Coronary Angiography
Conditions
Keywords
Bifurcations, Drug eluting-stents, Provisional stenting
Brief summary
Percutaneous treatment of bifurcation lesion is a complex procedure. After main vessel stent implantation, the side branch became jailed and the carina can be displaced resulting in complete occlusion of this vessel. Re-wiring the side branch in this conditions may result difficult and some times impossible. There is no agreement regarding the need of side branch pre-dilation (before main vessel stent implantation) to reduce these complications. Researchers from European Bifurcation Club have proposed no to pre-dilate the side branch to avoid vessel dissection and difficulties in rewiring the true lumen of the vessel. On the contrary, our group has a good experience in the treatment of bifurcation lesions treated with side branch pre-dilation. Aims: 1.- To determine the efficacy of the side-branch pre-dilation in patients with bifurcations lesions treated with provisional T stenting. 2.- To determine the success rate and incidence of complications in patients with and without side-branch pre-dilation, as well as economic impact in terms of number of used wires.
Detailed description
Introduction: Percutaneous treatment of bifurcation lesion is a complex procedure. After main vessel stent implantation, the side branch became jailed and the carina can be displaced resulting in complete occlusion of this vessel. Re-wiring the side branch in this conditions may result difficult and some times impossible. There is no agreement regarding the need of side branch pre-dilation (before main vessel stent implantation) to reduce these complications. Researchers from European Bifurcation Club have proposed no to pre-dilate the side branch to avoid vessel dissection and difficulties in rewiring the true lumen of the vessel. On the contrary, our group has a good experience in the treatment of bifurcation lesions treated with side branch pre-dilation. Aims: 1.- To determine the efficacy of the side-branch pre-dilation in patients with bifurcations lesions treated with provisional T stenting. 2.- To determine the success rate and incidence of complications in patients with and without side-branch pre-dilation, as well as economic impact in terms of number of used wires. Design: Prospective and randomized study. Patients and methods: The series is constituted by 420 patients with bifurcations lesions that will be treated with drug-eluting stents; 210 patients will be treated with side branch pre-dilation before main vessels stent implantation, while the remaining 210 patients will be randomized to no pre-dilation of the side-branch. Primary end point: * TIMI flow at Side Branch after main vessel stent implantation. Secondary end points: * Time of re-wiring. * Number of used wires. * % of stenosis at Side Branch. * Levels of CK and TpI after the procedure. * Related cardiac events at 9 months. Relevance: Currently there has been controversy over the use of the side branch pre-dilation in patients with bifurcations lesions treated with provisional T-stenting. However, we have no comparative study in the literature.
Interventions
PROCEDUREPre-dilation side branch
Balloon pre-dilation of the side branch to facilitate the ulterior wire access.
Sponsors
Hospital Universitario Reina Sofia de Cordoba
Fundación Pública Andaluza Progreso y Salud
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients with atherosclerotic coronary disease and bifurcation lesions an significant stenosis of the side branch. * Main vessels diameter greater than 2.5 mm in diameter at the operator's visual estimate. * The side branch should exceed 2.25 mm in diameter at the operator's visual estimate. * Patients with damage to the main branch of any length and the side branch lesions smaller than 5 mm in length. * Patients with bifurcation lesions fulfilling the following morphologies of the classification of Medina: 1 1 1, 1 0 1, 0 1 1. * Treatment of bifurcation lesions with previsional drug eluting stents. * Symptoms of stable angina or acute coronary syndrome.
Exclusion criteria
* Contraindication to drug eluting stent implantation. * Cardiogenic shock. * Coexistence of other serious systemic diseases. * Patients in whom it is impossible to guide placement in the side branch before stent implantation in the main vessel. * Patients with bifurcation lesions and side branch less than 2 mm.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Side branch coronary flow after main vessels stent implantation | Immediately after catheterization procedure |
Secondary
| Measure | Time frame |
|---|---|
| Time required for rewiring of the side branch | Inmediately after catheterization procedure |
| Number of used wires | Inmediately after catheterization procedure |
| Levels of markers of myocardial injury (CK and TpI) after the procedure | Immediately after catheterization procedure |
| Related cardiac events at 9 months | Immediately after catheterization procedure |
Countries
Spain
Outcome results
None listed