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

Abstract

VA Cooperative Studies Program #571 (DIVA) was designed to evaluate the efficacy of drugeluting 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 targetvessel 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-thananticipated 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.

The short‐ and long‐term outcomes of percutaneous intervention with drug‐eluting stent vs bare‐metal stent in saphenous vein graft disease: An updated meta‐analysis of all randomized clinical trials

“…We identified 6 RCTs with a pooled sample of 1582 patients; 1456 (92%) were male. There were 797 patients in the DES group and 785 in the BMS group.…”

“…Third, the samples of patients enrolled in the previous trials were small in size (3 trials had ≤80 patients), with only 2 trials enrolling relatively larger number of patients (DIVA enrolled 599 and analyzed 597; Is Drug‐Eluting Stenting Associated With improved Results in Coronary Artery Bypass Grafts? [ISAR‐CABG] enrolled 610) . Fourth, different trials reported variable embolic protective device utilization (ISAR‐CABG <5% and DIVA >65%) .…”

“…[ISAR‐CABG] enrolled 610) . Fourth, different trials reported variable embolic protective device utilization (ISAR‐CABG <5% and DIVA >65%) . These devices might have influenced the outcomes, as they provide additional protection for periprocedural MACE.…”

“…Another meta‐analysis of 5 RCTs showed a significant reduction of TVR in patients who received first‐generation DES in comparison with BMS . The result of the Drug‐Eluting Stents vs. Bare Metal Stents in Saphenous Vein Graft Angioplasty (DIVA) trial, which used a large percentage of second‐generation DES in comparison with BMS, was reported recently with both short‐ and long‐term clinical outcomes . Within this context, we conducted an updated meta‐analysis to compare the clinical outcomes of DES vs BMS in SVG lesions in both short‐term (≤12 months) and long‐term (>12 months) follow‐up.…”

A comprehensive meta‐analysis of randomized controlled trials comparing drug‐eluting stents with bare‐metal stents in saphenous vein graft interventions

“…Since then, several RCTs have shown that DESs decrease the risk of target vessel revascularization (TVR) without affecting mortality . However, the most recently reported DIVA (DESs vs. BMSs in Saphenous Vein Graft Angioplasty) trial showed that DESs may not improve TVR in SVG compared to BMSs . Therefore, we conducted an updated comprehensive meta‐analysis of RCTs comparing DESs versus BMSs for SVG interventions using the largest sample size to date.…”