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Summary Background Few studies have examined the efficacy of drug-eluting stents (DES) for reducing aortocoronary saphenous vein bypass graft (SVG) failure compared with bare-metal stents (BMS) in patients undergoing stenting of de-novo SVG lesions. We assessed the risks and benefits of the use of DES versus BMS in de-novo SVG lesions. Methods Patients were recruited to our double-blind, randomised controlled trial from 25 US Department of Veterans Affairs centres. Eligible participants were aged at least 18 years and had at least one significant de-novo SVG lesion (50–99% stenosis of a 2·25–4·5 mm diameter SVG) requiring percutaneous coronary intervention with intent to use embolic protection devices. Enrolled patients were randomly assigned, in a 1:1 ratio, by phone randomisation system to receive a DES or BMS. Randomisation was stratified by presence or absence of diabetes and number of target SVG lesions requiring percutaneous coronary intervention (one or two or more) within each participating site by use of an adaptive scheme intended to balance the two stent type groups on marginal totals for the stratification factors. Patients, referring physicians, study coordinators, and outcome assessors were masked to group allocation. 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 revascularisation. The DIVA trial is registered with ClinicalTrials.gov, number NCT01121224. Findings Between Jan 1, 2012, and Dec 31, 2015, 599 patients were randomly assigned to the stent groups, and the data for 597 patients were used. The patients' mean age was 68·6 (SD 7·6) years, and 595 (>99%) patients were men. The two stent groups were similar for most baseline characteristics. At 12 months, the incidence of target vessel failure was 17% (51 of 292) in the DES group versus 19% (58 of 305) in the BMS group (adjusted hazard ratio 0·92, 95% CI 0·63–1·34, p=0·70). Between-group differences in the components of the primary endpoint, serious adverse events, or stent thrombosis were not significant. Enrolment was stopped before the revised target sample size of 762 patients was reached. Interpretation In patients undergoing stenting of de-novo SVG lesions, no significant differences in outcomes between those receiving DES and BMS during 12 months of follow-up were found. The study results have important economic implications in countries with high DES prices such as the USA, because they suggest that the lower-cost BMS can be used in SVG lesions without compromising either safety or efficacy. Funding US Department of Veterans Affairs Cooperative Studies Program.

Myocardial scar is a substrate for reentrant ventricular arrhythmias and is associated with poor prognosis. Fragmented QRS (fQRS) on 12-lead ECG represents myocardial conduction delays due to myocardial scar in patients with coronary artery disease (CAD).The purpose of this study was to determine whether fQRS is associated with increased ventricular arrhythmic event and mortality in patients with CAD and nonischemic dilated cardiomyopathy (DCM).Arrhythmic events and mortality were studied in 361 patients (91% male, age 63.3 +/- 11.4 years, mean follow-up 16.6 +/- 10.2 months) with CAD and DCM who received an implantable cardioverter-defibrillator for primary or secondary prophylaxis. fQRS included various RSR' patterns (QRS duration120 ms), such asor =1 R prime or notching of the R wave or S wave present on at least two contiguous leads of those representing anterior (V(1)-V(5)), lateral (I, aVL, V(6)), or inferior (II, III, aVF) myocardial segments.fQRS was present in 84 (23%) patients (fQRS group) and absent in 100 (28%) patients (non-fQRS group). Wide QRS (wQRS; QRS durationor =120 ms) was present in 177 (49%) patients. Kaplan-Meier analysis revealed that event-free survival for an arrhythmic event (implantable cardioverter-defibrillator shock or antitachycardia pacing) was significantly lower in the fQRS group than in the non-fQRS and wQRS groups (P.001 and P.019, respectively). fQRS was an independent predictor of an arrhythmic event but not of death.fQRS on 12-lead ECG is a predictor of arrhythmic events in patients with CAD and DCM. fQRS is associated with a significantly decreased time to first arrhythmic event compared with non-fQRS and wQRS.

Nonischemic dilated cardiomyopathy (NICM) is associated with diffuse global hypokinesia on echocardiography. However, NICM also may be associated with segmental wall-motion abnormalities (SWMAs) even in the presence of global hypokinesia, probably secondary to patchy myocardial scars.Because myocardial scars serve as substrate for reentry, the purpose of this study was to determine whether SWMA is a predictor of ventricular arrhythmic events in NICM.Echocardiographic parameters and appropriate implantable cardioverter-defibrillator (ICD) therapy for arrhythmic events (shock or antitachycardia pacing) were studied in NICM patients with an ICD. Two-dimensional echocardiography of the left ventricle was recorded in a 16-segment model. SWMA was defined by the presence of akinesia or moderate to severe hypokinesia in at least two segments. Patients were divided into one of two groups according to the presence (SWMA group) or the absence (non-SMWA group) of SWMA.SWMA was present in 47.5% of 101 patients (mean age 58.0 ± 15.6 years, 85% male, primary prophylaxis indication 46%, mean ejection fraction 26% ± 9%, mean follow-up 29 ± 18.4 months) studied. No significant difference in mean age, ejection fraction, and QRS duration was seen between SWMA and non-SWMA groups. The SWMA group had a significantly higher incidence of arrhythmic events than did the non-SWMA group (65% vs 15%, P.001). Kaplan-Meier survival analysis revealed that SMWA was associated with significantly reduced time to first arrhythmic event (P = .001). SWMA (P0.001), New York Heart Association heart failure class (P = .016), and secondary prevention indication for ICD placement (P = .005) were significant independent predictors of an arrhythmic event. SWMA did not predict mortality.SWMA is an independent predictor of arrhythmic events in patients with NICM.