Acute Coronary Syndrome, Coronary Artery Disease, Myocardial Infarction, Percutaneous Coronary Intervention, Stent Thrombosis
Conditions
Keywords
drug-eluting stent, polymer-free stent, sirolimus, percutaneous coronary intervention, target lesion failure, registry, real-world evidence
Brief summary
POLARIS is a prospective, single-centre, single-arm observational pilot registry evaluating the real-world safety and efficacy of the Focus np (Abluminus np, Concept Medical, Tampa, FL, USA) polymer-free sirolimus-eluting stent in consecutive adult patients undergoing percutaneous coronary intervention (PCI). The primary endpoint is target lesion failure (TLF) at 12 months, defined per Academic Research Consortium-2 (ARC-2) criteria as the device-oriented composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularisation. Patients treated since January 2021 will be retrospectively identified and prospectively consented, with follow-up through 5 years. The registry will provide the first Western clinical evidence on this CE-marked device and serve as a template for a future national Swiss multicentre registry.
Detailed description
BACKGROUND. Newer-generation drug-eluting stents (DES) remain associated with late stent-related adverse events at approximately 2% per year, driven by neoatherosclerosis, delayed endothelial healing, and chronic inflammation attributable to permanent polymer coatings. Polymer-free DES were developed to remove this substrate. The polymer-free sirolimus-based submicron carrier-eluting stent Focus np (Abluminus np, Concept Medical, Tampa, FL, USA) (after: study device) is a novel polymer-free sirolimus-eluting stent built on a thin-strut (73 micrometres) cobalt-chromium platform, with drug delivery via biodegradable phospholipid submicron carriers (200-300 nm) confined to the abluminal surface, and a proprietary fusion coating extending sirolimus up to 5 mm beyond the stent edges. The device received CE marking on 24 January 2020. Only limited non-randomized Indian clinical data exist; no Western clinical data have been published. OBJECTIVES. Primary: to evaluate device-oriented safety and efficacy (TLF at 12 months) of the stent in an all-comer population undergoing PCI at Geneva University Hospitals. Secondary: TLF at 2 and 5 years; individual components of TLF (cardiac death, target vessel MI, clinically indicated target lesion revascularisation) at 30 days, 12 months, 2 years, and 5 years; patient-oriented composite endpoint (all-cause death, any MI, any revascularisation); stent thrombosis (definite / probable, ARC-2, with temporal classification); target vessel failure; major bleeding (BARC 3 or 5); all-cause mortality; and late lumen loss when angiographic follow-up is available. DESIGN. Prospective, single-centre, single-arm observational registry (Category A research with human subjects per the Swiss Human Research Act). Hybrid enrolment: retrospective identification from January 2021, prospective consent, and prospective follow-up at 30 days, 12 months, 2 years, and 5 years via medical records and telephone interview. POPULATION. All consecutive adult patients (\>= 18 years) treated with at least one study device stent at Geneva University Hospitals since January 2021, with an indication for PCI according to current European or American guidelines, able to provide written informed consent, and with sufficient knowledge of French, German, English, or Italian. STATISTICS. Exploratory, descriptive analysis. Binary endpoints with Clopper-Pearson 95% confidence intervals; time-to-event analysis by Kaplan-Meier with Greenwood 95% CIs. Pre-specified exploratory subgroup analyses (sex, clinical presentation, diabetes, age, lesion complexity, stent length) presented as forest plots without between-group p-values. Sensitivity analyses include per-protocol, complete-case, landmark (30 days to 12 months), Fine-Gray competing-risk, and tipping point analyses. Analyses in Python (lifelines, pandas, scipy, statsmodels). Reporting follows STROBE.
Interventions
DEVICEPolymer-free sirolimus-based submicron carrier-eluting stent Focus np (Abluminus np, Concept Medical, Tampa, FL, USA)
Thin-strut (73 micrometres) cobalt-chromium coronary stent with polymer-free submicron phospholipid carriers (200-300 nm) delivering sirolimus exclusively to the abluminal surface, and fusion coating extending sirolimus deposition up to 5 mm beyond the stent edges. CE-marked 24 January 2020. Available diameters 2.25-4.0 mm and lengths 8-40 mm. Manufactured by Concept Medical, Tampa, FL, USA. Implantation and peri-procedural care follow operator discretion and institutional standard of care.
Sponsors
Dorian Garin
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>= 18 years at the time of the index procedure. * Percutaneous coronary intervention performed at Geneva University Hospitals between January 2021 and December 2025. * Implantation of at least one study device * Indication for PCI according to current European or American guidelines. * Able and willing to provide written informed consent. * Sufficient knowledge of French, German, English, or Italian to understand the patient information document.
Exclusion criteria
* Documented refusal to participate in research through opt-out from general consent. * Inability to provide informed consent (cognitive impairment or other). * Inability to be contacted for informed consent (no valid contact information, or unreachable after three contact attempts). * Life expectancy less than 12 months due to non-cardiac comorbidities at the time of consent. * Participation in another clinical trial that would interfere with the endpoints of this registry.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target Lesion Failure (TLF) | 12 months | Device-oriented composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularisation, defined per Academic Research Consortium-2 (ARC-2) criteria. Binary categorical variable analysed by time-to-first-event method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target Lesion Failure (TLF) at 2 and 5 years | 2 years; 5 years | Same ARC-2 composite definition as primary endpoint, assessed at 2 and 5 years. |
| Cardiac death | 30 days; 12 months; 2 years; 5 years | — |
| Target vessel myocardial infarction | 30 days; 12 months; 2 years; 5 years | Myocardial infarction attributable to the target vessel, defined per ARC-2 and the 4th Universal Definition of Myocardial Infarction. |
| Clinically indicated target lesion revascularisation | 30 days; 12 months; 2 years; 5 years | — |
| Patient-oriented composite endpoint (POCE) | 12 months; 2 years; 5 years | Composite of all-cause death, any myocardial infarction, and any revascularisation. |
| Definite or probable stent thrombosis (ARC-2) | Acute (0-24h), subacute (1-30d), late (30d-1y), very late (>1y), up to 5 years | — |
| Target vessel failure (TVF) | 12 months; 2 years; 5 years | Composite of cardiac death, target vessel myocardial infarction, and clinically indicated target vessel revascularisation. |
| Major bleeding (BARC type 3 or 5) | 12 months; 2 years; 5 years | — |
| All-cause mortality | 12 months; 2 years; 5 years | — |
| Late lumen loss (mm) | At clinically indicated follow-up angiography, up to 5 years | In-stent late lumen loss by quantitative coronary angiography, assessed only in patients undergoing clinically indicated follow-up angiography. |
Countries
Switzerland
Contacts
CONTACTJuan F Iglesias, MD, FESC, FACC
CONTACTDorian Garin, MD
PRINCIPAL_INVESTIGATORJuan F Iglesias, MD, FESC, FACC
Geneva University Hospitals (HUG), Interventional Cardiology Unit
STUDY_DIRECTORDorian Garin, MD
Geneva University Hospitals (HUG), Department of Cardiology
Outcome results
None listed