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PROTECT AF: Difference between revisions
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: 66% of the time in patients on this intervention | : 66% of the time in patients on this intervention | ||
; Ischaemic stroke (event/patient year): 15/694.6 vs. 6/372.3, RR= 1.34 (95% CI 0.60–4.29), non-inferiority probability= | ; Ischaemic stroke (event/patient year): 15/694.6 vs. 6/372.3, RR= 1.34 (95% CI 0.60–4.29), non-inferiority probability=71.8%, superiority probability=20.1% | ||
; Cardiovascular/unexplained death (event/patient year): 5/708.4 vs. 10/374.9, RR= 0.26 (95% CI 0.08–0.77), non-inferiority probability> | ; Cardiovascular/unexplained death (event/patient year): 5/708.4 vs. 10/374.9, RR= 0.26 (95% CI 0.08–0.77), non-inferiority probability >99.9%, superiority probability=99.3% | ||
; Haemorrhagic stroke (event/patient year): 1/708.4 vs. 6/373.4, RR=0.09 (95% CI 0.00–0.45), non-inferiority probability > | ; Haemorrhagic stroke (event/patient year): 1/708.4 vs. 6/373.4, RR=0.09 (95% CI 0.00–0.45), non-inferiority probability >99.9%, superiority probability=99.8% | ||
; Systemic embolism (event/patient year): 2/707.8 vs 0/374.9 | ; Systemic embolism (event/patient year): 2/707.8 vs 0/374.9 | ||
; All stroke (event/patient year): 16/694.6 vs. 12/370.8, RR= 0.71 (95% CI: 0.35–1.64), non-inferiority probability | ; All stroke (event/patient year): 16/694.6 vs. 12/370.8, RR= 0.71 (95% CI: 0.35–1.64), non-inferiority probability 99.3%, superiority probability=76.9% | ||
; All-cause mortality (event/patient year): 21/708.4 vs. 18/374.9, RR | ; All-cause mortality (event/patient year): 21/708.4 vs. 18/374.9, RR 0.62 (95% CI: 0.34–1.24), non-inferiority probability >99.9%, superiority probability 90.7% | ||
===Subgroup Analysis=== | ===Subgroup Analysis=== | ||
* HR with treatment in men was lower than that for women (p=0·03; all other interaction tests p>0·40). | * HR with treatment in men was lower than that for women (p=0·03; all other interaction tests p>0·40). | ||
** For men, HR | ** For men, HR 0.32 (95% CI 0.13–0.77) | ||
** For women, HR | ** For women, HR 1.47 (95% CI 0.52–4.11) | ||
No other significant subgroup effects were seen (including age, CHADS2 score, type of AF, LAA size, LVEF). This did not change with the publication of the follow up data in 2013. | No other significant subgroup effects were seen (including age, CHADS2 score, type of AF, LAA size, LVEF). This did not change with the publication of the follow up data in 2013. | ||
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===Adverse Events=== | ===Adverse Events=== | ||
; Serious pericardial effusion (need for percutaneous or surgical drainage): 22 (4.8%) vs. 0 | ; Serious pericardial effusion (need for percutaneous or surgical drainage): 22 (4.8%) vs. 0 | ||
; Major bleeding (required at least 2 units of packed red blood cells or surgery to correct): 16 (3.5%) vs. 10 ( | ; Major bleeding (required at least 2 units of packed red blood cells or surgery to correct): 16 (3.5%) vs. 10 (4.1%) | ||
; Haemorrhagic stroke (all but on in the control group resulted in death): 1 ( | ; Haemorrhagic stroke (all but on in the control group resulted in death): 1 (0.2%) vs. 6 (2.5%) | ||
; Procedure-related ischaemic stroke: 5 ( | ; Procedure-related ischaemic stroke: 5 (1.1%) vs. 0 | ||
; Device embolisation: 3 ( | ; Device embolisation: 3 (0.6%) vs. 0 | ||
; Other procedural complications: 2 ( | ; Other procedural complications: 2 (0.4%) vs. 0 (esophageal tear and procedure-related arrhythmia) | ||
==Criticisms== | ==Criticisms== | ||