Chronic Renal Failure, Coronary Artery Disease
Conditions
Keywords
Severely calcified coronary lesion, Rotational atherectomy, Chronic kidney disease, Intravascular ultrasound, Percutaneous coronary intervention
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.
Interventions
DEVICEPercutaneous coronary intervention (PCI)
Optimal stent expansion by IVUS-guided PCI.
Sponsors
Guillermo Galeote; MD, PhD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| The healthcare cost analysis between elective atherectomy and conventional atherectomy (bailout) | Follow-up 5 years. | During follow-up 5 years. |
| 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 |
| In-hospital complications | during hospitalization stay until discharge | Target lesion revascularization, target vessel revascularization, non-target vessel revascularization, stent thrombosis, vascular complications, and death |
| 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 |
| Procedure and fluoroscopy times | Periprocedural | Measured in minutes |
Countries
Spain
Contacts
Primary ContactGuillermo Galeote, PhD, MD
Backup ContactArtemio García-Escobar, MD
Outcome results
None listed