One-year clinical outcome of amphilimus polymer-free drug-eluting stent in diabetes mellitus patients Insight from the ASTUTE registry (AmphilimuS Italian mUlticenTre rEgistry)

Antonio Colombo, Cosmo Godino, Michael Donahue, Luca Testa, Mauro Chiarito, Anna Giulia Pavon, Riccardo Colantonio, Alberto Cappelletti, Alberto Monello, Valeria Magni, Diego Milazzo, Rosario Parisi, Annamaria Nicolino, Shahram Moshiri, Rossella Fattori, Gianfranco Aprigliano, Altin Palloshi, Giuseppe Caramanno, Matteo Montorfano, Francesco Bedogni & 2 others Alberto Margonato, Carlo Briguori

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

Background Despite several improvements in drug-eluting stent (DES) technology, patients with diabetes mellitus (DM) are affected by higher rate of adverse events after PCI with DES, mainly in terms of target lesion revascularization (TLR). The Cre8 stent, a polymer-free amphilimus-eluting stent (AES), has shown promising preliminary results in DM patients. The ASTUTE registry was conceived to assess clinical performance of this polymer-free AES in DM in a "real-world" multicenter-independent cohort of patients. Methods 1216 consecutive patients (1637 lesions) treated with Cre8 between August 2011 and January 2015 were retrospectively enrolled and divided in two groups: DM and non-DM patients. The primary and secondary endpoints were target lesion failure (TLF) and TLR at 1-year, respectively. Results 1-Year clinical outcome was available for 407 (80%) DM and 566 (84%) non-DM patients. Diabetic patients were more frequently affected by hypertension (p <0.001) and dyslipidemia (p <0.001) and more frequently dialyzed (p = 0.010). At 1-year, TLF occurred in 50 (5.1%) overall patients, and was similar in DM and non-DM patients (4.9 vs 5.3%, respectively, p = 0.788). The secondary endpoint (TLR) occurred in 3% of overall patients and similarly in DM and non-DM patients (3.7 vs 2.5%, respectively, p = 0.273). Primary and secondary endpoints were similar also between insulin and non-insulin dependent DM patients. Conclusions The results of this large, real-world, multicenter-independent registry show that Cre8 AES has similar safety and efficacy profile in DM as well as non-DM patients, reducing the adverse outcomes related to DM in patients undergoing PCI. A large randomized trial will be necessary to definitely prove these preliminary findings.

Original languageEnglish
Pages (from-to)113-120
Number of pages8
JournalInternational Journal of Cardiology
Volume214
DOIs
Publication statusPublished - Jul 1 2016

Fingerprint

Drug-Eluting Stents
Registries
Diabetes Mellitus
Polymers
Stents
Dyslipidemias
Type 2 Diabetes Mellitus

Keywords

  • Amphilimus
  • Diabetes mellitus
  • Polymer-free drug eluting
  • Stent restenosis

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

One-year clinical outcome of amphilimus polymer-free drug-eluting stent in diabetes mellitus patients Insight from the ASTUTE registry (AmphilimuS Italian mUlticenTre rEgistry). / Colombo, Antonio; Godino, Cosmo; Donahue, Michael; Testa, Luca; Chiarito, Mauro; Pavon, Anna Giulia; Colantonio, Riccardo; Cappelletti, Alberto; Monello, Alberto; Magni, Valeria; Milazzo, Diego; Parisi, Rosario; Nicolino, Annamaria; Moshiri, Shahram; Fattori, Rossella; Aprigliano, Gianfranco; Palloshi, Altin; Caramanno, Giuseppe; Montorfano, Matteo; Bedogni, Francesco; Margonato, Alberto; Briguori, Carlo.

In: International Journal of Cardiology, Vol. 214, 01.07.2016, p. 113-120.

Research output: Contribution to journalArticle

Colombo, A, Godino, C, Donahue, M, Testa, L, Chiarito, M, Pavon, AG, Colantonio, R, Cappelletti, A, Monello, A, Magni, V, Milazzo, D, Parisi, R, Nicolino, A, Moshiri, S, Fattori, R, Aprigliano, G, Palloshi, A, Caramanno, G, Montorfano, M, Bedogni, F, Margonato, A & Briguori, C 2016, 'One-year clinical outcome of amphilimus polymer-free drug-eluting stent in diabetes mellitus patients Insight from the ASTUTE registry (AmphilimuS Italian mUlticenTre rEgistry)', International Journal of Cardiology, vol. 214, pp. 113-120. https://doi.org/10.1016/j.ijcard.2016.03.088
Colombo, Antonio ; Godino, Cosmo ; Donahue, Michael ; Testa, Luca ; Chiarito, Mauro ; Pavon, Anna Giulia ; Colantonio, Riccardo ; Cappelletti, Alberto ; Monello, Alberto ; Magni, Valeria ; Milazzo, Diego ; Parisi, Rosario ; Nicolino, Annamaria ; Moshiri, Shahram ; Fattori, Rossella ; Aprigliano, Gianfranco ; Palloshi, Altin ; Caramanno, Giuseppe ; Montorfano, Matteo ; Bedogni, Francesco ; Margonato, Alberto ; Briguori, Carlo. / One-year clinical outcome of amphilimus polymer-free drug-eluting stent in diabetes mellitus patients Insight from the ASTUTE registry (AmphilimuS Italian mUlticenTre rEgistry). In: International Journal of Cardiology. 2016 ; Vol. 214. pp. 113-120.
@article{6be04ad25ee24e3290e2f23ab3fd9e25,
title = "One-year clinical outcome of amphilimus polymer-free drug-eluting stent in diabetes mellitus patients Insight from the ASTUTE registry (AmphilimuS Italian mUlticenTre rEgistry)",
abstract = "Background Despite several improvements in drug-eluting stent (DES) technology, patients with diabetes mellitus (DM) are affected by higher rate of adverse events after PCI with DES, mainly in terms of target lesion revascularization (TLR). The Cre8 stent, a polymer-free amphilimus-eluting stent (AES), has shown promising preliminary results in DM patients. The ASTUTE registry was conceived to assess clinical performance of this polymer-free AES in DM in a {"}real-world{"} multicenter-independent cohort of patients. Methods 1216 consecutive patients (1637 lesions) treated with Cre8 between August 2011 and January 2015 were retrospectively enrolled and divided in two groups: DM and non-DM patients. The primary and secondary endpoints were target lesion failure (TLF) and TLR at 1-year, respectively. Results 1-Year clinical outcome was available for 407 (80{\%}) DM and 566 (84{\%}) non-DM patients. Diabetic patients were more frequently affected by hypertension (p <0.001) and dyslipidemia (p <0.001) and more frequently dialyzed (p = 0.010). At 1-year, TLF occurred in 50 (5.1{\%}) overall patients, and was similar in DM and non-DM patients (4.9 vs 5.3{\%}, respectively, p = 0.788). The secondary endpoint (TLR) occurred in 3{\%} of overall patients and similarly in DM and non-DM patients (3.7 vs 2.5{\%}, respectively, p = 0.273). Primary and secondary endpoints were similar also between insulin and non-insulin dependent DM patients. Conclusions The results of this large, real-world, multicenter-independent registry show that Cre8 AES has similar safety and efficacy profile in DM as well as non-DM patients, reducing the adverse outcomes related to DM in patients undergoing PCI. A large randomized trial will be necessary to definitely prove these preliminary findings.",
keywords = "Amphilimus, Diabetes mellitus, Polymer-free drug eluting, Stent restenosis",
author = "Antonio Colombo and Cosmo Godino and Michael Donahue and Luca Testa and Mauro Chiarito and Pavon, {Anna Giulia} and Riccardo Colantonio and Alberto Cappelletti and Alberto Monello and Valeria Magni and Diego Milazzo and Rosario Parisi and Annamaria Nicolino and Shahram Moshiri and Rossella Fattori and Gianfranco Aprigliano and Altin Palloshi and Giuseppe Caramanno and Matteo Montorfano and Francesco Bedogni and Alberto Margonato and Carlo Briguori",
year = "2016",
month = "7",
day = "1",
doi = "10.1016/j.ijcard.2016.03.088",
language = "English",
volume = "214",
pages = "113--120",
journal = "International Journal of Cardiology",
issn = "0167-5273",
publisher = "Elsevier Ireland Ltd",

}

TY - JOUR

T1 - One-year clinical outcome of amphilimus polymer-free drug-eluting stent in diabetes mellitus patients Insight from the ASTUTE registry (AmphilimuS Italian mUlticenTre rEgistry)

AU - Colombo, Antonio

AU - Godino, Cosmo

AU - Donahue, Michael

AU - Testa, Luca

AU - Chiarito, Mauro

AU - Pavon, Anna Giulia

AU - Colantonio, Riccardo

AU - Cappelletti, Alberto

AU - Monello, Alberto

AU - Magni, Valeria

AU - Milazzo, Diego

AU - Parisi, Rosario

AU - Nicolino, Annamaria

AU - Moshiri, Shahram

AU - Fattori, Rossella

AU - Aprigliano, Gianfranco

AU - Palloshi, Altin

AU - Caramanno, Giuseppe

AU - Montorfano, Matteo

AU - Bedogni, Francesco

AU - Margonato, Alberto

AU - Briguori, Carlo

PY - 2016/7/1

Y1 - 2016/7/1

N2 - Background Despite several improvements in drug-eluting stent (DES) technology, patients with diabetes mellitus (DM) are affected by higher rate of adverse events after PCI with DES, mainly in terms of target lesion revascularization (TLR). The Cre8 stent, a polymer-free amphilimus-eluting stent (AES), has shown promising preliminary results in DM patients. The ASTUTE registry was conceived to assess clinical performance of this polymer-free AES in DM in a "real-world" multicenter-independent cohort of patients. Methods 1216 consecutive patients (1637 lesions) treated with Cre8 between August 2011 and January 2015 were retrospectively enrolled and divided in two groups: DM and non-DM patients. The primary and secondary endpoints were target lesion failure (TLF) and TLR at 1-year, respectively. Results 1-Year clinical outcome was available for 407 (80%) DM and 566 (84%) non-DM patients. Diabetic patients were more frequently affected by hypertension (p <0.001) and dyslipidemia (p <0.001) and more frequently dialyzed (p = 0.010). At 1-year, TLF occurred in 50 (5.1%) overall patients, and was similar in DM and non-DM patients (4.9 vs 5.3%, respectively, p = 0.788). The secondary endpoint (TLR) occurred in 3% of overall patients and similarly in DM and non-DM patients (3.7 vs 2.5%, respectively, p = 0.273). Primary and secondary endpoints were similar also between insulin and non-insulin dependent DM patients. Conclusions The results of this large, real-world, multicenter-independent registry show that Cre8 AES has similar safety and efficacy profile in DM as well as non-DM patients, reducing the adverse outcomes related to DM in patients undergoing PCI. A large randomized trial will be necessary to definitely prove these preliminary findings.

AB - Background Despite several improvements in drug-eluting stent (DES) technology, patients with diabetes mellitus (DM) are affected by higher rate of adverse events after PCI with DES, mainly in terms of target lesion revascularization (TLR). The Cre8 stent, a polymer-free amphilimus-eluting stent (AES), has shown promising preliminary results in DM patients. The ASTUTE registry was conceived to assess clinical performance of this polymer-free AES in DM in a "real-world" multicenter-independent cohort of patients. Methods 1216 consecutive patients (1637 lesions) treated with Cre8 between August 2011 and January 2015 were retrospectively enrolled and divided in two groups: DM and non-DM patients. The primary and secondary endpoints were target lesion failure (TLF) and TLR at 1-year, respectively. Results 1-Year clinical outcome was available for 407 (80%) DM and 566 (84%) non-DM patients. Diabetic patients were more frequently affected by hypertension (p <0.001) and dyslipidemia (p <0.001) and more frequently dialyzed (p = 0.010). At 1-year, TLF occurred in 50 (5.1%) overall patients, and was similar in DM and non-DM patients (4.9 vs 5.3%, respectively, p = 0.788). The secondary endpoint (TLR) occurred in 3% of overall patients and similarly in DM and non-DM patients (3.7 vs 2.5%, respectively, p = 0.273). Primary and secondary endpoints were similar also between insulin and non-insulin dependent DM patients. Conclusions The results of this large, real-world, multicenter-independent registry show that Cre8 AES has similar safety and efficacy profile in DM as well as non-DM patients, reducing the adverse outcomes related to DM in patients undergoing PCI. A large randomized trial will be necessary to definitely prove these preliminary findings.

KW - Amphilimus

KW - Diabetes mellitus

KW - Polymer-free drug eluting

KW - Stent restenosis

UR - http://www.scopus.com/inward/record.url?scp=84964414223&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84964414223&partnerID=8YFLogxK

U2 - 10.1016/j.ijcard.2016.03.088

DO - 10.1016/j.ijcard.2016.03.088

M3 - Article

VL - 214

SP - 113

EP - 120

JO - International Journal of Cardiology

JF - International Journal of Cardiology

SN - 0167-5273

ER -