Information collected during a long-term follow-up analysis of the PROTECT-AF trial is highlighting the fact that Boston Scientific’s “Watchman” beats out Warfarin in terms of safety and efficacy in patients with nonvalvular AF.
This newest analysis monitored data collected from the PROTECT-AF trial’s 800 participating patients for about 45 months (an aggregate of 2,621 patient-years), explained Dr. Vivek Y. Reddy, one of the trial’s researchers. Reddy, who teaches at Mount Sinai School of Medicine, New York, made his comments during the presentation that was held at the Heart Rhythm Society 2013 Scientific Sessions. Just like what happened in a previous analysis that occurred when the study was at its 1500-patient-per-year mark, the newer information showed that the Watchman was better than Warfarin at helping to prevent strokes, systemic embolisms and sudden heart-related death. While the PROTECT study showed that there was an increase in adverse safety effects by the Watchman in comparison to Warfarin, this new analysis shows that the Watchman was the same or better at controlling major bleeding events and strokes.
“This is statistically nonsignificant for the first time,” Reddy said. “The reason is, even though there [was] a high number of [mostly procedure-related] events up front in the Watchman group, there [were] cumulative events in the Warfarin group. So by the time we have the four-year analysis, the event rate is statistically similar.”
Strokes and major bleeding risks have long been a problem for patients taking anticoagulant medications. Even though Warfarin is the most popular medication being used in AF patients right now, it does come with bleeding risks. Doctors have been trying to find a medication that will aid in preventing major uncontrollable bleeding for years, and for now this study is suggesting that the search may be winding down. Other drugs that were previously used to treat AF include another anticoagulant like Multaq. Multaq is made by Sanofi-Aventis and has been linked to serious side effects including a worsening of the heart condition, liver failure and lung toxicity. It is for this reason that the FDA has recommended that doctors only prescribe Multaq if all other medications fail to work.
If you or a loved one has suffered from liver failure or a worsening heart condition after being treated with Multaq, contact the attorneys at Greg Jones today for a free consultation. I am experienced at fighting Multaq lawsuits and may be able to help you recover money for your injuries.
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