Trial reportClinical research in cardiology : official journal of the German Cardiac Society2019
Polymer-free drug-coated coronary stents in diabetic patients at high bleeding risk: a pre-specified sub-study of the LEADERS FREE trial.
Trial report in Clinical research in cardiology : official journal of the German Cardiac Society, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01623180 (A Prospective Randomized Comparison of the BioFreedom Biolimus A9 Drug Coated Stent Versus the Gazelle Bare Metal Stent in Patients With High Risk of Bleeding.), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Prospective Randomized Comparison of the BioFreedom Biolimus A9 Drug Coated Stent Versus the Gazelle Bare Metal Stent in Patients With High Risk of Bleeding.
Who cites it
8 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.
- Polymer-free stents for percutaneous coronary intervention in diabetic patients: a systematic review and meta-analysis.Future cardiology · 2024Pooled it
- Clinical outcomes after permanent polymer or polymer-free stent implantation in patients with diabetes mellitus: The ReCre8 diabetes substudy.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2022Trial
- Ten-year clinical outcomes of polymer-free versus durable polymer new-generation drug-eluting stent in patients with coronary artery disease with and without diabetes mellitus : Results of the Intracoronary Stenting and Angiographic Results: Test Efficacy of Sirolimus- and Probucol- and Zotarolimus-Eluting Stents (ISAR-TEST 5) trial.Clinical research in cardiology : official journal of the German Cardiac Society · 2021Trial
- Polymer-free drug-coated vs. bare-metal coronary stents in patients undergoing non-cardiac surgery: a subgroup analysis of the LEADERS FREE trial.Clinical research in cardiology : official journal of the German Cardiac Society · 2021Trial
- Role of Polymer-Free Drug-Eluting Stents in Insulin-Dependent Diabetic Patients Undergoing Percutaneous Coronary Intervention: An Observational Study.Journal of personalized medicine · 2025Article
- Drug Coated Balloon in the Treatment of De Novo Coronary Artery Disease: A Narrative Review.Journal of clinical medicine · 2023Review
- Polyhedral erythrocytes in intracoronary thrombus and their association with reperfusion in myocardial infarction.Clinical research in cardiology : official journal of the German Cardiac Society · 2019Article
- Incidence, predictors, and outcomes of DAPT disruption due to non-compliance vs. bleeding after PCI: insights from the PARIS Registry.Clinical research in cardiology : official journal of the German Cardiac Society · 2019Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 7 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveDiabetics are at increased risk after stent implantation and potentially sensitive to the type of stent and dual anti-platelet therapy (DAPT). The randomized, double-blind LEADERS FREE trial compared 2432 patients at high bleeding risk (HBR) receiving either a polymer-free BA9-coated stent (DCS) or a bare metal stent (BMS) with 1 month of DAPT, and showed superior safety and efficacy of the DCS at 2 years. We report outcomes at 2 years of the pre-specified diabetic subgroup. METHODS AND
resultsThe diabetic sub-group comprised 805 (33.1%) patients; 262 (10.8%) were insulin-dependent (IDDM). Compared to non-diabetics, diabetics were younger and had more risk factors and multi-vessel disease. They suffered higher rates of death (15.6 vs. 12.2%, p = 0.01), cardiac death (8.3 vs. 5.9%, p = 0.02), myocardial infarction (MI) (11.1 vs. 7.8%, p = 0.009) and definite/probable stent thrombosis (3.1 vs. 1.7%, p = 0.01), but rates of clinically-indicated TLR (9.1 vs. 9.5%, p = 0.93) and BARC 3-5 bleeding (10.2 vs. 8.4%, p = 0.20) were comparable. Compared to diabetic patients treated with a BMS, diabetic DCS recipients required less clinically driven TLR (6.3 vs. 12.2%, p = 0.006). The primary safety endpoint (cardiac death, MI, definite/probable stent thrombosis) occurred numerically less frequently in the DCS group (14.9 vs. 19.7%, p = 0.10), and was significantly lower in IDDM patients (13.8 vs. 25.4%, p = 0.03). BARC 3-5 was similar for patients treated with DCS (9.9%) and BMS (10.5%, p = 0.84).
conclusionsIn diabetic HBR patients, DCS significantly reduced re-intervention rates over BMS, and showed a strong trend towards a safety benefit at 2 years. CLINICAL
trial registrationClinicalTrials.gov number: NCT01623180.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.