Rationale and design of the Drug-Eluting Stents vs Bare-Metal Stents in Saphenous Vein Graft Angioplasty (DIVA) Trial.

VA Cooperative Studies Program #571 (DIVA) was designed to evaluate the efficacy of drug-eluting stents (DES) for reducing aortocoronary saphenous vein bypass graft (SVG) failure when compared with bare-metal stents (BMS) in participants undergoing stenting of de novo SVG lesions. Participants undergoing clinically indicated stenting of de novo SVG lesions were randomized in a 1:1 ratio to DES or BMS. Randomization was stratified by presence/absence of diabetes mellitus and the number of target SVG lesions (1 vs ≥2) within each participating site. At sites that did not routinely administer 12-months of dual antiplatelet therapy after SVG stenting participants without acute coronary syndromes received 1 month of open-label clopidogrel, followed by 11 months of clopidogrel for those assigned to DES and 11 months of placebo for those assigned to BMS. The primary endpoint was the 12-month incidence of target-vessel failure (defined as the composite of cardiac death, target-vessel myocardial infarction, or target-vessel revascularization). Secondary endpoints included the incidence of other clinical endpoints and the incremental cost-effectiveness of DES relative to BMS. Due to lower-than-anticipated target-vessel failure rates, target enrollment was increased from 519 to 762. The study had randomized 599 participants when recruitment ended in December 2015. The DIVA trial will provide clarity on the appropriate stent type for de novo SVG lesions.

Percutaneous coronary intervention versus coronary bypass surgery in United States veterans with diabetes.

OBJECTIVES: This study sought to determine the optimal coronary revascularization strategy in patients with diabetes with severe coronary disease. BACKGROUND: Although subgroup analyses from large trials, databases, and meta-analyses have found better survival for patients with diabetes with complex coronary artery disease when treated with surgery, a randomized trial comparing interventions exclusively with drug-eluting stents and surgery in patients with diabetes with high-risk coronary artery disease has not yet been reported. METHODS: In a prospective, multicenter study, 198 eligible patients with diabetes with severe coronary artery disease were randomly assigned to either coronary artery bypass grafting (CABG) (n = 97) or percutaneous coronary intervention (PCI) with drug-eluting stents (n = 101) and followed for at least 2 years. The primary outcome measure was a composite of nonfatal myocardial infarction or death. Secondary outcome measures included all-cause mortality, cardiac mortality, nonfatal myocardial infarction, and stroke. RESULTS: The study was stopped because of slow recruitment after enrolling only 25% of the intended sample size, leaving it severely underpowered for the primary composite endpoint of death plus nonfatal myocardial infarction (hazard ratio: 0.89; 95% confidence interval: 0.47 to 1.71). However, after a mean follow-up period of 2 years, all-cause mortality was 5.0% for CABG and 21% for PCI (hazard ratio: 0.30; 95% confidence interval: 0.11 to 0.80), while the risk for nonfatal myocardial infarction was 15% for CABG and 6.2% for PCI (hazard ratio: 3.32; 95% confidence interval: 1.07 to 10.30). CONCLUSIONS: This study was severely underpowered for its primary endpoint, and therefore no firm conclusions about the comparative effectiveness of CABG and PCI are possible. There were interesting differences in the components of the primary endpoint. However, the confidence intervals are very large, and the findings must be viewed as hypothesis generating only. (Coronary Artery Revascularization in Diabetes; NCT00326196).

A comparison of anterior chamber and posterior chamber intraocular lenses after vitreous presentation during cataract surgery: the Department of Veterans Affairs Cooperative Cataract Study.

PURPOSE: To compare the efficacy and safety of anterior chamber (AC) intraocular lenses (IOLs) and posterior chamber (PC) IOLs implanted after vitreous presentation during extracapsular cataract extraction (ECCE). DESIGN: The study was a prospective, long-term, randomized clinical trial conducted at 19 Department of Veterans Affairs medical centers across the United States. METHODS: There were 438 eyes (438 patients) that met preliminary eligibility criteria, suffered vitreous presentation during ECCE (phacoemulsification or classical extracapsular technique), and had sufficient capsular support for a PC IOL without sutures after anterior vitrectomy randomized to either a PC IOL (230 patients) or an AC IOL (208 patients). Patients were examined at 3, 6, and 12 months post-surgery and yearly thereafter. Minimum follow-up was 1 year. The primary outcome measure of best-corrected visual acuity at 1 year was obtained by a masked certified examiner. RESULTS: More PC IOL patients (91%) achieved visual acuity of 20/40 or better at 1 year than AC IOL patients (79%), a highly significant difference (P =.003). There was no significant difference between the two groups for patient's rating of vision or adverse events. Over 84% of the PC IOL patients and over 77% of the AC IOL patients rated their vision as good or better at 1 year as opposed to only 7% giving such ratings before surgery. For at least one rating period during the first year, 13.2% of the combined study patients had cystoid macular edema, 8.5% had posterior capsule opacification, 5.7% had glaucoma, and 3.7% had retinal detachment. CONCLUSION: In the presence of sufficient capsular support, a PC IOL should be implanted after vitreous presentation during ECCE.