Antithrombotic Therapy in Patients With Atrial Fibrillation and Acute Coronary Syndrome Treated Medically or With Percutaneous Coronary Intervention or Undergoing Elective Percutaneous Coronary Intervention: Insights From the AUGUSTUS Trial.

BACKGROUND: The safety and efficacy of antithrombotic regimens may differ between patients with atrial fibrillation who have acute coronary syndromes (ACS), treated medically or with percutaneous coronary intervention (PCI), and those undergoing elective PCI. METHODS: Using a 2×2 factorial design, we compared apixaban with vitamin K antagonists and aspirin with placebo in patients with atrial fibrillation who had ACS or were undergoing PCI and were receiving a P2Y12 inhibitor. We explored bleeding, death and hospitalization, as well as death and ischemic events, by antithrombotic strategy in 3 prespecified subgroups: patients with ACS treated medically, patients with ACS treated with PCI, and those undergoing elective PCI. RESULTS: Of 4614 patients enrolled, 1097 (23.9%) had ACS treated medically, 1714 (37.3%) had ACS treated with PCI, and 1784 (38.8%) had elective PCI. Apixaban compared with vitamin K antagonist reduced International Society on Thrombosis and Haemostasis major or clinically relevant nonmajor bleeding in patients with ACS treated medically (hazard ratio [HR], 0.44 [95% CI, 0.28-0.68]), patients with ACS treated with PCI (HR, 0.68 [95% CI, 0.52-0.89]), and patients undergoing elective PCI (HR, 0.82 [95% CI, 0.64-1.04]; Pinteraction=0.052) and reduced death or hospitalization in the ACS treated medically (HR, 0.71 [95% CI, 0.54-0.92]), ACS treated with PCI (HR, 0.88 [95% CI, 0.74-1.06]), and elective PCI (HR, 0.87 [95% CI, 0.72-1.04]; Pinteraction=0.345) groups. Compared with vitamin K antagonists, apixaban resulted in a similar effect on death and ischemic events in the ACS treated medically, ACS treated with PCI, and elective PCI groups (Pinteraction=0.356). Aspirin had a higher rate of bleeding than did placebo in patients with ACS treated medically (HR, 1.49 [95% CI, 0.98-2.26]), those with ACS treated with PCI (HR, 2.02 [95% CI, 1.53-2.67]), and those undergoing elective PCI (HR, 1.91 [95% CI, 1.48-2.47]; Pinteraction=0.479). For the same comparison, there was no difference in outcomes among the 3 groups for the composite of death or hospitalization (Pinteraction=0.787) and death and ischemic events (Pinteraction=0.710). CONCLUSIONS: An antithrombotic regimen consisting of apixaban and a P2Y12 inhibitor without aspirin provides superior safety and similar efficacy in patients with atrial fibrillation who have ACS, whether managed medically or with PCI, and those undergoing elective PCI compared with regimens that include vitamin K antagonists, aspirin, or both. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02415400.

The recurrence of iatrogenic femoral artery pseudoaneurysm after occlusion by ultrasound guided percutaneous thrombin injection.

AIMS: To evaluate efficacy of percutaneous ultrasound-guided thrombin injection (UGTI) of iatrogenic femoral artery pseudoaneurysm (PSA) and to identify the risk factors associated with PSA recurrence. METHODS AND RESULTS: We treated 140 patients aged 76 years (range 49-83) presented with femoral artery PSA after cardiac catheterisation by percutaneous UGTI (500 IU/ml solution of activated human thrombin). Factors associated with the recurrence of PSA were analysed. One hundred nineteen patients were successfully treated by one injection of thrombin (immediate success rate 85%). In 19 patients (13.6%), short local compression following injection was needed for complete occlusion (overall success rate 98.6%, 138/140). In one case, progression of PSA required conversion to surgery (0.7%). In one patient with pre-existing stenosis of superficial femoral artery, acute limb ischaemia developed after UGTI (0.7%). The recurrence of PSA in 30-days follow-up (10 patients, 7%) was associated with obesity (BMI>30, OR=1.39, 95% CI 1.09-1.78, p<0.05), and with extensive combination of anti-aggregation and anti-coagulation therapy (OR=2.11, 95% CI 1.23-3.62, p<0.0001) as revealed by both univariate and multivariate analysis. CONCLUSIONS: The UGTI is a safe and effective treatment of iatrogenic femoral artery PSA. Recurrence is low and associated with obesity and extensive use of combined anti-aggregation and anti-coagulation therapy.

Left internal mammary artery bypass dysfunction after revascularization of moderately narrowed coronary lesions. Colour-duplex ultrasound versus angiography study.

BACKGROUND: The left internal mammary artery (LIMA) is the conduit of choice for revascularization of coronary arteries and its popularity further increases in the era of mini-invasive coronary surgery. The aim of this study was first, to assess the accuracy of CDUS in predicting the LIMA graft dysfunction as compared to angiography, and secondly, to correlate the postoperative status of the LIMA graft with preoperative coronary artery stenosis severity of the bridged lesion. METHODS AND RESULTS: We examined 111 patients (pts) by colour-duplex ultrasound after myocardial revascularization by LIMA bypass (3.8 +/- 3.2 years after revascularization). LIMA was detected from the left supraclavicular approach at rest using the 7.5 MHz linear transducer. The ultrasound results were compared to contemporaneous angiography. The LIMA bypass patency was correlated with the preoperative coronary artery stenosis severity. The LIMA was detected by ultrasound in 92.8% (103) pts. At angiography, LIMA was patent and functional in 85 pts (76.6%, group A); in 25 subjects LIMA was stenosed or dysfunctional (22.5%, group B). In one patient the coronary subclavian steal syndrome was detected (0.9%). Haemodynamically moderate stenosis (50-60% by preoperative quantitative coronary angiography) was grafted in 5 pts of group A (6%), but in 10 pts of group B (40%) (P < 0.0001 vs group A). A peak systolic to peak diastolic velocity ratio (SDVR) of <2.0 yielded optimal accuracy to detect the absence of LIMA bypass dysfunction with a negative predictive value of 95%. CONCLUSION: 1. Revascularization of angiographically moderate coronary lesions is associated with a higher risk of postoperative graft dysfunction. 2. Colour-duplex ultrasound is a useful non-invasive tool for the postoperative follow-up of pts with a LIMA graft.

Percutaneous coronary interventions in Europe 1992-2003.

AIMS: The purpose of this registry is to collect data on trends in interventional cardiology within Europe. Special interest focuses on relative increases and ratios in newer revascularization approaches and its distribution in different regions in Europe. We report the data of the year 2003 and give an overview of the development of coronary interventions since 1992, when the first data collection was performed. METHODS AND RESULTS: Questionnaires were distributed yearly to delegates of all national societies of cardiology represented in the European Society of Cardiology to collect the case numbers of all local institutions and operators. The overall numbers of coronary angiographies increased from 1992 to 2003 from 684,000 to 1,993,000 (from 1,250 to 3,500 per million inhabitants). The respective numbers for percutaneous coronary interventions (PCI-coronary angioplasty) and coronary stenting procedures increased from 184,000 to 733,000 (from 335 to 1,300) and from 3,000 to 610,000 (from 5 to 1,100), respectively. Germany has been the most active country for the past years with 653,000 angiographies (7,800), 222,000 angioplasties (2,500), and 180,000 stenting procedures (2,200) in 2003. The indication has shifted towards acute coronary syndromes, as demonstrated by raising rates of interventions for acute myocardial infarction over the last decade. The procedures are more readily performed and safer, as shown by increasing rate of "ad hoc" PCI and decreasing need for emergency coronary artery bypass surgery (CABG). In 2003, use of drug-eluting stents had further increased. However, an enormous variability is reported with the highest rate in Portugal (55%). CONCLUSION: Interventional cardiology in Europe is still expanding, mainly but not exclusively due to rapid growth in the eastern European countries. A number of new coronary revascularization procedures introduced over the years have all but disappeared. Only stenting has experienced an exponential growth. The same can be forecast for drug-eluting stenting.