Predilation of Side Branch During Percutaneous Treatment of Bifurcation Lesions With Provisional T Stenting

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.

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.

Eligibility Criteria:
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.