Randomized controlled trials have shown improved short-term bleeding outcomes for bivalirudin compared to unfractionated heparin (UFH) in patients undergoing percutaneous coronary intervention (PCI) for stable angina and acute coronary syndrome. This study analyzed the impact of bivalirudin-based anticoagulation strategy versus UFH-based anticoagulation strategy on long-term bleeding complications and major adverse cardiac events in patients undergoing PCI in routine clinical practice. From September 2005 to April 2009, 3,367 consecutive patients who underwent PCI for stable angina or non–ST-segment elevation acute coronary syndrome at Brigham and Women’s Hospital were studied. Of these patients, 2,228 patients (66%) received UFH and 1,139 (34%) received bivalirudin. Bleeding complication and major adverse cardiac event rates were compared at discharge, 30 days, and 1 year. In a propensity-score matched analysis, bivalirudin-based anticoagulation strategy was associated with lower bleeding complications at 30 days (7.0% vs 13.7%, p = 0.001) and 1 year (12.7% vs 18.9%, p = 0.013). Major adverse cardiac event rates were not significantly different between groups at discharge, 30 days, and 1 year (6.4% vs 8.3%, p = 0.103; 9.4% vs 10.9%, p = 0.449; 12.1% vs 14.8%, p = 0.235, respectively). There was no difference in all-cause mortality rates between the 2 groups (0.9% vs 0.8%, p = 0.808, at discharge; 1.9% vs 3.6%, p = 0.112, at 30 days; 3.6% vs 5.5%, p = 0.195, at 1 year). In conclusion, in a real-world cohort of patients undergoing PCI, bivalirudin-based anticoagulation strategy is associated with a significant decrease in risk of bleeding complications after 30 days and 1 year compared to a UFH-based anticoagulation strategy with no increase in risk for major adverse cardiac events.
Optimal antithrombotic treatment in patients undergoing percutaneous coronary intervention (PCI) is crucial to balance the risk of bleeding after PCI versus ischemic complications. Bivalirudin, a direct thrombin inhibitor, has been extensively investigated as an intraprocedural antithrombotic therapy in patients with stable angina, non–ST-segment elevation (NSTE) acute coronary syndrome (ACS), and ST-segment elevation myocardial infarction. Bivalirudin, when used with or without glycoprotein IIb/IIIa inhibitors (GPI) during PCI, has been found to be superior to unfractionated heparin (UFH) with or without GPI in decreasing 30-day bleeding complications without significant increase in the rate of ischemic events. Moreover, studies have shown that bivalirudin is noninferior to UFH for rates of 1-year mortality. Other studies have shown 1-year bleeding and mortality rates to be superior in bivalirudin-treated patients undergoing PCI for acute ST-segment elevation myocardial infarction compared to UFH-treated patients. Whether this bleeding safety profile with bivalirudin over UFH in patients with stable angina and NSTE ACS is preserved at 1 year in routine clinical practice is not consistently reported. We sought to compare the risk of bleeding and major adverse cardiac events (MACEs) at discharge, 30 days, and 1 year in a prospective cohort of patients who received UFH-based or bivalirudin-based anticoagulation strategy during PCI for stable angina or NSTE ACS in routine clinical practice.
Methods
We prospectively evaluated consecutive patients undergoing PCI from September 2005 to April 2009 at Brigham and Women’s Hospital (Boston, Massachusetts). All patients who received UFH-based or bivalirudin-based anticoagulation at the time of PCI for stable angina or NSTE ACS were included for analysis. Exclusion criteria included ST-segment elevation myocardial infarction, long-term total occlusions, and patients who received heparin and bivalirudin. If a patient had multiple PCI procedures during an admission, only the index procedure was included in the analysis. Patients were divided into 3 cohorts based on the length of follow-up: inpatients (inpatient follow-up group), patients who had 30-day follow-up (30-day group), and patients who had 1-year follow-up (1-year group). Informed written consent was obtained from all patients, and the study was approved by the local institutional review board.
A prospective catheterization laboratory database, based on the American College of Cardiology/National Cardiovascular Data Registry data collection tool, was used to record clinical and procedural data elements for each patient. Thirty-day and 1-year outcomes were collected for PCI cases performed from September 2006 to March 2009 and from September 2005 to April 2008, respectively. Thirty-day and 1-year outcomes were obtained through telephone interviews when patients were surveyed regarding postprocedural complications including bleeding, blood transfusions, repeat hospitalizations, access site complications, repeat cardiac catheterization or PCI, and myocardial infarction.
PCIs were performed according to standard protocol. Unless contraindicated, all patients who underwent PCI received aspirin and clopidogrel according to standard American College of Cardiology/American Heart Association recommendations. Bivalirudin was recommended as the anticoagulant of choice for patients treated for stable coronary artery disease and low-risk unstable angina. Patients presenting with high-risk unstable angina and NSTE myocardial infarction were treated with bivalirudin at the discretion of the interventional cardiologist. Patients undergoing thrombectomy or rotational atherectomy and those patients already on heparin with an activated clotting time >180 seconds were recommended to be treated with UFH. Final anticoagulation treatment decisions were made at the discretion of the treating interventional cardiologist. Patients in the bivalirudin group received a bolus of bivalirudin 0.75 mg/kg before the guidewire crossed the lesion followed by an infusion of 1.75 mg/kg/hour for the duration of the procedure. Patients in the UFH group received a bolus of 60 to 80 U/kg plus an infusion of 12 U/kg/hour to achieve an activated clotting time of 250 to 300 seconds during PCI. When a GPI was considered, eptifibatide or abciximab was used at standard recommended doses. Patients who received GPI and UFH or bivalirudin were also included in our study because such an anticoagulation strategy was compared in the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) and Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE-2) trials. When stenting occurred, it was at the discretion of the treating physician as to whether the patient received a bare metal or drug-eluting stent. Standard postprocedural therapy included aspirin (81 to 325 mg indefinitely) and clopidogrel (75 mg/day for ≥1 month in patients with bare metal stents and for ≥12 months in patients with drug-eluting stents, unless contraindicated).
Primary outcomes of the study included a composite bleeding end point at discharge, 30 days, and 1 year. The secondary outcome was defined as a composite outcome of death, recurrent myocardial infarction, and repeat revascularization (MACEs). Composite bleeding end point for the inpatient cohort was defined as any access site bleeding (defined as external bleeding from the access site requiring a blood transfusion and/or prolongation of hospital stay; and/or cause a decrease in hemoglobin >3.0 g/dl; or a hematoma >10 cm for femoral access or >2 cm for radial access; or >5 cm for brachial access) or any bleeding from a gastrointestinal, genitourinary, retroperitoneal, or unknown source that resulted in >3 g/dl decrease in hemoglobin and/or requiring blood transfusion and/or prolongation of hospital stay. Composite bleeding end point for the 30-day and 1-year follow-up cohorts was defined as any bleeding requiring hospitalization or blood transfusion or physician visit/intervention. Periprocedural myocardial infarction was defined by the presence of ≥1 of the following criteria: (1) evolutionary ST-segment elevation, development of new Q waves in ≥2 contiguous electrocardiographic leads, or new left bundle branch; (2) biochemical evidence of myocardial necrosis (creatine kinase-MB fraction >3 times the upper limit of normal).
Statistical analysis was performed using SAS 9.2 (SAS Institute, Cary, North Carolina) and SPSS 17.0 for Windows (SPSS, Inc., Chicago, Illinois). Data are expressed as mean ± SD for continuous variables and as percentage for categorical variables. Student’s t test was used to compare continuous variables, and chi square-test or Fisher’s exact test was used to compare categorical variables. A p value <0.05 was considered to indicate statistical significance. To prevent selection bias, a propensity-score matching analysis using a greedy matching protocol was performed for the propensity to use a given antithrombotic agent. To calculate the propensity score, the following 31 variables were entered into a nonparsimonious logistic regression model : age, body mass index, female gender, smoking, diabetes, hypertension, hyperlipidemia, previous myocardial infarction, previous PCI, previous coronary artery bypass graft, history of congestive heart failure, history of cerebrovascular disease, history of peripheral vascular disease, presence of cardiogenic shock, renal failure, salvage PCI, NSTE myocardial infarction, unstable angina, high-risk lesion, left main coronary artery PCI, presence of coronary thrombus, international normalized ratio, calcified coronary disease, use of drug-eluting stent, number of diseased vessels, rotablator use, maximum diameter of vascular access sheath, access through the femoral artery, access through the radial artery, use of femoral venous access, and use of vascular closure device. Subjects were matched using a caliper width equal to 0.6 of the SD of the logit of the propensity score.
Results
The study patient flow for inclusion and follow-up and results of the propensity-score matching are shown in Figure 1 . Of the 4,825 patients who underwent PCI from September 1, 2005 to April 30, 2009, 1,458 patients were excluded from this analysis based on exclusion criteria described in Methods. Of the 3,367 patients included in the final analysis, 2,228 patients (66%) had received UFH-based anticoagulation strategy and 1,139 patients (34%) had received bivalirudin-based anticoagulation strategy during PCI. GPI was used in 877 patients (39%) in the UFH group and in 44 patients (4%) in the bivalirudin group. In-hospital outcomes were available for the entire cohort. One-year follow-up interviews were begun in September 2006 for patients who underwent PCI the previous year. Therefore, 30-day outcomes were not available for the first year. Similarly, 1-year outcomes were not available for the cases performed in the last 12 months of the study period. As a result, 2,224 patients were eligible for 30-day follow-up and 2,590 patients were eligible for 1-year follow-up. Response rates for the 30-day and 1-year follow-ups were 67% (1,488 of 2,224) and 58% (1,491 of 2,590), respectively. A propensity-score matching algorithm successfully matched 59% (1,986 of 3,367) of eligible inpatients, 63% (932 of 1,488) of eligible patients with 30-day follow-up, and 59% (878 of 1,491) of eligible patients with 1-year follow-up.
Baseline characteristics of the study cohort and the propensity-score matched inpatient cohort are presented in Table 1 . After propensity-score matching, baseline characteristics were more evenly distributed, although there was still a higher proportion of UFH-treated patients with GPI (30.4% vs 4.1%, p <0.001) or rotational atherectomy (5.0% vs 1.8%, p <0.001). The difference in baseline characteristics of patients who did and did not respond to follow-up telephone inquiries is presented in Table 2 .
| Variable | Before Propensity-Score Matching | After Propensity-Score Matching | ||||
|---|---|---|---|---|---|---|
| Heparin (n = 2,228) | Bivalirudin (n = 1,139) | p Value | Heparin (n = 993) | Bivalirudin (n = 993) | p Value | |
| Age (years) | 68.2 ± 12 | 68.6 ± 11.7 | 0.304 | 68.6 ± 11.3 | 68.9 ± 11.7 | 0.506 |
| Women | 678 (30.4%) | 339 (29.8%) | 0.690 | 294 (29.6%) | 303 (30.5%) | 0.660 |
| Body mass index (kg/m 2 ) | 29.4 ± 6.2 | 29.2 ± 5.5 | 0.304 | 29.1 ± 5.35 | 29.2 ± 5.6 | 0.829 |
| Diabetes mellitus | 765 (34.3%) | 407 (35.7%) | 0.421 | 356 (35.9%) | 348 (35%) | 0.707 |
| History of renal insufficiency | 164 (7.4%) | 70 (6.1%) | 0.190 | 71 (7.2%) | 63 (6.3%) | 0.474 |
| Renal dialysis | 68 (3.1%) | 16 (1.4%) | 0.004 | 26 (2.6%) | 15 (1.5%) | 0.083 |
| Cerebrovascular disease history | 224 (10.1%) | 118 (10.3%) | 0.781 | 108 (10.9%) | 101 (10.2%) | 0.609 |
| Previous percutaneous coronary intervention | 694 (31.1%) | 391 (34.3%) | 0.062 | 339 (34.1%) | 340 (34.2%) | 0.962 |
| Previous coronary artery bypass grafting | 474 (21.3%) | 215 (18.9%) | 0.103 | 205 (20.6%) | 200 (20.1%) | 0.781 |
| Previous myocardial infarction | 709 (31.8%) | 359 (31.5%) | 0.858 | 332 (33.4%) | 317 (31.9%) | 0.473 |
| Chronic stable angina history | 601 (27%) | 514 (45.1%) | <0.001 | 413 (41.6%) | 420 (42.3%) | 0.750 |
| Heart failure history | 358 (16.1%) | 155 (13.6%) | 0.06 | 143 (14.4%) | 136 (13.7%) | 0.651 |
| Hypertension | 1,909 (85.7%) | 1,020 (89.6%) | 0.002 | 891 (89.7%) | 882 (88.8%) | 0.514 |
| Hyperlipidemia | 1,978 (88.8%) | 1,060 (93%) | <0.001 | 917 (92.3%) | 919 (92.5%) | 0.865 |
| Smoker | 1,505 (67.5%) | 744 (65.3%) | 0.194 | 663 (66.8%) | 655 (66%) | 0.704 |
| Peripheral vascular disease history | 309 (13.9%) | 143 (12.6%) | 0.290 | 136 (13.7%) | 127 (12.8%) | 0.551 |
| Non–ST-segment elevation myocardial infarction | 736 (33%) | 128 (11.2%) | <0.001 | 136 (13.7%) | 128 (12.9%) | 0.597 |
| Unstable angina | 506 (22.7%) | 201 (17.6%) | 0.001 | 199 (20%) | 198 (19.9%) | 0.955 |
| Glycoprotein IIb/IIIa inhibitor use | 877 (39.4%) | 44 (3.9%) | <0.001 | 302 (30.4%) | 41 (4.1%) | <0.001 |
| High-risk lesion | 630 (28.2%) | 184 (16.2%) | <0.001 | 173 (17.4%) | 180 (18.1%) | 0.681 |
| Left main coronary artery percutaneous coronary intervention | 95 (4.3%) | 26 (2.3%) | 0.003 | 25 (2.5%) | 26 (2.6%) | 0.887 |
| Percutaneous coronary intervention with no stent | 152 (6.8%) | 76 (6.7%) | 0.870 | 78 (7.9%) | 71 (7.2%) | 0.551 |
| Drug-eluting stent | 1,729 (77.6%) | 868 (76.2%) | 0.361 | 752 (75.7%) | 756 (76.1%) | 0.834 |
| Thrombus | 184 (8.3%) | 38 (3.3%) | <0.001 | 41 (4.13%) | 35 (3.52%) | 0.452 |
| Number of narrowed coronary arteries | 1.78 ± 1.11 | 1.78 ± 1.04 | 1.00 | 1.78 ± 1.1 | 1.8 ± 1.04 | 0.754 |
| Calcified lesion | 204 (9.2%) | 52 (4.6%) | <0.001 | 55 (5.5%) | 51 (5.1%) | 0.690 |
| Rotablator use | 126 (5.7%) | 18 (1.6%) | <0.001 | 50 (5.0%) | 18 (1.8%) | <0.001 |
| Radial artery access | 152 (6.8%) | 19 (1.7%) | <0.001 | 22 (2.22%) | 19 (2%) | 0.636 |
| Venous access | 353 (15.8%) | 154 (13.5%) | 0.075 | 152 (15.3%) | 144 (14.5%) | 0.614 |
| Vascular closure device | 1,752 (78.7%) | 958 (84.1%) | <0.001 | 826 (83.2%) | 838 (84.4%) | 0.465 |
| Variable | 30-Day Follow-Up | 1-Year Follow-Up | ||||
|---|---|---|---|---|---|---|
| 30-Day Follow-Up (n = 1,488) | No 30-Day Follow-Up (n = 736) | p Value | 1-Year Follow-Up (n = 1,491) | No 1-Year Follow-Up (n = 1,099) | p Value | |
| Age (years) | 68.2 ± 11.6 | 67.4 ± 12.7 | 0.139 | 69.4 ± 11.1 | 67.9 ± 12.7 | 0.001 |
| Women | 451 (30.3%) | 230 (31.2%) | 0.651 | 428 (28.7%) | 349 (31.8%) | 0.094 |
| Body mass index (kg/m 2 ) | 29.4 ± 5.9 | 29.4 ± 6.4 | 0.735 | 29.4 ± 6 | 29.1 ± 5.8 | 0.217 |
| Diabetes mellitus | 525 (35.3%) | 272 (36.9%) | 0.420 | 489 (32.8%) | 398 (36.2%) | 0.070 |
| History of renal insufficiency | 103 (6.9%) | 65 (8.8%) | 0.109 | 98 (6.6%) | 72 (6.5%) | 0.983 |
| Renal dialysis | 33 (2.2%) | 25 (3.4%) | 0.101 | 30 (2%) | 25 (2.3%) | 0.647 |
| Cerebrovascular disease history | 144 (9.7%) | 83 (11.3%) | 0.241 | 150 (10.1%) | 131 (11.9%) | 0.133 |
| Previous percutaneous coronary intervention | 498 (33.5%) | 237 (32.2%) | 0.550 | 476 (31.9%) | 352 (32%) | 0.955 |
| Previous coronary artery bypass grafting | 319 (21.4%) | 152 (20.7%) | 0.669 | 313 (21%) | 219 (19.9%) | 0.507 |
| Previous myocardial infarction | 484 (32.5%) | 255 (34.6%) | 0.318 | 437 (29.3%) | 365 (33.2%) | 0.034 |
| Chronic stable angina history | 523 (35.1%) | 226 (30.7%) | 0.037 | 525 (35.2%) | 333 (30.3%) | 0.009 |
| Heart failure history | 222 (14.9%) | 136 (18.5%) | 0.032 | 206 (13.8%) | 163 (14.8%) | 0.465 |
| Hypertension | 1,320 (88.7%) | 646 (87.8%) | 0.516 | 1,290 (86.5%) | 940 (85.5%) | 0.473 |
| Hyperlipidemia | 1,372 (92.2%) | 665 (90.4%) | 0.139 | 1,337 (89.7%) | 980 (89.2%) | 0.683 |
| Smoker | 1,010 (67.9%) | 484 (65.8%) | 0.317 | 1,010 (67.7%) | 719 (65.4%) | 0.216 |
| Peripheral vascular disease history | 212 (14.2%) | 113 (15.4%) | 0.487 | 182 (12.2%) | 159 (14.5%) | 0.093 |
| Non–ST-segment elevation myocardial infarction | 384 (25.8%) | 219 (29.8%) | 0.049 | 332 (22.3%) | 303 (27.6%) | 0.002 |
| Unstable angina | 278 (18.7%) | 164 (22.3%) | 0.045 | 302 (20.3%) | 264 (24%) | 0.022 |
| Glycoprotein IIb/IIIa inhibitor use | 319 (21.4%) | 181 (24.6%) | 0.094 | 424 (28.4%) | 359 (32.7%) | 0.021 |
| High-risk lesion | 338 (22.7%) | 172 (23.4%) | 0.730 | 360 (24.1%) | 286 (26%) | 0.275 |
| Left main coronary artery percutaneous coronary intervention | 53 (3.6%) | 19 (2.6%) | 0.219 | 62 (4.2%) | 33 (3%) | 0.122 |
| Percutaneous coronary intervention with no stent | 117 (7.9%) | 47 (6.4%) | 0.210 | 113 (7.6%) | 71 (6.5%) | 0.274 |
| Drug-eluting stent | 1,051 (70.6%) | 525 (71.3%) | 0.733 | 1,168 (78.3%) | 848 (77.2%) | 0.476 |
| Thrombus | 89 (6%) | 51 (6.9%) | 0.701 | 83 (5.6%) | 74 (6.7%) | 0.257 |
| Number of narrowed coronary arteries | 1.8 ± 1.1 | 1.8 ± 1.1 | 0.299 | 1.8 ± 1.1 | 1.8 ± 1.1 | 0.237 |
| Calcified disease | 104 (7%) | 65 (8.8%) | 0.123 | 125 (8.4%) | 73 (6.6%) | 0.099 |
| Rotablator use | 3 (0.2%) | 0 | 0.223 | 9 (0.6%) | 4 (0.4%) | 0.394 |
| Radial artery access | 74 (4.9%) | 38 (5.2%) | 0.847 | 64 (4.3%) | 38 (3.4%) | 0.280 |
| Venous access | 226 (15.2%) | 103 (14%) | 0.456 | 233 (15.6%) | 169 (15.4%) | 0.862 |
| Vascular closure device | 1,210 (81.3%) | 608 (82.6%) | 0.458 | 1,210 (81.2%) | 913 (83%) | 0.209 |
Primary and secondary outcomes of this analysis for the entire patient cohort and propensity-score matched groups are presented in Table 3 and Figures 2 and 3 . The composite bleeding end point during in-hospital stay was found to be higher in the UFH group than in the bivalirudin group (4.8% vs 1.8%, p <0.001, in unadjusted patient cohort; 3.5% vs 2.1%, p = 0.058, in propensity-score matched cohort). This difference in the composite bleeding end point was largely due to a higher incidence of nonaccess site bleeding (bleeding from unknown location requiring a transfusion and/or prolonging hospital stay, and/or causing a decrease in hemoglobin >3.0 g/dl) noted in the UFH group than in the bivalirudin group. All other bleeding outcomes were not significantly different between groups. At 30 days and 1 year, bleeding complications were significantly higher in the UFH group than in the bivalirudin group after propensity-score matching (13.7% vs 7.1%, p = 0.001, at 30 days; 18.9% vs 12.8%, p = 0.013, at 1 year). This difference in the composite bleeding end point at 30 days and 1 year was largely due to the bleeding that required physician visit or intervention.
| Before Propensity-Score Matching | After Propensity-Score Matching | |||||
|---|---|---|---|---|---|---|
| Heparin | Bivalirudin | p Value | Heparin | Bivalirudin | p Value | |
| Inpatient outcomes | ||||||
| Patients | 2,228 | 1,139 | 3,367 | 993 | 993 | 1,986 |
| Composite bleeding end point | 106 (4.76%) | 21 (1.84%) | <0.001 | 35 (3.52%) | 21 (2.11%) | 0.058 |
| Gastrointestinal bleeding | 11 (0.49%) | 2 (0.17%) | 0.159 | 2 (0.2%) | 2 (0.2%) | 1.00 |
| Retroperitoneal bleeding | 5 (0.22%) | 1 (0.08%) | 0.374 | 1 (0.1%) | 1 (0.1%) | 1.00 |
| Access site hematoma | 9 (0.4%) | 2 (0.17%) | 0.272 | 2 (0.2%) | 2 (0.2%) | 1.00 |
| Genitourinary bleeding | 1 (0.04%) | 0 | 0.475 | 0 | 0 | — |
| Other bleeding ⁎ | 79 (3.54%) | 16 (1.4%) | <0.001 | 30 (3.02%) | 16 (1.61%) | 0.037 |
| Bleeding requiring blood transfusion | 35 (1.58%) | 6 (0.53%) | 0.009 | 6 (0.6%) | 6 (0.6%) | 1.00 |
| Death/myocardial infarction/revascularization | 157 (7%) | 97 (8.5%) | 0.127 | 64 (6.4%) | 83 (8.3%) | 0.103 |
| Periprocedural myocardial infarction | 121 (5.4%) | 89 (7.8%) | 0.007 | 51 (5.1%) | 75 (7.5%) | 0.027 |
| Repeat percutaneous coronary intervention | 22 (0.9%) | 1 (0.08%) | 0.003 | 10 (1%) | 0 | 0.002 |
| Coronary artery bypass graft | 2 (0.09%) | 0 | 0.312 | 0 | 0 | — |
| Death | 25 (1.12%) | 9 (0.8%) | 0.362 | 8 (0.81%) | 9 (0.91%) | 0.808 |
| 30-Day outcomes | ||||||
| Patients | 914 | 574 | 1,488 | 466 | 466 | 932 |
| Composite bleeding end point | 121 (13.2%) | 41 (7.14%) | <0.001 | 64 (13.73%) | 33 (7.08%) | 0.001 |
| Hospitalization due to bleeding | 14 (1.53%) | 7 (1.22%) | 0.619 | 10 (2.14%) | 4 (0.85%) | 0.106 |
| Bleeding requiring blood transfusion | 9 (0.98%) | 7 (1.22%) | 0.669 | 5 (1.07%) | 4 (0.85%) | 0.738 |
| Death/myocardial infarction/revascularization | 98 (10.7%) | 59 (10.3%) | 0.786 | 44 (9.4%) | 51 (10.9%) | 0.449 |
| Myocardial infarction | 41 (4.5%) | 42 (7.3%) | 0.021 | 22 (4.7%) | 36 (7.7%) | 0.058 |
| Repeat percutaneous coronary intervention | 21 (2.3%) | 8 (1.4%) | 0.220 | 7 (1.5%) | 7 (1.5%) | 1.000 |
| Coronary artery bypass graft | 2 (0.22%) | 2 (0.35%) | 0.638 | 2 (0.42%) | 1 (0.21%) | 0.563 |
| Death | 42 (4.6%) | 9 (1.57%) | 0.002 | 17 (3.64%) | 9 (1.93%) | 0.112 |
| 1-Year outcomes | ||||||
| Patients | 996 | 495 | 1,491 | 439 | 439 | 878 |
| Composite bleeding end point | 186 (18.7%) | 61 (12.32%) | 0.002 | 83 (18.9%) | 56 (12.75%) | 0.013 |
| Hospitalization due to bleeding | 35 (3.51%) | 19 (3.83%) | 0.752 | 16 (3.64%) | 17 (3.87%) | 0.859 |
| Bleeding requiring blood transfusion | 19 (1.9%) | 9 (1.81%) | 0.905 | 6 (1.36%) | 7 (1.59%) | 0.780 |
| Death/myocardial infarction/revascularization | 137 (13.7%) | 68 (13.7%) | 0.993 | 53 (12.1%) | 65 (14.8%) | 0.235 |
| Myocardial infarction | 51 (5.1%) | 37 (7.5%) | 0.069 | 21 (4.8%) | 35 (8%) | 0.053 |
| Repeat percutaneous coronary intervention | 27 (2.7%) | 10 (2%) | 0.419 | 8 (1.8%) | 9 (2%) | 0.807 |
| Coronary artery bypass grafting | 7 (0.7%) | 5 (1.01%) | 0.532 | 2 (0.45%) | 5 (1.13%) | 0.255 |
| Death | 59 (5.92%) | 16 (3.23%) | 0.025 | 24 (5.46%) | 16 (3.64%) | 0.195 |
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