Optimal medical therapy in patients with stable coronary artery disease in Poland: the ISCHEMIA trial experience.

Introduction: Optimal medical therapy (OMT) is the cornerstone of treatment for stable coronary disease with the ISCHEMIA trial showing similar outcomes using OMT with or without an initial invasive approach. Objectives: To describe OMT goal attainment in Polish ISCHEMIA participants compared with other countries. Patients and methods: Among 5179 trial participants, 333 were randomized in Poland. The median follow-up was 3.2 years. OMT targets were: not smoking, high-intensity statin therapy, low-density lipoprotein cholesterol (LDL-C) of less than 70 mg/dl, systolic blood pressure of less than 140 mm Hg, aspirin therapy, and ACEI / ARB, and ß-blocker therapy if indicated. Results: Compared with 36 other countries, at randomization, patients in Poland were older (67 [62­75] y vs 65 [58­71] y); P <⁠0.001), more often female (30% vs 22%; P = 0.002), with a longer history of angina (3 [1­9] y vs 1 [0­3] y; P <⁠0.001), and there were more cases of prior myocardial infarction (32% vs 18%; P <⁠0.01) and revascularization (PCI, 40% vs 19%; CABG, 11% vs 3%; P <⁠0.001 for both). The number of OMT goals attained increased from baseline to follow-up visits (5 [4­5] vs 6 [5­6]; P <⁠0.001) in Poland and other countries alike (P = 0.89 vs P = 0.14). In Poland, significant improvements were achieved regarding high-intensity statin therapy (27% vs 50%), LDL-C <⁠70 mg/dl (29% vs 65%), and systolic blood pressure of less than 140 mm Hg (63% vs 81%) (P <⁠0.001 for all), whereas not-smoking (89% vs 89%), aspirin (90% vs 88%), ACEI / ARB (93% vs 95%), and ß-blocker therapy (94% vs 90%) remained high. Conclusions: With regular surveillance and contemporary medical therapy, high OMT goal attainment was achievable among the participants of the ISCHEMIA trial in Poland relative to other countries. There is still room for improvement in LDL-C and blood pressure management.

Device Thrombosis After Percutaneous Left Atrial Appendage Occlusion Is Related to Patient and Procedural Characteristics but Not to Duration of Postimplantation Dual Antiplatelet Therapy.

BACKGROUND: Device-related thrombus (DRT) after left atrial appendage occlusion is a worrisome finding with little knowledge about when to expect it and how to prevent it. This study sought to investigate correlates of DRT after left atrial appendage occlusion, its time of diagnosis, and particularly, association with postimplantation dual antiplatelet therapy duration. METHODS AND RESULTS: Consecutive patients (n=102) after left atrial appendage occlusion with AMPLATZER Cardiac Plug/Amulet (n=59) or WATCHMAN (n=43) were included in a prospective registry (October 2011-May 2016). Follow-up was done at 1.5, 3 to 6, and 12 months postimplantation. DRT was classified as early (at 1.5 month), late (at 3-6 month), or very late (at 12-month follow-up). Postimplantation dual antiplatelet therapy was recommended for 30 to 180 days and decided independently by attending physicians. Final analysis included 99 patients, 42 (42.4%) females, with median CHA2DS2-VASc of 4.0 (interquartile range [IQR], 3.0-5.0) and median HAS-BLED score of 2.0 (IQR, 1.0-3.0). DRTs were observed in 7 (7.1%) patients: 2 (28.6%) early, 2 (28.6%) late, and 3 (42.9%) very late. When compared with patients without DRT, those with DRT presented more often with a history of prior thromboembolism (5 [71.4%] versus 28 [30.4%]; P=0.04), had lower left ventricular ejection fraction (50.0 [IQR, 35.0-55.0] versus 60.0 [IQR, 55.0-66.0]; P<0.01), and had greater proportion of patients with deep device implantation (6 [85.7%] versus 36 [39.1%]; P=0.04) and with larger devices implanted (30.0 mm [IQR, 27.0-33.0] versus 25.0 mm [IQR, 24.0-28.0]; P<0.01). Postimplantation dual antiplatelet therapy duration was not different between the 2 groups (12.4 weeks [IQR, 6.0-49.7] with DRT versus 13.0 weeks [IQR, 7.3-26.0] without DRT; P=0.77). CONCLUSIONS: In this real-world series, DRT was observed early, late, and very late after left atrial appendage occlusion. It was related to patient and procedural characteristics but not to postimplantation dual antiplatelet therapy duration.