J O U R NA  O F  T HE  A M E R I C AN  CO LL EG E  O F  C AR DI O L O G Y                                                                                                                                                          VOL. 6 4 ,  N O.  1 ,  201 4

ª  201  B T H  A MERICA  C O L LEG O CA RDI O LOG F O UN D A T I ON                                                                                                                            ISS  0735 -1 09 7 / $ 3 6 . 00

P U BLIS HE B  E L S EVIE I N C .                                                                                                                                                                            h ttp : / /dx.d o i.org / 10.101 6/j.jacc.20 1 4 .04.029






Prospective Randomized Evaluation of  the Watchman Left Atrial Appendage Closure Device in Patients With Atrial Fibrillation Versus Long-Term Warfarin Therapy


The  PREVAIL  Trial



David R. Holmes JR, MD,* Saibal Kar,  MD,y Matthew J. Price, MD,z Brian Whisenant, MD,x Horst Sievert, MD,k Shephal K. Doshi, MD,{ Kenneth Huber, MD,#  Vivek Y. Reddy, MD**







BACKGROUND In the  PROTECT AF (Watchman Left Atrial Appendage ClosurTechnology for Embolic Protection in Patients With Atrial Fibrillation)  trial that evaluated patients with nonvalvular atrial brillation (NVAF), left atrial appendage (LAA) occlusion  was noninferior to warfarin  for stroke prevention, but a periprocedural safety hazard  was identied.


OBJECTIVES The goal  of this  study  was to assess  the  safety and  efficacy  of LAA occlusion  for stroke  prevention  in patients with NVAF compared with long-term warfarin  therapy.


METHODS This randomized trial further assessed the  efficacy  and safety of the  Watchman device.  Patients with NVAF who had  a CHADS2 (congestive heart failure,  hypertension, age  >75 years,  diabetes mellitus, and  previous stroke/ transient ischemic  attack) score  $2 or 1 and  another risk factor were  eligible.  Patients were  randomly assigned (in a

2:1 ratio)  to undergo LAA occlusion  and subsequent discontinuation of warfarin  (intervention group,  n ¼ 269)  or receive chronic  warfarin  therapy (control group,  n ¼ 138). Two efficacy  and  1 safety coprimary  endpoints were  assessed.


RESULTS At 18 months, the  rate  of the  rst coprimary  efcacy  endpoint (composite of stroke, systemic embolism [SE], and cardiovascular/unexplained death) was 0.064 in the  device  group  versus  0.063 in the  control group  (rate  ratio  1.07 [95% credible  interval (CrI): 0.57 to 1.89])  and did not achieve  the  prespecied criteria  noninferiority (upper boundary of

95% CrI $1.75). The rate for the second coprimary efcacy endpoint (stroke or SE >7 days postrandomization) was 0.0253 versus  0.0200 (risk difference 0.0053 [95% CrI: –0.0190 to 0.0273]), achieving  noninferiority. Early safety events occurred in 2.2%  of the  Watchman arm, significantly lower  than  in PROTECT AF, satisfying the  pre-specied safety per- formance goal. Using a broader, more inclusive definition of adverse effects, these still were lower in PREVAIL (Watchman LAA Closure  Device in Patients With Atrial Fibrillation  Versus Long Term Warfarin Therapy)  trial than  in PROTECT AF (4.2%  vs. 8.7%;  p ¼ 0.004). Pericardial  effusions requiring  surgical repair decreased from 1.6% to 0.4% (p ¼ 0.027), and those requiring  pericardiocentesis decreased from 2.9%  to 1.5% (p ¼ 0.36), although the  number of events was small.

CONCLUSIONS In this  trial,  LAA occlusion  was noninferior to warfarin  for ischemic  stroke  prevention or SE >7 days’ post-procedure.  Although noninferiority was not  achieved for overall  efficacy,  event rates were  low and  numerically comparable in both  arms.  Procedural safety has significantly improved. This trial provides additional data  that LAA occlusion  is a reasonable alternative to warfarin  therapy for stroke  prevention in patients with NVAF who do not have an absolute contraindication to short-term warfarin  therapy.  (J Am Coll Cardiol 2014;64:1–12)  © 2014  by the  American College  of Cardiology  Foundation.




From the *Mayo  Clinic,  Rochester, Minnesota; yCedars Sinai  Medical Center, Los  Angeles, California; zScripps Clinic,  La Jolla, California; xIntermountain Medical Center, Salt  Lake  City,  Utah; kCardiovasculares Centrum, Frankfurt, Germany; {Pacific Heart Institute,  Santa Monica, California; #Saint Luke’s  Mid  America Heart Institute,  Kansas City,  Missouri; and the **Mount Sinai



   دانلود : Iranathero_1393-05-18_Watchman.pdf           حجم فایل 601 KB