Effects of DES Platforms on Markers of Endothelial Damage and Inflammation (PLATFORM)

March 6, 2013 updated by: Francesco Pelliccia, University of Roma La Sapienza

Randomized Comparison of the Effects of PLatinum Chromium Everolimus-eluting Stent vs. cobAlT Chromium Everolimus-eluting Stent on inFlammatOry maRkers and Endothelial daMage - The PLATFORM Trial

Percutaneous coronary intervention (PCI) with stenting may induce endothelial damage/dysfunction and inflammatory reactions, which in turn delay healing and endothelialization and may lead to restenosis and atherosclerosis within the stented segments. Drugs and polymers are considered the protagonists of these pathophysiologic processes whereas the role of stent platforms remains poorly defined.It remains unknown, conversely, if stent platforms affect the extent of post-PCI endothelial damage and inflammation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Percutaneous coronary intervention (PCI) with stenting may induce endothelial damage/dysfunction and inflammatory reactions, which in turn delay healing and endothelialization and may lead to restenosis and atherosclerosis within the stented segments.

Drugs and polymers are considered the protagonists of these pathophysiologic processes whereas the role of stent platforms remains poorly defined.

Due to advances in stent technology, stent platforms have evolved from the cobalt-chromium (CoCr) to the platinum-chromium (PtCr) stent series. At present, the PROMUS Element stent (which uses the PtCr platform) employs an identical polymer, drug, drug formulation and dose density to the CoCr XIENCE V stent.

The PLATINUM WH trial is the only randomized trial comparing the PROMUS Element stent with the XIENCE V stent in a total of 1,530 patients. The study met its primary end-point demonstrating that the PROMUS Element stent is non-inferior to the XIENCE V stent. The 12-month rare of target lesion failure was 3.4% in the PROMUS Element stent and 2.9% in the XIENCE V stent.

Pre-clinical animal studies, however, suggest that the PtCr platform might have important advantages over the CrCo platform, as improved vascular compatibility and early and late healing for PtCr devices compared with CoCr stents have been demonstrated.

In a rabbit denudation model, it was shown that at 14 days the luminal surface area is incompletely endothelialised with the CrCo stents but nearly complete for the PtCr stents. Similarly, another experimental study has shown that overall strut coverage, including endothelial cell coverage plus non-endothelial cell coverage (focal platelet and fibrin aggregates inter-mixed with red blood cells and inflammatory cells), is significantly lower at 14 days with the CoCr stent than with the PtCr OMEGA stent. Additionally, a recent investigation has shown that the thinner-strut PtCr stent is associated with reduced fibrin deposition and more rapid fibrin clearance in porcine coronary arteries compared with CrCo stent, thus suggesting that the PtCr stent platform may induce less injury compared with previous-generation platforms.

The primary objective of this study is to perform a randomized comparison of the biohumoral effects of platinum chromium everolimus-eluting stent (PtCr EES) vs. cobalt chromium everolimus-eluting stent (CoCr EES), i.e. stents with different platforms but identical drug and polymer.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00166
        • University La Sapienza

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A de novo native coronary artery lesions (reference vessel diameter:2.5-3.75 mm)
  • Class I indication to elective percutaneous coronary intervention
  • Stable conditions and no recent acute coronary syndromes
  • Normal baseline values of markers of myocardial damage (creatine kinase, creatine kinase-MB, myoglobin, and troponin I)
  • Able to understand and willing to sign the informed CF

Exclusion Criteria:

• Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: platinum chromium EES
Patients undergoing PCI with stenting will have implantation of platinum chromium everolimus-eluting stents
Device: platinum chromium everolimus-eluting stent
An everolimus-eluting stent with a platinum chromium platform
Other Names:
  • Promus ElementTM, Boston Scientific Corporation, Natick, MA, USA
ACTIVE_COMPARATOR: cobalt chromium everolimus-eluting stent
Patients undergoing PCI with stenting will have implantation of cobalt chromium everolimus-eluting stents
Device: cobalt chromium everolimus-eluting stent
An everolimus-eluting stent with cobalt chromium platform
Other Names:
  • Xience VTM, Abbott Laboratories, Abbott Park, IL, USA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-PCI changes in markers of endothelial damage
Time Frame: Baseline and 24 hours after PCI

Changes 24 hours after PCI in the following indexes of endothelial damage:

  1. von Willebrand Factor (vWF)
  2. sE-selectin
  3. Vascular cell adhesion molecule (sVCAM-1)
  4. Intercellular adhesion molecule (sICAM-1)
Baseline and 24 hours after PCI
Post-PCI changes in markers of inflammation
Time Frame: Baseline and 24 hours after PCI

Changes 24 hours after PCI in the following inflammatory markers:

  1. C-reactive protein (CPR)
  2. Fibrinogen
  3. Plasminogen activator inhibitor (PAI-1)
  4. Interleukin-6 (IL-6)
Baseline and 24 hours after PCI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
12-month rate of MACE
Time Frame: Up to 12 months
12-months incidence of major adverse cardiac events (MACE-death, myocardial infarction, target vessel revascularization)
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (ANTICIPATED)

December 1, 2015

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

December 6, 2011

First Submitted That Met QC Criteria

December 8, 2011

First Posted (ESTIMATE)

December 9, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

March 7, 2013

Last Update Submitted That Met QC Criteria

March 6, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 655/2011/D

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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