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Background Even in the current drug-eluting stent era, revascularization for coronary stenosis with fractional flow reserve (FFR) between 0.75 and 0.80, the so-called “gray zone,” is a matter of debate. Previous studies have reported conflicting results regarding outcomes of revascularization versus deferral for coronary stenosis when FFR values are in the gray zone, but these studies have had differing designs and populations. We therefore will investigate whether medical therapy plus percutaneous coronary intervention (PCI) is superior to medical therapy alone in reducing major cardiovascular events in patients presenting with coronary stenosis with gray zone FFR values. Methods/design This is a prospective, multicenter, open-label, parallel group, randomized, controlled, superiority study. A total of 410 eligible participants will be recruited and randomized to either the medical therapy plus PCI group or the medical therapy alone group. The primary endpoint is 1-year major adverse cardiac events (MACEs), defined as a combined endpoint of all-cause death, nonfatal myocardial infarction (MI), or unplanned target vessel revascularization (TVR). Secondary endpoints include MACE at 2 and 5 years. Moreover, each individual component of the primary endpoint, cardiovascular death, target vessel-related and non-target vessel-related MI, all MI, clinically driven TVR or non-TVR, all revascularization, stent thrombosis, and angina symptom status will be evaluated at 1, 2, and 5 years. Discussion This is the first prospective, multicenter, randomized, controlled study to investigate the superiority of medical therapy plus PCI over medical therapy by itself in reducing major cardiovascular events in patients presenting with coronary stenosis with “gray zone” FFR values. The results will help interventional cardiologists in making revascularization decisions regarding coronary stenosis with gray zone FFR values. Trial registration University Hospital Medical Information Network Clinical Trials Registry, UMIN000031526 . Registered on 1 March 2018.

Recently, it has been reported that large infarcts associated with terminal QRS distortion (QRSDIS) on the admission electrocardiograms of patients with ST-elevation myocardial infarctions (STEMIs) may be caused by a failure to achieve thrombolysis in myocardial infarction (TIMI) grade 3 flow after primary percutaneous coronary intervention (PCI). However, the relationship between QRSDIS and final infarct size when TIMI grade 3 flow could be achieved by primary PCI is still unclear. Sixty-two consecutive patients with first anterior STEMI and who achieved TIMI grade 3 flow by primary PCI were classified into two groups according to the presence (Group A, n = 18) or absence (Group B, n = 44) of QRSDIS. Two weeks after the onset of acute myocardial infarction, Group A had a larger left ventricular (LV) end-systolic volume index (LVESVI) and a lower LV ejection fraction (LVEF) than Group B (LVESVI: 38 ± 13 vs 31 ± 12 ml/m 2 , P = 0.025: LVEF: 42% ± 10% vs 51% ± 10%, P = 0.004). Through multivariate analysis, independent predictors of poor LV systolic function (LVEF < 40%) were determined to be the presence of QRSDIS (odds ratio 21.04, P = 0.021) and proximal left anterior descending artery occlusion (odds ratio 16.15, P = 0.033). Myocardial damage could not be reduced in patients experiencing STEMI with QRSDIS, even when TIMI grade 3 flow could be achieved by primary PCI, as much as in patients experiencing STEMI without QRSDIS.

Background: Even in the current drug-eluting stent era, revascularization for coronary stenosis with fractional flow reserve (FFR) between 0.75 and 0.80, the so-called “gray zone”, is a matter of debate. Previous studies have reported conflicting results regarding outcomes of revascularization vs. deferral for coronary stenosis when FFR values in the gray zone, but have had differing study designs and populations. We therefore investigate whether medical therapy plus percutaneous coronary intervention (PCI) is superior to medical therapy alone in reducing major cardiovascular events in patients presenting coronary stenosis with gray-zone FFR values. Methods: This is a prospective, multicenter, open-label, parallel group, randomized, controlled, superiority study. A total of 410 eligible participants will be recruited and randomized to either the medical therapy plus PCI or the medical therapy alone group. The primary endpoint is one-year major adverse cardiac event (MACE), defined as a combined endpoint of all-cause death, non-fatal myocardial infarction (MI), or unplanned target vessel revascularization (TVR). Secondary endpoints include MACE at 2 and 5 years. Moreover, each individual component of the primary endpoint, cardiovascular death, target vessel-related and non-target vessel-related MI, all MI, clinically-driven TVR or non-TVR, all revascularization, stent thrombosis, and angina symptom status will be evaluated at 1, 2, and 5 years. Discussion: This is the first prospective, multicenter, randomized, controlled study to investigate the superiority of medical therapy plus PCI over medical therapy by itself in reducing major cardiovascular events in patients presenting coronary stenosis with “gray-zone” FFR values. The results will help interventional cardiologists in making revascularization decisions regarding coronary stenosis with gray-zone FFR values. Trial registration: University Hospital Medical Information Network Clinical Trials Registry, ID: UMIN000031526. Registered on 1 March 2018. Key Words: Coronary physiology, fractional flow reserve, medical therapy, percutaneous coronary intervention

Acquired hemophilia A (AHA) is a rare, life-threatening bleeding disorder caused by autoantibodies against coagulation factor VIII (FVIII). Immunosuppressive therapy for AHA aims to arrest bleeding by eliminating FVIII inhibitors. Factor VIII activity overshoot after complete remission (CR) has been reported anecdotally, but details remain unclear. We retrospectively analyzed data from 17 patients with AHA who achieved CR under immunosuppressive therapy between 2009 and 2019 at Gunma University Hospital. FVIII activity overshoot was defined as ≥ 150%. All 17 patients had low FVIII activity (median 2.1%; range < 1.0–8.9%) due to FVIII inhibition (median 14.7 BU/mL; range 2.0–234.0) and all achieved CR within a median of 39 (range 19–173) days. Overshoot occurred in 11 (64.7%) patients and maximal FVIII activity reached > 200% in six of them. The median duration from CR to overshoot was 13 (range 0–154) days. The FVIII overshoot was transient (72.7%) or persistent (27.3%). Venous thromboembolism developed as a complication of overshoot in one patient due to iliac vein compression by a massive hematoma. Overshoot of FVIII activity after CR occurs more frequently than previously expected in patients with AHA.