Advertisement

Topics

A Trial of Everolimus-eluting Stents and Paclitaxel-eluting Stents for Coronary Revascularization in Daily Practice: The COMPARE Trial

2014-07-23 21:11:46 | BioPortfolio

Summary

Instead of treating in-stent restenosis, the best strategy for patients is preventing in-stent restenosis. Recent advances in the understanding of the cellular mechanism responsible for smooth muscle cell proliferation (neointimal hyperplasia), together with improvement in stent coating and eluting technology have provided the scientific background to develop drug eluting stents. Drug eluting stents (DES) are now the most promising development in interventional cardiology. Different classes of drugs mounted in a polymer layer on the surface of the stent have shown to be very effective in preventing neointimal hyperplasia. Currently there are 7 DES stents CE marked and commercially available on the market. Two stents, respectively the sirolimus eluting Cypher™ stent and the paclitaxel eluting Taxus™ stent, are in clinical use since 2002. The Cypher™ stent consists of the Bx sonic stent/balloon platform. The stent is coated with a non-degradable biocompatible PBMA/PEVA polymer which elutes sirolimius. The Taxus™ stent consists of the Express2 balloon/stent platform coated with non-degradable biocompatible Translute™ polymer which elutes paclitaxel.

Recent large randomized trials like RAVEL, SIRIUS, E-SIRIUS C-SIRIUS (Cypher™ versus bare metal BX sonic™ stent), TAXUS II, IV, V, VI (Taxus versus bare metal Express™ stent) have shown that DES dramatically reduce the incidence of in-stent restenosis and subsequently the need for target lesion revascularization in patients with non complex and moderate long de-novo coronary lesions in vessels with a diameter between 2.5 -3.5 mm.1-11 Considering the very encouraging results of these early clinical trials with so far mid long term follow-up, there is the need to explore the utilization of DES in the other subsets of coronary lesions like: long lesions, chronic total occlusions, venous graft lesions, thrombotic lesions, restenosis lesions, ostial and bifurcation lesions and lesions in large vessels.

As the result from the previous reported randomized trials, FDA and other regulatory institutes require that new DES are now being evaluated against one of the former DES (Cypher or Taxus). The XIENCE-V stent is a second generation DES, with thinner and more flexible Cobalt-Chromium stent struts, compared to the first generation Stainless Steel stent struts of Cypher and Taxus. This study addresses the questions whether the XIENCE-V™ stent has superior clinical results as the Taxus™ stent in the general population that is being referred for percutaneous coronary intervention (PCI).

Objective of the study:

The main objective of the study is a head tot head comparison of the everolimus coated XIENCE-V™ stent with the paclitaxel coated TAXUS™ stent in order to observe whether there is a difference in clinical outcome between both stents.

Efficacy of both stents will be assessed by the composite end point of: all death, non fatal myocardial infarction and target vessel revascularization.

Study design:

Single center, randomised, open label study in all-comers referred for PCI.

Study population:

Approximately 1600 consecutive patients with coronary artery disease who are eligible according to the in- and exclusion criteria will be enrolled and randomized on a 1:1 basis.

Primary study parameters/outcome of the study:

The primary end point of the study is the composite end point of: all death, non fatal myocardial infarction, target vessel revascularization at 1 year.

Secondary study parameters/outcome of the study:

The secondary end points of the study are:

A) The combined endpoint of cardiac death, non fatal myocardial infarction, ischemic driven target lesion revascularization (TLR) rate at 1, 6 and 12 months follow-up.

B) The combined endpoint of all death, non fatal myocardial infarction, target vessel revascularization (TVR) rate at 2, 3, 4 and 5 years.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

The burden for the patient consists of filling in 8 questionnaires (1 A4 per questionnaire) in 5 years time.

The first 3 questionnaires in the first year are also requested for monitoring purposes by the Ministry of Health and the Dutch Cardiology Society (Nederlandse Vereniging Voor Cardiologie; NVVC).

There is no risk for the patient related to participation in this study. The patient will receive a Taxus or Xience-V stent anyhow, if the indication for a DES stent exists.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Conditions

Stable Angina

Intervention

everolimus stent, paclitaxel stent

Location

Maasstad Hospital
Rotterdam
Netherlands
3075 EA

Status

Completed

Source

Maasstad Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:11:46-0400

Clinical Trials [2767 Associated Clinical Trials listed on BioPortfolio]

Evaluation of Vascular Regeneration After a Drug Eluting Stent Implantation

This is a prospective cohort, one center. twenty patients who will undergo percutaneous stent implantation with everolimus eluting stent will be include. The primary endpoint was the corre...

SPIRIT II: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System

Prospective, randomized, active-control, single blind, parallel two-arm multi-center clinical trial comparing XIENCE V® Everolimus Eluting Coronary Stent System to the approved commercial...

Randomized Evaluation of Sirolimus-eluting Versus Everolimus-eluting Stent Trial

The purpose of this study is to evaluate whether the newly-approved everolimus-eluting stent is not inferior to the sirolimus-eluting stent in terms of the rate of target-lesion revascular...

STACCATO: Stent sTrut Apposition and Coverage in Coronary ArTeries: an Optical Coherence Tomography (OCT) Study

Assessment of vessel healing after DES implantation in STEMI, NSTEMI and stable/unstable angina patients: a randomized comparison between everolimus and biolimus A9-eluting stents: an opti...

Comparison of the Efficacy of Paclitaxel-releasing Balloon Catheter System Versus the Everolimus-Eluting Stent System for Treatment of In-Stent Restenosis Lesions - Harmonizing Optimal Strategy for Treatment of In-Stent Restenosis Lesions (The HOST-ISR Tr

In-stent restenosis (ISR) lesions are considered one of the toughest lesions that interventional cardiologists encounter in the drug eluting stent (DES) era. The current consensus in treat...

PubMed Articles [4371 Associated PubMed Articles listed on BioPortfolio]

The Pt-Cr everolimus-eluting stent with bioabsorbable polymer in the treatment of patients with acute coronary syndromes. Results from the SYNERGY ACS registry.

We investigated the safety and efficacy of the bioabsorbable polymer-coated, everolimus-eluting coronary stent (SYNERGY) stent in a real-world study population with acute coronary syndromes (ACS).

Peri-stent contrast staining post-everolimus eluting stent deployment disappeared in a very short duration.

Angiographic and clinical performance of a paclitaxel coated balloon compared to a 2nd generation sirolimus eluting stent in patients with in-stent restenosis- the BIOLUX randomized controlled trial.

The optimal treatment of in-stent restenosis (ISR) remains unknown. This study evaluates the efficacy and safety of a paclitaxel coated balloon compared to a 2nd generation sirolimus eluting stent in ...

Efficacy of a paclitaxel-eluting biliary metal stent with sodium caprate in malignant biliary obstruction: a prospective randomized comparative study.

 The placement of a self-expandable metal stent (SEMS) is widely used in patients with unresectable malignant biliary obstructions, but SEMSs are susceptible to occlusion by tumor ingrowth or overgr...

Everolimus drug-eluting stent performance in patients with long coronary lesions: The multicenter Longprime registry.

To assess the efficacy and safety of the Xience Prime everolimus-eluting stent (EES) in long coronary lesions in a real-world population.

Medical and Biotech [MESH] Definitions

The new and thickened layer of scar tissue that forms on a PROSTHESIS, or as a result of vessel injury especially following ANGIOPLASTY or stent placement.

Surgical construction of an artificial opening (stoma) for external fistulization of a duct or vessel by insertion of a tube with or without a supportive stent.

Postoperative hemorrhage from an endovascular AORTIC ANEURYSM repaired with endoluminal placement of stent grafts (BLOOD VESSEL PROSTHESIS IMPLANTATION). It is associated with pressurization, expansion, and eventual rupture of the aneurysm.

An injectable formulation of albumin-bound paclitaxel NANOPARTICLES.

A type of surgical portasystemic shunt to reduce portal hypertension with associated complications of esophageal varices and ascites. It is performed percutaneously through the jugular vein and involves the creation of an intrahepatic shunt between the hepatic vein and portal vein. The channel is maintained by a metallic stent. The procedure can be performed in patients who have failed sclerotherapy and is an additional option to the surgical techniques of portocaval, mesocaval, and splenorenal shunts. It takes one to three hours to perform. (JAMA 1995;273(23):1824-30)

More From BioPortfolio on "A Trial of Everolimus-eluting Stents and Paclitaxel-eluting Stents for Coronary Revascularization in Daily Practice: The COMPARE Trial"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Stent
A stent is a small mesh tube that's used to treat narrow or weak arteries. Arteries are blood vessels that carry blood away from your heart to other parts of your body.  A stent is placed in an artery as part of a procedure called angioplasty. &...

Rheumatology
Arthritis Fibromyalgia Gout Lupus Rheumatic Rheumatology is the medical specialty concerned with the diagnosis and management of disease involving joints, tendons, muscles, ligaments and associated structures (Oxford Medical Diction...


Searches Linking to this Trial