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Investigators try to assess the safety of 6-months or 12-months maintenance of dual antiplatelet therapy (DAPT, aspirin + clopidogrel) in patients undergoing percutaneous coronary intervention using the Zotarolimus-eluting, Resolute Integrityâ„¢ stent (Medtronic Vascular Inc, Santa Rosa, CA) or the BioMatrixâ„¢ stent (Biosensors. Singapore).
Dual antiplatelet therapy (DAPT) has proven the most effective treatment in reducing thrombotic complications after drug eluting stent (DES) implantation. Although the optimal duration of antiplatelet therapy is still under investigation, late stent thrombosis (ST) with DES has pushed the recommendation for duration of clopidogrel therapy for one year or more, in patients without risks for bleeding. However, recent controversies regarding the risk of stent thrombosis in patients receiving DES has brought up the issue of the appropriate duration of antiplatelet therapy after percutaneous coronary intervention, and a recent study reported that the use of extended DAPT for a period longer than 12 months in patients who had received DES was not significantly more effective than aspirin monotherapy in reducing the rate of myocardial infarction (MI) or death for cardiac causes.
Zotarolimus-eluting stent (Resolute Integrityâ„¢) and biolimus-eluting stent with biodegradable polymer system (BioMatrixâ„¢) share several similarities. Both stents are flexible thin strut stents eluting sirolimus-analogue drugs targeting at mammalian target of rapamycin. The advantages that Resolute Integrityâ„¢ stent strut is quite thin and coated with highly biocompatible polymer and BioMatrixâ„¢ stent has the abluminal drug coating system with biodegradable polymer might provide clinical studies showing that both stents are quite safe as well as efficacious. Moreover, recent report showed that continuation of clopidogrel for only 3 months after implantation of Endeavor stent seems to be safe in low-to-moderate coronary artery risk group. Based on these clinical evidences, the duration of DAPT continuation for 12 months or less after implantation of Resolute Integrityâ„¢ or BioMatrixâ„¢ stent, 'the second generation DES', would be safe, however, there are no data available about this. Therefore, the purpose of this study is to assess the safety of 6-months or 12-months maintenance of DAPT in patients undergoing percutaneous coronary intervention (PCI) using Resolute Integrityâ„¢ or BioMatrixâ„¢ stent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 6-month dual anti-platelet therapy | Experimental | maintain dual anti-platelet agents for 6 months |
|
| 12-month dual anti-platelet therapy | Active Comparator | maintain dual anti-platelet agents for 12 months |
|
| Zotarolimus eluting stent arm | Active Comparator | implant with zotarolimus eluting stent (Resolute Integrity) |
|
| Biolimus eluting stent arm | Active Comparator | implant with biolimus eluting stent (Biomatrix) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 6-month dual anti-platelet therapy | Drug | Aspirin and P2Y12 inhibitor after percutaneous coronary intervention continues for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| A composite of major adverse cardiac events (MACE; cardiac death, target vessel MI and ischemia driven-target lesion revascularization; TLR) |
| 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hyuck moon Kwon | Gangnam Severance Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32588238 | Derived | Jang JY, Jung HW, Lee BK, Shin DH, Kim JS, Hong SJ, Ahn CM, Kim BK, Ko YG, Choi D, Hong MK, Park KW, Gwon HC, Kim HS, Kwon HM, Jang Y. Impact of PRECISE-DAPT and DAPT Scores on Dual Antiplatelet Therapy Duration After 2nd Generation Drug-Eluting Stent Implantation. Cardiovasc Drugs Ther. 2021 Apr;35(2):343-352. doi: 10.1007/s10557-020-07008-7. |
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If PI and scientific committee approve to share individual participant data to other researchers.
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| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000080903 | Dual Anti-Platelet Therapy |
| D001241 | Aspirin |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D004359 | Drug Therapy, Combination |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D012459 | Salicylates |
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|
| 12-month dual anti-platelet therapy | Drug | Aspirin and P2Y12 inhibitor after percutaneous coronary intervention continues for 12 months |
|
|
| Zotarolimus eluting stent | Device | Zotarolimus eluting stent is applied to coronary stenotic lesion |
|
| Biolimus eluting stent | Device | Biolimus eluting stent is applied to coronary stenotic lesion |
|
| D062385 |
| Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |