Clinical Outcomes Before and After Complete Everolimus-Eluting Bioresorbable Scaffold Resorption: Five-Year Follow-Up From the ABSORB III Trial.

BACKGROUND: The Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) provides early drug delivery and mechanical support similar to those of metallic drug-eluting stents, followed by complete resorption in ≈3 years with recovery of vascular structure and function. The ABSORB III trial demonstrated noninferior rates of target lesion failure (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) at 1 year with BVS compared with cobalt chromium everolimus-eluting stents. Between 1 and 3 years and cumulative to 3 years, adverse event rates (particularly target vessel myocardial infarction and scaffold thrombosis) were increased after BVS. We sought to assess clinical outcomes after BVS through 5 years, including beyond the 3-year time point of complete scaffold resorption. METHODS: Clinical outcomes from ABSORB III were analyzed by randomized device (intention to treat) cumulative to 5 years and between 3 and 5 years. RESULTS: Rates of target lesion failure, target vessel myocardial infarction, and scaffold thrombosis were increased through the 5-year follow-up with BVS compared with everolimus-eluting stents. However, between 3 and 5 years, reductions in the relative hazards of the BVS compared with everolimus-eluting stents were observed, particularly for target lesion failure (hazard ratio, 0.83 [95% CI, 0.55-1.24] versus 1.35 [95% CI, 1.02-1.78]; Pint=0.052) and scaffold thrombosis (hazard ratio, 0.26 [95% CI, 0.02-2.87] versus 3.23 [95% CI, 1.25-8.30]; Pint=0.056) compared with the 0- to 3-year time period. CONCLUSIONS: In the ABSORB III trial, cumulative 5-year adverse event rates were increased after BVS compared with everolimus-eluting stents. However, the period of excess risk for BVS ended at 3 years, coincident with complete scaffold resorption. CLINICAL TRIAL REGISTRATION: URL: https://clinicaltrials.gov. Unique identifier: NCT01751906.

3-Year Clinical Outcomes With Everolimus-Eluting Bioresorbable Coronary Scaffolds: The ABSORB III Trial.

BACKGROUND: The Absorb everolimus-eluting poly-L-lactic acid-based bioresorbable vascular scaffold (BVS) provides early drug delivery and mechanical support functions similar to metallic drug-eluting stents (DES), followed by complete bioresorption in approximately 3 years with recovery of vascular structure and function. The ABSORB III trial demonstrated noninferior rates of target lesion failure (cardiac death, target vessel myocardial infarction [TVMI], or ischemia-driven target lesion revascularization) at 1 year in 2,008 patients with coronary artery disease randomized to BVS versus cobalt-chromium everolimus-eluting stents (EES). OBJECTIVES: This study sought to assess clinical outcomes through 3 years following BVS implantation. METHODS: Clinical outcomes from the ABSORB III trial were analyzed by randomized treatment assignment cumulative through 3 years, and between 1 and 3 years. RESULTS: The primary composite endpoint of target lesion failure through 3 years occurred in 13.4% of BVS patients and 10.4% of EES patients (p = 0.06), and between 1 and 3 years in 7.0% versus 6.0% of patients, respectively (p = 0.39). TVMI through 3 years was increased with BVS (8.6% vs. 5.9%; p = 0.03), as was device thrombosis (2.3% vs. 0.7%; p = 0.01). In BVS-assigned patients, treatment of very small vessels (those with quantitatively determined reference vessel diameter <2.25 mm) was an independent predictor of 3-year TLF and scaffold thrombosis. CONCLUSIONS: In the ABSORB III trial, 3-year adverse event rates were higher with BVS than EES, particularly TVMI and device thrombosis. Longer-term clinical follow-up is required to determine whether bioresorption of the polymeric scaffold will influence patient prognosis. (ABSORB III Randomized Controlled Trial [RCT] [ABSORB-III]; NCT01751906).

Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease.

BACKGROUND: In patients with coronary artery disease who receive metallic drug-eluting coronary stents, adverse events such as late target-lesion failure may be related in part to the persistent presence of the metallic stent frame in the coronary-vessel wall. Bioresorbable vascular scaffolds have been developed to attempt to improve long-term outcomes. METHODS: In this large, multicenter, randomized trial, 2008 patients with stable or unstable angina were randomly assigned in a 2:1 ratio to receive an everolimus-eluting bioresorbable vascular (Absorb) scaffold (1322 patients) or an everolimus-eluting cobalt-chromium (Xience) stent (686 patients). The primary end point, which was tested for both noninferiority (margin, 4.5 percentage points for the risk difference) and superiority, was target-lesion failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization) at 1 year. RESULTS: Target-lesion failure at 1 year occurred in 7.8% of patients in the Absorb group and in 6.1% of patients in the Xience group (difference, 1.7 percentage points; 95% confidence interval, -0.5 to 3.9; P=0.007 for noninferiority and P=0.16 for superiority). There was no significant difference between the Absorb group and the Xience group in rates of cardiac death (0.6% and 0.1%, respectively; P=0.29), target-vessel myocardial infarction (6.0% and 4.6%, respectively; P=0.18), or ischemia-driven target-lesion revascularization (3.0% and 2.5%, respectively; P=0.50). Device thrombosis within 1 year occurred in 1.5% of patients in the Absorb group and in 0.7% of patients in the Xience group (P=0.13). CONCLUSIONS: In this large-scale, randomized trial, treatment of noncomplex obstructive coronary artery disease with an everolimus-eluting bioresorbable vascular scaffold, as compared with an everolimus-eluting cobalt-chromium stent, was within the prespecified margin for noninferiority with respect to target-lesion failure at 1 year. (Funded by Abbott Vascular; ABSORB III ClinicalTrials.gov number, NCT01751906.).

Clinical study on cholesterol-lowering effect of RYR Cholestin among Americans with moderate hy-percholesterolemia / 上海预防医学

[Objective] To evaluate lipid -lowering efficacy and safety of RYR Cholestin , or Monascus purpureus (Red Yeast) Rice, in Americans with moderate hypercholesterolemia. [Methods] This study was an open-label, self-control, and multi-center clinical trial.A total of 187 subjects were entered into this trial (serum LDL-Cholesterol 3.50~4.92 mmol/L,total cholesterol 5.18~7.25 mmol/L, male:female=116∶71) , of whom 162 completed the study .Subjects were placed on the NCEP Step I Diet throughout the study and RYR Cholestin (2.4 g/day) was administered for 8 weeks following initial 4-week diet control . [ Results] Being on the diet alone for 4 weeks resulted in no significant changes in serum lipids .RYR Cholestin treatment for 8 weeks reduced serum total cholesterol , LDL-Cholesterol and triglycerides by 16 .6%, 24 .0%, and 25 .2%, respectively , and increased HDL-Cholesterol by 14 .3%( all P<0 .001 ) .There were 97 .5% of patients having ≥10% improvement in at least one of lipid risk factors, and 79.0%having ≥20% improvement.Discontinuation of RYR Cholestin intervention for 14 d led to a return of serum lipids to baseline of pre -study .And 29 possible product -related mild adverse re-actions were reported . [ Conclusion] RYR Cholestin is well tolerated and effective in reducing total and LDL-Cholesterol, and triglycerides, as well as in increasing HDL-Cholesterol in hypercholesterolemic patients, but those indicators return to the beginning baseline when the treatment is discontinued .

Results from a phase II multicenter, double-blind placebo-controlled study of Del-1 (VLTS-589) for intermittent claudication in subjects with peripheral arterial disease.

BACKGROUND: This study compared VLTS-589 (plasmid encoding the angiomatrix protein Del-1 in conjunction with poloxamer 188) with poloxamer 188 control, for the treatment of intermittent claudication in patients with moderate to severe peripheral arterial disease. METHODS: Subjects with bilateral intermittent claudication and peak walking time (PWT) between 1 and 10 minutes on 2 qualifying (reproducible; within 25% of each other) treadmill tests were enrolled. Patients received VLTS-589 or poloxamer 188 control, administered as 21 intramuscular injections to each lower extremity (42 mL in each extremity). In addition to safety and tolerability, efficacy evaluations compared to baseline included the following: change in PWT at 90 days (primary end point), change in claudication onset time, change in ankle brachial index (ABI), and change in quality of life measures. RESULTS: A total of 105 patients were randomized and treated. During the 30, 90, and 180 days follow-up, mean PWT, claudication onset time, and ABI were significantly increased compared to baseline values in both treatment groups with no significant difference between groups in the primary or secondary end points. In addition, both groups demonstrated significantly improved quality of life at follow-up vs baseline, with no significant differences between groups. Serious adverse events were similar in both groups--none were definitely treatment-related. CONCLUSION: Intramuscular delivery of both Del-1 expressing plasmid and the control resulted in significant improvement in exercise capacity compared to baseline at 30, 90, and 180 days. There was no difference in outcome measures associated with the Del-1 plasmid.