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1

Retrospective Analysis of ACS Patients with EES or R-ZES

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We retrospectively analyzed the ACTION-ACS, a pooled large patient ACS database involving
two interventional large-volume academic centers based in Poland: the Department of
Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, and the
Nicolaus Copernicus University, Bydgoszcz, Poland. Information on the follow-up events was
site-reported and adjudicated by a trained physician-investigator. Data of consecutive
patients with ACS, undergoing PCI with EES (Xience, Abbott Vascular, Santa Clara, CA, USA
and Promus Element, Boston Scientific, Natick, MA, USA) or R-ZES (Resolute Integrity,
Resolute Onyx, Medtronic, Fridley, MN, USA), were collected between November 2009 and
February 2017 (Figure 1). Relevant
baseline information, procedural, and clinical outcomes at follow-up were entered into
prespecified electronic case report forms. Angioplasty and stent selection were performed
according to standard techniques at the discretion of the interventional cardiologist. All
patients were prescribed dual antiplatelet therapy (DAPT) consisting of acetylsalicylic
acid, 75 to 100 mg daily, and a P2Y12 inhibitor for at least 1 year according to
guidelines.
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2

Dual Antiplatelet Therapy in DES Patients

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Adults who were candidates for dual antiplatelet therapy following treatment with FDA-approved drug-eluting or bare metal stents were enrolled. Detailed inclusion and exclusion criteria are listed in the Supplementary Appendix. Each subject provided written informed consent at enrollment.
The primary analytic population and focus of this report is subjects treated with drug-eluting stents only (results in subjects treated with bare metal stents will be reported in a separate publication; see Figure 1). Drug-eluting stents included sirolimus-eluting stents (Cypher, Cordis), zotarolimus-eluting stents (Endeavor, Medtronic), paclitaxel-eluting stents (TAXUS, Boston Scientific), and everolimus-eluting stents (Xience, Abbott Vascular and PROMUS, Boston Scientific). It was recommended that all subjects receive either clopidogrel at a maintenance dose of 75 mg daily or prasugrel at a maintenance dose of 10 mg daily (a dose of 5 mg daily was recommended in subjects weighing less than 60 kg).13 (link) The recommended maintenance aspirin dosage was 75 to 162 mg daily, continued indefinitely.
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3

Vascular Healing Assessment Following EES Implantation in Calcified Coronary Stenosis

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The study protocol was carried out in accordance with the Declaration of Helsinki and was approved by Ethical Committee of Osaka Metropolitan University Graduate School of Medicine (Approval Number: 2020–271). This retrospective observational study enrolled 31 patients, treated at Osaka Metropolitan University Hospital from June 2015 to June 2021, who fulfilled the following eligibility criteria: (1) patients who underwent PCI using FD-OCT, (2) patients with severely calcified coronary stenosis (calcium arc > 180°), (3) patients who underwent PCI using atherectomy devices (rotational or orbital atherectomy), (4) patients who underwent BP-EES (Synergy, Boston Scientific, Marlborough, MA, USA) or DP-EES (Xience, Abbott Vascular, Santa Clara, CA, USA) implantation, and (5) patients who underwent follow-up coronary angiography and FD-OCT observation of the target vessels in 180 to 730 days after EES implantation, aiming to evaluate the early to mid-term vascular healing. Patients with acute thrombosis in the culprit lesion after PCI were excluded (n = 1). A total of 30 patients with 30 lesions were finally included in the statistical analysis.
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4

Paclitaxel-iopromide Balloon vs. DES

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The different devices are specified in Table 1. As a balloon, the polymer‐free paclitaxel‐iopromide–coated balloon SeQuent Please (B. Braun Melsungen AG, Melsungen, Germany) is used. The DES group consists of 2 stent types: the everolimus‐eluting Xience stent (Abbott Vascular, Santa Clara, CA; also distributed as the Promus stent by Boston Scientific Natick, MA), and the paclitaxel‐eluting Taxus Element stent (Boston Scientific). Initially, the study was started with the paclitaxel‐eluting Taxus Element stent as comparator to use devices with similar agents. However, after inclusion of 20% of patients, the paclitaxel‐eluting stent was no longer available.23, 24 To continue the trial, the steering committee decided to replace the initial comparator stent with the best‐in‐class later‐generation DES (ie, the everolimus‐eluting stent). Accordingly, the sample size was increased to comply with the different efficacy of the 2 comparator stents.
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5

Optical Coherence Tomography of BVS vs EES

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Between March and June 2013, 26 consecutive patients underwent OCT immediately after implantation of 40 BVS (Absorb, Abbott Vascular, Santa Clara, CA, USA). Elective patients as well as patients presenting with acute coronary syndrome (ACS) were included. The OCT data of these patients were retrospectively compared with those of 34 consecutive patients after implantation of 40 metallic everolimus-eluting stents (EES, Xience, Abbott Vascular, Santa Clara, CA, USA).
Patient characteristics were collected from the medical records of each patient, device characteristics and deployment strategies were collected from the database of the cardiac catheter laboratory. This study was approved by the ethics committee of the Medical University of Vienna and all patients gave their written informed consent.
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6

Comparative Analysis of Drug-Eluting Stents

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The second-and third-generation DESs were defined as everolimus-eluting stents with a durable polymer (Xience [Abbott Vascular, Santa Clara, California] and Promus [Boston Scientific, Natick, Massachusetts]), zotarolimus-eluting stents with a durable polymer (Resolute [Medtronic, Minneapolis, Minnesota]), everolimus-eluting stents with a bioabsorbable polymer (Synergy [Boston Scientific, Natick, Massachusetts]), biolimus-eluting stents with a biodegradable polymer (Nobori [Terumo, Tokyo, Japan]), Ultimaster sirolimus-eluting stents with a biodegradable polymer (Ultimaster [Terumo, Tokyo, Japan] and Orsiro [Biotronik, Bülach, Switzerland]), Biomatrix biolimus A9 (BA9)-eluting stents with a biodegradable polymer, and BioFreedom BA9-coated stents (Biosensors, Newport Beach, California) [3 (link)].
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7

Observational Study of PCI in Poland

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The data were obtained from a prospective, observational registry of all patients treated with PCI in four interventional cardiology centers in Poland (Sosnowiec, Raciborz, Chorzow, Czestochowa) without cardiac surgery on site. We performed a retrospective screening of unselected individuals (n = 21 400) treated with PCI between 2010 and 2016. We included all consecutive patients with AMI (STEMI and NSTEMI) who underwent single or multi-vessel revascularization with either a BP-SES (ALEX, Balton, Warsaw, Poland) or a DP-EES (XIENCE, Abbott Vascular, Santa Clara, CA) during the index procedure. Relative contributions of the centers in terms of number of patients included were as follows: Czestochowa 39.3%, Sosnowiec 28.8%, Chorzow 16.1% and Raciborz 15.8%. Follow-up data for patients treated in the years 2015–2016 are currently not available. Therefore, for the final analysis only patients treated between 2010 and 2014 were selected, because 1-year follow-up data were available for all the patients. Due to the observational nature of the study and lack of any interference in the diagnostic and therapeutic decision-making process no permission was required from the Institutional Review Board and Bioethics Committee.
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8

Comparative Coronary Stent Evaluation

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Stents for implantation were chosen from first-generation DES durable polymer
based [Paclitaxel-eluting stents (PES) (Taxus, Boston Scientific Corporation,
Maple Grove, MN, USA) or Sirolimus-eluting stent (SES) (Cypher, Cordis, USA)] or
second-generation DES [Everolimus-eluting stent (EES) (Promus, Boston Scientific
Corporation; Xience, Xience Prime, Abbott Vascular, Santa Clara, CA, USA),
Zotarolimus-eluting stent (ZES) (Endeavor, Resolute, Medtronic, Minneapolis, MN,
USA), and Biolimus-eluting stent (BES) (Biolimus A9, Biosensors International,
Switzerland)].
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9

Durable vs. Biodegradable Polymer DES Performance

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The following stents in the ROCK registry had durable polymers and were analyzed as the DP-DES group: 1. Xience (Abbott Vascular, Santa Clara, CA, USA), a cobalt chromium everolimus eluting stent (CoCr-EES) with strut thickness 81 μm. (n = 99) 2. Resolute Onyx (Medtronic, Santa Rosa, CA, USA), a zotarolimus eluting stent (ZES) with strut thickness 81 μm. (n = 61) 3. Endeavor (Medtronic, Santa Rosa, CA, USA), a ZES with strut thickness 91 μm. (n = 32) 4. Promus (Boston Scientific, Marlborough, MA, USA), a platinum chromium everolimus eluting stent (PtCr-EES) with strut thickness 81 μm (n = 80).
Meanwhile, the following stents in the ROCK registry had biodegradable polymers and were analyzed as the DP-DES group: 1. Ultimaster (Terumo, Tokyo, Japan), a cobalt chromium sirolimus eluting stent (CoCr-SES) with strut thickness 80 μm. (n = 44) 2. Orsiro (Biotronik, Berlin, Germany), a CoCr-SES with strut thickness 60 μm for stent diameter 2.25–3.0 mm and 80 μm for larger diameters. (n = 31) 3. Synergy (Boston Scientific, Marlborough, MA, USA), a platinum chromium everolimus eluting stent (PtCr-EES) with strut thickness 74 μm. (n = 150) 4. Nobori (Terumo, Tokyo, Japan), a stainless steel biolimus eluting stent (BES) with strut thickness 112 μm. (n = 6) 5. Biomatrix (Biosensors International, Morges, Switzerland), a CoCr-BES with strut thickness 83 μm (n = 7).
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10

Coronary Stent Restenosis Patterns

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A total of 66 ISR lesions were identified in 41 consecutive patients enrolled in this study. We found 44 ISR within G1 DES: 21 sirolimus-eluting stents (SES) (Cypher SELECT, Cordis, Miami Lakes, FL, USA) and 23 paclitaxel-eluting stents (PES) (Taxus EXPRESS and Liberté, Boston Scientific, Natick, MA, USA). We also identified 22 ISR lesions in G2 DES: of which 11 everolimus-eluting stents (EES) (9 Xience, Abbott Vascular, Santa Clara, CA, USA; and 2 Promus, Boston Scientific, Natick, MA, USA) 10 zotarolimus-eluting stents (ZES) (Resolute, Medtronic, Santa Rosa, CA, USA) and 1 biolimus-eluting stent (BES) (BioMatrix Flex, Biosensors Inc, Newport Beach, CA, USA) (Fig. 3). Coronary angiography was clinically driven in 58.2% of cases and electively scheduled in the remaining. Only 5 lesions (7.6%) required balloon pre-dilatation before OCT pullback.

Schematic view of enrolled stents, according to generation, eluted drug and brand. For acronyms see “Results” chapter.

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