Effects of DES Platforms on Markers of Endothelial Damage and Inflammation

Coronary Artery Disease Clinical Trial

— PLATFORM  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01489202
• Other study ID #: 655/2011/D
• Status: Not yet recruiting
• Phase: Phase 4
• First received: December 6, 2011
• Last updated: March 6, 2013
• Start date: September 2014
• Est. completion date: December 2016

Study information

• Verified date: March 2013
• Source: University of Roma La Sapienza
• Contact: Francesco Pelliccia, MD, PhD
• Phone: +393483392006
• Email: f.pelliccia[@]mclink.it
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• platinum chromium everolimus-eluting stent
An everolimus-eluting stent with a platinum chromium platform
• cobalt chromium everolimus-eluting stent
An everolimus-eluting stent with cobalt chromium platform

Locations

Country	Name	City	State
Italy	University La Sapienza	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-PCI changes in markers of endothelial damage	Changes 24 hours after PCI in the following indexes of endothelial damage: von Willebrand Factor (vWF); sE-selectin; Vascular cell adhesion molecule (sVCAM-1); Intercellular adhesion molecule (sICAM-1)	Baseline and 24 hours after PCI	No
Primary	Post-PCI changes in markers of inflammation	Changes 24 hours after PCI in the following inflammatory markers: C-reactive protein (CPR); Fibrinogen; Plasminogen activator inhibitor (PAI-1); Interleukin-6 (IL-6)	Baseline and 24 hours after PCI	No
Secondary	12-month rate of MACE	12-months incidence of major adverse cardiac events (MACE—death, myocardial infarction, target vessel revascularization)	Up to 12 months	No