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"Wildgoose, Peter"
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Batgirl. Vol. 3, Summer of lies
\"An innocent bystander close to Batgirl gets caught in the crossfire of her feud with Catwoman. Cat vs. Bat! Who will win? An old romance, a villain with a vendetta, and a painful brush with the past make this is an event no Batgirl or Nightwing fan will want to miss! Batgirl and Nightwing's feelings for each other have always run deep...but is their bond built on more than Bat Family loyalty and a long-ago childhood crush? When an old villain comes back into Babs' life, she and Dick will have to reopen painful wounds and remember a time they'd hoped would remain forgotten. Soon, Batgirl and Nightwing discover the true identity of the villain and come to the horrible realization that they've walked straight into a trap! A trap years in the making...and it may be inescapable.\"-- Provided by publisher.
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An open-label, randomized, controlled, multicenter study exploring two treatment strategies of rivaroxaban and a dose-adjusted oral vitamin k antagonist treatment strategy in subjects with atrial fibrillation who undergo percutaneous coronary intervention (PIONEER AF-PCI)
Guidelines recommendations regarding anticoagulant therapy after percutaneous coronary intervention (PCI) among patients with atrial fibrillation (AF) rely on retrospective, nonrandomized observational data. Currently, patients are treated with triple-therapy (dual antiplatelet therapy [DAPT] + oral anticoagulation therapy), but neither the duration of DAPT nor the level of anticoagulation has been studied in a randomized fashion. Recent studies also suggest dual pathway therapy with clopidogrel plus oral anticoagulation therapy may be superior, and other studies suggest that novel oral anticoagulants such as rivaroxaban may further improve patient outcomes.
PIONEER AF-PCI (ClinicalTrials.gov NCT01830543) is an exploratory, open-label, randomized, multicenter clinical study assessing the safety of 2 rivaroxaban treatment strategies and 1 vitamin K antagonist (VKA) treatment strategy in subjects who have paroxysmal, persistent, or permanent nonvalvular AF and have undergone PCI with stent placement. Approximately 2,100 subjects will be randomized in a 1:1:1 ratio to receive either rivaroxaban 15 mg once daily plus clopidogrel 75 mg daily for 12 months (a WOEST trial–like strategy), or rivaroxaban 2.5 mg twice daily (with stratification to a prespecified duration of DAPT 1, 6, or 12 months, an ATLAS trial–like strategy), or dose-adjusted VKA once daily (with stratification to a prespecified duration of DAPT 1, 6, or 12 months, traditional triple therapy). All patients will be followed up for 12 months for the primary composite end point of Thrombolysis in Myocardial Infarction major bleeding, bleeding requiring medical attention, and minor bleeding (collectively, clinically significant bleeding).
The PIONEER AF-PCI study is the first randomized comparison of VKA vs novel oral anticoagulant therapy in patients with NVAF receiving antiplatelet therapy after PCI to assess the relative risks of bleeding complications.
Journal Article
Trial design: Rivaroxaban for the prevention of major cardiovascular events after transcatheter aortic valve replacement: Rationale and design of the GALILEO study
Optimal antithrombotic treatment after transcatheter aortic valve replacement (TAVR) is unknown and determined empirically. The direct factor Xa inhibitor rivaroxaban may potentially reduce TAVR-related thrombotic complications and premature valve failure.
GALILEO is an international, randomized, open-label, event-driven, phase III trial in more than 1,520 patients without an indication for oral anticoagulation who underwent a successful TAVR (ClinicalTrials.govNCT02556203). Patients are randomized (1:1 ratio), 1 to 7days after a successful TAVR, to either a rivaroxaban-based strategy or an antiplatelet-based strategy. In the experimental arm, subjects receive rivaroxaban (10mg once daily [OD]) plus acetylsalicylic acid (ASA, 75-100mg OD) for 90days followed by rivaroxaban alone. In the control arm, subjects receive clopidogrel (75mg OD) plus ASA (as above) for 90days followed by ASA alone. In case new-onset atrial fibrillation occurs after randomization, full oral anticoagulation will be implemented with maintenance of the original treatment assignment. The primary efficacy end point is the composite of all-cause death, stroke, myocardial infarction, symptomatic valve thrombosis, pulmonary embolism, deep venous thrombosis, and systemic embolism. The primary safety end point is the composite of life-threatening, disabling, and major bleeding, according to the Valve Academic Research Consortium definitions.
GALILEO will test the hypothesis that a rivaroxaban-based antithrombotic strategy reduces the risk of thromboembolic complications post-TAVR with an acceptable risk of bleeding compared with the currently recommended antiplatelet therapy–based strategy in subjects without need of chronic oral anticoagulation.
Journal Article
Rivaroxaban thromboprophylaxis in ambulatory patients with pancreatic cancer: Results from a pre‐specified subgroup analysis of the randomized CASSINI study
Background Pancreatic cancer patients are at risk for venous thromboembolism (VTE); the value of thromboprophylaxis has not been definitively established. Methods This trial randomized cancer patients initiating a new regimen and at high risk for VTE (Khorana score ≥2) to rivaroxaban 10 mg or placebo up to day 180. This analysis examined the subset of pancreatic cancer patients. The primary efficacy endpoint was the composite of symptomatic deep‐vein thrombosis (DVT), asymptomatic proximal DVT, any pulmonary embolism, and VTE‐related death. The primary safety endpoint was International Society on Thrombosis and Haemostasis–defined major bleeding. Results In total, 49/1080 (4.5%) patients enrolled had baseline VTE on screening, with higher rates (24/362 [6.6%]) in pancreatic cancer and they were not randomized. Of 841 randomized patients, 273 (32.5%) had pancreatic cancer; 155/273 (57% in each arm) completed the double‐blind period. The primary endpoint occurred in 13/135 (9.6%) patients in the rivaroxaban group and in 18/138 (13.0%) in the placebo group (hazard ratio [HR] = 0.70; 95% CI, 0.34‐1.43; P = .328) in up‐to‐day‐180 period and 5/135 (3.7%) patients receiving rivaroxaban and 14/138 (10.1%) receiving placebo in the intervention period (HR = 0.35; 95% CI, 0.13‐0.97; P = .034). Major bleeding was similar (2 [1.5%] receiving rivaroxaban and 3 [2.3%] receiving placebo). Correlative biomarker studies demonstrated significant decline in D‐dimer (weeks 8 and 16) in patients randomized to rivaroxaban compared to placebo (P < .01). Conclusions In ambulatory pancreatic cancer patients, rivaroxaban did not result in significantly lower incidence of VTE or VTE‐related death in the 180‐day period. During the intervention period, however, rivaroxaban substantially reduced VTE without increasing major bleeding, suggesting benefit of rivaroxaban prophylaxis in this setting. Trial registration: ClinicalTrials.gov identifier, NCT02555878. Thromboprophylaxis with rivaroxaban is safe and effective in the prevention of venous thromboembolism in ambulatory patients with pancreatic cancer receiving systemic therapy, with a low number needed to treat. Given the favorable risk‐benefit ratio and convenience of the oral route of administration, these findings should inform guideline recommendations for high‐risk patients.
Journal Article
Impact of Co-morbidities and Patient Characteristics on International Normalized Ratio Control Over Time in Patients With Nonvalvular Atrial Fibrillation
This study determined the association between co-morbidities, including heart failure (HF) and time in therapeutic range (TTR), in patients with nonvalvular atrial fibrillation. Longitudinal patient-level anticoagulation management records collected from 2006 to 2010 were analyzed. Adult patients with nonvalvular atrial fibrillation who used warfarin for a 12-month period with no gap of >60 days between visits were identified. TTR <55% was defined as “lower” TTR. CHADS2 score of ≥2 was defined as “higher” CHADS2. Logistic regression analyses were conducted to determine the association between co-morbidities and TTR. A total of 23,425 patients met the study criteria. The mean age ± SD was 74.8 ± 9.7 years, with 84.8% aged ≥65 years. The most common co-morbidities were hypertension (41.7%), diabetes (24.1%), HF (11.7%), and previous stroke (11.1%). The mean TTR ± SD was 67.3 ± 14.4%, with 18.6% of patients in the lower TTR range. In multivariate analyses using age, gender, hypertension, diabetes, stroke, and region as covariates, HF (adjusted odds ratio [OR] 1.41, 95% confidence interval [CI] 1.28 to 1.56; p <0.001), diabetes (OR 1.28, 95% CI 1.19 to 1.38; p <0.001), and previous stroke (OR 1.15, 95% CI 1.04 to 1.27; p <0.001) were associated with lower TTR. In a second set of multivariate analyses using gender and region as covariates, a higher CHADS2 score was associated with lower TTR (OR 1.11, 95% CI 1.04 to 1.18; p <0.001). In conclusion, HF was associated with the greatest likelihood of a lower TTR, followed by diabetes, then stroke. Anticoagulation control may be more challenging for patients with these conditions.
Journal Article
Rivaroxaban thromboprophylaxis for gastric/gastroesophageal junction tumors versus other tumors: A post hoc analysis of the randomized CASSINI trial
Prophylactic anticoagulation with rivaroxaban significantly reduced the risk of cancer‐associated thrombosis during the intervention period in the CASSINI trial. Direct oral anticoagulants may increase the risk of gastrointestinal (GI) tract bleeding in patients with an in situ GI tract cancer or lesion.
This post hoc analysis characterized the efficacy and safety of rivaroxaban in patients with and without gastric/gastroesophageal junction (G/GEJ) tumors.
Primary and secondary efficacy end points and adjudicated bleeding events, including bleeding sites, were analyzed for the intent‐to‐treat population by cancer type (G/GEJ vs non‐G/GEJ) for the 180‐day observation period.
In patients with G/GEJ tumors, the rates for the primary efficacy end point were 3.4% for rivaroxaban versus 6.9% for placebo (hazard ratio [HR], 0.45; 95% confidence interval [CI], 0.11‐1.80). In patients with non‐G/GEJ tumors, the rivaroxaban group had a lower risk of the primary end point (6.6% vs 9.3%; HR, 0.70; 95% CI, 0.40–1.21). Rates of major bleeding in patients with G/GEJ tumors were 4.6% (4/88) versus 1.2% (1/85) for rivaroxaban and placebo; rates in patients with non‐G/GEJ tumors were 1.3% (4/317) versus 0.9% (3/319), respectively.
Excluding patients with G/GEJ tumors resulted in a definable population of cancer patients who achieved an improved benefit‐risk balance from rivaroxaban prophylaxis.
Journal Article
Rivaroxaban for Thromboprophylaxis in High-Risk Ambulatory Patients with Cancer
A placebo-controlled trial assessed the efficacy of rivaroxaban to prevent venous thrombosis in patients with cancer at high risk for thrombosis. The thrombosis rate was lower with rivaroxaban, but for the 180-day assessment period, the difference was not significant. Bleeding was approximately twice as common in the rivaroxaban group.
Journal Article
Risk for Venous Thromboembolism Recurrence Among Rivaroxaban-treated Patients Who Continued Versus Discontinued Therapy: Analyses Among Patients with VTE
The EINSTEIN-Extension trial showed that an extended rivaroxaban treatment significantly reduced the risk for venous thromboembolic (VTE) recurrence. The present study assessed the risk for VTE recurrence and major bleeding associated with extended rivaroxaban treatment in a clinical practice setting among patients with VTE.
A retrospective study was conducted using claims data from February 2011 to April 2015. It included adult patients who initiated rivaroxaban therapy within 7 days after their first VTE and who continuously used rivaroxaban for at least 3 months (index date: end of initial 3-month treatment). Categorized into discontinued and continued cohorts, patients were followed up from the index date until the end of continuous treatment (continued cohort) or end of data or reinitiation of oral anticoagulant therapy (discontinued cohort). Using inverse probability of treatment weights controlling for confounders, adjusted Kaplan-Meier rates of recurrent VTE and major bleeding events were compared.
The analysis showed that, compared with the discontinued cohort (n = 1,536), the continued cohort (n = 5,933) had a significantly lower VTE recurrence rate after an additional 3 months (0.70% vs 1.70%), 6 months (1.41% vs 2.34%), 9 months (1.82% vs 3.01%), and 12 months (1.97% vs 3.01%) of treatment (all, p < 0.05). The difference in the cumulative event rates for major bleeding was not statistically significant. Similar results were obtained in an analysis among patients with VTE receiving rivaroxaban for ≥6 months.
Our results suggest that, in clinical practice settings, patients with VTE who continued rivaroxaban therapy after the initial 3- or 6-month treatment period had a significantly lower risk for VTE recurrence without a statistically significant increased risk for major bleeding.
Journal Article
Prevention of Bleeding in Patients with Atrial Fibrillation Undergoing PCI
This trial compared standard therapy (dual antiplatelet therapy plus a vitamin K antagonist) with two regimens containing rivaroxaban plus antiplatelet therapy. The rivaroxaban groups had reduced rates of bleeding and similar efficacy in preventing cardiovascular events.
Approximately 5 to 8% of patients who undergo percutaneous coronary intervention (PCI) have atrial fibrillation.
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Dual antiplatelet therapy (DAPT) with a P2Y
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inhibitor and aspirin is superior to oral anticoagulation with a vitamin K antagonist in reducing the risk of thrombosis in patients undergoing placement of a first-generation stent,
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but oral anticoagulation is superior to DAPT in reducing the risk of ischemic stroke in patients with atrial fibrillation.
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The treatment strategy for patients with atrial fibrillation who have received stents must balance the risk of stent thrombosis and ischemic stroke with the risk of bleeding. A common guideline-supported . . .
Journal Article
A Controlled Trial of Rivaroxaban after Transcatheter Aortic-Valve Replacement
Patients who had undergone successful TAVR were randomly assigned to receive either a rivaroxaban-based antithrombotic regimen or an antiplatelet-based antithrombotic regimen. At 17 months, the primary outcome of death or thromboembolic complications occurred more frequently with rivaroxaban.
Journal Article