New-generation metallic DES (EES/BES) were not superior to BVS in terms of angiographic LLL and clinical outcomes. (Comparison of Everolimus- and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents [EVERBIO II]; NCT01711931).

This first clinical study failed to demonstrate any significant difference regarding safety or efficacy between these two types and generations of drug-eluting stents (DES).

BackgroundSecond-generation everolimus-eluting stents (EES) and third generation biolimus-eluting stents (BES) have been shown to be superior to first-generation paclitaxel-eluting stents (PES) and second-generation sirolimus-eluting stents (SES). However, neointimal proliferation and very late stent thrombosis is still an unresolved issue of drug-eluting stent (DES) implantation overall. The Absorb™ (Abbott Vascular, Abbott Park, IL, USA) is the first CE approved DES with a bioresorbable vascular scaffold (BVS) thought to reduce long-term complication rates. The EVERBIO II trial was set up to compare the BVS safety and efficacy with both EES and BES in all patients viable for inclusion.Methods/DesignThe EVERBIO II trial is a single-center, assessor-blinded, randomized trial. The study population consists of all patients aged ≥18 years old undergoing percutaneous coronary intervention. Exclusion criterion is where the lesion cannot be treated with BVS (reference vessel diameter >4.0 mm). A total of 240 patients will be enrolled and randomly assigned into 3 groups of 80 with either BVS, EES or BES implantation. All patients will undergo a follow-up angiography study at 9 months. Clinical follow-up for up to 5 years will be conducted by telephone. The primary endpoint is in-segment late lumen loss at 9 months measured by quantitative coronary angiography. Secondary endpoints are patient-oriented major adverse cardiac event (MACE) (death, myocardial infarction and target-vessel revascularization), device-oriented MACE (cardiac death, myocardial infarction and target-lesion revascularization), stent thrombosis according to ARC and binary restenosis at follow-up 12 months angiography.DiscussionEVERBIO II is an independent, randomized study, aiming to compare the clinical efficacy, angiographic outcomes and safety of BVS, EES and BES in all comer patients.Trial registrationThe trial listed in clinicaltrials.gov as NCT01711931.

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AimPercutaneous coronary interventions require an arterial approach and administration of antithrombotic drugs. This may lead to bleeding complications. The aim of this study was to test whether “The Secret” – a pagan prayer – is effective in reducing post-interventional bleeding.DesignRandomised controlled trial.SettingMonocentric, tertiary care centre.ParticipantsFrom January to July 2022, 200 patients (aged >18 years) undergoing elective coronary angiography were included in the study.InterventionThe intervention group received “The Secret”in addition to the normal procedure. The control group was treated according to standard practice.Main outcome measuresThe primary outcome was the rate of in-hospital bleeding according to the Bleeding Academic Research Consortium (BARC) consensus definition.ResultsThe rate of bleeding was similar in both groups (“The Secret” group vs control group) with 16% versus 14% (p=0.69) of BARC 1, 12% versus 13% (p=0.81) of BARC 2, and 0% versus 0% of BARC 3 and 5 (p=1.00). Most (76%) of the participants believed that “The Secret”would be efficient in preventing bleeding.ConclusionsThis study demonstrates no effect on bleeding after percutaneous coronary procedures. A large majority of our study population believe that “The Secret”can have a positive effect on their hospital care.

Background: The Academic Research Consortium has identified a set of major and minor risk factors in order to standardize the definition of a high bleeding risk (ACR-HBR). Oral anticoagulation is a major criterion frequently observed.Aims: The objective of this study is to quantify the risk of bleeding in patients on oral anticoagulation with at least one additional major ACR-HBR criteria in the Cardio-Fribourg Registry.Methods: Between 2015 and 2017, consecutive patients undergoing percutaneous coronary intervention were prospectively included in the Cardio-Fribourg registry. The study population included patients with ongoing long-term oral anticoagulation (OAC) and planned to receive triple antithrombotic therapy. Patients were divided in two groups: patients on OAC with at least one additional major ACR-HBR criteria vs. patients on OAC without additional major ACR-HBR criteria. The primary endpoint was any bleeding during the 24-month follow-up. Secondary bleeding endpoint was defined as Bleeding Academic Research Classification (BARC) ≥3.Results: Follow-up was completed in 142 patients at high bleeding risk on OAC, of which 33 (23%) had at least one additional major ACR-HBR criteria. The rate of the primary endpoint was 55% in patients on OAC with at least one additional ACR-HBR criteria compared with 14% in patients on OAC without additional ACR-HBR criteria (hazard ratio, 3.88; 95%CI, 1.85–8.14; p < 0.01). Patients with additional major ACR-HBR criteria also experienced significantly higher rates of BARC ≥ 3 bleedings (39% at 24 months).Conclusion: The presence of at least one additional ACR-HBR criterion identifies patients on OAC who are at very high risk of bleeding after percutaneous coronary intervention.