RecruitingPhase 4NCT05984537

A Study on the Impact of Bivalirudin Usage During PCI for High-risk Plaques on Post-PCI Coronary Microcirculation.

A Study on the Impact of Bivalirudin Usage During Percutaneous Coronary Intervention for High-risk Plaques in the Coronary Artery on Post Percutaneous Coronary Intervention Coronary Microcirculation.

Sponsor

Peking University First Hospital

Enrollment

70 participants

Start Date

Jul 1, 2023

Study Type

INTERVENTIONAL

Conditions

Coronary Microvascular Dysfunction

Summary

In this study, investigators enrolled patients with coronary heart disease who were scheduled to undergo percutaneous coronary intervention (PCI) and had high-risk plaques according to computed tomography angiography (CTA). During the PCI procedure, patients will be randomly assigned to receive either bivalirudin or standard heparin anticoagulation therapy. Investigators will compare the post-PCI coronary angiography-derived index of microcirculatory resistance (CaIMR), thrombolysis in myocardial infarction (TIMI) blood flow grade, CTFC (corrected TIMI frame count), TIMI myocardial perfusion grading(TMPG), levels of troponin, and major adverse cardiac events (MACE) during a follow-up period of 6 months between the two groups. Investigators aim to explore the potential benefits of bivalirudin perioperative anticoagulation therapy in improving coronary microvascular dysfunction (CMD) after PCI for high-risk plaques in coronary artery lesions.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

aged 18 years or older;
diagnosed with non-ST-segment elevation myocardial infarction or unstable angina pectoris;
scheduled to undergo elective coronary angiography and intervention;
coronary computed tomography angiography showing high-risk plaque features within 3 months prior to the procedure;
voluntary participation in the study and signed informed consent.

Exclusion Criteria8

prior PCI of the target vessel within 3 months;
cardiogenic shock, active bleeding, bleeding disorders, irreversible coagulation dysfunction, severe liver dysfunction (Child-Pugh class C), severe renal dysfunction (eGFR \< 30 ml/min/1.73m2), and dependence on dialysis;
life expectancy less than 1 year;
chronic total occlusion of the target vessel;
poor opacification of the target vessel, severe vessel overlap or distortion, and inability to completely expose the lesion site;
allergy to contrast agents, verapamil, or its excipients;
severe uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg);
subacute bacterial endocarditis.

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Interventions

DRUGBivalirudin

Participants in the bivalirudin group received a one-time intravenous injection of 0.75 mg/kg during PCI, and then received a continuous intravenous infusion of 1.75 mg/kg/h for 4 hours according to the participants' condition after PCI.

DRUGstandard heparin

Participants in the standard heparin group received a one-time intravenous injection of 50 U/kg of standard heparin during PCI.