Systematic Post-Implementation Evaluation of Stents

Study Overview
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Brief Summary
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To conduct a quality assurance project to establish the differences in health care processes and cost effectiveness of having the thin-strut Orsiro stent versus the thicker strut Promus stent on the shelf (i.e. as the most accessible stent).

Detailed Description
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Background: Individual patient-level randomized trials have suggested that the ultrathin strut Orsiro stent is associated with a lower risk of adverse ischemic events than the thin strut Promus stent. However, there are theoretical advantages of each stent in regards to usability, delivery and radial strength. Study design: The SPECS trial is a prospective, open-label, cross-sectional, cluster randomized quality assurance project, in which cardiac catheterization laboratories (hereafter referred to as center) in Västra Götaland Sweden will participate. Each week each center will place either Orsiro or Promus in the shelf in the cath lab as the most accessible stent (their workhorse stent). The specific stent to be placed on the shelf at each center each week will be randomly decided. All patients will be treated according to local treatment guidelines and at the discretion of the interventional cardiologists, including the choice of stents. The patients will be identified via the Swedish Web-System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies (SWEDEHEART) registry. The events at will be identified and extracted from Patient registry (Socialstyrelsen), Population registry (Folkbokföringen), Causes of death registry (Socialstyrelsen). Stent usage will be monitored via SWEDEHEART and local databases (stents for which the package was opened but the stent discarded). Study population: Patients undergoing percutaneous coronary intervention (PCI) in Västra Götaland. Primary objectives: To investigate the cost-effectivess of placing either thin or thick strut stents on the shelf in the cath lab. To investigate the weekly costs associated with placing either thin or thick strut stents on the shelf in the cath lab. All outcomes will be tracked over time to assess whether greater experience with the thin strut stents results in changes in any cost differences over time. If a sufficient number of patients are treated over the course of the project, retrospective analyses may be conducted using the assigned shelf stent as an instrument for assessing the effect of thin vs. thick stents on outcomes.

Official Title
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Systematic Post-Implementation Evaluation of Stents

Conditions
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Myocardial Ischemia

Intervention / Treatment
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* Device: Orsiro stent on shelf
* Device: Promus stent on shelf


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing PCI at any hospital participating in the study Exclusion Criteria: None
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Promus stent on shelf<br>Control | Device: Promus stent on shelf<br>* Cluster randomization to Promus stent on shelf vs. treatment<br>|
| Orsiro stent on shelf<br>Treatment | Device: Orsiro stent on shelf<br>* Cluster randomization to Orsiro stent on shelf vs. control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost effectiveness ratio (percent) | Cost effectiveness of Orsiro compared to Promus on shelf. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| How long time did the procedure take? | Procedure time (continuous variable) | During the procedure | 
| How many other stents were used? | Proportion of other stents used (percent) | During the procedure | 
| How many additional units were needed? | Number of adjunct devices used | During the procedure | 
| How many patients were treated? | Number of patients treated | 1 week | 
| Composite of all-cause death, myocardial infarction, or coronary revascularization | Cumulative risk of death, myocardial infarction, or coronary revascularization | 1- year |