Three-month dual antiplatelet treatment versus twelve-month dual antiplatelet treatment after coronary artery bypass grafting: A multicentre, double-blinded, randomised controlled trial
Data files
Mar 31, 2026 version files 883.38 KB
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at_occ_main.csv
30.93 KB
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baseline.csv
232.90 KB
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Code_and_software.txt
4.63 KB
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event_main.csv
139.59 KB
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graft_main.csv
122.20 KB
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README.md
14.97 KB
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svg_occ_main.csv
261.25 KB
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svg_pa_main.csv
76.91 KB
Abstract
Objective: To evaluate whether 3-month dual antiplatelet therapy (DAPT) preserves the efficacy of the 12-month treatment in saphenous vein graft occlusion while reducing the associated bleeding risk.
Design: Multicentre, non-inferiority, double-blind, randomised controlled trial.
Setting: Thirteen cardiac surgery centres in China; enrolment between February 2023 and July 2024.
Participants: 2300 participants aged 18 to 80 years who underwent elective primary coronary artery bypass grafting with ≥1 saphenous vein graft.
Interventions: Participants were randomly assigned (1:1) to receive DAPT (ticagrelor 90 mg twice daily plus aspirin 100 mg once daily) for 12 months or the same dual antiplatelet regimen for the first 3 months, followed by ticagrelor placebo plus aspirin for the next 9 months.
Main Outcomes and Measures: The primary outcomes were one-year saphenous vein graft occlusion (non-inferiority) and Bleeding Academic Research Consortium [BARC] type 2, 3, or 5 bleeding (superiority). The secondary outcome included major adverse cardiovascular events (MACCE), saphenous vein graft failure, venous or arterial graft stenosis, and venous or arterial graft occlusion.
Results: 2290 patients (mean [SD] age 61.46 ± 8.37 years, 20.61% women) were included in the modified intention-to-treat set. The mean number of saphenous vein graft segments was 2.48 ± 0.76. A total of 2070 patients (90.39%) with a total of 5125 saphenous vein graft segments were assessed at one year. Saphenous vein graft occlusion occurred in 280 of 2596 (10.79%) in the 3-month DAPT group and 283 of 2529 (11.19%) in the 12-month DAPT group (absolute difference -0.31%, 95% CI -3.13 to 2.52; P for non-inferiority = 0.008). During a median follow-up of 368 [IQR 358-382] days, BARC type 2, 3, or 5 bleeding occurred in 95 patients (8.26%) treated with 3-month DAPT and 149 patients (13.19%) treated with 12-month DAPT (absolute difference -4.67%, 95%CI -7.18 to -2.16; P < 0.001). Numbers needed-to-treat were 21 (95% CI 13 to 46) to prevent one bleeding event. MACCE occurred in 26 (2.27%) patients in the 3-month DAPT group and 27 (2.67%) patients in the 12-month DAPT group (absolute difference -0.11%, 95% CI -1.48 to 1.26). Other secondary outcomes were also similar between groups.
Conclusions and Relevance: The 3-month DAPT strategy was non-inferior to 12-month DAPT in saphenous vein graft occlusion and superior in reducing bleeding risk.
Trial Registration: ClinicalTrials.gov Identifier: NCT05380063.
Dataset DOI: 10.5061/dryad.jsxksn0qs
Description of the data and file structure
This dataset is the rawdata for the TOPCABG study, and corresponds to the paper entitled "Three-month Dual Antiplatelet Treatment versus Twelve-month Dual Antiplatelet Treatment after Coronary Artery Bypass Grafting: A Multicentre, Double-blinded, Randomised Controlled Trial".
Files and variables
File: at_occ_main.csv
Description: This file contains data on the occlusion status of arterial grafts.
Variables
| Variable name | Variable label | Value label | Variable catagery |
|---|---|---|---|
| pid | Patient ID | Character | |
| COL_INV | Intervention group | A=12-month DAPT; B=3-month DAPT | Character |
| site | Site | Character | |
| occluded_status | Arterial grafts occlusion | 1=occluded; 0=not occluded | Numeric |
File: graft_main.csv
Description: This file contains data on the occlusion and stenosis status of saphenous vein grafts.
Variables
| Variable name | Variable label | Value label | Variable catagery |
|---|---|---|---|
| pid | Patient ID | Character | |
| COL_INV | Intervention group | A=12-month DAPT; B=3-month DAPT | Character |
| site | Site | Character | |
| occluded_status | Any graft occlusion | 1=occluded; 0=not occluded | Numeric |
| stenosis_status | Any graft stenosis | 1=stenosis; 0=no stenosis | Numeric |
File: event_main.csv
Description: This file contains data on clinical events occurred during the study. For each event time, day 0 corresponds to the day of randomization.
Variables
| Variable name | Variable label | Value label | Variable catagery |
|---|---|---|---|
| pid | Patient ID | Character | |
| COL_INV | Intervention group | A=12-month DAPT; B=3-month DAPT | Character |
| site | Site | Character | |
| blood | Blood event | 1=Yes; 0=No | Numeric |
| blood_day | Blood time | Numeric | |
| death_cvd | Cardiovascular death event | 1=Yes; 0=No | Numeric |
| death_cvd_day | Cardiovascular death time | Numeric | |
| mi | Non-fatal MI event | 1=Yes; 0=No | Numeric |
| mi_day | Non-fatal MI time | Numeric | |
| stroke | Non-fatal stroke event | 1=Yes; 0=No | Numeric |
| stroke_day | Non-fatal stroke time | Numeric | |
| revas_cor | Revascularization event | 1=Yes; 0=No | Numeric |
| revas_cor_day | Revascularization time | Numeric | |
| mace | MACCEs event | 1=Yes; 0=No | Numeric |
| mace_day | MACCEs time | Numeric | |
| svgf | SVG failure event | 1=Yes; 0=No | Numeric |
| revas_svg | SVG revascularization event | 1=Yes; 0=No | Numeric |
| mi_svg | SVG‑territory MI event | 1=Yes; 0=No | Numeric |
| death | Death event | 1=Yes; 0=No | Numeric |
| death_day | Death time | Numeric |
File: svg_pa_main.csv
Description: This file contains data on the patency status of saphenous vein grafts.
Variables
| Variable name | Variable label | Value label | Variable catagery |
|---|---|---|---|
| pid | Patient ID | Character | |
| COL_INV | Intervention group | A=12-month DAPT; B=3-month DAPT | Character |
| site | Site | Character | |
| patent_status | SVG patency | 1=patent; 0=not patent | Numeric |
File: baseline.csv
Description: This file contains baseline characteristics for study participants.
Variables
| Variable name | Variable label | Value label | Variable catagery |
|---|---|---|---|
| pid | Patient ID | Character | |
| COL_INV | Intervention group | A=12-month DAPT; B=3-month DAPT | Character |
| AGE | Age, years | Numeric | |
| men | Sex | 1; 0 (due to anonymized policy) | Numeric |
| smoke_status | Smoking status | 1=Never; 2=Current smoker; 3=Former smoker | Numeric |
| Ht_cat | categories of height | <160; 160-170; 171-180; >180 (due to anonymized policy) | Character |
| Wt_cat | categories of weight | <60; 60-70; 71-80; >80 (due to anonymized policy) | Character |
| BMI | Body-mass index, kg/m2 | Numeric | |
| Diabetes | Diabetes | 1=Yes; 0=No | Numeric |
| HTN | Hypertension | 1=Yes; 0=No | Numeric |
| Lipid | Hyperlipidaemia | 1=Yes; 0=No | Numeric |
| PAD | Peripheral vascular disease | 1=Yes; 0=No | Numeric |
| Cere | Cerebrovascular disease | 1=Yes; 0=No | Numeric |
| ACS_2w | Acute coronary syndrome | 1=Yes; 0=No | Numeric |
| MI | Previous myocardial infarction | 1=Yes; 0=No | Numeric |
| PCI | Previous percutaneous coronary intervention | 1=Yes; 0=No | Numeric |
| CCS | Angina severity (CCS class) | 1=I class; 2=II class; 3=III class; 4=IV class | Numeric |
| NYHA | Heart function severity (NYHA class) | 1=I class; 2=II class; 3=III class; 4=IV class | Numeric |
| Cre | Creatine, μmol/L | Numeric | |
| PRE_EGFR | eGFR, mL/min/1.73m2 | Numeric | |
| LDLC | LDL-C, mmol/L | Numeric | |
| LVEF | Left ventricular ejection fraction | Numeric | |
| Bypass | Cardiopulmonary bypass usage | 1=Yes; 0=No | Numeric |
| Onpump | On-pump surgery | 1=Yes; 0=No | Numeric |
| No_touch | No-touch technique for saphenous vein grafts | 1=Yes; 0=No | Numeric |
| Seq_SVG | Sequential bypass configuration for saphenous vein grafts | 1=Yes; 0=No; 99=Missing | Numeric |
| T_GRAFT | Mean total grafts segments/case | Numeric | |
| A_GRAFT | Mean total artery grafts segments/case | Numeric | |
| V_GRAFT | Mean total saphenous vein grafts segments/case | Numeric | |
| BB | β blocker | 1=Yes; 0=No | Numeric |
| RASI | ACEI or ARB | 1=Yes; 0=No | Numeric |
| Statin | Statin | 1=Yes; 0=No | Numeric |
| SYNTAX | SYNTAX score | Numeric |
File: svg_occ_main.csv
Description: This file contains data on the occlusion status of saphenous vein grafts.
Variables
| Variable name | Variable label | Value label | Variable catagery |
|---|---|---|---|
| pid | Patient ID | Character | |
| COL_INV | Intervention group | A=12-month DAPT; B=3-month DAPT | Character |
| occluded_status | SVG occlusion | 1=occluded; 0=not occluded | Numeric |
| site | Site | Character | |
| sub_AGE_65 | Subgroup_Age | 1=≥65 years; 0=<65 years | Numeric |
| sub_men | Subgroup_Men | 1=Men; 0=Women | Numeric |
| sub_BMI_25 | Subgroup_BMI | 1=≥25; 0=<25 | Numeric |
| sub_ACS_2w | Subgroup_Acute coronary syndrome | 1=Yes; 0=No | Numeric |
| sub_HTN | Subgroup_Hypertension | 1=Yes; 0=No | Numeric |
| sub_Diabetes | Subgroup_Diabetes | 1=Yes; 0=No | Numeric |
| sub_Lipid | Subgroup_Hyperlipidaemia | 1=Yes; 0=No | Numeric |
| sub_MI | Subgroup_myocardial infarction | 1=Yes; 0=No | Numeric |
| sub_CUR_SMK | Subgroup_Current smoker | 1=Yes; 0=No | Numeric |
| sub_EF_50 | Subgroup_Left ventricular ejection fraction | 1=≥50; 0=<50 | Numeric |
| sub_EGFR_60 | Subgroup_eGFR | 1=≥60; 0=<60 | Numeric |
| sub_STATIN | Subgroup_Statin | 1=Yes; 0=No | Numeric |
| sub_BB | Subgroup_β blocker | 1=Yes; 0=No | Numeric |
| sub_RASI | Subgroup_ACEI or ARB | 1=Yes; 0=No | Numeric |
| sub_Onpump | Subgroup_Pump-use | 1=On-pump; 0=Off-pump | Numeric |
| sub_GRAFT_3 | Subgroup_Number of SVG segments | 1=≥3; 0=<3 | Numeric |
| sub_SYNTAX | Subgroup_SYNTAX | 1=<23; 2=23-32; 3=>32 | Numeric |
| sub_seq | Subgroup_Sequential bypass | 1=Yes; 0=No | Numeric |
File: Code_and_software.txt
Description: This file contains software requirements and corresponding analysis codes.
Access information
Other publicly accessible locations of the data:
- None.
Data was derived from the following sources:
- None.
Human subjects data
All participants provided explicit written informed consent prior to enrollment, which included permission for the use of their de-identified data for research purposes.
Before data sharing, all datasets were rigorously de-identified in accordance with applicable ethical guidelines and data protection regulations. Specifically, all direct identifiers were removed. Indirect identifiers were either removed or aggregated, and dates were converted to relative time intervals where appropriate. Each participant was assigned a unique study identification number to replace personal identifiers.