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

Guillermo Galeote; MD, PhD

Status: Unknown

Conditions: Coronary Artery Disease; Chronic Renal Failure

Treatments: Device: Percutaneous coronary intervention (PCI)

Study type: Interventional

Funder types: Other

Identifiers

NCT05353946

00001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 124 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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124 participants in 2 patient groups

Elective Rotational Atherectomy

Active Comparator group

Description:

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.

Treatment:

Device: Percutaneous coronary intervention (PCI)

Bailout Rotational Atherectomy

Active Comparator group

Description:

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.

Treatment:

Device: Percutaneous coronary intervention (PCI)