Table 2

Summary of observational studies included in the review by length of follow-up, bleeding definition used and in-hospital management strategy

Primary authorLocationSettingStudy designLength of follow-upBleeding criteriaIn-hospital management strategyNParticipants with bleed (n)Crude incidence of bleeding per 100 persons and 95% CIQuality score
Cuisset et al 29 FranceInpatientProspective cohort1 monthTIMI major/minorPCI597162.68 (1.66 to 4.31)*2
Braun et al 26 SwedenRegistryRetrospective cohort3 monthsBARC 2–5PCI263269.89 (6.84 to 14.1)*5
Amin et al 21 USARegistryRetrospective cohort6 monthsBARC 1–5PCI9290224624.2 (23.3 to 25.1)*5
Amin et al 20 USARegistryRetrospective cohort12 monthsBARC 1PCI3560133537.5 (35.9 to 39.1)*4
Lattuca et al 36 FranceInpatientProspective cohort12 monthsBARC 1–3PCI36913235.8 (31.1 to 40.8)*5
Bacquelin et al 22 FranceRegistryProspective cohort12 monthsBARC 2–5PCI1006797.85 (6.35 to 9.68)*5
Palmerini et al 59 MulticentreUnclearProspective cohort12 monthsBARC (any)PCI1053413.91 (2.89 to 5.26)*5
Kassaian et al 33 IranRegistryProspective cohort12 monthsGUSTO mild, moderate, severeNR1640231.40 (0.94 to 2.10)*4
Yetgin et al 54 The NetherlandsRegistryCohort12 monthsTIMI majorPCI2443230.94 (0.63 to 1.41)*5
Fosbol et al 30 USARegistryProspective cohort12 monthsBleed leading to hospitalisationNR761992812.2 (11.5 to 12.9)*6
Tsai et al 85 TaiwanRegistryRetrospective cohort12 monthsGastrointestinal bleedNR35802737.63 (6.80 to 8.54)*5
Garay et al 70 SpainRegistryRetrospective cohort12 monthsBleed leading to hospitalisation, transfusion or suspension of antithromboticsNR1375695.02 (3.98 to 6.30)*3
Garay et al 55 MulticentreRegistryCohort12 monthsIntracranial bleeding or bleed leading to hospitalisation or transfusionPCI15 4014893.18 (2.91 to 3.46)*5
Effron et al 50 USARegistryRetrospective cohort12 monthsBleed leading to hospitalisation or transfusionPCI15 7884923.12 (2.86 to 3.40)*4
Brinkert et al 47 CanadaRegistryCohort12 monthsHospitalisation with major bleedingPCI, angiography, medically22 3125882.72 (2.51 to 2.94)*5
Ko et al 68 CanadaRegistryCohort12 monthsBleed leading to hospitalisationPCI86722302.65 (2.33 to 3.01)*6
Boggon et al 25 UKRegistryRetrospective cohort12 monthsAny bleeding in patient GPRD or HES recordNR7543NR11.4 (10.4 to 12.6)†5
Carrero et al 28 SwedenRegistryProspective cohort12 monthsMajor bleedNR36 0013330.92 (0.83 to 1.03)*7
Graipe et al 31 SwedenRegistryProspective cohort12 monthsIntracranial bleedNR187 3865900.32 (0.30 to 0.34)6
Wang et al 44 USARegistryCohort12 monthsHaemorrhagic strokeNR169 8633350.20 (0.18 to 0.22)5
Barra et al 23 PortugalInpatientProspective cohort13.4 months (mean)TIMI/GUSTO major criteriaNR852607.04 (5.51 to 8.96)*3
Sra et al 41 CanadaInpatientProspective cohort15 monthsBARC 1–5PCI203444021.6 (19.9 to 23.5)*5
Caneiro-Queija et al 48 SpainRegistryCohort455 days (median)BARC 2–3PCI422950011.8 (10.9 to 12.8)*6
Sørensen et al 40 DenmarkRegistryProspective cohort476.5 days (mean)Fatal and non-fatal bleedPCI40 81219674.82 (4.62 to 5.03)*5
Raposeiras-Roubín et al 52 MulticentreRegistryCohort17.2 months (mean)BARC 3 or 5PCI4310661.53 (1.21 to 1.94)*6
Cuschieri et al 61 USARegistryRetrospective cohort1.7 years (mean)Gastrointestinal bleedNR32181073.33 (2.76 to 4.00)*4
Wong et al 45 UKInpatientRetrospective cohort21 monthsCURE major/life threateningNR224156.70 (4.10 to 10.8)*4
Buresly et al 62 CanadaRegistryCohort654 days (mean)Bleed leading to hospitalisationNR21 44314286.66 (6.33 to 7.00)*3
Voss et al 43 New ZealandRegistryCohort1.94 years (mean)OtherNR36662065.88 (5.15 to 6.71)*4
Brener et al 57 USA and GermanyRegistryProspective cohort24 monthsTIMI, GUSTO and ACUITY Major bleedPCI85824305.17 (4.71 to 5.66)*5
Ertaş et al 51 TurkeyRegistryCohort24 monthsPhysician-confirmed bleeding eventNR1010212.08 (1.36 to 3.16)*4
Blin et al 46 FranceRegistryCohort3 yearsHospitalisation with bleedingNR1585493.09 (2.35 to 4.06)*5
Chamberlain et al 27 USARegistryCohort4.3 yearsOtherNR115931226.9 (24.5 to 29.6)*6
Kazi et al 69 USARegistryRetrospective cohort4.42 years (mean)Major spontaneous bleedingPCI22 5273681.63 (1.48 to 1.81)*5

  • *Incidence and associated 95% CI calculated from data within study.

  • †Incidence and associated 95% CI reported within study per 100 person years.

  • ACUITY, acute catheterisation and urgent intervention triage strategy; AMI, acute myocardial infarction; BARC, Bleeding Academic Research Consortium; CURE, clopidogrel in unstable angina to prevent recurrent events; GPRD, General Practice Research Database; GUSTO, global use of strategies to open occluded arteries; HES, hospital episodes statistics; NR, not reported; PCI, percutaneous coronary intervention; TIMI, thrombolysis in myocardial infarction.