Abstract
Background
Left atrial appendage closure (LAAC) with the Watchman Device (Boston Scientific, MN) is an alternative to warfarin for stroke risk reduction in high risk non-valvular atrial fibrillation (NVAF) patients. This analysis presents the most updated clinical event rates over the longest course of follow-up for the 2 randomized clinical trials: PROTECT AF (5 yrs) and PREVAIL (3 yrs).
Methods
LAAC clinical event rates and stroke outcomes were from pooled PROTECT AF 5-year and PREVAIL 3-year patient-level data were aggregated and analyzed on an intent-to-treat basis.
Results
The baseline risk of stroke for the732 device patients included in the analysis was 3.6% based on a medican CHA2DS2-VASc score of 3.4. Procedural complications included effusion (4.4%), major bleeding (2.3%), stroke (1.0%), and device embolization (0.5%). Rate Ratios for ischemic stroke, hemorrhagic stroke, and major bleeding post-procedure were 1.35, 0.16, and 0.62, respectively. Among patients who suffered a stroke in the device group, Modified Rankin Scores (MRS) were 75.8% (0-2), 3.0% (3), 15.2% (4-5), and 6.1% (6).
Conclusion
Using the combined randomized clinical data, along with increased follow-up, provides the most complete evaluation of WATCHMAN efficacy. Consistently low rates of events, comparable to those expected with anticoagulation in this high risk population, support an LAAC therapy strategy for stroke risk reduction in NVAF patients.
Categories
STRUCTURAL: Left Atrial Appendage Exclusion
Left atrial appendage closure (LAAC) with the Watchman Device (Boston Scientific, MN) is an alternative to warfarin for stroke risk reduction in high risk non-valvular atrial fibrillation (NVAF) patients. This analysis presents the most updated clinical event rates over the longest course of follow-up for the 2 randomized clinical trials: PROTECT AF (5 yrs) and PREVAIL (3 yrs).
Methods
LAAC clinical event rates and stroke outcomes were from pooled PROTECT AF 5-year and PREVAIL 3-year patient-level data were aggregated and analyzed on an intent-to-treat basis.
Results
The baseline risk of stroke for the732 device patients included in the analysis was 3.6% based on a medican CHA2DS2-VASc score of 3.4. Procedural complications included effusion (4.4%), major bleeding (2.3%), stroke (1.0%), and device embolization (0.5%). Rate Ratios for ischemic stroke, hemorrhagic stroke, and major bleeding post-procedure were 1.35, 0.16, and 0.62, respectively. Among patients who suffered a stroke in the device group, Modified Rankin Scores (MRS) were 75.8% (0-2), 3.0% (3), 15.2% (4-5), and 6.1% (6).
Conclusion
Using the combined randomized clinical data, along with increased follow-up, provides the most complete evaluation of WATCHMAN efficacy. Consistently low rates of events, comparable to those expected with anticoagulation in this high risk population, support an LAAC therapy strategy for stroke risk reduction in NVAF patients.
Categories
STRUCTURAL: Left Atrial Appendage Exclusion
| Original language | English (US) |
|---|---|
| Pages (from-to) | B11 |
| Journal | Journal of the American College of Cardiology |
| Volume | 68 |
| Issue number | 18S |
| DOIs | |
| State | Published - Nov 1 2016 |