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 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
124
Optimal stent expansion by IVUS-guided PCI.
La Paz University Hospital
Madrid, Spain
RECRUITINGThe 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.
Time frame: Periprocedural and 30 days after the procedure
The healthcare cost analysis between elective atherectomy and conventional atherectomy (bailout)
During follow-up 5 years.
Time frame: Follow-up 5 years.
Contrast-induced nephropathy
Contrast-induced nephropathy 48 hours after the procedure.
Time frame: 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
Time frame: 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.
Time frame: Periprocedural
Procedure and fluoroscopy times
Measured in minutes
Time frame: 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
Time frame: Periprocedural
In-hospital complications
Target lesion revascularization, target vessel revascularization, non-target vessel revascularization, stent thrombosis, vascular complications, and death
Time frame: during hospitalization stay until discharge
Major cardiovascular events
Death, myocardial infarction, target lesion revascularization, target vessel revascularization, and non-target vessel revascularization
Time frame: 1,2,3,4 and 5 years after procedure
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