Clinical trial NCT05584280: Systematic Post-Implementation Evaluation of Stents
Official title: Systematic Post-Implementation Evaluation of Stents
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myocardial Ischemia
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2022-10-18
Enrollment: 6000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing PCI at any hospital participating in the study

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing PCI at any hospital participating in the study

Exclusion Criteria:

* None

Primary outcomes:
measure: Cost effectiveness ratio (percent)
timeFrame: 1 year
Secondary outcomes:
measure: How long time did the procedure take?
timeFrame: During the procedure
measure: How many other stents were used?
timeFrame: During the procedure
measure: How many additional units were needed?
timeFrame: During the procedure
measure: How many patients were treated?
timeFrame: 1 week
measure: Composite of all-cause death, myocardial infarction, or coronary revascularization
timeFrame: 1- year
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Kardiologen
Study officials:
References: