In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
PERSEUS Workhorse: 1,249 PERSEUS Small Vessel: 223
Actual Number of Sites Enrolled
PERSEUS Workhorse: 90 PERSEUS Small Vessel: 28
Patient Followup Rate
PERSEUS Workhorse: 92% at five years PERSEUS Small Vessel: 93.7% at five years
Final Safety Findings
PERSEUS Workhorse: Results at five years: -MACE (cardiac death, MI, TVR) TAXUS Express (18.2%) and TAXUS
Element (18.6%) -All death TAXUS Express (6.9%) and TAXUS Element (6.8%) -All death and MI TAXUS Express (9.6%) and TAXUS Element (10.6%) -Non-cardiac death TAXUS Express (2.9%) and TAXUS Element (3.3%) -ARC stent thrombosis, definite/probable TAXUS Express (0.7%) and TAXUS Element (1.1%)
At five years, there were no statistically significant differences between the groups in any of the safety outcomes examined.
PERSEUS Small Vessel: Results at five years: -MACE (cardiac death, MI, TVR) TAXUS Element (30.2%) and BMS (41.3%, P<0.05) -All death TAXUS Element (14.9%) and BMS (9.6%) -All death and MI TAXUS Element (15.9%) and BMS (15.2%) -Non-cardiac death TAXUS Element (15.9%) and BMS (15.2%) -ARC stent thrombosis, definite/probable TAXUS Element (0.6%) and BMS (2.1%)
Final Effectiveness Findings
PERSEUS Workhorse: Results at five years: -Target lesion failure (TLF) TAXUS Express (13.7%) and TAXUS Element
(12.8%) -Target vessel failure (TVF) TAXUS Express (17.9%) and TAXUS Element (17.5%) -Target vessel revascularization (TVR) TAXUS Express (13.3%) and TAXUS Element (13.3%)
There was no statistically significant difference between the groups in any of the effectiveness outcomes examined.
PERSEUS Small Vessel: Results at five years: -Target lesion failure (TLF) TAXUS Element (21.5%) and BMS (35.2%, P<0.05) -Target vessel failure (TVF) TAXUS Element (30.2%) and BMS (39.4%) -Target vessel revascularization (TVR) TAXUS Element (23.6%) and BMS (34.9%, P<0.05)
Study Strengths and Weaknesses
The PERSEUS Workhorse study was prospective, randomized, controlled, single-blind, non-inferiority trial with a sample size
of 1,262 subjects. The PERSEUS Workhorse study met its performance goals. The PERSEUS Workhorse PAS included only subjects with a study stent implanted (n=1,249) and followed them up to five years. Strengths of this PAS include randomized treatment assignment; a low rate of attrition in both treatment groups, thus minimizing selection bias; and a large sample size. The PERSEUS Small Vessel study was a prospective, single-aim, superiority trial with an historical control. A total of 223 subjects were implanted with the TAXUS Element stent and compared with 125 matched bare metal (BMS) Express stent subjects from the TAXUS V trial. The subjects were followed-up to five years. Strengths of this PAS include a control group; and a low rate of attrition, thus minimizing selection bias.
Recommendations for Labeling Changes
A labeling change is recommended to add a summary of the post-approval study results including
study strengths and limitations. The updated label will reflect the long-term performance of the device from the pre-market cohorts.