The REMEDEE trial: 5Year results on a novel combined sirolimuseluting and endothelial progenitor cells capturing stent
Catheter. cardiovasc. interv
; 95(6): 1076-1084, May., 2020. tab., graf.
Article
in English
| Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP
| ID: biblio-1100379
Responsible library:
BR79.1
ABSTRACT
OBJECTIVES:
To evaluate the long-term safety and efficacy of the novel combined sirolimus-eluting endothelial progenitor cell capture Combo stent (OrbusNeich, Fort Lauderdale, FL) at 5 years in the REMEDEE (Randomized study to Evaluate the safety and effectiveness of an abluMinal sirolimus coated bio-Engineered stEnt) trial.BACKGROUND:
Drug-eluting stents have limited restenosis and reintervention but are complicated by late and very late thrombosis and accelerated neoatherosclerosis. Alternative or adjunctive technologies are needed to address these limitations.METHODS:
A total of 183 patients with de novo lesions in native coronary arteries were randomized 21 to Combo (n = 124) or Taxus Liberté (n = 59). Primary endpoint was 9 month angiographic in-stent late lumen loss and the secondary endpoint was the occurrence of major adverse events (MACE) through 5-year follow-up.RESULTS:
Compared with Taxus, after 5 years the Combo stent was associated with similar rates of MACE (18.3% vs. 16.9%, p = .89), cardiac death (0.8% vs. 5.1%, p = .07), myocardial infarction (4.1% vs. 3.4%, p = .81), target lesion (9.4% vs. 10.2%, p = .78), and target vessel revascularization (14.4% vs. 11.9%, p = .73). No cases of definite stent thrombosis were reported in the Combo group. The follow-up rate at 5 years was 97.7%.CONCLUSION:
At 5-year follow-up, the Combo stent remained clinically safe and effective with an overall low rate of MACE comparable to Taxus.
Full text:
Available
Collection:
National databases
/
Brazil
Database:
Sec. Est. Saúde SP
/
SESSP-IDPCPROD
Main subject:
Drug-Eluting Stents
/
Percutaneous Coronary Intervention
Type of study:
Controlled clinical trial
Language:
English
Journal:
Catheter. cardiovasc. interv
Year:
2020
Document type:
Article
Institution/Affiliation country:
Cardiology Practice and Hospital/DE
/
Cardiovascular Research Foundation/US
/
Institut Jantung Negara/MY
/
Instituto Dante Pazzanese de Cardiologia/BR
/
Instituto de Cardiologia de Triangulo Mineiro/BR
/
Lukaskrankenhaus GmbH/DE
/
Queen Mary Hospital/CN
/
Royal Adelaide Hospital/AU
/
Sarawak Heart Centre/MY
/
Ziekenhuis Netwerk Antwerpen Middelheim/BE