This article is more than 5 years old. Information may no longer be current.
Outcomes similar with DES vs. BMS in saphenous vein graft lesions
New data from the DIVA trial show that use of drug-eluting stents or bare-metal stents may yield similar clinical outcomes in patients who need stenting of saphenous vein graft lesions.
At 12 months, the primary endpoint of target vessel failure — defined as a composite of cardiac death, target vessel MI or target vessel revascularization — was similar at 17% among patients randomly assigned DES vs. 19% among patients randomly assigned BMS (adjusted HR = 0.92; 95% CI, 0.63-1.34). During longer follow-up (median, 2.7 years), TVF occurred in 1 in 3 patients, and was not different based on type of stent used, Cardiology Today’s Intervention Editorial Board Member Emmanouil S. Brilakis, MD, PhD, from VA North Texas Health Care System in Dallas, Minneapolis Heart Institute and University of Texas Southwestern Medical School, and colleagues reported in The Lancet.
12-month, long-term outcomes
DIVA was a double-blind, randomized controlled trial performed at 25 U.S. Department of Veterans Affairs centers. Researchers enrolled patients aged 18 years and older who had one or more significant saphenous vein graft lesions, defined as 50% to 99% stenosis of a 2.25-mm to 4.5 mm diameter saphenous vein graft, requiring PCI with intent to use an embolic protection device. From 2012 to 2015, 599 patients were randomly assigned to PCI with DES or BMS. The current report focuses on data from 597 patients, as two were excluded due to consent issues. The mean age of the patients was 69 years, and more than 99% were men.
During the index procedure, treatment focused on one target saphenous vein graft with multiple saphenous vein graft lesions in 13% of patients, multiple saphenous vein grafts in 4% and native coronary artery lesions in 16%.
Stent use was based on operator preference. Among patients assigned DES, 88% received a second-generation device (63% everolimus-eluting stents; 26% zotarolimus-eluting stents). Among those assigned BMS, newer-generation devices with thin struts were used.
Sixty-nine percent of patients underwent PCI with an embolic protection device. According to the researchers, “DIVA had higher use of embolic protection devices than any previous [saphenous vein graft] stenting trial.”
The original sample size was increased to 762 patients after the researchers observed a “lower-than-anticipated overall TVF rate” after 384 randomizations. However, enrollment was stopped on Dec. 31, 2015, before reaching the revised sample size, due to slow enrollment and funding.
The researchers reported no significant differences between the groups in individual components of the primary endpoint, serious adverse events or stent thrombosis at 12 months or at the median follow-up of 2.7 years. During the 2.7-year follow-up, the rate of TVF was 37% with DES vs. 34% with BMS (aHR = 1.1; 95% CI, 0.84-1.43). Additionally, the researchers reported no difference in risk for definite/probable stent thrombosis or postprocedural bleeding at either time point.
Clinical, financial implications
To date, four other randomized studies have been conducted in this area. However, previous research yielded “conflicting results,” according to Brilakis and colleagues. Three studies showed DES benefit, whereas one showed harm. The DIVA study provides further insight into the risks and benefits of DES vs. BMS in saphenous vein grafts, as it details greater experience with embolic protection device use and did not mandate routine angiographic follow-up.
The researchers discussed several potential reasons underlying the absence of benefit with DES in the DIVA study, including the different pathophysiology of saphenous vein graft atherosclerosis, the large burden of comorbidities among patients with a previous history of CABG and the lower risk for restenosis with use of thin-strut BMS.
This study also highlights important economic implications for use of DES or BMS in this patient population.
“The study results have important economic implications in countries with high DES prices such as the [United States], because they suggest that the lower-cost BMS can be used in [saphenous vein graft] lesions without compromising either safety or efficacy,” Brilakis and colleagues wrote. – by Katie Kalvaitis
Disclosures: Brilakis reports he has received consultant/speaker honoraria from Abbott Vascular, Acist, Amgen, Asahi, Cardiovascular Systems Inc., Elsevier, GE Healthcare, Medicure, Medtronic and Nitiloop; research support from Boston Scientific and Osprey; and he has served on the board of directors of the Cardiovascular Innovations Foundation and the board of trustees of the Society for Cardiovascular Angiography and Interventions. Please see the study for all other authors’ relevant financial disclosures.