41 research outputs found
Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease
BACKGROUND
We evaluated whether rivaroxaban alone or in combination with aspirin would be more
effective than aspirin alone for secondary cardiovascular prevention.
METHODS
In this double-blind trial, we randomly assigned 27,395 participants with stable atherosclerotic vascular disease to receive rivaroxaban (2.5 mg twice daily) plus aspirin (100 mg
once daily), rivaroxaban (5 mg twice daily), or aspirin (100 mg once daily). The primary outcome was a composite of cardiovascular death, stroke, or myocardial infarction. The study was stopped for superiority of the rivaroxaban-plus-aspirin group after
a mean follow-up of 23 months.
RESULTS
The primary outcome occurred in fewer patients in the rivaroxaban-plus-aspirin group
than in the aspirin-alone group (379 patients [4.1%] vs. 496 patients [5.4%]; hazard
ratio, 0.76; 95% confidence interval [CI], 0.66 to 0.86; P<0.001; z=−4.126), but major
bleeding events occurred in more patients in the rivaroxaban-plus-aspirin group (288
patients [3.1%] vs. 170 patients [1.9%]; hazard ratio, 1.70; 95% CI, 1.40 to 2.05;
P<0.001). There was no significant difference in intracranial or fatal bleeding between
these two groups. There were 313 deaths (3.4%) in the rivaroxaban-plus-aspirin group
as compared with 378 (4.1%) in the aspirin-alone group (hazard ratio, 0.82; 95% CI,
0.71 to 0.96; P=0.01; threshold P value for significance, 0.0025). The primary outcome
did not occur in significantly fewer patients in the rivaroxaban-alone group than in the
aspirin-alone group, but major bleeding events occurred in more patients in the rivaroxaban-alone group.
CONCLUSIONS
Among patients with stable atherosclerotic vascular disease, those assigned to rivaroxaban (2.5 mg twice daily) plus aspirin had better cardiovascular outcomes and more
major bleeding events than those assigned to aspirin alone. Rivaroxaban (5 mg twice
daily) alone did not result in better cardiovascular outcomes than aspirin alone and
resulted in more major bleeding events. (Funded by Bayer; COMPASS ClinicalTrials.gov
number, NCT01776424.
Venous Thrombosis in Cancer Patients: Insight from the Frontline Survey
10.1634/theoncologist.8-4-381Oncologist84381-388OCOL
Use, Safety and Effectiveness of Subintimal Angioplasty and Re-Entry Devices for the Treatment of Femoropopliteal Chronic Total Occlusions: A Systematic Review of 87 Studies and 4,665 Patients
Background: Subintimal angioplasty (SIA) is often utilized to cross femoropopliteal (FP) artery chronic total occlusions (CTOs). Re-entry devices (RED) can further assist with true lumen re-entry. Objective: To systematically review the literature for studies reporting on the use of SIA, with or without RED. Methods: A systematic review according to the PRISMA guidelines was performed. Quantitative synthesis was applied when possible. Results: 87 studies and 4665 patients (5161 lesions) were included (63.9% male). 46.7% of patients had critical limb ischemia at the time of the intervention. Two RED types were used (Pioneer and Outback). Sixty-eight studies included lesions treated with SIA without RED, 17 studies included lesions treated with RED only, and two studies included a comparison between the two treatment methods. In total, 3898 (83.6%) patients were treated with SIA without RED and 754 (12.2%) with RED. Procedural success rate ranged from 64.5%–100% (92.5% for SIA without RED, 88.3% for RED cases). The complication rate ranged from 1.6% - 28% among different studies (cumulative rates: SIA: 9.1%, RED 9.3%). Perforations occurred in 1.6% of the total population (n = 46). Primary patency at one year ranged from 22% to 94.1%. Newer studies had a higher patency rate, ranging from 70% to 94.1%. Conclusion: SIA with or without RED is a valuable alternative to intraluminal crossing for endovascular treatment of FP CTOs. Procedural success was excellent for both techniques, while the cumulative complication rate was numerically lower in the RED group. Short- and long-term outcomes were acceptable for both techniques. © 201