Table 1.
General characteristics of studies included in present systematic review.
| Study | Type of Study | Risk Score | Enrollment (Time, Place) | Number of Patients | Clinical Setting | Age Median/Mean | Bleeding Events | ||
|---|---|---|---|---|---|---|---|---|---|
| Number (%) | Definition | Time | |||||||
| Costa et al., 2017 [22] | RTS | PRECISE-DAPT (derivation cohort) | 139 different clinical sites from 12 countries worldwide | 14,963 | PCI + stent | 65.0 | 218 (1.5) | TIMI major or minor bleeding | 1 year |
| PRECISE-DAPT (validation cohort—PLATO) | – | 8595 | 61.0 | 145 (1.7) | TIMI major or minor bleeding | 1 year | |||
| PRECISE-DAPT (validation cohort—BernPCI) | Switzerland, between 23 February 2009, and 31 December 2014 | 6172 | 67.2 | 94 (1.5) |
TIMI major or minor bleeding | 1 year | |||
| Choi et al., 2018 [14] | RTS | PRECISE-DAPT ACUITY CRUSADE |
Korea, between November 2008 and November 2015 | 904 | PCI + stent | 65.5 | 119 (13.2) | TIMI major or minor bleeding | 1 year |
| 80 (8.8) | GUSTO moderate or severe | ||||||||
| 154 (17) | BARC ≥ 3a | ||||||||
| Abu-Assi et al., 2018 [15] | RTS | PRECISE-DAPT PARIS |
Spain, between January 2012 and March 2015 | 1926 | ACS + PCI + stent | 65.1 | 136 (7.1) | BARC type 2, 3 or 5 | 1 year |
| 53 (2.8) | BARC type 3 or 5 | ||||||||
| Ueki et al., 2020 [18] | OBS | ARC-HBR | Switzerland, between January 2009 and December 2016 | 12,121 | PCI + stent | 75.5 HBR |
304 (6.4) HBR | BARC type 3 or 5 | 1 year |
| 62.8 non-HBR |
140 (1.9) non-HBR |
||||||||
| Yeh et al., 2016 [23] | RTS | DAPT (derivation cohort) | 11 countries, from August 2009 to May 2014 | 11,648 | PCI + stent | 61.3 | 215 (1.8) | GUSTO moderate or severe | 12–30 m |
| DAPT (validation cohort—PROTECT) | 36 countries, from June 2007 through July 2014 | 8136 | 62.0 | 37 (0.5) | |||||
| Baber et al., 2016 [24] | OBS | PARIS (derivation cohort) | United States and Europe between July 2009 and December 2010 | 4190 | PCI + drug eluting stent | 67.8 MB | 133 (3.3) | BARC type 3 or 5 | 2 year |
| 63.6 no MB | |||||||||
| PARIS (validation cohort) | – | 8130 | 63.6 | 296 (3.6) | Bleeding requiring hospitalization or transfusion | ||||
| Bianco et al., 2019 [25] | RTS | PRECISE-DAPT PARIS |
12 European centers from January 2012 to December 2016 (RENAMI registry) | 4424 | ACS + PCI + stent | 60.9 | 83 (1.88) | BARC type 3 or 5 | 14 m |
| Raposeiras-Roubin et al., 2018 [26,32] | RTS | BleeMACS (derivation + internal validation cohort) | 15 hospitals from North and South America, Europe and Asia from November 2003 through June 2014 | 15,401 | ACS + PCI | 63.6 | 489 (3.2) | Any intracranial bleeding or any other bleeding leading to hospitalization and/or red blood transfusion ≥ 1 unit not related to procedures/surgery | 1 year |
| Sharma et al., 2017 [27] | OBS | Original | 10 hospitals from United States between 2009 and 2011 (PRISM study) | 3128 | PCI | 64.5 (BARC ≥ 1) | 2554 (81.6) | BARC type ≥ 1 and BARC type ≥ 2 (except BARC type 4 and 5) | 1 year |
| Flores-Rios et al., 2012 [16] | OBS | CRUSADE ACUITY-HORIZONS ACTION |
Spain, single hospital, between January 2006 and December 2010 | 1391 | STEMI + primary PCI | 64.0 | 136 (9.8) | Composite of intracranial or intraocular bleeding; access site hemorrhage requiring intervention; reduction in hemoglobin ≥ 4g/dL without or ≥ 3g/dL with overt bleeding source; reoperation for bleeding; blood transfusion | in-hospital |
| Ariza-Sole et al., 2013 [17] | OBS | CRUSADE ACTION Mehran |
Spain, single hospital, between October 2009 and April 2012 | 1064 | STEMI + primary PCI | 61.7 | 33 (3.1) | Major bleeding defined by TIMI, BARC type 3 or 5 | in-hospital |
| Costa et al., 2015 [28] | RTS | CRUSADE ACUITY HAS-BLED |
Three Italian centers (PRODIGY study) | 1946 | PCI + stent | 76.3 MB |
53 (2.7) | Major bleeding defined by TIMI, GUSTO and BARC type 3 or 5 | 6 m/24 m |
| 68.9 no MB | |||||||||
| 62.8 non-HBR | 140 (1.9) non-HBR | ||||||||
| Choi et al., 2020 [29] | Analy-sis from RCT | PRECISE-DAPT | 31 centers in Republic of Korea (SMART-DATE trial) | 2712 | ACS + PCI | 74.0 HBR | 10 (1.5) HBR | BARC type 3–5 | 18 m |
| 57.7 non-HBR | 6 (0.3) non-HBR | ||||||||
| Kawashima et al., 2020 [30] | Analy-sis from RCT | PRECISE-DAPT CRUSADE ACUITY |
130 hospitals in 18 countries between July 2013 to November 2015 | 14,709 | PCI | 64.6 | – | BARC type 3 or 5 | 30 d |
| Cao et al., 2020 [19] | OBS | ARC-HBR | Tertiary care center in New York, between January 2014 and December 2017 | 9623 | PCI + stent | 71.7 HBR | 390 (9.1) HBR | Bleeding event requiring either hospitalization or blood transfusion | 1 year |
| 61.8 non-HBR | 172 (3.2) non-HBR | ||||||||
| Song et al., 2018 [20] | OBS | DAPT PARIS |
Single hospital in China, from 1 January to 31 December 2013 | 6088 | PCI + DES | 58.3 | 30 (0.50) | BARC type 3 or 5 | 2 year |
| Ueda et al., 2018 [21] | OBS | DAPT | Sweden, between 1 January 2006 and 31 December 2013 | 41,101 | PCI + stent | 61.2 high DAPT score | 311 (0.75) | GUSTO moderate or severe | 30 m |
| Gragnano et al., 2020 [31] | Analy-sis from RCT | PRECISE-DAPT (GLOBAL LEADERS trial) | 130 sites in 18 countries | 14,928 | PCI + DES | 62.5 low PRECISE-DAPT | 163 (2.18) control group | BARC type 3 or 5 | 1 year and 2 year |
| 75.0 high PRECISE-DAPT | |||||||||
| PRECISE-DAPT (GLASSY trial) | Sub-study of GLOBAL LEADERS trial with patients enrolled at the 20 highest recruiting sites | 7134 | 62.7 low PRECISE-DAPT | 91 (2.54) control group | |||||
| 75.9 high PRECISE-DAPT | |||||||||
RTS = retrospective; OBS = observational; RCT = randomized controlled trial; HBR = high bleeding risk; MB = major bleeding.