A Prospective Cohort Study of PCI Strategies for Severely Calcified Lesions of Complex Coronary Arteries in the Elderly

Study Overview
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Brief Summary
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The aim of this observational study is to compare the prognostic outcomes of various PCI strategies in elderly patients with complex coronary calcified lesions. The patients will be classified into two groups and assigned different PCI strategies, either stenting or stenting combined with pharmacologic balloon implantation. The investigators will assess the one-year prognosis for major adverse cardiovascular events in these patients.

Official Title
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A Prospective Cohort Study of PCI Strategies for Severely Calcified Lesions of Complex Coronary Arteries in the Elderly

Conditions
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Coronary Heart Disease

Intervention / Treatment
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* Device: DES
* Device: DCB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 60 years; Meet the indications for coronary intervention; IVUS examination suggests severe calcified lesions (calcification angle >270°) or OCT examination suggests severe calcified lesions (calcification angle >180° and/or length >5mm and/or thickness >0.5mm); The diameter of the target lesion vessel is greater than 2.75mm; The total length of the lesion is more than 60mm and/or the number of lesions to be treated is ≥3 and/or the number of vessels to be treated is ≥2. Exclusion Criteria: inability to provide written informed consent; inability to administer antiplatelet agents and anticoagulant therapy; the subject is participating in other unfinished clinical trials; life expectancy <1 year; non-in situ vascular lesions; patients with haemodynamic instability; Previous stroke within 6 months. left main stem lesions.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DES Group<br>All lesions in these patients were treated with DES | Device: DES<br>* drug eluting stent<br>|
| DES+DCB Group<br>These patients were treated using a combination of DES and DCB | Device: DES<br>* drug eluting stent<br>Device: DCB<br>* drug-coated balloon<br>|
| DCB Group<br>All lesions in these patients were treated with DCB | Device: DCB<br>* drug-coated balloon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACEs | A Composite Event Including Cardiac Death, Myocardial Infarction, Stroke, and Target Vessel Revascularization | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Death | Cardiac Death | 12 months | 
| Myocardial Infarction | Myocardial Infarction | 12 months | 
| Target Vessel Revascularization | Target Vessel Revascularization | 12 months | 
| Stroke | Stroke | 12 months | 
| BRCA 2,3-5 | BRCA 2,3-5 | 12 months |