Clinical trial NCT00325884: Long-term Outcomes of Patients After Coronary Bifurcation Stenting
Official title: Long-term Outcomes of Patients After Coronary Bifurcation Stenting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Death
Myocardial Infarction
Keywords: coronary artery disease
bifurcation lesions
percutaneous interventions
stenting
outcomes
death
myocardial infarction
Lead sponsor: VA Boston Healthcare System
Sponsor class: FED
First posted: 2006-05-15
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient receiving drug eluting or bare metal coronary stents for coronary bifurcation lesions

Brief summary: The purpose of this study is to assess the long-term clinical outcomes after stenting bifurcation coronary artery lesions, and to determine whether simple or more complex techniques are associated with a better clinical outcome. We will also assess the risk factors associated with poorer clinical outcomes

Detailed description: Coronary artery disease affecting the branch points of coronary arteries (bifurcation lesions) has a higher rate of restenosis after angioplasty than disease in regions not involving branch points. Post-procedural angiographic outcomes and in-hospital outcomes have been documented for a variety of techniques, but none have examined the long-term clinical outcomes.

Long-term clinical outcomes are important from the patients point of view and also determine the use of resources. Knowledge of the long-term outcomes from the various techniques used to treat bifurcation lesions would be important in determining guidelines for the treatment of bifurcation lesions. If simple techniques offer similar or better outcomes than more complex strategies, then this would justify simpler techniques such as main vessel stenting that would use less resources, expose the patient to less radiation, and contrast related to prolonged angioplasty procedures.

Comparisons: We will compare the long-term outcomes of simple versus complex stent techniques, and determine other risk factors for long-term outcome

Eligibility criteria: Inclusion Criteria:

* de novo coronary artery lesion in a main branch with at least a 50% stenosis
* lesions involve the ostium of a side branch artery
* main branch and side branch with reference diameters of at least 2mm
* at least one stent used to treat the lesion

Exclusion Criteria:

* restenosis lesions
* reference side branch artery less than 2mm diameter
* multiple bifurcation lesions

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: West Roxbury
country: United States
facility: VA Boston Healthcare System
state: Massachusetts
Study officials:
affiliation: VA Boston Healthcare System
name: Scott Kinlay, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zamani P, Kinlay S. Relationship of side-branch intervention and drug-eluting stents to long-term outcomes after coronary bifurcation stenting. J Am Coll Cardiol 2008; 51(suppl B): B50-B51
citation: Zamani P, Kinlay S. Long-term risk of clinical events from stenting side branches of coronary bifurcation lesions with drug-eluting and bare-metal stents: an observational meta-analysis. Catheter Cardiovasc Interv. 2011 Feb 1;77(2):202-12. doi: 10.1002/ccd.22750.