Table 2

Potential inappropriate use of NOAC therapy in oral anticoagulant-naïve patients with AF in 2015–2016

Characteristics (N; %)NOACVKA
n=65 010
Dabigatran n=9085Rivaroxaban n=54 456Apixaban n=64 300Total NOAC
n=1 27 841
Contraindications or non-approved indication/dose 1457 (16.0)8614 (15.8)9542 (14.8)19 613 (15.3)NA
Any valvular heart disease649 (7.1)4146 (7.6)6122 (9.5)10 917 (8.5)16 461 (25.3)
 Prosthetic heart valve (mechanical or bioprosthetic valves)106 (1.2)665 (1.2)1096 (1.7)1867 (1.5)6726 (10.3)
Recently hospitalised for coagulopathy, purpura and other haemorrhagic conditions*90 (1.0)479 (0.9)596 (0.9)1165 (0.9)2142 (3.3)
Liver fibrosis and cirrhosis*50 (0.6)282 (0.5)367 (0.6)699 (0.5)1174 (1.8)
Recent gastrointestinal ulceration or intracranial haemorrhage†40 (0.4)120 (0.2)248 (0.4)408 (0.3)350 (0.5)
Recently or currently treated cancer*417 (4.6)2531 (4.6)2898 (4.5)5846 (4.6)4252 (6.5)
Reduced-dose NOAC not approved for stroke prevention in patients with AF in Europe357 (3.9)1844 (3.4)NA2201 (3.5)NA
Inappropriate use during follow-up
No monitoring of renal function at initiation637 (16.8)3804 (15.5)3642 (14.5)8083 (15.1)5401 (17.0)
No monitoring of renal function in the year postinitiation378 (10.0)2347 (9.6)2138 (8.5)4863 (9.1)2984 (9.4)
Non-persistence patterns, N (%)
 One reimbursement only605 (15.9)2666 (10.9)1771 (7.1)5042 (9.4)2426 (7.6)
 One-year treatment discontinuation rates§984 (25.9)6210 (25.4)4524 (18,0)11 718 (21,9)8399 (26.4)
Concomitant use of drug increasing the risk of bleeding¶ 2639 (29.3)15 797 (29.3)18 556 (29.2)36 992 (29.3)33 025 (52.3)
Antiplatelet agents or parenteral anticoagulants1728 (19.2)10 386 (19.3)12 382 (19.5)24 496 (19.4)28 112 (44.5)
 Parenteral anticoagulants287 (3.2)1577 (2.9)1520 (2.4)3384 (2.7)12 078 (19.1)
 Antiplatelet agents1490 (16.6)9179 (17.0)11 170 (17.6)21 839 (17.3)19 710 (31.2)
  Aspirin1336 (14.8)8215 (15.2)10 026 (15.8)19 577 (15.5)17 770 (28.1)
NSAIDs375 (4.2)2111 (3.9)2017 (3.2)4503 (3.6)1030 (1.6)
SSRIs and SSNRIs836 (9.3)4852 (9.0)5880 (9.2)11 568 (9.1)7317 (11.6)
  • *Comorbidities identified using hospitalisation and/or LTD data, and/or specific procedures during a rolling 1-year period preceding the initiation of OAC therapy.

  • †Comorbidities identified using hospitalisation data during a rolling 6-week period preceding the initiation of OAC therapy.

  • ‡Data on patients with at least a 1 year of follow-up ie, patients initiating OAC in 2015 after excluding patients who died and those hospitalised for 3 months or longer (n=3796; 24 483; 25 118; 53 397 and 31 777 for dabigatran, rivaroxaban, apixaban, total NOAC and total VKA new users, respectively); period considered (unless otherwise stated): rolling 1-year period following the initiation of OAC therapy (index date included).

  • §1-year crude discontinuation rate for patients initiating OAC in 2015 who died and those hospitalised for 3 months or longer, defined as prolonged treatment discontinuation ie, 90-day gap with no medication coverage after the 30-day coverage period of a refill.

  • ¶Data for new users still alive after a 45-day period following the index date (n=9001; 53 885; 63 578; 126 464 and 63 180 for dabigatran, rivaroxaban, apixaban, total NOAC and total VKA new users, respectively); period considered: rolling 6-week period following the initiation of OAC therapy (index date included).

  • AF, atrial fibrillation; ATE, arterial thromboembolic events; NA, not applicable; NOAC, non-vitamin K antagonist oral anticoagulant; NSAIDs, non-steroidal anti-inflammatory drugs; SSNRIs, selective serotonin-norepinephrine reuptake inhibitors; SSRIs, selective serotonin reuptake inhibitors; VKA, vitamin K antagonist.