Randomized 2x2 Factorial Trial Comparing the Cre8 Amphilimus-sirolimus Eluting Stent vs. the Synergy Everolimus-eluting Stent and a Personalized vs. Standard Duration of Dual Antiplatelet Therapy in All-comers Patients Undergoing Percutaneous Coronary Intervention
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,106
- 试验地点
- 13
- 主要终点
- Number of Participants with Device-oriented composite endpoint (DOCE) for the comparison between the Cre8 AES and the Synergy EES.
研究概览
简要总结
New-generation metallic drug-eluting stents represent the standard of care among patients undergoing percutaneous coronary intervention (PCI). Currently, few data are available as regards to the safety and efficacy of the Cre8 amphilimus-eluting stent (Cre8 AES, Alvimedica, Instanbul, Turkey) in comparison with the biodegradable polymer everolimus-eluting stent (Synergy EES, Boston Scientific, Marlborough, MA, USA). Results from randomized trials and meta-analyses consistently indicate that prolonged dual antiplatelet therapy (DAPT) after PCI reduces ischemic events, but invariably conveys an excess of clinically relevant bleeding, which is proportional to the duration of treatment. It has been estimated, indeed, that for every non-fatal ischemic event avoided with prolonged DAPT, two or more clinically relevant bleeding events have to be expected. Given the trade-off between benefits and risks and the lack of mortality benefit in favor of prolonged DAPT, expert consensus suggests that DAPT duration should be individualized based on ischemic versus bleeding risks. At this regard, the DAPT score has been recently proposed as standardized tool to identify patients who derive benefit or lack from a prolonged course of DAPT. However, a prospective assessment of the DAPT score is lacking and whether a personalized duration of DAPT based on the DAPT score improves the net clinical benefit remains unknown.
The objective of the study is to compared the safety and the efficacy of the Cre8 AES with the Synergy EES and a personalized DAPT duration based on the DAPT score with a standard DAPT duration among patients undergoing PCI.
详细描述
The objective of the trial is:
i) to evaluate the efficacy and safety of the Cre8 AES vs. the Synergy EES in a broadly unselected patient population with coronary artery disease undergoing PCI; ii) to compare the safety and efficacy of a personalized DAPT duration (3-, 6-, or 24-month) guided by the application of the DAPT score with a standard DAPT duration (12-month) after PCI.
In particular, the objectives of the trial are to test the following hypothesis:
- The Cre8 AES is non-inferior to the Synergy EES with regards to a device-oriented composite endpoint (DOCE) at 1-year follow-up.
- A personalized DAPT duration based on the DAPT score is superior to a standard DAPT duration with regards to a net adverse clinical endpoint (NACE) at 2-year follow-up.
This is a prospective, randomized, multicenter, investigator-initiated, assessor-blind trial to be conducted at interventional cardiology centers in Italy. Patients undergoing PCI will be randomized in a 2-by-2 randomization fashion to undergo PCI with the Cre8 AES or Synergy EES and to receive a personalized or standard DAPT duration. All patients will be followed at 3-, 6-, 12- and 24-month after PCI for clinical endpoints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years;
- •Clinical evidence of coronary artery disease requiring PCI with DES implantation;
- •Any coronary lesion sized 2.25-4.5 mm by visual estimation.
排除标准
- •Inability to provide informed consent;
- •Active bleeding requiring medical attention (BARC ≥2);
- •Need for chronic oral anticoagulant therapy;
- •Planned surgery within 3 months;
- •Known hypersensitivity or allergy to aspirin or any P2Y12 receptor inhibitor (clopidogrel, prasugrel, ticagrelor), heparin, contrast agent, or any DES-components;
- •Previous treatment with bioresorbable vascular scaffolds;
- •Participation in another study that has not reached the primary endpoint;
- •A life expectancy of less than 24 months;
- •Female of childbearing potential;
- •Under judicial protection, tutorship or curatorship.
研究组 & 干预措施
Cre8 AES and personalized DAPT duration
Percutaneous coronary intervention with implantation of a Cre8 amphilimus- eluting stent for coronary artery disease.
Personalized duration of dual antiplatelet therapy for 3-, 6-, or 24-month after percutaneous coronary intervention based on the DAPT score.
干预措施: Percutaneous coronary intervention with implantation of amphilimus-eluting stents for coronary artery disease. (Device)
Cre8 AES and personalized DAPT duration
Percutaneous coronary intervention with implantation of a Cre8 amphilimus- eluting stent for coronary artery disease.
Personalized duration of dual antiplatelet therapy for 3-, 6-, or 24-month after percutaneous coronary intervention based on the DAPT score.
干预措施: Personalized DAPT duration (Drug)
Cre8 AES and standard DAPT duration
Percutaneous coronary intervention with implantation of a Cre8 amphilimus- eluting stent for coronary artery disease.
Standard duration of dual antiplatelet therapy for 12-month after percutaneous coronary intervention.
干预措施: Percutaneous coronary intervention with implantation of amphilimus-eluting stents for coronary artery disease. (Device)
Cre8 AES and standard DAPT duration
Percutaneous coronary intervention with implantation of a Cre8 amphilimus- eluting stent for coronary artery disease.
Standard duration of dual antiplatelet therapy for 12-month after percutaneous coronary intervention.
干预措施: Standard DAPT duration (Drug)
Synergy EES and personalized DAPT duration
Percutaneous coronary intervention with implantation of a Synergy everolimus-eluting stent for coronary artery disease.
Personalized duration of dual antiplatelet therapy for 3-, 6-, or 24-month after percutaneous coronary intervention based on the DAPT score.
干预措施: Percutaneous coronary intervention with implantation of everolimus-eluting stents for coronary artery disease. (Device)
Synergy EES and personalized DAPT duration
Percutaneous coronary intervention with implantation of a Synergy everolimus-eluting stent for coronary artery disease.
Personalized duration of dual antiplatelet therapy for 3-, 6-, or 24-month after percutaneous coronary intervention based on the DAPT score.
干预措施: Personalized DAPT duration (Drug)
Synergy EES and standard DAPT duration
Percutaneous coronary intervention with implantation of a Synergy everolimus-eluting stent for coronary artery disease.
Standard duration of dual antiplatelet therapy for 12-month after percutaneous coronary intervention.
干预措施: Percutaneous coronary intervention with implantation of everolimus-eluting stents for coronary artery disease. (Device)
Synergy EES and standard DAPT duration
Percutaneous coronary intervention with implantation of a Synergy everolimus-eluting stent for coronary artery disease.
Standard duration of dual antiplatelet therapy for 12-month after percutaneous coronary intervention.
干预措施: Standard DAPT duration (Drug)
结局指标
主要结局
Number of Participants with Device-oriented composite endpoint (DOCE) for the comparison between the Cre8 AES and the Synergy EES.
时间窗: 12 months
The composite of cardiovascular death, myocardial infarction not clearly attributable to a non-target vessel, or clinically-driven target-lesion revascularization.
Number of Participants with Net adverse clinical endpoint (NACE) for the comparison between a personalized and standard DAPT duration.
时间窗: 24 months
The composite of all-cause death, any myocardial infarction, stroke, urgent target-vessel revascularization, or BARC type 2 to 5 bleeding at 24-month follow-up.
次要结局
- Number of Participants with Stroke(12- and 24-month)
- Number of Participants with Myocardial infarction(12- and 24-month)
- Number of Participants with Clinically-driven target-lesion revascularization(12- and 24-month)
- Number of Participants with Death from cardiovascular causes(12- and 24-month)
- Number of Participants with All-cause death(12- and 24-month)
- Number of Participants with Definite or probable stent thrombosis(12- and 24-month)
- Number of Participants with Definite stent thrombosis(12- and 24-month)
- Number of Participants with Any revascularization(12- and 24-month)
- Number of Participants with Clinically-driven target-vessel revascularization(12- and 24-month)
- Number of Participants with Urgent target-vessel revascularization(12- and 24-month)
- Number of Participants with Urgent non-target-vessel revascularization(12- and 24-month)
- Number of Participants with Any target-lesion revascularization(12- and 24-month)
- Number of Participants with Any target-vessel revascularization(12- and 24-month)
- Number of Participants with Bleeding events(12- and 24-month)
研究者
Giovanni Esposito
Professor of Cardiology
Federico II University