A Prospective Multicenter Evaluation of the Accuracy of a Novel Implanted Continuous Glucose Sensor: PRECISE II.

BACKGROUND: Persistent use of real-time continuous glucose monitoring (CGM) improves diabetes control in individuals with type 1 diabetes (T1D) and type 2 diabetes (T2D). METHODS: PRECISE II was a nonrandomized, blinded, prospective, single-arm, multicenter study that evaluated the accuracy and safety of the implantable Eversense CGM system among adult participants with T1D and T2D (NCT02647905). The primary endpoint was the mean absolute relative difference (MARD) between paired Eversense and Yellow Springs Instrument (YSI) reference measurements through 90 days postinsertion for reference glucose values from 40 to 400 mg/dL. Additional endpoints included Clarke Error Grid analysis and sensor longevity. The primary safety endpoint was the incidence of device-related or sensor insertion/removal procedure-related serious adverse events (SAEs) through 90 days postinsertion. RESULTS: Ninety participants received the CGM system. The overall MARD value against reference glucose values was 8.8% (95% confidence interval: 8.1%-9.3%), which was significantly lower than the prespecified 20% performance goal for accuracy (P < 0.0001). Ninety-three percent of CGM values were within 20/20% of reference values over the total glucose range of 40-400 mg/dL. Clarke Error Grid analysis showed 99.3% of samples in the clinically acceptable error zones A (92.8%) and B (6.5%). Ninety-one percent of sensors were functional through day 90. One related SAE (1.1%) occurred during the study for removal of a sensor. CONCLUSIONS: The PRECISE II trial demonstrated that the Eversense CGM system provided accurate glucose readings through the intended 90-day sensor life with a favorable safety profile.

Carotid artery revascularization in high surgical risk patients with the NexStent and the Filterwire EX/EZ: 1-year results in the CABERNET trial.

OBJECTIVE: The multicenter, single-arm CABERNET trial evaluated outcomes in high-surgical-risk patients with carotid artery stenosis treated with the NexStent plus FilterWire EX/EZ Emboli Protection System. BACKGROUND: For patients at high surgical risk, carotid artery stenting (CAS) offers a less invasive alternative to carotid endarterectomy (CEA). METHODS: The trial enrolled 454 high-surgical-risk patients with carotid stenosis by angiography > or = 50% for symptomatic patients and > or = 60% for asymptomatic patients. The comparator primary endpoint was the 1-year major adverse event (MAE, defined as any death, stroke, or myocardial infarction [MI]) rate. It was compared with a proportionally weighted objective performance criterion (OPC) of 12.1% representative of published CEA results in similar patients plus a prespecified noninferiority margin (delta) of 4%. A second primary endpoint was the composite rate of 30-day MAE plus late (31-365 days) ipsilateral stroke. RESULTS: Symptoms of carotid stenosis were present in 24.2% of patients; 36.6% of patients were considered high-surgical-risk due to comorbid risk factors and 63.4% due to anatomic risk factors. The rate of 30-day MAE plus late ipsilateral stroke was 4.7% (20/438). The comparator primary endpoint of 1-year MAE was 11.6% (51/438) and was noninferior to the OPC of 12.1% (95% upper confidence interval of 14.5% versus OPC plus delta of 16.1%, P = 0.005). Late ipsilateral stroke was 0.7% and target vessel revascularization at 1 year was 2.4%. CONCLUSIONS: The CABERNET trial demonstrates that CAS with NexStent and FilterWire is noninferior to (equivalent or better than) traditional CEA at 1 year in high-surgical-risk patients based on historical controls.

Staged bilateral carotid stenting, an effective strategy in high-risk patients - insights from a prospective multicenter trial.

OBJECTIVE: To prospectively evaluate outcomes of high-risk patients undergoing bilateral carotid artery stenting (CAS). METHODS: A total of 747 patients at increased risk for carotid endarterectomy (CEA) were enrolled in a prospective registry at 47 US sites of the Boston Scientific EPI: A Carotid Stenting Trial for Risk Surgical Patients (BEACH) trial. Among them, 78 (10.4%) patients underwent contralateral CAS > 30 days after the primary CAS procedure. Patients were followed at 1, 6, and 12 months, and annually thereafter for 3 years. The primary endpoint was the cumulative incidence of non Q-wave myocardial infarction within 24 hours, periprocedural (

Paclitaxel-eluting stents vs vascular brachytherapy for in-stent restenosis within bare-metal stents: the TAXUS V ISR randomized trial.

CONTEXT: Restenosis within bare-metal stents is often treated with repeat percutaneous coronary intervention, although subsequent recurrence rates are high, with vascular brachytherapy (VBT) affording the best results. The effectiveness of drug-eluting stents in this setting has not been established. OBJECTIVE: To investigate the safety and efficacy of the polymer-based, slow-release paclitaxel-eluting stent in patients with restenotic lesions after prior stent implantation in native coronary arteries. DESIGN, SETTING, AND PATIENTS: Prospective, multicenter, randomized trial conducted between June 6, 2003, and July 16, 2004, at 37 North American academic and community-based institutions in 396 patients with in-stent restenosis of a previously implanted bare-metal coronary stent (vessel diameter, 2.5-3.75 mm; lesion length, < or =46 mm). INTERVENTIONS: Patients were randomly assigned to undergo angioplasty followed by VBT with a beta source (n = 201) or paclitaxel-eluting stent implantation (n = 195). Clinical and angiographic follow-up at 9 months was scheduled in all patients. MAIN OUTCOME MEASURE: Ischemia-driven target vessel revascularization at 9 months. RESULTS: Diabetes mellitus was present in 139 patients (35.1%). Median reference vessel diameter was 2.65 mm and median lesion length was 15.3 mm. In the VBT group, new stents were implanted in 22 patients (10.9%) and in the paclitaxel-eluting stent group, multiple stents were required in 57 patients (29.2%), with median stent length of 24 mm. Follow-up at 9 months was complete in 194 patients in the VBT group and 191 patients in the paclitaxel-eluting stent group (96.5% and 97.9%, respectively). For VBT and paclitaxel-eluting stents, respectively, the number of events and 9-month rates for ischemic target lesion revascularization were 27 (13.9%) vs 12 (6.3%) (relative risk [RR], 0.45; 95% confidence interval [CI], 0.24-0.86; P = .01); for ischemic target vessel revascularization, 34 (17.5%) vs 20 (10.5%) (RR, 0.60; 95% CI, 0.36-1.00; P = .046); and for overall major adverse cardiac events, 39 (20.1%) vs 22 (11.5%) (RR, 0.57; 95% CI, 0.35-0.93; P = .02), with similar rates of cardiac death or myocardial infarction (10 [5.2%] vs 7 [3.7%]; RR, 0.71; 95% CI, 0.28-1.83; P = .48) and target vessel thrombosis (5 [2.6%] vs 3 [1.6%]; RR, 0.61; 95% CI, 0.15-2.50; P = .72). Angiographic restenosis at 9 months was 31.2% (53 of 170 patients) with VBT and 14.5% (25 of 172 patients) with paclitaxel-eluting stents (RR, 0.47; 95% CI, 0.30-0.71; P<.001). CONCLUSION: Treatment of bare-metal in-stent restenotic lesions with paclitaxel-eluting stents rather than angioplasty followed by VBT reduces clinical and angiographic restenosis at 9 months and improves event-free survival. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00287573.

Outcomes of secondary interventions after abdominal aortic aneurysm endovascular repair.

PURPOSE: We assessed the distribution of secondary interventions after aortic stent grafting (EVAR) performed to treat infrarenal abdominal aortic aneurysm (AAA), and evaluated clinical success and survival in patients who underwent a secondary procedure (group 2) compared with patients who did not undergo a secondary procedure (group 1). METHODS: Two hundred fifty patients (mean age, 71.3 years) with asymptomatic AAAs (mean aneurysm diameter, 54.5 mm) underwent treatment with commercially available stent grafts. Mean follow-up was 28 months (median, 25 months). Secondary procedures were defined as any additional procedures performed after initial graft placement to treat endoleak, migration, kinking, stenosis, or occlusion. Overall clinical success was defined according to reporting standards of the Society for Vascular Surgery/American Association for Vascular Surgery. RESULTS: Sixty-eight patients (27%) required 112 secondary procedures, with a mean time from initial graft placement of 18.2 months. Patients who received grafts since removed from the market required more secondary procedures (59%, procedure:patient ratio) compared with patients who received devices still on the market (21%; P =.001). Thirty-six patients (53%) required a single secondary procedure, 24 patients (35%) required two procedures, 5 patients (10%) required three procedures, 2 patients (3%) required four procedures, and 1 patient required five secondary procedures. Ninety-eight procedures (87%) were performed with endovascular methods, including placement of 42 additional covered stent grafts (36 iliac, 6 aortic), with a success rate of 85%; 35 embolization procedures (21 lumbar, 9 internal iliac artery, 5 mesenteric), with only 23 (65%) successful; 14 angioplasty procedures, with 85% successful; 4 thrombolysis procedures, 2 of them successful (50%); and 3 successfully placed new endografts within a previous endovascular graft. Surgical secondary operations included nine femorofemoral bypass procedures and three femoral thromboendarterectomies, all of which remain patent; one cerclage of an external iliac limb; and one laparoscopic repair of a type II endoleak, which was successful. Overall clinical success rate for EVAR was 84% (211 of 250) in this series. Clinical success rate in groups 1 and 2 was 91% (166 of 182) versus 66% (45 of 68; P =.001) if all endoleaks on the most recent computed tomography scans are taken into account, and 94% (171 of 182) versus 76% (52 of 68; P =.001) if type II endoleak without aneurysm growth is not considered failure. The survival rate and rupture-free survival in groups 1 and 2 were, respectively, 97.7% +/- 1.0% and 98.5% +/- 1.4% at 1 month, 95.9% +/- 1.5% and 96.9% +/- 2.1% at 6 months, 94.4% +/- 2.0% and 93.2% +/- 3.4% at 1 year, and 80.8% +/- 5.2% and 88.5% +/- 5.0% at 3 years (P =.273, log-rank test). CONCLUSION: With close follow-up and a significant number of secondary operations, this 8-year experience has not included any aneurysm ruptures to date. Secondary operations did not lead to increased mortality, but were associated with more surgical conversions and with a higher clinical failure rate.