SPECS: Systematic Post-Implementation Evaluation of Stents
Study Details
Study Description
Brief Summary
To investigate the efficacy of the Orsiro versus Promus stents.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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. A head-o-head comparison of Orsiro versus Promus in regard to the 1-year and long-term risks of adverse ischemic events will be conducted.
Study design:
The SPECS trial is a prospective, multicenter, open-label, cross-sectional, cluster randomized clinical study, in which cardiac catheterization laboratories (hereafter referred to as center) in Västra Götaland Sweden will participate. Each week each center will use either Orsiro or Promus as their workhorse stent. The specific stent to be used by each center each week will be randomly decided.
All patients will be treated according to local treatment guidelines.
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). Compliance with the randomization will be monitored via SWEDEHEART.
Study population:
6000 patients undergoing percutaneous coronary intervention (PCI) in 3 centers in Västra Götaland.
Primary objective:
To investigate the efficacy of the Orsiro versus Promus stents.
Primary endpoint:
Cumulative risk of death, myocardial infarction or target vessel revascularization at 1 year.
Key secondary endpoints:
-
5-year risk of death, myocardial infarction or target vessel revascularization
-
Procedural factors: what to include?
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Procedural complications: what to include?
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Cumulative risk of the following events over the course of the study period:
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All-cause death
-
Myocardial infarction
-
Target vessel revascularization
-
Stent thrombosis
Statistical assumptions and power calculation:
The study has an estimated power of 91.8% to demonstrate the superiority of Orsiro versus Promus for the primary composite endpoint, using a two-sided Wald Z-test and the following assumptions:
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A sample of 300 clusters in a cross-over cluster randomized trial
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An average of 20 subjects per cluster
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A 1-year rate of the primary composite endpoint of 9.0% in the Promus (control) arm.
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A 1-year rate of the primary composite endpoint of 6.3% in the Orsiro (treatment) arm - corresponding to a relative risk reduction of 30%.
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In intra-cluster correlation of 0.02.
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A two-sided significance level (α) of 0.05.
-
See Chapter 231 in PASS Sample Size Software documentation, www.ncss.com. An adaptive design (according to the method described by Pocock and Mehta) will be used such that the conditional power will be calculated after 22 months, with an option to continue the study up to a maximum of 36 months to increase sample size if the conditional power falls below 90% but within the promising zone.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Promus stent Control |
Device: Promus stent
Cluster randomization to Promus stent vs. treatment
|
| Experimental: Orsiro stent Treatment |
Device: Orsiro stent
Cluster randomization to Orsiro stent vs. control
|
Outcome Measures
Primary Outcome Measures
- Death, Myocardial infarction or Target vessel revascularization [1 year]
Cumulative risk of death, myocardial infarction or target vessel revascularization
Secondary Outcome Measures
- Death, Myocardial infarction or Target vessel revascularization [5 Year]
Cumulative risk of death, myocardial infarction or target vessel revascularization
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients undergoing PCI at any hospital participating in the study
Exclusion Criteria:
- None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kardiologen | Göteborg | Sweden | 41345 |
Sponsors and Collaborators
- Vastra Gotaland Region
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SPECS - 01