Evaluation of the safety and efficacy of the Cobra PzF NanoCoated coronary stent in routine, consecutive, prospective, and high-risk patients: The e-Cobra study.


Journal

Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
ISSN: 1522-726X
Titre abrégé: Catheter Cardiovasc Interv
Pays: United States
ID NLM: 100884139

Informations de publication

Date de publication:
01 07 2021
Historique:
revised: 02 05 2020
received: 25 08 2019
accepted: 24 05 2020
pubmed: 18 6 2020
medline: 21 10 2021
entrez: 18 6 2020
Statut: ppublish

Résumé

The Cobra PzF coronary stent is cobalt chromium with flat thin struts, nano-coated with Polyzene-F that enhance rapid reendothelialization and reduce the risk of stent thrombosis and restenosis. It is designed to overcome shortfalls of BMS and DES in patients requiring short DAPT duration. To report procedural and 1-year clinical outcomes following Cobra PzF stent implantation in routine practice PCI. e-Cobra registry is a multicenter prospective study to evaluate Cobra PzF stent in routine practice in patients deemed appropriate for short DAPT after PCI. The primary endpoint was MACE rate at 12 months (Cardiac death, MI, TLR). The secondary endpoint was definite stent thrombosis at 12 months. Among 940 patients (72% men, 72.8 ± 13.4 years) with multiple co-morbidities, 47% had acute coronary syndromes, and 62% were defined as high bleeding risk. A total of 1,229 lesions were treated with 1,314 stents. 36% of patients had lesion type B2 or C classification. Angiographic success was achieved in all cases. One-year follow-up was available for 97% of patients. The primary endpoint occurred in 9.0% of patients, including cardiac death 3.7%, MI 4.8%, and TLR 4.3%. Definite stent thrombosis occurred in six out of 915 (0.7%). The Cobra PzF stent was safe and effective in routine practice patients and seems feasible in situations when short DAPT or Mono Antiplatelet Therapy (MAPT) is needed. One-year follow-up was associated with satisfactory clinical outcomes and validate previously reported data.

Sections du résumé

BACKGROUND
The Cobra PzF coronary stent is cobalt chromium with flat thin struts, nano-coated with Polyzene-F that enhance rapid reendothelialization and reduce the risk of stent thrombosis and restenosis. It is designed to overcome shortfalls of BMS and DES in patients requiring short DAPT duration.
AIMS
To report procedural and 1-year clinical outcomes following Cobra PzF stent implantation in routine practice PCI.
METHODS
e-Cobra registry is a multicenter prospective study to evaluate Cobra PzF stent in routine practice in patients deemed appropriate for short DAPT after PCI. The primary endpoint was MACE rate at 12 months (Cardiac death, MI, TLR). The secondary endpoint was definite stent thrombosis at 12 months.
RESULTS
Among 940 patients (72% men, 72.8 ± 13.4 years) with multiple co-morbidities, 47% had acute coronary syndromes, and 62% were defined as high bleeding risk. A total of 1,229 lesions were treated with 1,314 stents. 36% of patients had lesion type B2 or C classification. Angiographic success was achieved in all cases. One-year follow-up was available for 97% of patients. The primary endpoint occurred in 9.0% of patients, including cardiac death 3.7%, MI 4.8%, and TLR 4.3%. Definite stent thrombosis occurred in six out of 915 (0.7%).
CONCLUSION
The Cobra PzF stent was safe and effective in routine practice patients and seems feasible in situations when short DAPT or Mono Antiplatelet Therapy (MAPT) is needed. One-year follow-up was associated with satisfactory clinical outcomes and validate previously reported data.

Identifiants

pubmed: 32548891
doi: 10.1002/ccd.29065
doi:

Substances chimiques

Coated Materials, Biocompatible 0

Types de publication

Journal Article Multicenter Study Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

45-54

Subventions

Organisme : CeloNova

Commentaires et corrections

Type : CommentIn

Informations de copyright

© 2020 Wiley Periodicals LLC.

Références

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Auteurs

Luc Maillard (L)

GCS ES Axium Rambot, Aix en Provence, France.

Axel de Labriolle (A)

Clinique du Pont de Chaumes, Montauban, France.

Camille Brasselet (C)

Polyclinique de Courlancy, Reims, France.

Benjamin Faurie (B)

Institut Cardiovasculaire, Groupe Hospitalier Mutualiste, Grenoble, France.

Nicolas Durel (N)

Clinique des Domes, Clermont Ferrand, France.

Fabien de Poli (F)

Center Hospitalier Haguenau, Haguenau, France.

Sébastien Bosle (S)

Center Hospitalier de Brive de la Gaillarde, Brive de la Gaillarde, France.

Hend Madiot (H)

Center Hospitalier Annecy Genevois, Metz-Tessy, France.

Jacques Berland (J)

Clinique Saint Hilaire, Rouen, France.

Loic Belle (L)

Center Hospitalier Annecy Genevois, Metz-Tessy, France.

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