Treatment Of Coronary Bifurcation Lesions: Stentcovering Of The Side Branch With And Without PCI Of The Side Branch: A Retrospective Analysis Of All Consecutive Patients

This retrospective observational study included patients (pts) with percutaneous coronary intervention (PCI) of a de novo coronary bifurcation lesion in one German center between January 2008 - August 2011. The investigators included all consecutive patients where the side branch was covered with a stent. Patients with ACS/cardiogenic shock were not excluded.

Two different methods were compared: group A represents patients with a simple strategy without any treatment of the side branch (SB). Group B consisted of patients where the SB was treated (PCI and/or stenting).

For the treatment of bifurcation lesions we used the concept of "provisional stenting", indications for the treatment of the SB were residual stenosis > 50 %, TIMI flow reduction < 2. Final-kissing PCI was intended in all patients of group B.

MACE during follow-up was evaluated in all patients.

Study Overview

• Status: Completed
• Conditions: Coronary Bifurcation Lesions

• Study Type: Observational
• Enrollment (Actual): 98

Contacts and Locations

Study Locations

• Germany
  • Rheinland-Pfalz
    • Neustadt/Weinstrasse, Rheinland-Pfalz, Germany, 67434
      • Hetzelstift

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

This retrospective observational study included patients (pts) with PCI of a de novo coronary bifurcation lesion in one German center between January 2008 - August 2011. We included all consecutive patients where the side branch was covered with a stent. Patients with ACS/cardiogenic shock were not excluded.

Description

Inclusion Criteria:

• All consecutive patients with a bifurcation lesion, where the side branch was covered with a stent placed inside the main branch.

Exclusion Criteria:

• Patients with an in-stent-restenosis, patients with a therapy using a drug coated balloon during the procedure (inside the main branch and/or the side branch) and patients where the side branch was not covered by the stent inside the main branch.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
PCI without treating the side branch
PCI with treating the side branch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Major adverse cardiac outcome	12 months

Collaborators and Investigators

• Sponsor: Krankenhaus Hetzelstift

Publications and helpful links

General Publications

• von Korn H, Stefan V, van Ewijk R, Chakraborty K, Sanwald B, Andel R, Hemker J, Hink U, Ohlow M, Lauer B, Muenzel T. Treatment of coronary bifurcation lesions: stent-covering of the side branch with and without PCI of the side branch: a retrospective analysis of all consecutive patients. BMC Cardiovasc Disord. 2013 Apr 4;13:27. doi: 10.1186/1471-2261-13-27.

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (ACTUAL): August 1, 2011
• Study Completion (ACTUAL): February 1, 2012

Study Registration Dates

• First Submitted: February 17, 2012
• First Submitted That Met QC Criteria: February 23, 2012
• First Posted (ESTIMATE): February 24, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): February 24, 2012
• Last Update Submitted That Met QC Criteria: February 23, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Coronary intervention; PCI of the side branch
• Other Study ID Numbers: Hetzel01