Impact of diabetes mellitus on short term vascular complications after TAVR: Results from the BRAVO-3 randomized trial
Subgroup analysis of a randomized controlled trial published in International journal of cardiology (2019)
Abstract
AIMS: The impact of diabetes mellitus (DM) on clinical outcomes after transcatheter aortic valve replacement (TAVR) remains unclear. The aim of this study was to investigate the impact of DM on short-term clinical outcomes after TAVR in a large randomized trial population. METHODS AND RESULTS: BRAVO-3 trial randomized 802 patients undergoing trans-femoral TAVR to procedural anticoagulation with bivalirudin or unfractionated heparin. The study population was divided according to the presence of DM, and further stratified according to the use of insulin. Net adverse cardiovascular outcomes (NACE - death, myocardial infarction (MI), stroke or major bleeding by Bleeding Academic Research Consortium (BARC) type 3b or above) was the primary outcome in-hospital and at 30-days. Of the total 802 randomized patients, 239 (30%) had DM at baseline, with 87 (36%) being treated with insulin. At 30-days, DM patients experienced numerically higher rates of net adverse cardiovascular events (16.3% vs. 14.4%, p=0.48) and acute kidney injury (19.7% vs. 15.1%, p=0.11), while non-DM (NDM) patients had numerically higher rates of cerebrovascular accidents (3.6% vs. 1.7%, p=0.22). After multivariable adjustment, DM patients had higher odds of vascular complications at 30-days (OR 1.57, p=0.03) and life-threatening bleeding both in-hospital (OR 1.50, p=0.046) and at 30-days (OR 1.50, p=0.03) with the excess overall risk primarily attributed to the higher rates observed among non-insulin dependent DM patients. CONCLUSIONS: Patients with DM had higher adjusted odds of vascular and bleeding complications up to 30-days post-TAVR. Overall, there was no significant association between DM and early mortality following TAVR.
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Summary
In the BRAVO-3 trial of 802 transfemoral TAVR patients, diabetes mellitus was associated with higher adjusted odds of vascular complications and life-threatening bleeding up to 30 days, with no significant effect on mortality.
Why This Matters for Hirudotherapy
Using the BRAVO-3 randomized trial population, this study investigated the impact of diabetes mellitus on short-term clinical outcomes following transcatheter aortic valve replacement (TAVR). The trial originally randomized patients to procedural anticoagulation with either bivalirudin or unfractionated heparin, but this secondary analysis focuses on predicting complications for diabetic patients. Bivalirudin (formerly Hirulog) is a synthetic peptide anticoagulant designed partly on the C-terminal sequence of hirudin, the anticoagulant of the medicinal leech (Maraganore et al., 1990); this paper studies the drug, not leech therapy.
Citation
Reference (Vancouver style)
Goel R, Power D, Tchetche D, Chandiramani R, Guedeney P, Claessen BE, et al. Impact of diabetes mellitus on short term vascular complications after TAVR: Results from the BRAVO-3 randomized trial. Int J Cardiol. 2019;297:22-29. doi:10.1016/j.ijcard.2019.09.063. PMID: 31630816
Bibliographic details (authors, volume, pages, DOI) are taken from the PubMed record.
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