Meta-analysis raises further concerns about bioresorbable scaffolds
medwireNews: The results of a meta-analysis add to evidence suggesting that bioresorbable vascular scaffolds (BVS) are associated with unfavorable clinical outcomes compared with drug-eluting stents (DES) among patients with coronary artery disease.
Ramez Nairooz (University of Arkansas for Medical Sciences, Little Rock, USA) and fellow researchers found that 6.9% of 1322 patients who underwent percutaneous coronary intervention (PCI) with everolimus-eluting BVS experienced device-oriented composite events (DOCE) at 2 years, compared with 4.5% of 1038 undergoing PCI with DES implantation.
These findings translate into an absolute risk increase of 1.4%, a relative risk increase of 53.0%, and a number needed to harm of 42 for BVS versus DES, reports the team in Heart.
The meta-analysis included data from three randomized controlled trials and two observational propensity score-matched analyses, and DOCE were defined as a composite of cardiac death, target vessel-myocardial infarction (TV-MI), and ischemia-driven target lesion revascularization (TLR).
Patients with BVS also experienced higher rates of TV-MI and definite stent thrombosis (ST) than those with DES, with corresponding rates of 4.0% versus 1.8% and 2.1% versus 0.6%, but there was no significant difference in the incidence of all-cause mortality and TLR between the two groups, at 1.2% versus 1.6% and 3.9% versus 2.7%, respectively.
Although not statistically significant, there was a numerically higher rate of very late definite ST (at >1 year) among patients with BVS compared with DES (0.7 vs 0.0%). The authors say that this finding is “alarming,” and that the results “were consistent among randomized and observational studies.”
“This increased risk of ST [is] believed by many to possibly be the initiating event of all the adverse outcomes with BVS,” they add.
Nairooz et al note that their meta-analysis was limited by the inclusion of observational studies “due to the scarcity of long-term data from randomised trials,” with only three trials having published 2-year outcomes of BVS versus DES to date.
And they conclude: “Randomised clinical trials should expeditiously report both long-term outcomes and predictors of adverse events with BVS versus DES.”
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