECT demonstrates that PFO closure with the Amplatzer PFO Occluder provides evidence of benefit over medical management alone, with very low device and procedure-related risks,” said lead investigator John D. Carroll, M.D., co-director of the Cardiac and Vascular Center and director of interventional cardiology at the University of Colorado. “The optimal secondary prevention strategy following a cryptogenic ischemic stroke in patients who are found to have a PFO has been unknown. This need to know is particularly intense for young stroke patients who have no or minimal traditional risk factors for ischemic stroke, yet face a risk of recurrent stroke for many decades. RESPECT makes progress in both removing the 'unknown' or cryptogenic cause of some strokes and providing high quality data from a large, long-term randomized trial.”

The RESPECT clinical trial was sponsored by St. Jude Medical Inc., which provided research support to the University of Colorado School of Medicine.

For more information: www.crf.org

Related Content

coherex Wave Crest LAA Occluder

Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System.

News | November 24, 2015
November 24, 2015 — Biosense Webster announced it has acquired Coherex Medical Inc., a privately held medical device
Feature | Cath Lab| November 24, 2015
November 24, 2015 — The U.S.
News | Heart Valve Repair| November 23, 2015
NaviGate Cardiac Structures Inc. (NCSI) announced that a first-in-human implant of its catheter-guided, mitral-valved...
Boston Scientific, Watchman FLX, LAA closure device, CE mark, first European implants

Image courtesy of Boston Scientific

News | Left Atrial Appendage (LAA) Occluders| November 20, 2015
Boston Scientific announced the first implants of the Watchman FLX left atrial appendage closure (LAAC) device
protein reprogramming, Stem Cells Translational Medicine, cardiac progenitor cells, CPCs, regenerative therapies
News | Stem Cell Therapies| November 13, 2015
A new study appearing in STEM CELLS Translational Medicine (SCTM) describes a highly efficient, protein-based method...
angina, abnormal heart blood flow, female-pattern heart disease, Cedars-Sinai Heart Institute study, AHA Scientific Sessions
News | Cardiac Diagnostics| November 13, 2015
Chest pain in female-pattern heart disease is linked with abnormal heart blood flow, a new Cedars-Sinai Heart Institute...
News | Antiplatelet and Anticoagulation Therapies| November 12, 2015
Preventing blood clots with drugs such as heparin has become a common practice for fighting some heart and lung...
pharmacist-physician collaboration, high blood pressure control, minority and low-income populations
News | Hypertension| November 12, 2015
November 12, 2015 — A pharmacist-physician collaborative effort to control blood pressure among a diverse group of pa
obese kids, eight years old, heart disease, MRI, Linyuan Jing
News | Cardiac Diagnostics| November 11, 2015
Imaging tests of obese children — some as young as 8 years old — showed signs of significant heart disease and heart...
Overlay Init