Xience V at Wake Forest University Baptist Medical Center (WFUBMC)

Study Overview
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Brief Summary
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The effectiveness, safety, and deliverability of second generation drug eluting stents (DES), including Xience V, will need to be examined in real world patients to provide the same level of evidence base and comfort that has accompanied the use of the first generation devices. Randomized clinical trials provide the fairest evaluation of outcomes by controlling for confounding patient and procedural characteristics; however, randomized clinical trials also exclude the very high risk patients that account for upwards of 80% of real world patient populations such as those at Wake Forest University Baptist Medical Center (WFUBMC). Clinical follow-up data including non-fatal MI, all cause mortality and stent thrombosis, as well as medications compliance, of patients undergoing stent therapy including Xience V in a real world patient population will be collected at WFUBMC. Existing data for several control groups will be used to compare outcomes with Xience V including a consecutively treated bare metal stent (BMS) cohort of 1,200 patients, and a DES cohort of 1,200 patients (900 sirolimus-eluting and 300 paclitaxel-eluting) treated between April 2004 and April 2005. Patients undergoing stent therapy in the year prior to use of Xience V, and contemporaneous patients receiving non-Xience V stent therapy during Xience V use will serve as additional controls. All patient data will be de-identified using unique blinded identification codes after data collection is completed. The null hypothesis of this study states that safety outcomes (stent thrombosis, non-fatal MI, death) with Xience V will be equivalent to historical and contemporaneous controls; effectiveness outcomes (target lesion and target vessel revascularization) with Xience V will be superior to historical and contemporaneous BMS controls, and equivalent to historical and contemporaneous DES controls; and the need for crossover to another stent type will be equal to that observed with historical DES controls. Outcomes will be reported using contemporary measures of clinical outcomes and analyzed using Cox proportional hazards survival analysis methodology. These data should provide important information on the clinical effectiveness and safety of Xience V in routine practice.

Official Title
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Xience V at WFUBMC: Real World Outcomes Using Second Generation DES

Conditions
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Percutaneous Coronary Intervention, Stents

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: percutaneous coronary intervention with stenting Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 18 Years

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 |
| --- | --- |
| Xience V<br>Percutaneous coronary intervention with Xience V stent placement | |
| Historical BMS<br>Percutaneous coronary intervention with bare metal stent placement prior to availability of Cypher, Taxus, or Xience V drug eluting stents at WFUBMC | |
| Historical DES<br>Percutaneous coronary intervention with drug eluting stent placement prior to availability of Xience V drug eluting stents at WFUBMC | |
| Contemporary BMS<br>Percutaneous coronary intervention with bare metal stent placement after Xience V drug eluting stents were available for use at WFUBMC | |
| Contemporary DES<br>Percutaneous coronary intervention with Cypher or Taxus drug eluting stent placement after Xience V drug eluting stents were available for use at WFUBMC | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of non-fatal myocardial infarction, death, or stent thrombosis |  | Annual landmark | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target lesion/vessel revascularization |  | Annual landmark | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stents, mortality, revascularization, stent thrombosis, Drug-Eluting Stents