Comparing the efficacy and safety of the Skyflow device with those of the Solitaire FR stent in patients with acute ischemic stroke: a prospective, multicenter, randomized, non-inferiority clinical trial.

BACKGROUND: Mechanical thrombectomy is the standard treatment for acute ischemic stroke (AIS) with large vessel occlusion (LVO) in the anterior circulation. This trial aimed to indicate whether Skyflow, a new thrombectomy device, could achieve the same safety and efficacy as Solitaire FR in the treatment of AIS. METHODS: This study was a prospective, multicenter, randomized, single blind, parallel, positive controlled, non-inferiority clinical trial. Patients with intracranial anterior circulation LVO within 8 hours from onset were included to receive thrombectomy treatment with either the Skyflow or Solitaire FR stent retriever. The primary endpoint was the rate of successful reperfusion (modified Treatment In Cerebral Infarction (mTICI) ≥2b) after the operation. The safety endpoints were the rate of symptomatic intracranial hemorrhage (sICH) and subarachnoid hemorrhage (SAH) at 24 hours after operation. RESULTS: A total of 95 and 97 patients were involved in the Skyflow group and Solitaire FR group, respectively. A successful reperfusion (mTICI ≥2b) was finally achieved in 84 (88.4%) patients in the Skyflow group and 80 (82.5%) patients in the Solitaire FR group. Skyflow was non-inferior to Solitaire FR in regard to the primary outcome, with the criterion of a non-inferiority margin of 12.5% (p=0.0002) after being adjusted for the combined center effect and the National Institutes of Health Stroke Scale (NIHSS) score. The rate of periprocedural sICH and SAH did not differ significantly between the two groups. CONCLUSION: Endovascular thrombectomy with the Skyflow stent retriever was non-inferior to Solitaire FR with regard to successful reperfusion in AIS due to LVO (with a pre-specified non-inferiority margin of 12.5%).

Bronchoplastic and pulmonary arterioplastic procedures in the treatment of bronchogenic carcinoma.

OBJECTIVES: Bronchoplastic and pulmonary arterioplastic procedures have become increasingly popular in recent years as an alternative to pneumonectomy, especially for patients with compromised cardiopulmonary reserve. We reviewed our experience with the procedure to determine the operative technique, indication for the procedure and long-term results. METHODS: From January 1981 to December 2000, 65 bronchoplasties, four pulmonary arterioplasties and three combined broncho-angioplasties were performed for bronchogenic carcinoma. RESULTS: Of the 72 patients, 31 had stage I disease, 29 had stage II and 12 had stage III disease. One patient (1.4%) died of bilateral pneumonitis postoperatively. Atelectasis occurred in two patients (2.8%), empyema in one (1.4%), and bronchial fistula in one (1.4%). There were no bronchial stenoses after bronchoplastic procedures, and no vascular complications after angioplastic procedures. The 1-, 3- and 5-year survival rates for the entire group were 86.0%, 47.0% and 29.8%, respectively. The difference in survival was significant between stage I and II disease (p=0.0001) and between stage I and III disease (p<0.0001), but not between stage II and III disease (p=0.0779). CONCLUSIONS: Bronchoplastic, pulmonary arterioplastic and broncho-angioplastic procedures can be performed safely. Bronchoplastic procedures offer patients with bronchogenic carcinoma a long-term result comparable to that with radical lung resection. Angioplastic and combined broncho-angioplastic procedures should only be used in patients who cannot tolerate pneumonectomy due to poor cardiopulmonary reserve.