Patrice Wendling

May 20, 2016

PARIS, FRANCE — Left atrial appendage occlusion (LAAO), new research suggests, can lower the risk of stroke in patients with atrial fibrillation (AF) and a history of intracerebral hemorrhage (ICH), a group not usually given chronic antithrombotic therapy due to an increased risk of bleeding.

After a median follow-up of 166 days, the rates of the composite primary end point of ischemic stroke, major bleeding, or all-cause mortality were 47.9 and 278.9 per 1000 patient-years in patients treated with LAAO and those given standard care, respectively.

"Those data definitely suggest LAAO might be a beneficial stroke-prevention strategy in these patients, but we really want to take it to a higher level of evidence and therefore have planned a randomized controlled clinical trial," Dr Jens Erik Nielsen-Kudsk (Aarhus University Hospital, Skejby, Denmark) said in a hot-line session at EuroPCR 2016. The randomized STROKECLOSE trial will start recruiting later this year.

Dr Ted Feldman (NorthShore University Health, Evanston, IL), session cochair and past president of the Society for Cardiovascular Angiography and Interventions (SCAI), said, "This is really very impressive and expected when you see some of the other randomized trial data in lower-risk populations." That said, he questioned postprocedure anticoagulation, noting that postprocedure management is one of the biggest problems in this relatively anticoagulation-contraindicated group.

Nielsen-Kudsk said the standard regimen in the Nordic region is to give aspirin monotherapy for 6 months and nothing thereafter if there is no other indication for antiplatelets, and that a few centers are using dual-antiplatelet therapy for 1 to 3 months.

No Consensus

Currently there is no consensus on how to treat AF post-ICH, and such patients are often left without anticoagulation because of the fear of recurrent serious bleeding, he noted. To evaluate whether LAAO might be beneficial in these patients, the investigators used propensity-score matching to compare 147 patients who were treated with the Amplatzer Cardiac Plug or Amulet LAA closure devices (St Jude Medical) at eight Nordic LAAO centers between 2009 and 2015 and 147 Danish registry patients who were treated with standard care and survived 180 days after admission with ICH between 2005 and 2014.

The relative risk of the primary composite outcome was reduced by 81% in patients treated with LAAO vs standard care after multivariate adjustment.

Clinical Outcomes: LAAO vs Standard Care

  HR 95% CI Relative risk reduction (%)
Composite 0.19 (0.08–0.46) 81
Ischemic stroke 0.35 (0.07–1.79) 65
Major bleeding 0.39 (0.12–1.28) 61
ICH 0.29 (0.03–2.82) 71
Mortality 0.08 (0.02–0.32) 92

Dr Jens Erik Nielsen-Kudsk

During a press briefing, Nielsen-Kudsk told reporters that the Amplatzer and Amulet devices were selected because they are the most frequently used in the Nordic area, "but of course it could be also relevant for the Watchman device."

He observed that the official recommendation for the Watchman is to put patients on 45 days of anticoagulation, but because of the greater bleeding risk in patients with a history of ICH, "you really want to lower their level of antithrombotic treatment."

Dr Nicolo Piazza (McGill University, Montreal, QC) said during the briefing that although the recommendation is for 45 days of anticoagulation, "real-world practice isn't necessarily that. Many of these patients are nonetheless put on dual-antiplatelet therapy or single-antiplatelet agents for 45 days, 3 months, 6 months; it's very heterogeneous out there."

Piazza told heartwire from Medscape that this is a common clinical problem but that evidence in these patients is scarce. Thus, a study like this is "very important because it will answer several questions for our everyday clinical practice."

Nielsen-Kudsk reports serving as a consultant to St Jude Medical. Piazza reports serving as a consultant to HighLife and Medtronic, and owning stock in HighLife.

Follow Patrice Wendling on Twitter: @pwendl. For more from theheart.org, follow us on Twitter and Facebook.

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