Paclitaxel-eluting balloon versus everolimus-eluting stent in patients with diabetes mellitus and in-stent restenosis: Insights from the randomized DARE trial

Autor: José P.S. Henriques, Martijn Meuwissen, Bimmer E. Claessen, Jan J. Piek, Jan Baan, Marleen H. van Wely, Kirsten Boerlage-van Dijk, René J. van der Schaaf, A T Marcel Gosselink, Atilla Dirkali, Jeroen Vendrik, E. Karin Arkenbout, Niels van Royen
Přispěvatelé: Cardiology, ACS - Atherosclerosis & ischemic syndromes, ACS - Pulmonary hypertension & thrombosis, Graduate School, ACS - Heart failure & arrhythmias, ACS - Microcirculation, ACS - Diabetes & metabolism, AGEM - Endocrinology, metabolism and nutrition, APH - Aging & Later Life
Rok vydání: 2019
Předmět:
Male
medicine.medical_specialty
Time Factors
Paclitaxel
medicine.medical_treatment
Vascular damage Radboud Institute for Health Sciences [Radboudumc 16]
Urology
Coronary Artery Disease
030204 cardiovascular system & hematology
Prosthesis Design
Balloon
Cardiac Catheters
Coronary Restenosis
03 medical and health sciences
All institutes and research themes of the Radboud University Medical Center
Percutaneous Coronary Intervention
0302 clinical medicine
Coated Materials
Biocompatible
Restenosis
Risk Factors
Diabetes mellitus
Diabetes Mellitus
medicine
Humans
Radiology
Nuclear Medicine and imaging
In patient
Everolimus
Prospective Studies
030212 general & internal medicine
Angioplasty
Balloon
Coronary
Adverse effect
Aged
Netherlands
business.industry
Vascular damage Radboud Institute for Molecular Life Sciences [Radboudumc 16]
Stent
Percutaneous coronary intervention
Cardiovascular Agents
Drug-Eluting Stents
General Medicine
Middle Aged
medicine.disease
Treatment Outcome
Drug-eluting stent
Female
Cardiology and Cardiovascular Medicine
business
Zdroj: Claessen, B E, Henriques, J P S, Vendrik, J, Boerlage-van Dijk, K, van der Schaaf, R J, Meuwissen, M, van Royen, N, Gosselink, A T M, van Wely, M H, Dirkali, A, Arkenbout, E K, Piek, J J & Baan, J 2019, ' Paclitaxel-eluting balloon versus everolimus-eluting stent in patients with diabetes mellitus and in-stent restenosis: Insights from the randomized DARE trial ', Catheterization and Cardiovascular Interventions, vol. 93, no. 2, pp. 216-221 . https://doi.org/10.1002/ccd.27814
Catheterization and Cardiovascular Interventions, 93, 216-221
Catheterization and cardiovascular interventions, 93(2), 216-221. Wiley-Liss Inc.
Catheterization and Cardiovascular Interventions, 93(2), 216-221. Wiley-Liss Inc.
Catheterization and Cardiovascular Interventions, 93, 2, pp. 216-221
ISSN: 1522-1946
Popis: Objectives: To investigate the relative performance of treatment with a paclitaxel-eluting balloon (PEB) compared with an everolimus-eluting stent (EES) for in-stent restenosis (ISR) in patients with diabetes mellitus (DM). Background: ISR remains a challenge in contemporary clinical practice, particularly in patients with DM. Methods: In the multicenter randomized DARE trial, patients with BMS or DES ISR were randomized in a 1:1 fashion to treatment with a PEB or an EES. Patients underwent angiographic follow-up after 6 months. For the purpose of this analysis, the relative performance of PEB versus EES in diabetic patients was investigated. Results: Of 278 patients enrolled in DARE, 88 (32%) had DM, of whom 46 were randomized to EES and 42 to PEB treatment. Of patients with DM, 48 (55%) had DES-ISR. Angiographic follow-up was available in 30 patients (72%) in the PEB group and 36 patients (78%) in the DES group. There were no differences in terms of 6-months minimal lumen diameter in diabetic patients treated with EES (1.46 ± 0.66 mm) versus PEB (1.78 ± 0.58 mm, P = 0.15). Adverse events at one year follow-up were similar in both groups, with Major Adverse Events (MAE, death, target vessel MI, or TVR) occurring in 17.4% in the EES group versus 11.9% in the PEB group, P = 0.44. Conclusions: In patients with ISR and DM, use of a PEB resulted in similar 6-months in-segment minimal lumen diameter and comparable rates of MAE. In-segment late loss at 6 months was significantly lower in the PEB arm. Although larger trials in DM patients with ISR are necessary, PEB is a promising treatment option obviating the need for additional stent implantation.
Databáze: OpenAIRE
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