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EWOLUTION: LAA closure device reduces risk for adverse events

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Lucas Boersma

MUNICH — The rates of adverse events at 2 years were reduced in patients with a history of ischemic and hemorrhagic stroke who received a left atrial appendage closure device, according to data from the EWOLUTION study presented at the European Society of Cardiology Congress.

Lucas Boersma, MD, PhD, FESC, of St. Antonius Hospital in Nieuwegein, the Netherlands, and Academic Medical Center, University of Amsterdam, and colleagues analyzed 2-year follow-up data from 1,025 patients who underwent a procedure with a left atrial appendage (LAA) closure device (Watchman, Boston Scientific).

As Cardiology Today previously reported, 1-year data from the real-world EWOLUTION registry showed that a LAA closure device successfully reduced stroke and had a high implant success rate among patients with nonvalvular atrial fibrillation, including those who were contraindicated for oral anticoagulation.

The primary endpoint was procedural success and safety, in addition to the incidence of bleeding, stroke and death after 2 years of follow-up. Follow-up was conducted based on the standard practice of the participating centers and included follow-up visits at 1 to 3 months post-procedure with a transesophageal echocardiogram and annual visits. A CHA2DS2-VASc score of at least 5 was seen in 49% of patients, whereas 40% had a HAS-BLED score of at least 3.

“If we look at the population as a whole, we see that this is a high-risk population, higher than in the prior randomized controlled trials, which is logical because this is what the guidelines in Europe actually ask us to do,” Boersma said during the presentation.

Patients with a history of ischemic stroke/transient ischemic attack, hemorrhagic stroke and major bleeding had higher CHA₂DS₂-VASc scores and HAS-BLED scores compared with the rest of the study population.

At 2 years, 85% of patients were treated with single antiplatelet therapy or no antithrombotic therapy. The largest shift to single therapy or no therapy occurred between 3 and 6 months, Boersma said.

The study population had an 83% reduction in ischemic stroke and an 80% reduction in ischemic stroke/TIA/systemic embolism compared with expected event rates if patients were untreated.

Patients with a CHA₂DS₂-VASc score of less than 3 had no cases of ischemic stroke, TIA or systemic embolism.

The stroke rate in this population was similar compared with data from prior randomized controlled trials of the device, Boersma said.

“This confirms the stroke protection potential that this technology has,” he said.

Patients in high-risk subgroups had a RR reduction for stroke similar to that seen in the overall population. Patients with a history of stroke/TIA had a mean CHA₂DS₂-VASc score of 5.5 and a RR reduction of 76% (expected rate, 9.5 events per 100 patient-years; actual rate, 2.3 events per 100 patient-years). The RR reduction was 81% in those with a history of hemorrhagic stroke and 85% in those with a history of major bleeding.

“The initial expected stroke/TIA/systemic embolism risk is high, but the observed rate is much lower, showing you the same 80% reduction for the population as a whole,” Boersma said.

There was a 46% reduction in major bleeding rates for all patients compared with historical data for vitamin K antagonist use.

Patients with a history of stroke/TIA had a RR reduction for major bleeding of 41%, those with a history of hemorrhagic stroke had a RR reduction of 67%, and the RR reduction for recurrent major bleeding in patients with a history of it was 30%.

“Risk profile, implant and left atrial appendage sealing success exceeded that of the prior randomized clinical trials with more experience, and we had lower procedural adverse event rates,” Boersma said. – by Darlene Dobkowski

Reference:

Boersma L, et al. Late Breaking Science in Interventional Cardiology 2. Presented at: European Society of Cardiology Congress; Aug. 25-29, 2018; Munich.

Disclosure: Boersma reports he has a financial relationship with Boston Scientific.