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Observational Study
. 2023 Dec 13:2023:8907315.
doi: 10.1155/2023/8907315. eCollection 2023.

In-Hospital and 1-Year Clinical Results from the French Registry Using Polymer-Free Sirolimus-Eluting Stents in Acute Coronary Syndrome and Stable Coronary Artery Disease

Quentin Landolff  1 , Marine Quillot  2 , Fabien Picard  3 , Patrick Henry  4 , Georgios Sideris  4   5 , Olivier Bizeau  6 , Christophe Piot  7 , Bernard Jouve  8 , Jérôme Rischner  9 , Mourad Mejri  10 , Claude Charmasson  11 , Raphael Lasserre  12 , Hervé Pouliquen  13 , Thierry Joseph  14 , Jacques Monsegu  15 , Bernard Karsenty  16 , Victoria Martin Yuste  17 , Nicolas Richet  18 , Guy Lapeyre  19 , Fabrizio Beverelli  20 , Farzin Beygui  21 , René Koning  1
Affiliations
Observational Study

In-Hospital and 1-Year Clinical Results from the French Registry Using Polymer-Free Sirolimus-Eluting Stents in Acute Coronary Syndrome and Stable Coronary Artery Disease

Quentin Landolff et al. J Interv Cardiol. .

Abstract

Objectives: The aim of this postmarket clinical study was to assess the safety and efficacy of the latest generation polymer-free sirolimus-eluting stents (PF-SES) in an all-comers population comparing outcomes in stable coronary artery disease (CAD) versus acute coronary syndrome (ACS) in France.

Background: The efficacy and safety of the first-generation PF-SES have already been demonstrated by randomized controlled trials and "all-comers" observational studies.

Methods: For this all-comers observational, prospective, multicenter study, 1456 patients were recruited in 22 French centers. The primary endpoint was target lesion revascularization (TLR) rate at 12 months and secondary endpoints included major adverse cardiac events (MACE) and bleeding.

Results: 895 patients had stable CAD and 561 had ACS. At 12 months, 2% of patients had a TLR, with similar rates between stable CAD and ACS (1.9% vs 2.2%, p = 0.7). The overall MACE rate was 5.2% with an expected higher rate in patients with ACS as compared to those with stable CAD (7.3% vs 3.9%, p = 0.007). The overall bleeding event rate was 4.5%, with similar rates in stable CAD as compared to ACS patients (3.8% vs 5.6%, p = 0.3). Dual antiplatelet therapy (DAPT) interruptions prior to the recommended duration occurred in 41.7% of patients with no increase in MACE rates as compared to patients who did not prematurely interrupt DAPT (3.9% vs 6.1%, p = 0.073).

Conclusions: The latest generation PF-SES is associated with low clinical event rates in these all-comers patients. There was a high rate of prematurely terminated DAPT, without any effect on MACE at 12 months. This trial is registered with NCT03809715.

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Conflict of interest statement

Quentin Landolff, Marine Quillot, Fabien Picard, Georgios Sideris, Raphael Lasserre, and René Koning report consulting fees from B. Braun. The other authors have no conflicts of interest to declare.

Figures

Figure 1
Figure 1
Comparison of two polymer-free sirolimus-eluting stents (PF-SES) with differences in stent architecture (top panel: Coroflex® ISAR and bottom panel: Coroflex® ISAR NEO, B. Braun) [4].
See this image and copyright information in PMC

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