The American Academy of Neurology (AAN) has released an updated practice advisory on "Patent foramen ovale and secondary stroke prevention" with a recommendation for PFO closure.MAT-2004545 v2.0| Item approved for OUS use only

 

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INT

Amplatzer PFO

A Turning Point
for PFO Closure

The Landmark RESPECT Trial

The RESPECT Trial1 offers conclusive evidence that using the Amplatzer PFO Occluder to close the patent foramen ovale (PFO) in patients with cryptogenic stroke, is more beneficial than medical therapy in preventing recurrent stroke.

  • Mohammed Mojadidi
  • Mohammed Mojadidi, et al.4

    More Robust Benefit with Amplatzer PFO

    The meta-analysis confirmed that “PFO closure was superior to medical therapy for secondary prevention of stroke…with a more robust benefit when the Amplatzer PFO Occluder from PC and RESPECT trials was used.”

More Patients, Longer Follow-Up

The RESPECT trial stands apart among PFO closure studies since it the largest clinical trial with the most extensive follow-up, spanning 13 years overall. The 980 enrolled patients were followed for a median of 5.9 years. Researchers ultimately collected over 5,810 patient years of data1—2 times more than in other PFO trials.

Very Low Rate of Adverse Events

RESPECT data revealed low rates of serious adverse events:1

0%

DEVICE EMBOLIZATION

0%

AORTIC EROSION/DISSECTION

0%

DEVICE THROMBUS

Excellent Procedural Results

The RESPECT trial data reveal high rates of technical and procedural success and excellent closure with the study’s highly stringent criteria. At only 6 months patients also demonstrated freedom from shunt—both at rest and during Valsalva.1

99.1%

TECHNICAL SUCCESS

96.1%

PROCEDURAL SUCCESS

94.2%

EFFECTIVE CLOSURE
(n ≤ 9 bubbles)

Rigorous Design Included Patients on Anticoagulants

Among the study’s inclusion criteria, RESPECT included patients on anticoagulation therapy—which was not true for other PFO trials REDUCE2 and CLOSE.3 Therefore the RESPECT trial provides a real world cross section of patients. RESPECT was conducted at 69 centers across the U.S. and Canada.

  • Significantly Less Risk of Recurrent Stroke

    The RESPECT trial further revealed a 62% relative risk reduction for recurrent cryptogenic ischemic stroke with the Amplatzer PFO Occluder vs medical therapy.1

    62% lower relative stroke risk

    The RESPECT trial further revealed a 62% relative risk reduction for recurrent cryptogenic ischemic stroke with the Amplatzer PFO Occluder vs medical therapy.1

    62% lower relative stroke risk

    In addition, there was a 45% relative risk reduction for any recurrent ischemic stroke over nearly 6 years of follow-up, compared to medical therapy.1
     

    45% lower relative stroke risk

    In addition, there was a 45% relative risk reduction for any recurrent ischemic stroke over nearly 6 years of follow-up, compared to medical therapy.1
     

    Significantly Less Risk of Recurrent Stroke

  • Low Rates of Atrial Fibrillation

    The RESPECT trial also revealed low rates of serious atrial fibrillation (AF) with the Amplatzer device, consistent with medical therapy.1 AF rates were somewhat higher in the REDUCE trial,2 which used a different PFO closure device.

    RATE

    (PER 100 PATIENT YEARS)

    		RESPECT1REDUCE2
    Serious AF†/Flutter0.220.65
    Any AF/Flutter0.761.90

    CLOSE trial data are not included since follow-up patient years was not reported.

  • 3 Trials Provide Conclusive Evidence of PFO Closure Superiority over Medical Management

    Three recent trials across the industry provide conclusive evidence that PFO closure is superior to medical management in reducing the risk of recurrent stroke.

     

    RESPECT1

    		REDUCE2

    CLOSE3

    Devices Used100% Amplatzer PFO Occluder39% GORE HELEX,
    61% GORE CARDIOFORM    		51% Amplatzer PFO Occluder;
    49% approved PFO devices
    Patients980664473
    Follow-Up

    5,810

    (median 5.9 yrs)

    2,232

    (median 3.2 yrs)

    Not Reported

    (median 5.4 yrs)

    Anticoaguant Allowed in Control Group?YesNoNo
    Relative Risk Reduction

    62%

    (Recurrent ischemic stroke of unknown mechanism)

    77%

    (Recurrent ischemic stroke)

    97%

    (Recurrent ischemic stroke)

    Effective Closure

    92%

    Freedom from > 9 bubbles (Evaluated after 6 months)

    94.5%

    Freedom from > 25 bubbles (Evaluated after 12 months)

    		Not Reported

AP2947037-WBO Rev. A

References

*Rates are calculated based on data in final publication.
† In RESPECT, serious AF was adjudicated by an independent board of physicians. In REDUCE, it was determined by the local investigator.

  1. Saver JL, et al. Long-term outcomes of patent foramen ovale closure or medical therapy after stroke. N Engl J Med. 2017; 377:1022-1032. doi: 10.1056/NEJMoa1610057.
  2. Søndergaard L, Kasner SE, Rhodes JF, et al. Patent foramen ovale closure or antiplatelet therapy for cryptogenic stroke. N Engl J Med. 2017; 377: 1033-1042. doi: 10.1056/NEJMoa1707404.
  3. Mas J-L, et al. Patent foramen ovale closure or anticoagulation vs. antiplatelets after stroke. N Engl J Med. 2017;377:1011-1021 and supplementary appendix. doi: 10.1056/NEJMoa1705915.
  4. Mojadidi MK, et al. Cryptogenic stroke and patent foramen ovale. J Am Coll Cardiol. 2018;71(9):1035-1043. doi: 10.1016/j.jacc.2017.12.059.
     

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