ABSTRACT
Background: Radial artery occlusion (RAO) remains the most frequent complication of trans-radial access. Once the radial artery is occluded, its future use as an access site for coronary procedures, or as a conduit for coronary bypass grafting or fistula for hemodialysis, will be precluded. Therefore, we aimed to assess the value of the short-term use of Rivaroxaban to prevent RAO after a trans-radial coronary procedure. Methods: This was a prospective, open-label, randomized study. The patients were randomly assigned (1:1) to one of two groups: those who received Rivaroxaban 10â mg for 7 days following the trans-radial coronary procedure (the Rivaroxaban Group) and those who received the standard treatment (the Control Group). The primary outcome was an occurrence of RAO evaluated by Doppler ultrasound at 30 days, and the secondary outcomes were hemorrhagic complications according to BARC classification. Results: We included 521 patients randomized into two Groups: the Control Group (N = 262) and the Rivaroxaban Group (N = 259). The 1-month RAO was significantly reduced in the Rivaroxaban Group as compared to the Control Group [6.9% vs. 13%; p = 0.011, OR = 0.5, (95% CI, 0.27-0.91)]. We noted no cases of severe bleeding events (BARC3-5). The overall incidence of minor bleeding (BARC1) was 2.3%, with no significant difference between the two groups [Rivaroxaban Group = 2.7%, Control Group = 1.9%, p = 0.54, OR= 1.4, (95%CI 0.44-4.5)]. Conclusions: Short-term postoperative anticoagulation with Rivaroxaban 10â mg for seven days reduces the rate of 1-month RAO.
ABSTRACT
INTRODUCTION: Very long coronary lesions account for 20% of coronary stenoses in the real world. There are few data on the effectiveness of angioplasty of these lesions with very long active stents (DES) in the literature. We conducted this study to assess the long-term outcomes of angioplasty with DES length ≥ 40 mm in a population with multiple cardiovascular risk factors. PATIENTS AND METHODS: This is a retrospective, multicenter, descriptive, and prognostic study, conducted between January 2015 and January 2020, in four Tunisian centers, including all patients who underwent angioplasty with a DES of length ≥ 40 mm with a follow-up of at least one year. The primary outcome was a combined criteria (major cardiovascular and Cerebral events: MACCE) (stroke, acute coronary syndrome, revascularization of the target lesion: TLR, cardiovascular death: CVD). RESULTS: We included 480 procedures. More than half of the patients had at least three risk factors. The prevalence of high blood pressure, diabetes and smoking were 61.1%, 56.6% and 60.4%, respectively. The treated lesions were complex: 23.54% calcified lesions, 8.75% chronic occlusions, 25% bifurcation lesions and 12.08% ostial lesions. The average length of the stents was 47.72 mm. We noted 17 cases of per-procedural complications (3.55%). The median follow-up was 35 months (extremes 1-60 months). The rate of stent thrombosis was 0.83%. The incidence of MACCE, TLR and CVD were respectively 16.25%, 8.12% and 5.2%. In multivariate analysis, diabetes (HR = 1.7, 95% CI [1.01-2.9]), dyslipidemia (HR = 2.08, 95% CI [1.3-3.3]), familial coronary artery disease (HR = 1.9, 95% CI [1.01-3.6]), left ventricle dysfunction (HR = 2.07, 95% CI [1.1-3.6]) and bifurcation lesions (HR = 1.9, 95% CI [1.2-3.14]) were the independent predictors of MACCE, while statin intake (HR = 0.38, 95% CI [0.19-0.78]) was a protective factor. CONCLUSION: Angioplasty with very long DES is associated with low levels of MACCE, TLR, stent thrombosis and CVD in our population. Therefore, it could be an interesting alternative to cardiac surgery. Randomized comparative studies of the two treatment options are needed.