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Drug-Coated Balloon (DCB) angioplasty is similar to plain old balloon angioplasty procedurally, but there is an anti-proliferative medication paclitaxel coated to the balloon. Treating ISR lesions with the DCB has the theoretical advantage of avoiding multiple stent layers and respecting the vessel anatomy. DCB has shown promising results for the treatment of ISR. Currently, DCB has a Class I indication to treat ISR recommended by European Society of Cardiology guidelines. In addition, some interventional cardiologist has also applied DCB in de novo lesions in their clinical practice.
Bleeding after PCI remains a substantial clinical problem. Bleeding post-PCI increases the risk of adverse outcomes such as death, non-fatal myocardial infarction, and prolongs hospital stay. Clinical data has suggested that major bleeding post-PCI would increase the risk of mortality 5.7-fold. The antiplatelet medications are the major cause of bleeding events post-PCI.
Current guidelines for stents recommended DAPT of aspirin plus a P2Y12 inhibitor for at least 12 months after stent implantation in patients with the acute coronary syndrome. Compared with the DES, because of the absence of metal inside the coronary artery, the use of DCB might theoretically allow shorter duration antiplatelet therapy. However, the optimal course of DAPT for the DCB treated patients remains controversial.
In 2013, the consensus from the German group suggested that for the acute coronary syndrome, DAPT should be used for 12 months. The consensus of DAPT developed by the European Society of Cardiology (ESC) in 2017 stated that "in patients treated with DCB, dedicated clinical trials investigating the optimal duration of DAPT are lacking." So far, there are no randomized data showing the optimal DAPT duration for the DCB treated patients.
In the current study, we use Aspirin + Ticagrelor for 1-month followed by Ticagrelor monotherapy for 5-month, afterward, Aspirin monotherapy for 6 months to be the antiplatelet regimen in the experimental arm, to compare with the Reference arm, which is Aspirin + Ticagrelor for 12-month in a non-inferiority statistical assumption, aiming to investigate the optimal duration of the DAPT in ACS patients after DCB treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm | Experimental | 1-month of Aspirin + Ticagrelor, followed by 5-month of Ticagrelor monotherapy; Afterward, Aspirin monotherapy for 6 months |
|
| Reference arm | Active Comparator | 12-month Aspirin plus Ticagrelor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin 100mg for 1-month (immediately after PCI) | Drug | Aspirin for 1-month immediately after PCI to be a part of medication treatment in the Experimental arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Net adverse clinical events (NACE) | NACE is a composite clinical endpoint of all-cause death, any stroke, any MI, any revascularization and BARC type 3 or 5 bleeding events | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Any ischemic or bleeding event | Any ischemic and bleeding event includes any all-cause death, any stroke, MI, BARC-defined type 3 bleeding, any revascularization and BARC-defined type 2 bleeding events | 1, 6 and 12 months |
| BARC type 3 or 5 bleeding events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ling Tao, MD,PHD | Xijing Hospital | Study Chair |
| Patrick Serruys, MD,PHD | National University of Ireland, Galway | Study Chair |
| Yoshinobu Onuma, MD,PHD | National University of Ireland, Galway | Study Chair |
| Chao Gao, MD,PHD | Xijing Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ling Tao | Xi'an | Shannxi | 710032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40164448 | Derived | Gao C, Zhu B, Ouyang F, Wen S, Xu Y, Jia W, Yang P, He Y, Zhong Y, Zhou Y, Guo Z, Shen G, Ma L, Xu L, Xue Y, Hu T, Wang Q, Liu Y, Zhang R, Liu J, Jiang Z, Xia J, Garg S, van Geuns RJ, Capodanno D, Onuma Y, Wang D, Serruys P, Tao L; REC-CAGEFREE II Investigators. Stepwise dual antiplatelet therapy de-escalation in patients after drug coated balloon angioplasty (REC-CAGEFREE II): multicentre, randomised, open label, assessor blind, non-inferiority trial. BMJ. 2025 Mar 31;388:e082945. doi: 10.1136/bmj-2024-082945. | |
| 38245724 |
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| Ticagrelor 90mg for 6-month (immediately after PCI) | Drug | Ticagrelor for 6-month immediately after PCI to be a part of medication treatment in the Experimental arm |
|
| Aspirin 100mg for 6-month (6-month post PCI) | Drug | Aspirin for 6-month at 6 months post-PCI (after the discontinuation of the 6-month Ticagrelor treatment) to be a part of medication treatment in the Experimental arm |
|
| Aspirin 100mg for 12-month (immediately after PCI) | Drug | Aspirin for 12-month immediately after PCI to be a part of medication treatment in the Reference arm |
|
| Ticagrelor 90mg for 12-month (immediately after PCI) | Drug | Ticagrelor for 12-month immediately after PCI to be a part of medication treatment in the Reference arm |
|
Bleeding events type 3 or 5 defined by BARC (Bleeding Academic Research Consortium) criteria |
| 1, 6 and 12 months |
| BARC type 2 ,3 or 5 bleeding events | Bleeding events type 2, 3 or 5 defined by BARC (Bleeding Academic Research Consortium) criteria | 1, 6 and 12 months |
| BARC defined type 2 bleeding events | Bleeding events type 2 defined by BARC (Bleeding Academic Research Consortium) criteria | 1, 6 and 12 months |
| Rate of NACE | NACE is a composite clinical endpoint of all-cause death, any stroke, any MI, any revascularization and BARC type 3 or 5 bleeding events | 1 and 6 months |
| Device-oriented Composite Endpoint (DoCE) | DoCE is a composite clinical endpoint of cardiac cause death, target vessel myocardial infraction (TV-MI), and Clinically individual target lesion revascularization (CI-TLR) | 1, 6 and 12 months |
| Cardiac death | Rates of individual components of DoCE | 1, 6 and 12 months |
| Target vessel myocardial infraction (TV-MI) | Rates of individual components of DoCE | 1, 6 and 12 months |
| Clinically individual target lesion revascularization (CI-TLR) | Rates of individual components of DoCE | 1, 6 and 12 months |
| Patient-oriented Composite Endpoint (PoCE) | The primary safety endpoint of PoCE is defined as all-cause death, any stroke, any MI, any revascularization | 1, 6 and 12 months |
| All-cause death | Rates of individual components of PoCE | 1, 6 and 12 months |
| Any MI | Rates of individual components of PoCE | 1, 6 and 12 months |
| Any stroke | Rates of individual components of PoCE | 1, 6 and 12 months |
| Any revascularization | Rates of individual components of PoCE | 1, 6 and 12 months |
| Target vessel failure (TVF) | Target vessel failure is defined as cardiovascular death, target vessel myocardial infraction (TV-MI), and clinically-indicated target vessel revascularization | 1, 6 and 12 months |
| Clinically-indicated target vessel revascularization | Rates of individual components of TVF | 1, 6 and 12 months |
| Definite/Probable stent thrombosis rates | 1, 6 and 12 months |
| Derived |
| Gao C, Zhu B, Liu J, Jiang Z, Hu T, Wang Q, Liu Y, Yuan M, Li F, Zhang R, Xia J, Onuma Y, Wang D, Serruys P, Tao L; REC-CAGEFREE II Study Group. Randomized evaluation of 5-month Ticagrelor monotherapy after 1-month dual-antiplatelet therapy in patients with acute coronary syndrome treated with drug-coated balloons: REC-CAGEFREE II trial rationale and design. BMC Cardiovasc Disord. 2024 Jan 20;24(1):62. doi: 10.1186/s12872-024-03709-1. |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| D000077486 | Ticagrelor |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
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