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This is an retrospective extended study of a randomized clinical trial (The HOST-EXAM trial ClinicalTrials.gov Identifier: NCT02044250).
Investigators will perform a retrospective analysis of all participants enrolled in this trial will be performed, until the longest follow-up duration.
The HOST-EXAM trial (ClinicalTrials.gov Identifier: NCT02044250) was an randomized clinical trial that was performed to compare head-to-head, the efficacy and safety between aspirin and clopidogrel monotherapy in patients who received PCI for coronary artery disease and required chronic maintenance antiplatelet therapy. From March 2014 through May 2018, a total of 5438 patients were enrolled, and follow-up was performed upto 24 months after randomization. After this study, randomization was unlocked and patients were followed-up based on the standard protocol.
Afterwards, the current study was planned to perform a extended follow-up of the HOST-EXAM population. The specific drug by the randomization group in the HOST-EXAM trial was not mandatory after the initial 24 months, therefore participants received medication according to the current guidelines, and according to the physicians preferences.
This is a observational, retrospective analysis of all clinical events after the randomization period. The prescribed medications and any clinical events will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clopidogrel group | This group are those who received clopidogrel 75mg qd as a single antiplatelet agent therapy after PCI. |
| |
| Aspirin group | This group are those who received aspirin 100mg qd as a single antiplatelet agent therapy after PCI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antiplatelet Agents | Drug | Patients who received a single antiplatelet agent will be analyzed according to the prescribed antiplatelet agent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient oriented composite outcome | A composite of all-cause death, nonfatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and major bleeding complication | From date of randomization until March, 2022. |
| Measure | Description | Time Frame |
|---|---|---|
| Thrombotic outcome | cardiac death, non-fatal MI, ischemic stroke, readmission due to ACS, and definite or probable stent thrombosis | From date of randomization until March, 2022. |
| Bleeding outcome |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause death | Death from any cause | From date of randomization until March, 2022. |
| Cardiac death | Death from a cardiac cause | From date of randomization until March, 2022. |
Inclusion Criteria:
Exclusion Criteria:
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Patients who were enrolled in the HOST-EXAM randomized clinical trial will be analyzed for an extended follow-up duration.
Patients enrolled in the HOST-EXAM trial were patients that received stenting with a drug-eluting stent and had successfully completed 6-18 months of DAPT without events.
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34010616 | Result | Koo BK, Kang J, Park KW, Rhee TM, Yang HM, Won KB, Rha SW, Bae JW, Lee NH, Hur SH, Yoon J, Park TH, Kim BS, Lim SW, Cho YH, Jeon DW, Kim SH, Han JK, Shin ES, Kim HS; HOST-EXAM investigators. Aspirin versus clopidogrel for chronic maintenance monotherapy after percutaneous coronary intervention (HOST-EXAM): an investigator-initiated, prospective, randomised, open-label, multicentre trial. Lancet. 2021 Jun 26;397(10293):2487-2496. doi: 10.1016/S0140-6736(21)01063-1. Epub 2021 May 16. | |
| 19482214 |
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The HOST-EXAM-Ex study is planning to continue follow-up until 2028. No individual participant data will be available before this. Any relevant inquiries should be sent to the central contact person or backup person.
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D010975 | Platelet Aggregation Inhibitors |
| ID | Term |
|---|---|
| D006401 | Hematologic Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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Bleeding Academic Research Consortium (BARC) type ≥2 bleeding
| From date of randomization until March, 2022. |
| Result |
| Antithrombotic Trialists' (ATT) Collaboration; Baigent C, Blackwell L, Collins R, Emberson J, Godwin J, Peto R, Buring J, Hennekens C, Kearney P, Meade T, Patrono C, Roncaglioni MC, Zanchetti A. Aspirin in the primary and secondary prevention of vascular disease: collaborative meta-analysis of individual participant data from randomised trials. Lancet. 2009 May 30;373(9678):1849-60. doi: 10.1016/S0140-6736(09)60503-1. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |