DIVA
Trial question
What is the role of drug-eluting stents in patients undergoing stenting of de-novo saphenous vein bypass graft lesions?
Study design
Multi-center
Double blinded
RCT
Population
597 patients (2 female, 595 male).
Inclusion criteria: patients who had at least one significant de-novo SVG lesion requiring PCI with intent to use embolic protection devices.
Key exclusion criteria: planned noncardiac surgery within 12 months of screening, ST-segment elevation acute MI, target SVG that was the last remaining vessel or was a left main equivalent, previous percutaneous treatment of the target vessel within the previous 12 months, or hemorrhagic diatheses.
Interventions
N=292 drug-eluting stents (coronary revascularization with drug-eluting stents).
N=305 bare metal stents (coronary revascularization with bare metal stents).
Primary outcome
Target vessel failure at 12 months
17%
19%
19.0 %
14.3 %
9.5 %
4.8 %
0.0 %
Drug-eluting
stents
Bare metal
stents
No significant
difference ↔
No significant difference in target vessel failure at 12 months (17% vs. 19%).
Secondary outcomes
No significant difference in death from any cause (8% vs. 7%).
No significant difference in MI during follow-up (10% vs. 10%; HR 0.94, 95% CI 0.56 to 1.57).
No significant difference in revascularization (19% vs. 17%; HR 1.11, 95% CI 0.76 to 1.61).
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In patients who had at least one significant de-novo SVG lesion requiring PCI with intent to use embolic protection devices, drug-eluting stents were not superior to bare metal stents with respect to target vessel failure at 12 months.
Reference
Brilakis ES, Edson R, Bhatt DL et al. Drug-eluting stents versus bare-metal stents in saphenous vein grafts: a double-blind, randomised trial. Lancet. 2018 May 19;391(10134):1997-2007.
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