Effect of Rivaroxaban and Aspirin in Patients With Peripheral Artery Disease Undergoing Surgical Revascularization: Insights From the VOYAGER PAD Trial.

BACKGROUND: Patients with peripheral artery disease requiring lower extremity revascularization (LER) are at high risk of adverse limb and cardiovascular events. The VOYAGER PAD trial (Vascular Outcomes Study of ASA [Acetylsalicylic Acid] Along With Rivaroxaban in Endovascular or Surgical Limb Revascularization for PAD) demonstrated that rivaroxaban significantly reduced this risk. The efficacy and safety of rivaroxaban has not been described in patients who underwent surgical LER. METHODS: The VOYAGER PAD trial randomized patients with peripheral artery disease after surgical and endovascular LER to rivaroxaban 2.5 mg twice daily plus aspirin or matching placebo plus aspirin and followed for a median of 28 months. The primary end point was a composite of acute limb ischemia, major vascular amputation, myocardial infarction, ischemic stroke, or cardiovascular death. The principal safety outcome was Thrombolysis in Myocardial Infarction major bleeding. International Society on Thrombosis and Haemostasis bleeding was a secondary safety outcome. All efficacy and safety outcomes were adjudicated by a blinded independent committee. RESULTS: Of the 6564 randomized, 2185 (33%) underwent surgical LER and 4379 (67%) endovascular. Compared with placebo, rivaroxaban reduced the primary end point consistently regardless of LER method (P-interaction, 0.43). After surgical LER, the primary efficacy outcome occurred in 199 (18.4%) patients in the rivaroxaban group and 242 (22.0%) patients in the placebo group with a cumulative incidence at 3 years of 19.7% and 23.9%, respectively (hazard ratio, 0.81 [95% CI, 0.67-0.98]; P=0.026). In the overall trial, Thrombolysis in Myocardial Infarction major bleeding and International Society on Thrombosis and Haemostasis major bleeding were increased with rivaroxaban. There was no heterogeneity for Thrombolysis in Myocardial Infarction major bleeding (P-interaction, 0.17) or International Society on Thrombosis and Haemostasis major bleeding (P-interaction, 0.73) on the basis of the LER approach. After surgical LER, the principal safety outcome occurred in 11 (1.0%) patients in the rivaroxaban group and 13 (1.2%) patients in the placebo group; 3-year cumulative incidence was 1.3% and 1.4%, respectively (hazard ratio, 0.88 [95% CI, 0.39-1.95]; P=0.75) Among surgical patients, the composite of fatal bleeding or intracranial hemorrhage (P=0.95) and postprocedural bleeding requiring intervention (P=0.93) was not significantly increased. CONCLUSIONS: The efficacy of rivaroxaban is associated with a benefit in patients who underwent surgical LER. Although bleeding was increased with rivaroxaban plus aspirin, the incidence was low, with no significant increase in fatal bleeding, intracranial hemorrhage, or postprocedural bleeds requiring intervention. Registration: URL: http://www.clinicaltrials.gov; Unique Identifier: NCT02504216.

Ultra-low profile polymer-filled stent graft for abdominal aortic aneurysm treatment: a two-year follow-up.

PURPOSE: This study evaluated 2 years of follow-up of the Ovation Abdominal Stent Graft System (TriVascular Inc., Santa Rosa, CA, USA) for endovascular repair (EVAR) of abdominal aortic aneurysms (AAAs). MATERIALS AND METHODS: This retrospective multicentre study included 36 patients (median age, 73.6 year) with AAAs (mean diameter, 5.65 cm) treated with the Ovation stent graft and followed up for at least 2 years. Safety and effectiveness of the Ovation stent graft were evaluated. Indications for EVAR were the following: AAA ≥5 cm, neck length ≥7 mm, angulation ≤60° and diameter <30 mm; the presence of neck calcification and thrombosis was not considered a contraindication; distal iliac landing zone length of 10 mm, and diameter between 5 and 20 mm. Patients were treated under a common protocol, including clinical and imaging follow-up at discharge, 30 days, 6 months, and annually for 5 years. Adverse events, clinical and imaging data and possible re-intervention were recorded. RESULTS: The Ovation stent graft was implanted successfully in 36 patients (100 %). None of the patients required conversion to open surgery, and none presented with an aneurysm rupture. Endograft stent fracture or migration was not observed in any case. No type I, III or IV endoleaks were observed; in 12 patients (33.3 %), a type II endoleak was noted, in one case with sac enlargement but not treated due to concomitant comorbidities and the patient's decision. CONCLUSIONS: The 2-year results of the Ovation Abdominal Stent Graft System demonstrate excellent safety and effectiveness in the treatment of patients with AAAs, particularly in those with challenging anatomical characteristics.

Treatment of abdominal aortic aneurysm with a new type of polymer-filled low profile device.

PURPOSE OF THE STUDY: To evaluate the mid-term safety and effectiveness of a novel stent graft for treatment of abdominal aortic aneurysm (AAA). METHODS: Thirty-three patients with AAA (20 males and 13 females; mean age: 71.3 y) were treated with the Ovation™ Abdominal Stent Graft System (TriVascular, Inc., Santa Rosa, CA, USA). Indications for endovascular aneurysm repair: AAA ≥ 5.5 cm, neck ≥ 7 mm, angulation ≤ 60° and with an inner wall diameter of no less than 16 mm and no greater than 30 mm; the presence of neck calcification and thrombosis is not much of a problem in this device because aortic seal is achieved with 2 polymer-filled sealing rings and the fixation by means of a suprarenal stent with 8 pairs of anchors. Patients were followed through discharge and returned for follow-up visits. The follow-up protocol included a CT-A exam at 1 and 12 months after the intervention; the mid-term follow up was performed at 3 and 6 months with contrast-enhanced ultrasound (CEUS). Mean follow-up duration was 18.6 months (range: 3-25 months). MAIN FINDINGS: Technical success was 100%. Mean implantation procedure time was 31.1 minutes, and median hospital stay was 4.6 days. None of the patients required conversion to open surgery, and no aneurysm enlargement, rupture, fracture, or migration were observed. No type I, III or IV endoleaks were observed. Hospitalization death rate was 0%. Death rate at 30 days was 0%. No major complications were observed. CONCLUSIONS: The first results from this 3-center study with the Ovation stent graft are promising with high technical success and excellent safety and effectiveness.

Preoperative n-3 polyunsatured fatty acids are associated with a decrease in the incidence of early atrial fibrillation following cardiac surgery.

BACKGROUND: Atrial fibrillation (AF) after cardiac surgery is associated with increased mortality, morbidity, and expenditure. Controversial data exist on possible preventive effects of n-3 polyunsatured fatty acids (PUFAs) against postoperative AF. We investigated whether preoperative PUFA therapy is effective in reducing AF after cardiac surgery during the surgical hospitalization and/or the cardiac rehabilitation period. METHODS: Over a 4-year period, 530 patients (363 men, 68.5%) with a mean age of 66.4 +/- 10.9 years, undergoing cardiac surgery were monitored for ''early AF'' and ''late AF'' defined as AF documented in the surgical department or during the rehabilitation program, respectively. RESULTS: The overall incidence of early AF in the whole study sample was 44.7%, whereas late AF occurred in 14.7% patients. Patients with AF had a longer length of hospital and rehabilitation stay (10.4 +/- 9.8 vs 9.5 +/- 9.2 days, P = .025 and 24.2 +/- 15.3 vs 21.1 +/- 8.3 days, P = .008, respectively). Early AF occurred in 31.0% of the patients with preoperative PUFAs compared with 47.3% of those without them (P = .006). Conversely, late AF was not influenced by preoperative PUFA regimen (11.9% vs 15.2%, P = .43). Preoperative PUFAs were independently associated with a 46% reduction in risk of early AF development (OR 0.54, 95% CI 0.31-0.92), after propensity score analysis. CONCLUSION: Preoperative PUFA therapy is associated with a decreased incidence of early AF after cardiac surgery but not late AF. Patients undergoing cardiac surgery may benefit from a preventive PUFA approach.