Coronary Rotational Atherectomy Elective vs. Bailout in Severely Calcified Lesions and Chronic Renal Failure

Not Applicable

• Conditions: Chronic Renal Failure; Coronary Artery Disease

• Registration Number: NCT05353946
• Lead Sponsor: Guillermo Galeote; MD, PhD

Brief Summary

The current role of the rotational atherectomy is for non-dilatable coronary lesions and for severely calcified lesions that may interfere with optimal stent expansion.

Severely calcified coronary lesions are associated with worse outcomes. In this regard, chronic kidney disease is associated with severely calcified coronary arteries.

Some evidence suggests that elective rotational atherectomy used by experienced operators can be safe and effective, minimizing time and complications for patients with heavily calcified lesions.

However, there is no direct randomized comparison between rotational atherectomy and angioplasty alone in the setting of chronic renal failure and with intravascular ultrasound assessment for detecting severely calcified coronary arteries.

Detailed Description

The current role of the rotational atherectomy is for non-dilatable coronary lesions and for severely calcified lesions that may interfere with optimal stent expansion.

Severely calcified coronary lesions are associated with worse outcomes. In this regard, chronic kidney disease is associated with severely calcified coronary arteries.

Some evidence suggests that elective rotational atherectomy used by experienced operators can be safe and effective, minimizing time and complications for patients with heavily calcified lesions.

However, there is no direct randomized comparison between rotational atherectomy and angioplasty alone in the setting of chronic renal failure and with intravascular ultrasound assessment for detecting severely calcified coronary arteries.

The aim of this study is to compare the healthcare cost analysis between elective atherectomy and conventional atherectomy (bailout). The secondary endpoints were stent placement success (defined as expansion with \<20% residual stenosis assessed by intravascular ultrasound and TIMI 3 flow without crossover or stent failure), procedure time, radiation exposure, periprocedural and in-hospital complications, and major cardiovascular adverse events at medium-term follow-up.

Study Timeline

• Study Start: 2019-02-02
• Status Verified: 2022-04
• Study First Submitted: 2022-04-06
• Study First Submitted QC: 2022-04-25
• Last Update Submitted: 2022-04-25
• Study First Posted: 2022-04-29
• Last Update Posted: 2022-04-29
• Primary Completion: 2022-12-27
• Study Completion: 2023-12-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

• Patients >18 years.
• Glomerular filtration rate (GFR) <60 mL/min/1.73 m2 for 3 months or more
• Stenosis ≥70% in a coronary artery with a diameter ≥2,5 mm.
• Severe angiographic calcification (affecting both sides of the arterial lumen)
• Any clinical scenario except acute myocardial infarction in the first seven days of evolution.
• Native coronary vessel or bypass graft.

Exclusion Criteria

• Absence of informed consent.
• Acute myocardial infarction in the first 7 days of evolution.
• Lesion in a single patent vessel.
• Calcified lesions with an angulation >60º, dissections, lesions with thrombus, and degenerated saphenous vein grafts.
• Hemodynamically unstable patients
• Patients with allergy to iodinated contrast media
• Patients with significant comorbidity and with a life expectancy of less than one year

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The healthcare cost analysis between elective atherectomy and conventional atherectomy (bailout)	Periprocedural and 30 days after the procedure	The costs included the items, supplies, and time used in the catheterization laboratory, and expenses caused by complications during hospital length of stay and 30 days after the procedure.

Secondary Outcome Measures

Name	Time	Method
Periprocedural complications	Periprocedural	Coronary dissection (NHLBI classification system), coronary perforation (Ellis classification system), no-reflow phenomenon (defined as less than TIMI 3 flow), and side branch occlusion
The amount of angioplasty balloons used in each group before stent deployment.	Periprocedural	Number of semi-compliant and non-compliant balloons used during procedure deployment.
In-hospital complications	during hospitalization stay until discharge	Target lesion revascularization, target vessel revascularization, non-target vessel revascularization, stent thrombosis, vascular complications, and death
The healthcare cost analysis between elective atherectomy and conventional atherectomy (bailout)	Follow-up 5 years.	During follow-up 5 years.
Contrast-induced nephropathy	48 hours after the procedure.	Contrast-induced nephropathy 48 hours after the procedure.
Stent placement success	Periprocedural	Defined as expansion with \<20% residual stenosis assessed by intravascular ultrasound and TIMI 3 flow without crossover or stent failure
Procedure and fluoroscopy times	Periprocedural	Measured in minutes
Major cardiovascular events	1,2,3,4 and 5 years after procedure	Death, myocardial infarction, target lesion revascularization, target vessel revascularization, and non-target vessel revascularization

Trial Locations

Locations (1)

La Paz University Hospital; 🇪🇸 Madrid, Spain