TT RCTs of patients who received a coronary stent | | | | |
PIONEER-AF-PCI,2 2016
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Nonvalvular AF and PCI with stent Mean age 70 y Elective PCI: 61.5% CHA2 DS2-VASc score: 0–1, 9.5%; 2–4, 54.7%; 5–7, 35.9% HAS-BLED score: ≤ 2, 29.8%; 3–4, 65.8%; ≥ 5, 4.5%
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Group 1: 15 mg/d of rivaroxaban (10 mg/d if CrCl 30–50 mL/min) and P2Y12 inhibitor for 12 mo Group 2: 2.5 mg of rivaroxaban twice daily and DAPT for 1, 6, or 12 mo; step down to rivaroxaban and ASA (75–100 mg/d) until 12 mo after stent Group 3: warfarin (INR 2.0–3.0) and DAPT for 1, 6, or 12 mo; step down to warfarin and ASA (75–100 mg/d) until 12 mo after stent P2Y12 inhibitor: 94% clopidogrel Proportion of patients taking 10 mg/d of rivaroxaban not reported
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Primary end point of clinically significant bleeding (composite of TIMI major and minor bleeding, and bleeding requiring medical attention): group 1, 16.8%; group 2, 18%; group 3, 26.7% P < .01 for groups 1 and 2 vs group 3; NNT = 11 and NNT = 12, respectively, at 1 y CV event (CV death, MI, or stroke): no difference
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DAPT duration for groups 2 and 3 (non-randomized): 1 mo, 15.8%; 6 mo, 34.9%; 12 mo, 49.3% PPI use at baseline: 38% Not powered to assess CV outcomes Difference in major bleeding was not statistically significant between groups
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ISAR-TRIPLE,8 2015
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Indication for long-term OAC and need for PCI Mean age 73 y > 65% stable angina > 80% AF DES: 100% CHADS2score: 0–1, 17%–21%; 2–3, 61%–64%; 4–5, 13%–20%; > 5, 1%–2% CHADS2score ≥ 3: 6 wk (22.4%) vs 6 mo (14.5%)
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Primary end point(composite of death, MI, stent thrombosis, stroke, and TIMI major bleeding): no difference at 9 mo
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No significant differences in secondary end points between groups, including TIMI major bleeding No net clinical benefit between 6 mo vs 6 wk of TT
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WOEST,9 2013
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Dual therapy (75 mg/d of clopidogrel and warfarin) for 12 mo vs TT (80–100 mg/d of ASA, 75 mg/d of clopidogrel, and warfarin) for 12 mo Target INR of 2.0–3.0 for both groups
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Primary end point (any bleeding at 1 y): 19.4% vs 44.4%, HR = 0.36, P < .0001, NNT = 4 Secondary end point (composite of death, MI, stroke, target vessel revascularization, and stent thrombosis): 11.1% vs 17.6%, HR = 0.6, P = .025, NNT = 16, driven by reduction in death
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Duration
–BMS: 1 mo to 1 y –DES: at least 1 y
No significant difference in TIMI major bleeding Underpowered for ischemic events PPI use at baseline: about one-third
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TT trials with direct OACs for secondary ACS prevention* | | | | |
ATLAS ACS 2-TIMI 51,10 2012
Randomized, double-blind phase 3 trial 44 countries (5.5% from North America) N = 15 526 Missing data for 15.5% patients who prematurely discontinued the study; vital status not obtained for 1117 (7.2%) at the end of the trial
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| In addition to ASA plus clopidogrel or ticlopidine:
Mean of 13 mo |
Primary end point (composite of CV death, MI, and stroke): placebo, 10.7%; 2.5-mg rivaroxaban, 9.1% (NNT = 63); 5-mg rivaroxaban, 8.8% (NNT = 53) Compared with placebo, 2.5 mg of rivaroxaban (but not 5 mg) decreased CV events (4.1% vs 2.7%) and overall mortality (4.5% vs 2.9%) (P < .05 for both) TIMI major bleeding not associated with CABG: placebo, 0.6%; 2.5-mg rivaroxaban, 1.8% (NNH = 84); 5-mg rivaroxaban, 2.4%(NNH = 56) Fatal bleeding: not statistically significant
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RE-DEEM,11 2011
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Recent ACS STEMI: 60% NSTEMI: 40% PCI: 55% Mean age 61 y
| In addition to ASA plus a P2Y12 inhibitor:
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Primary end point (major [ISTH] or clinically relevant minor bleeding) at 6 mo: placebo, 2.2%; 50 mg, 3.5%; 75 mg, 4.3%; 110 mg, 7.9%; and 150 mg, 7.8%; P < .001 for linear trend Ischemic CV events: not statistically significant (underpowered to assess)
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Addition of dabigatran to DAPT in post-MI patients was associated with a dose-dependent increase in major or clinically relevant minor bleeding 110-mg and 150-mg dabigatran groups associated with a 4-fold higher risk of bleeding than placebo
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APPRAISE-2,12 2011
Randomized, double-blind trial After enrolling 7392 patients, terminated prematurely owing to increased bleeding risk without reduction in ischemic events
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| In addition to ASA plus a P2Y12 inhibitor:
Median 8 mo |
Primary end point (CV death, MI, or stroke): apixaban, 7.5% vs placebo, 7.9% (P = .51) TIMI major bleeding: apixaban, 1.3% vs placebo, 0.5% (NNH = 125)
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