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

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.