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

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

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.

Study Overview

• Status: Completed
• Conditions: Percutaneous Coronary Intervention; Stents

• Study Type: Observational
• Enrollment (Actual): 59

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27517
      • Wake Forest University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults with coronary artery disease seen at WFUBMC cardiac catheterization laboratory who received percutaneous coronary intervention with placement of one or more stents

Description

Inclusion Criteria:

• percutaneous coronary intervention with stenting

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
Xience V; Percutaneous coronary intervention with Xience V stent placement
Historical BMS; Percutaneous coronary intervention with bare metal stent placement prior to availability of Cypher, Taxus, or Xience V drug eluting stents at WFUBMC
Historical DES; Percutaneous coronary intervention with drug eluting stent placement prior to availability of Xience V drug eluting stents at WFUBMC
Contemporary BMS; Percutaneous coronary intervention with bare metal stent placement after Xience V drug eluting stents were available for use at WFUBMC
Contemporary DES; 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?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Target lesion/vessel revascularization	Annual landmark

Collaborators and Investigators

• Sponsor: Wake Forest University
• Collaborators: Abbott
• Investigators: Principal Investigator: Robert J Applegate, MD, Wake Forest University

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: July 10, 2009
• First Submitted That Met QC Criteria: July 10, 2009
• First Posted (Estimate): July 13, 2009

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: November 2, 2017
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: mortality; stents; Drug-Eluting Stents; revascularization; stent thrombosis
• Other Study ID Numbers: ACS-6814