Outcomes of 10,312 patients treated with everolimus-eluting bioresorbable scaffolds during daily clinical practice - results from the European Absorb Consortium.

OBJECTIVES: To asses mid-term clinical outcomes of bioresorbable vascular scaffolds (BVS) for the treatment of coronary artery disease in a large-scale all-comers population. BACKGROUND: Several clinical settings are underrepresented in randomized studies investigating BVS against drug-eluting stents. Whether their results can be translated into the heterogeny patient population seen during daily routine requires further investigation. METHODS: The European ABSORB Consortium comprises the following European registries: GABI-R, ABSORB UK Registry, ABSORB France, BVS RAI Registry, and REPARA BVS Registry, which all prospectively collected patient-level data regarding outcomes following unrestricted BVS implantation. The primary endpoint of target lesion failure (TLF) includes cardiac death, target-vessel myocardial infarction (TVMI) and target-lesion revascularisation (TLR) at 12 months. The incidence of scaffold thrombosis (ST) according to ARC criteria was also assessed. Multivariable analysis was used to adjust for differences in patient and lesion characteristics. RESULTS: A total of 10,312 patients (mean age 58.4 ± 11.4 y) underwent BVS implantation during routine practice. The 12-month follow-up was complete in 95.5% of patients. At 12 months, the primary endpoint of TLF occurred in 3.6%; its components cardiac death, TVMI and TLR were documented in 1.2%, 1.8%, and 2.6%, respectively. The definite/probable ST rate was 1.7%. Absence of predilatation, discontinuation of DAPT and scaffold diameter below 3 mm were independent predictors of ST. CONCLUSIONS: The EAC demonstrates reasonable real-world clinical outcome data after BVS implantation. However, the rate of scaffold thrombosis remains high.

Use, Persistence, Efficacy, and Safety of Apixaban in Patients with Non-Valvular Atrial Fibrillation in Unselected Patients in Germany. Results of the Prospective Apixaban in Atrial Fibrillation (APAF) Registry.

INTRODUCTION: Apixaban has been shown to be superior to warfarin in patients with non-valvular atrial fibrillation in the randomized ARISTOTLE trial and its use is recommended in current guidelines. There are only scarce data about its use, efficacy, and safety in unselected patients in Germany. METHODS AND RESULTS: The APAF registry is a prospective non-interventional study enrolling 5015 patients with non-valvular atrial fibrillation. Of these, 1349 (26.9%) patients were initially treated with apixaban and followed up at 3 and 12 months. The dose of apixaban used was 1 × 2.5 mg in 1.6%, 2 × 2.5 mg in 30.4%, and 2 × 5 mg daily in 68.0% of patients, respectively. Inappropriate underdosing of apixaban was observed in 22.3%, mostly in elderly patients with higher HAS-BLED Score and a history of bleeding. Persistence to apixaban after 1 year was 88.6%, while the dose was changed in 3.7% of patients. Switching to other NOACs or VKAs occurred in 5.1%. After 12 months, all-cause mortality was 5.0%, non-fatal stroke occurred in 0.4%, non-fatal myocardial infarction in 0.6%, ISTH major bleeding in 0.8%, moderate or minor bleeding in 4.3% of patients, respectively. CONCLUSIONS: In this prospective experience in unselected patients with atrial fibrillation, persistence to apixaban was high, and efficacy and safety were comparable to the results in clinical trials, supporting its use in clinical practice.

Comparison of current German and European practice in cardiac resynchronization therapy: lessons from the ESC/EHRA/HFA CRT Survey II.

INTRODUCTION: The European CRT Survey II was introduced to offer insights into CRT implantation practice in Europe. We compared the national data from the participating German centres with that of the other European countries with regard to differences in patient selection, implant results, and initial properties. METHODS AND RESULTS: 11,088 patients were enrolled in 288 centres from 42 countries between 2015 and 2017. Of these, 675 (6.1%) were included in 17 centres in Germany. Patients from Germany were older, had more comorbidities and more symptoms of heart failure (HF) than patients from other European countries. There were no differences with regard to HF aetiology and guideline-directed medical treatment was overall well implemented. There was a high use of CRT in patients with atrial fibrillation, even higher in German patients. CRT was most often applied due to HF with wide QRS complex (class I recommendation) but with relatively higher frequency in Germany due to HF with primary indication for an implantable cardioverter-defibrillator (class IIb) or a pacemaker with expected pacing dependency (class I). The overall implant success rate was high with some differences in the implant procedure. The use of remote monitoring was lower in Germany. CONCLUSION: This analysis from the European CRT Survey II overall shows good guideline adherence, high implantation success and a low rate of complications in daily practice. There are some regional differences in baseline characteristics, CRT indication, and procedural aspects. The use of remote monitoring in Germany lags behind other European countries.

Long-term outcome after thrombus aspiration in non-ST-elevation myocardial infarction: results from the TATORT-NSTEMI trial : Thrombus aspiration in acute myocardial infarction.

AIMS: To investigate the long-term prognostic value of aspiration thrombectomy in conjunction with primary percutaneous coronary intervention (PCI) compared to conventional PCI in patients with non-ST-elevation myocardial infarction (NSTEMI). METHODS: In the randomized TATORT-NSTEMI (Thrombus aspiration in thrombus containing culprit lesions in non-ST-elevation myocardial infarction) trial, NSTEMI patients with thrombus containing culprit lesions were randomized to either PCI with aspiration thrombectomy or conventional PCI. The endpoint was a combination of all-cause death, reinfarction and new congestive heart failure. RESULTS: From 440 patients initially randomized, outcome data were available in 432 (98.2%) patients at a median follow-up of 4.9 (interquartile range [IQR] 4.4-5.0) years. Thrombectomy was associated with a significant reduction of the combined endpoint compared to conventional PCI (19.9% vs. 30.7%, p = 0.01). This finding was primarily driven by a reduced rate of reinfarction with thrombectomy (3.4% vs. 10.3%, p = 0.01). Thrombectomy was still independently associated with the combined endpoint after multivariable adjustment (hazard ratio [HR] 0.47, 95% confidence interval [CI] 0.30-0.76, p = 0.002). Findings were consistent across all analyzed subgroups (p values for interaction all > 0.05). CONCLUSIONS: In NSTEMI, thrombus aspiration is associated with favorable clinical outcome during long-term follow-up. CLINICAL TRIAL REGISTRATION: NCT01612312.

Sex-Related Procedural Aspects and Complications in CRT Survey II: A Multicenter European Experience in 11,088 Patients.

OBJECTIVES: This study sought to compare sex difference for procedural aspects and complications in the European Society of Cardiology CRT Survey II, exploring whether adverse events were related to the type of CRT device implanted. BACKGROUND: Sex-related differences in procedural aspects and complications in patients undergoing cardiac resynchronization therapy (CRT) implantation has not been explored in a real-life population. METHODS: A post-hoc analysis of procedural data and complications in different sexes and factors associated with events was performed from data collected in the European Society of Cardiology CRT Survey II. RESULTS: Of all patients (n = 11,088) included, 24.3% were women. The mean age (70 years of age) of male and female recipients was similar. Female patients more frequently had an idiopathic cardiomyopathy (67.4% vs. 44.1%) and fewer comorbidities, including atrial fibrillation (34.8% vs. 42.8%), diabetes (29.1% vs. 32.1%), chronic obstructive lung disease (10.3% vs. 12.6%), and renal failure (28.7% vs. 31.9%), compared with men. More women compared with men had a pacemaker (56.6% vs. 46.3%) and much less often an implantable cardioverter-defibrillator (CRT-D) (19.0% vs. 34.7%) implant. Periprocedural event rate was the highest in women with CRT with defibrillator (7.1% vs. 4.8% in men), followed by women with a CRT with pacing (5.5% vs. 4.4% in men). The higher periprocedural event rate in CRT-D women was attributable primarily to the occurrence of pneumothorax (1.4%), coronary sinus dissection (2.1%), and pericardial tamponade (0.3%). The rate of in-hospital major adverse events (6.0%) and complications necessitating reoperation (4.0%) was not different among sex and device type. CONCLUSIONS: Women are more likely to experience adverse procedure-related events during CRT implantation. Thus, preventive strategies should be employed to minimize complication rate.