Effects of DES Platforms on Markers of Endothelial Damage and Inflammation

NCT ID: NCT01489202

Last Updated: 2013-03-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-12-31

Brief 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.

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

platinum chromium EES

Patients undergoing PCI with stenting will have implantation of platinum chromium everolimus-eluting stents

Group Type: ACTIVE_COMPARATOR

platinum chromium everolimus-eluting stent

Intervention Type: DEVICE

An everolimus-eluting stent with a platinum chromium platform

cobalt chromium everolimus-eluting stent

Patients undergoing PCI with stenting will have implantation of cobalt chromium everolimus-eluting stents

Group Type: ACTIVE_COMPARATOR

cobalt chromium everolimus-eluting stent

Intervention Type: DEVICE

An everolimus-eluting stent with cobalt chromium platform

Interventions

platinum chromium everolimus-eluting stent

An everolimus-eluting stent with a platinum chromium platform

Intervention Type: DEVICE

cobalt chromium everolimus-eluting stent

An everolimus-eluting stent with cobalt chromium platform

Intervention Type: DEVICE

Other Intervention Names

Promus ElementTM, Boston Scientific Corporation, Natick, MA, USA; Xience VTM, Abbott Laboratories, Abbott Park, IL, USA

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Francesco Pelliccia

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University La Sapienza

Rome, , Italy

Countries

Italy

Central Contacts

Francesco Pelliccia, MD, PhD

Role: CONTACT

f.pelliccia@mclink.it

+393483392006

Cesare Greco, MD

Role: CONTACT

cesare.greco@uniroma1.it

+39 335 8381320

References

Pelliccia F, Del Prete G, Del Prete A, Greco C, Gaudio C. Effects of percutaneous coronary intervention and stenting with different drug-eluting coatings and platforms on endothelial damage and inflammation. Int J Cardiol. 2012 Apr 19;156(2):242-3. doi: 10.1016/j.ijcard.2012.01.059. Epub 2012 Feb 22. No abstract available.

Reference Type: DERIVED

PMID: 22360944 (View on PubMed)

Other Identifiers

655/2011/D

Identifier Type: -

Identifier Source: org_study_id