Clinical trial NCT01090856: Predilation of Side Branch During Percutaneous Treatment of Bifurcation Lesions With Provisional T Stenting
Official title: Predilation of Side Branch During Percutaneous Treatment of Bifurcation Lesions With Provisional T Stenting.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Angiography
Keywords: Bifurcations
Drug eluting-stents
Provisional stenting
Lead sponsor: Andalusian Network for Design and Translation of Advanced Therapies
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Reina Sofia de Cordoba
First posted: 2010-03-23
Enrollment: 420
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Side branch coronary flow after main vessels stent implantation
timeFrame: Immediately after catheterization procedure
Secondary outcomes:
measure: Time required for rewiring of the side branch
timeFrame: Inmediately after catheterization procedure
measure: Number of used wires
timeFrame: Inmediately after catheterization procedure
measure: Levels of markers of myocardial injury (CK and TpI) after the procedure
timeFrame: Immediately after catheterization procedure
measure: Related cardiac events at 9 months
timeFrame: Immediately after catheterization procedure
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
Study officials:
affiliation: Hospital Universitario Reina Sofia de Cordoba
name: Manuel Pan Alvarez-Osorio, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pan M, Medina A, Suarez de Lezo J, Romero M, Melian F, Pavlovic D, Hernandez E, Segura J, Marrero J, Torres F, et al. Follow-up patency of side branches covered by intracoronary Palmaz-Schatz stent. Am Heart J. 1995 Mar;129(3):436-40. doi: 10.1016/0002-8703(95)90264-3.
citation: Pan M, Suarez de Lezo J, Medina A, Romero M, Hernandez E, Segura J, Castroviejo JR, Pavlovic D, Melian F, Ramirez A, Castillo JC. Simple and complex stent strategies for bifurcated coronary arterial stenosis involving the side branch origin. Am J Cardiol. 1999 May 1;83(9):1320-5. doi: 10.1016/s0002-9149(99)00093-4.
citation: Pan M, Suarez de Lezo J, Medina A, Romero M, Segura J, Ramirez A, Pavlovic D, Hernandez E, Ojeda S, Adamuz C. A stepwise strategy for the stent treatment of bifurcated coronary lesions. Catheter Cardiovasc Interv. 2002 Jan;55(1):50-7. doi: 10.1002/ccd.10057.
citation: Pan M, de Lezo JS, Medina A, Romero M, Segura J, Pavlovic D, Delgado A, Ojeda S, Melian F, Herrador J, Urena I, Burgos L. Rapamycin-eluting stents for the treatment of bifurcated coronary lesions: a randomized comparison of a simple versus complex strategy. Am Heart J. 2004 Nov;148(5):857-64. doi: 10.1016/j.ahj.2004.05.029.
citation: Pan M, Suarez de Lezo J, Medina A, Romero M, Delgado A, Segura J, Ojeda S, Pavlovic D, Ariza J, Fernandez-Duenas J, Herrador J, Urena I. [Six-month intravascular ultrasound follow-up of coronary bifurcation lesions treated with rapamycin-eluting stents: technical considerations]. Rev Esp Cardiol. 2005 Nov;58(11):1278-86. Spanish.
citation: de Lezo JS, Medina A, Pan M, Delgado A, Segura J, Pavlovic D, Melian F, Romero M, Burgos L, Hernandez E, Urena I, Herrador J. Rapamycin-eluting stents for the treatment of unprotected left main coronary disease. Am Heart J. 2004 Sep;148(3):481-5. doi: 10.1016/j.ahj.2004.03.011.
citation: Medina A, Suarez de Lezo J, Pan M. [A new classification of coronary bifurcation lesions]. Rev Esp Cardiol. 2006 Feb;59(2):183. No abstract available. Spanish.
citation: Pan M, Suarez de Lezo J, Medina A, Romero M, Delgado A, Segura J, Ojeda S, Mazuelos F, Hernandez E, Melian F, Pavlovic D, Esteban F, Herrador J. Drug-eluting stents for the treatment of bifurcation lesions: a randomized comparison between paclitaxel and sirolimus stents. Am Heart J. 2007 Jan;153(1):15.e1-7. doi: 10.1016/j.ahj.2006.10.017.
citation: Pan M, Medina A, Romero M, Ojeda S, Martin P, Suarez de Lezo J, Segura J, Mazuelos F, Novoa J, Suarez de Lezo J. Assessment of side branch predilation before a provisional T-stent strategy for bifurcation lesions. A randomized trial. Am Heart J. 2014 Sep;168(3):374-80. doi: 10.1016/j.ahj.2014.05.014. Epub 2014 Jun 6.