Timing of Anticoagulant Administration During Radial Access Percutaneous Coronary Intervention: the HERA-PCI Study (Heparin Early for Radial Access Percutaneous Coronary Intervention)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 550
- 试验地点
- 2
- 主要终点
- Rate of radial artery occlusion
研究概览
简要总结
While the reduced hemorrhagic risk of radial access for percutaneous coronary intervention compared to femoral access is well-established, its main complication remains radial artery occlusion, which can occur in up to 30% of patients. Anticoagulation is the primary preventive measure recommended in clinical practice to reduce the risk of this complication, typically involving heparin injection during the procedure in most centers. However, data on the effect of the timing of heparin injection are limited. The investigators hypothesize that injection of heparin before sheath insertion may reduce the rate of radial artery occlusion compared with injection after sheath insertion.
详细描述
Prevention of radial occlusion relies on optimal hemostasis and anticoagulation. Previous studies have demonstrated a decrease incidence of radial artery occlusion through hemostasis at the puncture site using short-duration mechanical compression methods, guided by mean arterial pressure measurement, or clinical tests evaluating hand vascularization. Anticoagulation plays a central role in the prevention of radial occlusion. It is currently recommended to administer a systemic anticoagulant during a procedure using radial access. Despite the lack of consensus on the nature of the anticoagulant, an international survey showed that more than 90% of interventional cardiologists use unfractionated heparin. The intensity of anticoagulation is also associated with the risk of radial artery occlusion, with previous studies showing that the risk is reduced with the use of "high doses" (5000 IU or 75 IU/kg) compared to "low doses" (<5000 IU or <50 IU/kg). A randomized controlled trial did not show any difference between intravenous and intra-arterial heparin injection via the sheath. No studies have examined the timing of anticoagulant administration relative to sheath insertion. In current practice, anticoagulant administration is typically done after sheath insertion in the radial artery. This common practice likely stems from historical concerns about conversion to femoral access (which is now rare due to improved devices for radial puncture and less consequential due to vascular closure systems used in femoral access, significantly reducing hemorrhagic risk).
No data is currently available on the optimal timing of anticoagulant administration, despite the potential modification of its local effect if the sheath is already in place in the radial artery during the anticoagulant injection, obstructing the radial artery lumen. Our hypothesis is that intravenous anticoagulant administration before sheath insertion in the radial artery is more effective than administration after sheath insertion in patients undergoing percutaneous coronary intervention via radial access. The expected outcomes include a reduction in the incidence of radial artery occlusion after the procedure, leading to a decrease in potential complications (acute hand ischemia, failure of the access route during a subsequent procedure, inability to create an ipsilateral arteriovenous fistula).
The primary objective is to evaluate the impact of the timing (early or late) of intravenous anticoagulant administration on the risk of radial occlusion during a percutaneous coronary intervention via radial access.
This is a single-center, comparative, randomized, single-blind study with blinded evaluation of the primary endpoint.
After providing information and verifying eligibility criteria, the investigator will obtain the patient's free, informed, and written consent before any intervention, on the day the coronary angiography is scheduled. Consent will be obtained in the patient's hospital room (Cardiology Day Hospital or conventional hospitalization unit).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •Patients having 18 years old or older, regardless of gender, undergoing percutaneous radial coronary intervention
- •Subject affiliated to a social protection health insurance
- •Subject able to understand the objectives and risks of the research and to provide dated and signed consent
- •Subject who has been informed of the results of the preliminary medical examination
排除标准
- •Contraindication to the use of heparin (history of heparin-induced thrombocytopenia)
- •Very high bleeding risk defined by recent bleeding (<6 months) of type 3 of the BARC classification
- •Subject in an exclusion period (determined by a previous or ongoing study)
- •Inability to give the subject enlightened information (subject in an emergency situation, difficulties in understanding the subject, etc.)
- •Subject under safeguard of justice
- •Subject under guardianship or curatorship
- •Pregnancy
- •Breastfeeding
- •Patient on anticoagulant treatment: anti-vitamin K, direct oral anticoagulants (DOACs).
研究组 & 干预措施
"heparin delayed injection"
Administration of heparin after sheath insertion
干预措施: Administration of heparin after sheath insertion (Procedure)
heparin early injection
Administration of heparin prior to sheath insertion
干预措施: Administration of heparin prior to sheath insertion (Procedure)
结局指标
主要结局
Rate of radial artery occlusion
时间窗: Day 1
The primary endpoint is the rate of radial artery occlusion, as determined by Doppler ultrasound at day 1.
次要结局
- Rate of symptomatic radial artery occlusion (acute hand ischemia) on day 1(Day1)
- Major cardiovascular events within the first 30 days following the percutaneous coronary intervention: cardiovascular death, myocardial infarction, and stroke.(Day 30)
- Local and general hemorrhagic events(Day 30)
- Rate of radial puncture failure.(Day 0)
- Rate of all-cause mortality on day 30.(Day 30)
