| Literature DB >> 36032388 |
Naoki Kubota1, Kazuyuki Ozaki1, Takumi Akiyama1, Yuzo Washiyama1, Shintaro Yoneyama1, Takeshi Okubo1, Ryutaro Ikegami1, Makoto Hoyano1, Takao Yanagawa1, Naohito Tanabe2, Takayuki Inomata1.
Abstract
Background: The correlation between the Japanese version of high bleeding risk (J-HBR) criteria and the Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy (PRECISE-DAPT) score is unknown, as is the relationship of both risk scores with ischemic events. Methods andEntities:
Keywords: Coronary artery disease; High bleeding risk; Percutaneous coronary intervention
Year: 2022 PMID: 36032388 PMCID: PMC9360984 DOI: 10.1253/circrep.CR-22-0059
Source DB: PubMed Journal: Circ Rep ISSN: 2434-0790
Baseline Characteristics of the Study Population
| Overall | J-HBR | PRECISE-DAPT score | |||||
|---|---|---|---|---|---|---|---|
| High (n=569) | Low (n=273) | P value | High (n=431) | Low (n=411) | P value | ||
| 70±12 | 74±10 | 62±11 | <0.01 | 77±8 | 63±10 | <0.01 | |
| 633 (75) | 393 (69) | 240 (88) | <0.01 | 292 (68) | 341 (83) | <0.01 | |
| 162±10 | 160±10 | 167±8 | <0.01 | 159±9 | 166±9 | <0.01 | |
| 61±13 | 57±13 | 69±12 | <0.01 | 55±12 | 68±13 | <0.01 | |
| 23±4 | 23±4 | 25±3 | <0.01 | 22±4 | 24±4 | <0.01 | |
| ACS | 421 (50) | 259 (46) | 162 (59) | <0.01 | 201 (47) | 220 (54) | 0.046 |
| STEMI | 268 (32) | 156 (27) | 112 (41) | 120 (28) | 148 (36) | ||
| NSTEMI | 53 (6) | 44 (8) | 9 (3) | 39 (9) | 14 (3) | ||
| UAP | 100 (12) | 59 (10) | 41 (15) | 42 (10) | 58 (14) | ||
| Stable CAD | 421 (50) | 310 (54) | 111 (41) | 230 (53) | 191 (46) | ||
| No. vessels | 1.7±0.8 | 1.7±0.8 | 1.5±0.7 | <0.01 | 1.8±0.8 | 1.6±0.8 | <0.01 |
| CTO | 100 (12) | 65 (11) | 35 (13) | 0.56 | 44 (10) | 56 (14) | 0.13 |
| Transradial | 202 (24) | 138 (24) | 64 (23) | 0.77 | 93 (22) | 109 (27) | 0.10 |
| Transfemoral | 637 (76) | 428 (75) | 209 (77) | 335 (78) | 302 (73) | ||
| Transbrachial | 3 (0.4) | 3 (0.5) | 0 (0) | 3 (0.6) | 0 (0) | ||
| Obesity | 250 (30) | 132 (23) | 118 (43) | <0.01 | 86 (20) | 164 (40) | <0.01 |
| Smoker | 542 (64) | 345 (61) | 197 (72) | <0.01 | 256 (59) | 286 (70) | <0.01 |
| Hypertension | 601 (71) | 433 (76) | 168 (61) | <0.01 | 331 (77) | 270 (66) | <0.01 |
| Diabetes | 368 (44) | 264 (46) | 104 (38) | 0.02 | 210 (49) | 158 (38) | <0.01 |
| Dyslipidemia | 510 (61) | 327 (57) | 183 (67) | <0.01 | 237 (55) | 273 (66) | <0.01 |
| Familial hypercholesterolemia | 14 (2) | 10 (2) | 4 (1) | 0.76 | 7 (2) | 7 (2) | 0.94 |
| Family history of CAD | 104 (12) | 65 (11) | 39 (14) | 0.24 | 49 (11) | 55 (13) | 0.37 |
| Previous coronary intervention | 131 (16) | 94 (17) | 37 (14) | 0.27 | 74 (17) | 57 (14) | 0.19 |
| Hemodialysis | 56 (7) | 56 (10) | 0 (0) | <0.01 | 54 (13) | 2 (0.5) | <0.01 |
| WBC (/mL) | 7,900±3,800 | 7,700±3,700 | 8,300±3,900 | 0.04 | 8,000±3,900 | 7,900±3,600 | 0.71 |
| Hb (g/dL) | 13±2 | 12±2 | 15±1 | <0.01 | 12±2 | 14±2 | <0.01 |
| Platelet count (×104/mL) | 22±8 | 22±9 | 23±6 | 0.052 | 22±9 | 23±8 | 0.053 |
| TG (mg/dL) | 125±98 | 115±80 | 145±123 | <0.01 | 105±55 | 145±124 | <0.01 |
| HDL-C (mg/dL) | 45±13 | 45±14 | 45±12 | 0.61 | 44±14 | 46±13 | 0.14 |
| LDL-C (mg/dL) | 99±36 | 95±35 | 108±38 | <0.01 | 92±34 | 107±37 | <0.01 |
| HbA1c (%) | 6.4±1.2 | 6.5±1.2 | 6.4±1.2 | 0.72 | 6.4±1.1 | 6.5±1.2 | 0.89 |
| Cr (mg/dL) | 1.5±1.9 | 1.7±2.2 | 0.8±0.2 | <0.01 | 2.0±2.4 | 0.8±0.5 | <0.01 |
| eGFR (mL/min/1.73 m2) | 60±27 | 53±26 | 75±21 | <0.01 | 45±23 | 76±21 | <0.01 |
| BNP (pg/mL) | 233±508 | 322±596 | 48±91 | <0.01 | 377±659 | 84±185 | <0.01 |
| Aspirin | 774 (92) | 509 (89) | 265 (97) | <0.01 | 381 (88) | 393 (96) | <0.01 |
| Clopidogrel | 557 (66) | 416 (73) | 141 (52) | <0.01 | 306 (71) | 251 (61) | <0.01 |
| Prasugrel | 181 (21) | 74 (13) | 107 (39) | <0.01 | 66 (15) | 115 (28) | <0.01 |
| Oral anticoagulant | 164 (19) | 164 (29) | 0 (0) | <0.01 | 99 (23) | 65 (16) | <0.01 |
| Statin | 710 (84) | 455 (80) | 255 (93) | <0.01 | 331 (77) | 379 (92) | <0.01 |
| Ezetimibe | 183 (22) | 99 (17) | 84 (31) | <0.01 | 59 (14) | 124 (30) | <0.01 |
| PCSK9 inhibitor | 7 (0.8) | 4 (0.7) | 3 (1.1) | 0.55 | 2 (0.5) | 5 (1.2) | 0.23 |
| PPI or H2 receptor blockers | 801 (95) | 531 (93) | 270 (99) | <0.01 | 394 (91) | 407 (99) | <0.01 |
Continuous variables are expressed as the mean±SD and were compared using Student’s t-test. Categorical variables are expressed as n (%) and were compared using the Chi-squared test. ACS, acute coronary syndrome; BMI, body mass index; BNP, B-type natriuretic peptide; CAD, coronary artery disease; Cr, creatinine; CTO, chronic total occlusion; eGFR, estimated glomerular filtration rate; Hb, hemoglobin; HBR, high bleeding risk; HDL-C, high-density lipoprotein cholesterol; J-HBR, Japanese version of high bleeding risk criteria; LDL-C, low-density lipoprotein cholesterol; NSTEMI, non-ST-elevation myocardial infarction; PCSK9, proprotein convertase subtilisin/kexin type 9 serine protease; PPI, proton pump inhibitor; STEMI, ST-elevation myocardial infarction; TG, triglycerides; UAP, unstable angina pectoris; WBC, white blood cell count.
Figure 1.Prevalence of each criterion included in the Japanese version of high bleeding risk (J-HBR). BW, body weight; CKD, chronic kidney disease; NSAIDs, non-steroidal anti-inflammatory drugs; PVD, peripheral vascular disease.
Figure 2.Correlation analysis between the Japanese version of high bleeding risk (J-HBR) criteria and the PRECISE-DAPT score.
Figure 3.Kaplan-Meier curves of (A) major bleeding and (B) ischemic events (myocardial infarction [MI] and ischemic stroke) according to high bleeding risk (HBR) status based on the Japanese version of high bleeding risk (J-HBR) criteria and the PRECISE-DAPT score. The presence of HBR (HBR(+)), was defined as a J-HBR score ≥1.0 and a PRECISE-DAPT score ≥25. PCI, percutaneous coronary intervention.
Figure 4.Receiver operating characteristic curves for the incidence of major bleeding and ischemic events (myocardial infarction [MI] and ischemic stroke) according to high bleeding risk (HBR) status based on the Japanese version of high bleeding risk criteria (J-HBR) and PRECISE-DAPT score. The optimal cut-off value on the J-HBR for predicting major bleeding events based on Youden’s Index was 1.5. AUC, area under the curve.
Figure 5.Kaplan-Meier curves of major bleeding and ischemic events (myocardial infarction [MI] and ischemic stroke) according the modified Japanese version of high bleeding risk criteria (J-HBR), in which a score ≥1.5 is taken to indicate high bleeding risk. PCI, percutaneous coronary intervention.
HRs for Bleeding and Ischemic Events According to the J-HBR and PRECISE-DAPT Score
| HR (95% CI) | P value | HR (95% CI) | P value | |
|---|---|---|---|---|
| J-HBR score ≥1.0 | PRECISE-DAPT Score ≥25 | |||
| Major bleeding events | ||||
| Crude | 2.69 (0.92–7.85) | 0.069 | 3.34 (1.34–8.37) | 0.01 |
| Age-adjusted | 2.18 (0.68–6.93) | 0.188 | 3.27 (1.09– 9.84) | 0.035 |
| Ischemic events (MI/ischemic stroke) | ||||
| Crude | 1.69 (0.55–5.20) | 0.357 | 3.52 (1.15–10.81) | 0.028 |
| Age-adjusted | 1.34 (0.39–4.62) | 0.643 | 3.86 (1.02–14.54) | 0.046 |
| J-HBR score ≥1.5 | ||||
| Major bleeding events | ||||
| Crude | 3.81 (1.43–10.15) | 0.007 | ||
| Age-adjusted | 3.47 (1.20–10.06) | 0.022 | ||
| Ischemic events (MI/ischemic stroke) | ||||
| Crude | 1.38 (0.53–3.62) | 0.515 | ||
| Age-adjusted | 1.06 (0.36–3.14) | 0.91 | ||
CI, confidence interval; HR, hazard ratio; J-HBR, Japanese version of high bleeding risk criteria; MI, myocardial infarction.
Sensitivity and Specificity of Each High Bleeding Risk Score for Predicting Major Bleeding Events at 1 Year
| Sensitivity (%) | Specificity (%) | |
|---|---|---|
| J-HBR score ≥1.0 | 84 | 32.9 |
| J-HBR score ≥1.5 | 80 | 47.2 |
| PRECISE-DAPT score ≥25 | 76 | 49.6 |
J-HBR, Japanese version of high bleeding risk criteria.