NCT01199419

Brief Summary

The objective of the present study is to analyze the cost-effectiveness of percutaneous coronary intervention (PCI) using TAXUS stents compared to the costs of coronary artery bypass surgery (CABG) in patients with multivessel coronary artery disease (CAD) in the first 5 years and then 10 years after intervention. Multivessel PCI or CABG was performed in 114 or 93 patients, respectively. Clinical outcomes, in terms of incidence of acute myocardial infarction (AMI), all-cause death, target vessel revascularization (TVR) and stroke, resource use and costs are analyzed prospectively over a 5 and 10-year follow-up (FUP) period. Overall costs consist of the baseline costs of the index procedure (PCI or CABG), clinical and angiographic procedure-related treatments during the entire FUP. The primary endpoint is cost-effectiveness and clinical effectiveness, defined as the reduction of the composite of major adverse cardiac and cerebrovascular events (MACCE).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
207

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
6.7 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2010

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

July 18, 2014

Status Verified

July 1, 2014

Enrollment Period

10.5 years

First QC Date

September 9, 2010

Last Update Submit

July 16, 2014

Conditions

Multivessel Coronary Artery Disease

Keywords

multivessel coronary artery diseasedrug-eluting stentCABGcost-effectiveness

Outcome Measures

Primary Outcomes (5)

  • Cost-effectiveness of percutaneous coronary intervention with Taxus stents compared to CABG in patients with multivessel coronary artery disease.

    in-hospital phase (up to 3 weeks)

  • Cost-effectiveness of percutaneous coronary intervention with Taxus stents compared to CABG in patients with multivessel coronary artery disease.

    6 months

  • Cost-effectiveness of percutaneous coronary intervention with Taxus stents compared to CABG in patients with multivessel coronary artery disease.

    12 months

  • Cost-effectiveness of percutaneous coronary intervention with Taxus stents compared to CABG in patients with multivessel coronary artery disease.

    5 years

  • Cost-effectiveness of percutaneous coronary intervention with Taxus stents compared to CABG in patients with multivessel coronary artery disease.

    10 years

Secondary Outcomes (21)

  • Occurrence of MACCE, defined as cardiac death, nonfatal myocardial infarction, target vessel revascularization and stroke

    6 months

  • Rate of target vessel revascularization

    6 months

  • Occurrence of non-fatal acute myocardial infarction

    6 months

  • Occurrence of cardiac death

    6 months

  • Calculation of the total costs

    in-hospital phase (up to 3 weeks)

  • +16 more secondary outcomes

Study Arms (2)

PCI

Procedure: comparison of PCI vs. CABG in multivessel disease

CABG

Procedure: comparison of PCI vs. CABG in multivessel disease

Interventions

comparison of PCI vs. CABG in multivessel diseasePROCEDURE

invasive treatment of coronary artery disease

CABGPCI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients, treated with multivessel disease requiring revascularization were consecutively included in this study.

You may qualify if:

  • two or three-vessel disease requiring percutaneous or surgical multivessel intervention with the aim of complete revascularization
  • age \> 18 years
  • clinical symptoms (stable or unstable angina) or signs of myocardial ischemia
  • ≥ 50% diameter stenosis of each lesion

You may not qualify if:

  • acute myocardial infarction (\< 48 h);
  • contraindications to clopidogrel, aspirin, heparin and taxol;
  • pregnancy or lack of protection against pregnancy or breast-feeding during the study;
  • hemorrhagic diathesis and platelet count \<100.000/ml3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna, Dept. of Cardiology

Vienna, 1090, Austria

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

September 9, 2010

First Posted

September 13, 2010

Study Start

January 1, 2004

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

July 18, 2014

Record last verified: 2014-07

Locations

AU(1)