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

Study Overview
=================
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.

Official Title
-----------------
CRATER Trial: Coronary Rotational Atherectomy Elective vs. Bailout in Patients With Severely Calcified Lesions and Chronic Renal Failure

Conditions
-----------------
Chronic Renal Failure, Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: Percutaneous coronary intervention (PCI)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Elective Rotational Atherectomy<br>Operators can decide elective use of rotational atherectomy (RA) or conventional angioplasty according to the calcification patterns of the coronary lesion evaluated by Intravascular ultrasound (IVUS) or by angiography if the IVUS cannot cross the lesion. Procedure is performed with a Rotablator system, consisting of a rotating olive-shaped burr whose leading hemisphere is coated with microscopic diamond chips. The proximal end of the device has a housing unit containing the burr advancer, a fiberoptic tachometer cable, an irrigation port, and a nitrogen gas delivery hose, which permits the rapidly rotating of the burr. The RA catheter is introduced into the coronary artery over a stainless steel 0.09-inch wire to cross the lesion, then advanced with a slow pecking motion at a speed of 160,000 to 190,000 rpm with each ablation run <15 seconds is performed. Burr size was with a burr/vessel ratio of 0.7. After RA, all patients received IVUS-guided percutaneous coronary intervention. | Device: Percutaneous coronary intervention (PCI)<br>* Optimal stent expansion by IVUS-guided PCI.<br>|
| Active Comparator: Bailout Rotational Atherectomy<br>The operators began with conventional angioplasty (non-compliant balloon dilatation) regardless of the calcification patterns in the coronary lesion, and rotational atherectomy (RA) can be used only as a bailout. | Device: Percutaneous coronary intervention (PCI)<br>* Optimal stent expansion by IVUS-guided PCI.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The healthcare cost analysis between elective atherectomy and conventional atherectomy (bailout) | 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. | Periprocedural and 30 days after the procedure | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Severely calcified coronary lesion, Rotational atherectomy, Chronic kidney disease, Intravascular ultrasound, Percutaneous coronary intervention