Comparison of biolimus eluted from an erodible stent coating with bare metal stents in acute ST-elevation myocardial infarction (COMFORTABLE AMI trial): rationale and design

Aims: Compared with bare metal stents (BMS), early generation drug-eluting stents (DES) reduce the risk of revascularisation in patients with ST-elevation myocardial infarction (STEMI) at the expense of an increased risk of very late stent thrombosis (ST). Durable polymer coatings for controlled drug release have been identified as a potential trigger for these late adverse events and this has led to the development of newer generation DES with durable and biodegradable polymer surface coatings with improved biocompatibility. In a recent all-comers trial, biolimus-eluting stents with a biodegradable polymer surface coating were found to reduce the risk of very late ST by 80% compared with sirolimus-eluting stents with durable polymer, which also translated into a lower risk of cardiac death and myocardial infarction (MI) beyond one year. Methods and results: The multicentre COMFORTABLE AMI trial (NCT00962416) randomly assigned 1,161 patients to treatment with biolimus-eluting stents with biodegrable polymer and bare metal stents of otherwise identical design at 11 international sites. The primary endpoint is a composite of cardiac death, target-vessel MI and target lesion revascularisation at one year. Assuming a relative risk reduction of 40% in event rates of the primary endpoint in favour of biolimus-eluting stents with biodegradable polymer, 1,064 patients will provide 80% power to demonstrate superiority. Clinical follow-up will be continued through five years. Conclusions: The COMFORTABLE AMI trial will determine whether biolimus-eluting stents with biodegradable polymer are superior to bare metal stents of otherwise identical design. This is the first randomised controlled trial (RCT) investigating DES with a biodegradable polymer surface coating for drug release in the treatment of patients with STEM

Transient injection site reaction to alirocumab during immune system activation: a case series.

Background Injection site reactions (ISRs) are known side effects of the proprotein convertase subtilisin kexin 9 (PCSK9) inhibitor alirocumab. Transient ISR to alirocumab after a long phase of good tolerability have not been reported previously. Case summary A 55-year-old woman (Patient 1) and a 77-year-old man (Patient 2) were treated with alirocumab for the management of dyslipidaemia. Both patients tolerated the treatment without side effects for 7 and 2 months, respectively. After an upper respiratory tract infection in Patient 1 and a first COVID-19 vaccination in Patient 2, both patients suddenly developed ISR with erythema, calor, and itching upon 2 (Patient 1) and 1 (Patient 2) subsequent injection(s), respectively. Symptoms resolved with local steroids, oral antihistamines, and cooling. After termination of the presumed immune system activated state, alirocumab was well tolerated again in both patients without recurrence of any ISR upon repeated applications. Discussion These are the first cases to report transient ISR to a PCSK9 inhibitor, possibly triggered by activation of the immune system, after prolonged good tolerability. Based on the transient and benign nature of the reaction, such patients should be encouraged to continue supervised treatment, as tolerability may return after resolution of the pro-inflammatory state

Pseudoaneurysm Repair With a Septal Occluder

Introduction: New treatment options, like endovascular aortic repair, reduced the mortality rate of patients suffering from complications after an acute type A aortic dissection repair. Nevertheless, initial successful treatment of an aortic dissection does not fully eliminate the risk of later adverse aortic events like anastomotic pseudoaneurysm. Pseudoaneurysm of the anastomosis between the ascending and the arch graft could initiate complications like peripheral embolization, dysphagia or compression of mediastinum organs. Re-operation via re-sternotomy bears enormous morbidity and mortality for these patients. There is a high unmet need for percutaneous therapeutic options to treat pseudoaneurysms. Case Presentation: A 59-year-old-man treated 15 years ago for type A aortic dissection, was hospitalized due to intermittent abdominal pain. A detailed examination revealed 2 pseudoaneurysms: 1 symptomatic at the level of the reimplanted celiac trunk and 1 asymptomatic at the anastomosis between the brachiocephalic trunk and the aortic arch graft. Due to multiple co-morbidities and previous operations, the risk for surgery was considered too high. Both pseudoaneurysm were treated percutaneously, the symptomatic 1 with covered stent and the asymptomatic with Amplatzer septal-occluder. Discussion: We present an alternative percutaneous therapy approach for treatment of pseudoaneurysm using a septaloccluder. A follow-up computed tomography 3 months later showed successfully excluded pseudoaneurysm

Progress with Drug-Eluting Stent Technology from Early to New Generation Devices

__Abstract__ Percutaneous coronary interventions (PCI) are among the most frequently performed medical interventions worldwide refl

Misconception of 'malignant' and 'scissor-like compression' of interarterial course in anomalous aortic origin of a coronary artery: a case series.

BACKGROUND The notion that the 'interarterial' segment of anomalous aortic origin of a coronary artery (AAOCA) is 'malignant' and 'scissor-like' compressed between the aorta and pulmonary artery (PA) is debated, owing to the lower pressure in the pulmonary system compared with that in the coronary system. However, data supporting or refuting this belief under stress conditions are lacking. CASE SUMMARY Three cases of right AAOCA with interarterial/intramural courses (52, 66, and 51 years old) were assessed. Invasively measured fractional flow reserve (FFR) under dobutamine was 0.85, 0.82, and 0.81, respectively. Intravascular ultrasound illustrated lateral vessel compression of the intramural course with a decrease of minimal lumen area (MLA) (i.e. 5.71-3.47 mm2, 5.88-4.00 mm2, and 5.85-4.06 mm2) under stress conditions with heart rates of 130, 140, and 150 b.p.m., respectively. Pulmonary artery pressure (PAP) increased from rest {s/d (m) [systolic/diastolic (mean)] 22/11 (15), 15/2 (5), and 24/6 (14) mmHg} to stress [s/d (m) 47/24 (36), 30/3 (11), and 36/22 (24) mmHg] and remained below aortic peak pressure (blood pressure, BP) rest [s/d (m) 116/64 (91), 94/48 (71), 99/53 and (62) mmHg]; BP stress [s/d (m) 142/63 (80), 123/63 (88), and 86/46 (62) mmHg]; coronary pressure (CoP) rest [s/d (m) 100/59 (80), 80/45 (62), and 83/47 (63) mmHg]; and CoP stress [s/d (m) 95/60 (69),101/54 (72), and 70/32 (50) mmHg]. CONCLUSION This case series challenges the assumption that the interarterial segment of AAOCA is scissor-like compressed by both the aorta and PA. The decrease in MLA and FFR under stress is due to the aorta's unidirectional lateral compression on the intramural segment. Additionally, the term 'malignant' should not be universally applied to all AAOCA cases with an interarterial course, as not all result in haemodynamic significance

Long-term outcome following successful endoscopic closure of tracheo-oesophageal fistulas with two cardiac amplatzer septal occluders in a patient with oesophageal cancer.

Acquired tracheo-oesophageal fistulas (TEFs) are rare and challenging complications in the course of oesophageal cancer. While surgery is the only curative treatment option for TEFs many patients are not eligible for surgery. Endoscopic treatment approaches such as tracheal- and/or oesophageal- stenting are available, but associated with complications like the development of new fistulas and mucus retention. Off- label-use of cardiac amplatzer occluder devices to close TEFs has been reported in few case-reports with inconsistent short-term outcomes. We report a case of successful closure of two adjacent TEFs with two partially overlapping cardiac amplatzer occluder devices. The insertion of a 12 mm and a 9 mm device was successful and without complications. The patient tolerated the cardiac amplatzer-devices well and could resume oral food uptake after 2 months. Two years after closure, the patient remained free of symptoms suggesting complete sealing of the fistulas