Clopidogrel Monotherapy After 1-Month DAPT in Patients With High Bleeding Risk or Complex PCI

BACKGROUND: High bleeding risk (HBR) and complex percutaneous coronary intervention (PCI) are major determinants for dual antiplatelet therapy (DAPT) duration. OBJECTIVES: The aim of this study was to evaluate the effects of HBR and complex PCI on short vs standard DAPT. METHODS: Subgroup analyses were conducted on the basis of Academic Research Consortium-defined HBR and complex PCI in the STOPDAPT-2 (Short and Optimal Duration of Dual Antiplatelet Therapy After Verulam's-Eluting Cobalt-Chromium Stent-2) Total Cohort, which randomly compared clopidogrel monotherapy after 1-month DAPT with 12-month DAPT with aspirin and clopidogrel after PCI. The primary endpoint was the composite of cardiovascular (cardiovascular death, myocardial infarction, definite stent thrombosis, or stroke) or bleeding (Thrombolysis In Myocardial Infarction [TIMI] major or minor) endpoints at 1 year. RESULTS: Regardless of HBR (n = 1, 893 [31.6%]) and complex PCI (n = 999 [16.7%]), the risk of 1-month DAPT relative to 12-month DAPT was not significant for the primary endpoint (HBR, 5.01% vs 5.14%; non-HBR, 1.90% vs 2.02%; P interaction = 0.95) (complex PCI, 3.15% vs 4.07%; noncomplex PCI, 2.78% vs 2.82%; P interaction = 0.48) and for the cardiovascular endpoint (HBR, 4.35% vs 3.52%; and non-HBR, 1.56% vs 1.22%; P interaction = 0.90) (complex PCI, 2.53% vs 2.52%; noncomplex PCI, 2.38% vs 1.86%; P interaction = 0.53), while it was lower for the bleeding endpoint (HBR, 0.66% vs 2.27%; non-HBR, 0.43% vs 0.85%; P interaction = 0.36) (complex PCI, 0.63% vs 1.75%; noncomplex PCI, 0.48% vs 1.22%; P interaction = 0.90). The absolute difference in the bleeding between 1- and 12-month DAPT was numerically greater in patients with HBR than in those without HBR (-1.61% vs -0.42%). CONCLUSIONS: The effects of 1-month DAPT relative to 12-month DAPT were consistent regardless of HBR and complex PCI. The absolute benefit of 1-month DAPT over 12-month DAPT in reducing major bleeding was numerically greater in patients with HBR than in those without HBR. Complex PCI might not be an appropriate determinant for DAPT durations after PCI. (Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent-2 [STOPDAPT-2], NCT02619760; Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent-2 for the Patients With ACS [STOPDAPT-2 ACS], NCT03462498)

Clopidogrel Monotherapy After 1-Month Dual Antiplatelet Therapy in Percutaneous Coronary Intervention: From the STOPDAPT-2 Total Cohort

[Background:] The benefit of clopidogrel monotherapy after 1-month dual antiplatelet therapy (DAPT) compared with 12-month DAPT with aspirin and clopidogrel was demonstrated in the STOPDAPT-2 (Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent-2), but not in the STOPDAPT-2 acute coronary syndrome (ACS); however, both trials were underpowered based on the actual event rates. [Methods:] We obtained the prespecified pooled population of 5997 patients as the STOPDAPT-2 total cohort (STOPDAPT-2: N=3009/STOPDAPT-2 ACS: N=2988; ACS: N=4136/chronic coronary syndrome [CCS]: N=1861), comprising 2993 patients assigned to 1-month DAPT followed by clopidogrel monotherapy, and 3004 patients assigned to 12-month DAPT with aspirin and clopidogrel after percutaneous coronary intervention. The primary end point was the composite of cardiovascular (cardiovascular death, myocardial infarction, definite stent thrombosis, or any stroke) or bleeding (Thrombolysis in Myocardial Infarction major/minor) end points at 1 year. [Results:] One-month DAPT was noninferior to 12-month DAPT for the primary end point (2.84% versus 3.04%; hazard ratio [HR], 0.94 [95% CI, 0.70–1.27]; Pnoninferiority=0.001; Psuperiority=0.68). There was no significant risk-difference for the cardiovascular end point between the 1- and 12-month DAPT groups (2.40% versus 1.97%; HR, 1.24 [95% CI, 0.88–1.75]; Pnoninferiority=0.14; Psuperiority=0.23). There was a lower risk of the bleeding end point with 1-month DAPT relative to 12-month DAPT (0.50% versus 1.31%; HR, 0.38 [95% CI, 0.21–0.70]; Psuperiority=0.002). One-month DAPT relative to 12-month DAPT was associated with a lower risk for major bleeding regardless of ACS or CCS (ACS: HR, 0.46 [95% CI, 0.23–0.94]; P=0.03, and CCS: HR, 0.26 [95% CI, 0.09–0.79]; P=0.02; Pinteraction=0.40), while it was associated with a numerical increase in cardiovascular events in ACS patients, but not in CCS patients, although not statistically significant and without interaction (ACS: HR, 1.50 [95% CI, 0.99–2.27]; P=0.053, and CCS: HR, 0.74 [95% CI, 0.38–1.45]; P=0.39; Pinteraction=0.08). [Conclusions:] Clopidogrel monotherapy after 1-month DAPT compared with 12-month DAPT with aspirin and clopidogrel had a benefit in reducing major bleeding events without being associated with increase in cardiovascular events

Changes in drinking behavior among evacuees after the Fukushima Daiichi Nuclear Power Plant accident:the Fukushima Health Management Survey

Introduction Traumatic experiences and disordered sleep are strongly associated with drinking problems. We examined the effects of experiencing the Great East Japan Earthquake and subsequent nuclear power plant accident, and of sleep problems, on behavioral changes observed in non-drinkers.Methods This study examined cross-sectional data from the Mental Health and Lifestyle Survey conducted among residents in restricted areas of Fukushima in 2012. Participants were 21,454 evacuees aged 20 years or older at the time of disaster. People who did not drink before the disaster but became drinkers afterwards were compared with the rest of the cohort. We analyzed the association between behavioral changes in non-drinkers and potentially predictive variables, using logistic regression.Results The behavioral change of non-drinkers becoming drinkers (n=2,148) was significantly related to being male (OR=1.93, 95% CI:1.74-2.15), being younger (21-49 yrs, OR=1.85, 95% CI: 1.60-2.13), having less educational attainment (up to high school graduate, OR=1.21, 95% CI:1.09-1.35), smoking (OR=1.22, 95% CI:1.08-1.38), losing family or relatives (OR=1.21, 95% CI:1.07-1.37), change in employment (OR=1.19, 95% CI:1.07-1.32), having severe sleep problems as measured by a Japanese version of the Athens Insomnia Scale (3-8, OR=1.45, 95% CI:1.30-1.62), and severity of traumatic symptoms as measured by the PTSD Checklist Stressor-Specific (PCL-S) score (<44, OR=1.33, 95% CI:1.17-1.51).Conclusion Having sleep problems and having more severe traumatic symptoms are significantly related to non-drinkers becoming drinkers

Bilateral Control of Flexible Master-Slave Arms with Time-Varying Delay Affected by Contact Force from Obstacle

A bilateral control system for flexible master-slave arms with time-varying delay affected by contact force from an obstacle is considered in this study. The proposed bilateral control system is constructed using a rigid master arm, a flexible slave arm actuated by a high-geared servomotor, and a communication network that causes the time-varying delay. The flexible slave arm is affected by contact force from the obstacle during motion. PD and PDS controllers are designed for controlling the rigid master and flexible slave arms, respectively. A Lyapunov function is used in order to prove the stability and passivity of the proposed system. Finally, performance of the proposed bilateral control system is verified by numerical simulations

Development of Parallelized AMR-PIC Plasma Simulation Code with Dynamic Domain Decomposition

To maintain load balance among processes in parallel calculation, we introduced a dynamic load balancing technique called Dynamic Domain Decomposition (DDD) into our newly developed multi-scale Particle-In-Cell (PIC) simulation code in which Adaptive Mesh Refinement (AMR) is incorporated. To evaluate the effectiveness of DDD, we performed test simulations with a model in which four particle clusters are non-uniformly distributed with different velocities. We confirmed that load imbalance among processes caused by non-uniform plasma distribution was successfully resolved by DDD and the computational time becomes almost half of that for simulation of the same model without using DDD