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BIOFLOW V demonstrates potential of ultrathin bioresorbable sirolimus-eluting stent in PCI

Roshini Claire Anthony
03 Oct 2017

The use of an ultrathin, bioresorbable polymer sirolimus-eluting stent resulted in better outcomes compared with a durable polymer everolimus-eluting stent in patients undergoing percutaneous coronary intervention (PCI) for de-novo, native coronary lesions, according to findings from the BIOFLOW V trial.

“[T]hese findings … show significant differences in target lesion failure and target vessel-related myocardial infarction [MI] that favour ultrathin strut, bioresorbable polymer sirolimus-eluting stents over durable polymer everolimus-eluting stents,” said the researchers.

At 12 months, incidence of target lesion failure (a composite of cardiovascular death, target vessel-related MI, or ischaemia-driven target lesion revascularization) was lower among patients who received a bioresorbable polymer sirolimus-eluting stent compared with those who received a durable polymer everolimus-eluting stent (6 percent vs 10 percent; p=0.0399), which was mostly due to a lower incidence of target vessel-related MI among patients who received the bioresorbable stent (5 percent vs 8 percent; p=0.0155). [Lancet 2017;doi:10.1016/S0140-6736(17)32249-3]

The incidence of cardiac death between the patients receiving the bioresorbable and durable stents was comparable at 12 months (<1 percent vs 1 percent; p=0.1153), as was the incidence of clinically driven target lesion revascularization (2 percent in each group; p=0.6856), while incidence of in-hospital MI was higher among patients using a durable stent compared with a bioresorbable one (7 percent vs 4 percent; p=0.0295).

A pooled analysis of primary endpoint results from this trial as well as that from the BIOFLOW II and IV trials (n=2,208) showed a 100 percent Bayesian posterior probability of the noninferiority of the bioresorbable polymer sirolimus-eluting stent to the durable polymer everolimus-eluting stent (Bayesian estimate target lesion failure rate difference, -2.6 percent).

In this multicentre trial (90 hospitals in 13 countries), adults (n=1,334) with ischaemic heart disease undergoing elective or urgent PCI were randomized to receive an ultrathin strut (60 µm) bioresorbable polymer sirolimus-eluting stent (n=884, mean age 64.5 years, 25 percent female) or a durable polymer everolimus-eluting stent (81 µm, n=450, mean age 64.6 years, 27 percent female). Approximately 50 percent of patients had acute coronary syndrome, while about one-third had diabetes mellitus at baseline.

All patients received aspirin (≥150 mg in 24 hours) and either clopidogrel (75 mg/day), ticagrelor (90 mg BID), or prasugrel (10 mg/day or 5 mg/day for individuals <60 kg) prior to the procedure, and dual antiplatelet therapy for ≥6 months post-procedure.

“[I]t is possible that the thinner stent struts of the bioresorbable polymer sirolimus-eluting stent … contributed to the lower frequencies of procedure-related MI and stent thrombosis observed,” said the researchers. “This observation is particularly relevant because the difference in adverse events is observed during a period before complete polymer dissolution.”

“[I]f the benefit is found to be related to an ultrathin stent design, a new focus in iterative stent development could be to further minimize strut thickness while maintaining drug delivery and mechanical properties,” they said.

As there is no evidence to suggest a class effect, the researchers attest that each specific stent type should be tested in clinical trials to determine the comparable safety and efficacy of bioresorbable polymer vs durable polymer drug-eluting stents. They also cautioned that the results may not extend to the entire population due to trial design excluding certain high-risk groups.

 

 

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Most Read Articles
Roshini Claire Anthony, 4 days ago

The combined use of piperacillin and tazobactam does not appear to be a suitable alternative to meropenem for patients with bloodstream infections caused by ceftriaxone-resistant Escherichia coli (E. coli) or Klebsiella pneumoniae (K. pneumoniae), according to results of the MERINO* trial.

Tristan Manalac, 19 May 2018
Taking oral antibiotics appears to increase the risk of nephrolithiasis, according to a recent study. Moreover, the risk seems to be compounded for individuals with recent antibiotic exposure and those who were exposed at a younger age.
2 days ago
Patients with inflammatory bowel disease are at increased risk of developing acute myocardial infarction (AMI) or heart failure, although the prevalence of traditional risk factors for such cardiovascular disorders appears to be low, as reported in a recent study.
3 days ago
Early renin-angiotensin-aldosterone system (RAAS) blockade with renin-angiotensin system inhibitors (RASI) leads to better short- and long-term renal outcomes in systemic lupus erythematosus (SLE) patients with antiphospholipid-associated nephropathy (aPLN), according to a study, adding that this renal protective effect is independent of RASI’s antihypertensive and antiproteinuric effects.