Drug-coated balloon for treatment of de-novo coronary artery lesions in patients with high bleeding risk (DEBUT): a single-blind, randomised, non-inferiority trial.

BACKGROUND: The optimal technique of percutaneous coronary intervention in patients at high bleeding risk is not known. The hypothesis of the DEBUT trial was that percutaneous coronary intervention with drug-coated balloons is non-inferior to percutaneous coronary intervention with bare-metal stents for this population. METHODS: The DEBUT trial is a randomised, single-blind non-inferiority trial done at five sites in Finland. Patients were eligible if they had an ischaemic de-novo lesion in a coronary artery or bypass graft that could be treated with drug-coated balloons, at least one risk factor for bleeding, and a reference vessel diameter of 2·5-4·0 mm. Those with myocardial infarction with ST-elevation, bifurcation lesions needing a two-stent technique, in-stent restenosis, and flow-limiting dissection or substantial recoil (>30%) of the target lesion after predilation were excluded. After successful predilation of the target lesion, patients were randomly assigned (1:1), by use of a computer-generated random sequence, to percutaneous coronary intervention with a balloon coated with paclitaxel and iopromide or a bare-metal stent. The primary outcome was major adverse cardiac events at 9 months. Non-inferiority was shown if the absolute risk difference was no more than 3%. All prespecified analyses were done in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT01781546. FINDINGS: Between May 22, 2013, and Jan 16, 2017, 220 patients were recruited for the study and 208 patients were assigned to percutaneous coronary intervention with drug-coated balloon (n=102) or bare metal stent (n=106). At 9 months, major adverse cardiac events had occurred in one patient (1%) in the drug-coated balloon group and in 15 patients (14%) in the bare-metal stent group (absolute risk difference -13·2 percentage points [95% CI -6·2 to -21·1], risk ratio 0·07 [95% CI 0·01 to 0·52]; p<0·00001 for non-inferiority and p=0·00034 for superiority). Two definitive stent thrombosis events occurred in the bare metal stent group but no acute vessel closures in the drug-coated balloon group. INTERPRETATIONS: Percutaneous coronary intervention with drug-coated balloon was superior to bare-metal stents in patients at bleeding risk. The drug-coated balloon-only coronary intervention is a novel strategy to treat this difficult patient population. Comparison of this approach to the new generation drug-eluting stents is warranted in the future. FUNDING: B Braun Medical AG, AstraZeneca, and Competitive State Research Funding of the Kuopio University Hospital Catchment Area.

Percutaneous coronary intervention with drug-coated balloon-only strategy in stable coronary artery disease and in acute coronary syndromes: An all-comers registry study.

OBJECTIVES: The aim of this single center all-comers retrospective registry study was to assess the efficacy and safety of percutaneous coronary intervention (PCI) using drug-coated balloon (DCB) in de novo lesions including large proximal coronary arteries. METHODS: A total of 487 PCIs were performed using paclitaxel-coated DCB in 562 de novo lesions with the possibility for bailout stenting in a patient population presenting with stable coronary artery disease (CAD) or acute coronary syndrome (ACS). Half of the patients had at least one risk factor for bleeding. All of the treated lesions were de novo and 60% of DCBs used were ≥ 3.0 mm in diameter. The median follow-up time was 18 months for MACE and 60 months for survival. RESULTS: The total mortality after DBC only strategy was 2.3 and 9.3% at 12 months in stable CAD and ACS, respectively. The 12-month MACE rate was 7.1 and 12% in stable CAD and ACS. The rate of ischemia-driven target lesion revascularization was only 1.4% in stable CAD and 2.8% after ACS at 12 months. Median duration of DAPT was one month. The 12 month rate of significant bleeding (Bleeding Academic Research Consortium types 2-5) was 5.9%. Acute vessel closure occurred only in one case (0.2%) after DCB treatment. Bailout stenting was used in 12% of lesions. CONCLUSIONS: PCI using DCB-only strategy with the possibility for provisional stenting is a safe and efficient in de novo coronary artery lesions in both stable CAD and ACS. This strategy may be useful especially in patients with high bleeding risk.

Ventricular fibrillation recorded and analysed within an area the size of a mobile phone: could it enable cardiac arrest recognition?

BACKGROUND: Recognition of out-of-hospital-cardiac arrests (OHCAs) at emergency medical communication centres is based on questions of OHCA symptoms, resulting in 50-80% accuracy rates. However, OHCAs might be recognized more promptly using 'rhythm-based' recognition, whereby a victim's cardiac rhythm is recorded with mobile phone technology that analyses and transmits recordings to emergency medical communication centres for further interpretation. OBJECTIVE: To examine whether the quality of normal cardiac rhythm and the rhythm with the best prognosis in OHCA, ventricular fibrillation (VF), is sufficient for 'rhythm-based' OHCA recognition when recorded within a mobile phone-sized device. PATIENTS AND METHODS: mid-sternum within an area the size of a mobile phone and analysed by automated external defibrillator (AED) software and two cardiologists. The rhythms were categorized as shockable or nonshockable. The cardiologists assessed the quality of the recordings. RESULTS: The AED software correctly analysed all normal rhythms and 15 of 22 VF rhythms. The VF duration was too short for automatic detection in seven cases. The cardiologists analysed all the normal rhythms and VF sequences correctly and graded them as high quality. CONCLUSION: The recordings of normal ECG rhythm and VF within an area the size of a mobile phone are of sufficient quality and could be used in 'rhythm-based' OHCA recognition. The VF period was too short for an accurate analysis by the AED software in some cases.

Percutaneous Coronary Intervention of Complex Calcified Lesions With Drug-Coated Balloon After Rotational Atherectomy.

OBJECTIVES: We investigated the safety and efficacy of PCI using drug-coated balloon (DCB) after rotational atherectomy (rotablation) in a retrospective single center study in patients with calcified de novo coronary lesions. The majority of patients had an increased risk for bleeding. BACKGROUND: DCB has been effective in the treatment of in-stent restenosis, small vessels, and bifurcations. DCB enables short one month dual antiplatelet treatment. No published data exist on the use of DCB after rotablation. METHODS: 82 PCIs were performed in 65 patients (mean age 72 ± 10 years) using rotablation followed by DCB treatment. The median follow-up time was 17 months. 82% of the patients had at least one risk factor for bleeding such as oral anticoagulation. 32% had an acute coronary syndrome. Median duration of dual antiplatelet treatment was 1 month. RESULTS: MACE (the composite of cardiovascular death, ischemia-driven target-lesion revascularization [TLR] or non-fatal myocardial infarction) occurred in 14% and 20% of the patients at 12 and 24 months, respectively. The rate of ischemia-driven TLR was 1.5% at 12 months and 3.0% at 24 months. No acute closure of the treated vessel occurred. Bailout stenting was needed in 10% of the PCIs. The incidence of significant bleeding was 9% at 12 months. CONCLUSIONS: This is the first study to show that PCI using DCB after preparation of calcified lesions with rotablation is safe and effective. This novel strategy may be considered especially in patients with a bleeding risk such as those using an oral anticoagulant.

The feasibility of recognizing the heart rhythm with an automated external defibrillator from an area the size of a mobile phone.

OBJECTIVE: Recognition of cardiac arrest (CA) during an emergency call leans on questions concerning CA symptoms and is correct in 50-83% of cases. If the heart rhythm could be recorded and analysed over a mobile phone or transmitted during the emergency call to the dispatch centre and analysed there, using software identical to one in an automated external defibrillator (AED), CA recognition could be more prompt. We investigated whether an AED can correctly analyse normal heart rhythms recorded within an area the size of a mobile phone. METHODS: Bipolar ECG signal was recorded using an AED in 20 healthy volunteers in four different positions during rest and muscle tension with small pads in an area the size of a mobile phone. Recordings obtained with standard pads in standard positions served as the reference. The recorded ECGs were analysed with an AED and by two cardiologists and categorized as shockable or nonshockable. RESULTS: All analyses were correct when the recordings were performed vertically at the midsternum level. Horizontally at this level, the AED made correct analyses in 95 and 65% of cases and the cardiologists in 100 and 88% of cases at rest and during muscle tension, respectively. In the lateral positions only the analyses by cardiologists partly reached 100% sensitivity. The analysis time of the AED was 7 s in all positions. CONCLUSION: ECGs can be analysed promptly with an AED within an area the size of a mobile phone. The most reliable recording position was vertical at the midsternum level.

[Update on Current Care Guidelines. Current Care Guideline: Stable Coronary Artery Disease]. / Kaypa Hoite-Suosituksen Paivitystiivistelma. Stabiili sepelvaltimotauti.

This guideline covers coronary heart disease symptoms, diagnosis and treatment. Stable coronary heart disease refers to a disease in, which patients have stable symptoms and evidence of ischemia or significant stenosis of coronary artery. Diagnosis is based on medical history and exercise test, which is the primary diagnostic test. Coronary angiography is in selected cases necessary to confirm the diagnosis and assess invasive treatment. Pharmacotherapy aims to improve the survival of the patient, relieve symptoms and improve quality of life. The guideline also deals with invasive treatment either with PCI or CABG.