Cost-effectiveness of PCI With Taxus vs CABG

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

207 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-01-31

Study Completion Date

2014-07-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Multivessel Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PCI

comparison of PCI vs. CABG in multivessel disease

Intervention Type PROCEDURE

invasive treatment of coronary artery disease

CABG

comparison of PCI vs. CABG in multivessel disease

Intervention Type PROCEDURE

invasive treatment of coronary artery disease

Interventions

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comparison of PCI vs. CABG in multivessel disease

invasive treatment of coronary artery disease

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No