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Polymer-free less effective than polymer-based stent for PCI?

Audrey Abella
19 Oct 2020

A polymer-free, thicker-strut, biolimus A9-eluting stent (BES) was not noninferior to a biodegradable-polymer, ultrathin-strut, sirolimus-eluting stent (SES) in unselected patients requiring percutaneous coronary intervention (PCI), the SORT OUT* IX trial has shown.

“The BES BioFreedom did not meet the criteria for noninferiority for major adverse cardiovascular events (MACE) at 12 months compared with the SES Orsiro in an all-comers population,” said the researchers.

“In our opinion, [the findings suggest that] the polymer-free BES [is] less efficacious than a conventional polymer-based drug-eluting stents (DES),” commented editorialists Professor Robert Byrne and Dr Róisín Colleran from the Mater Private Hospital in Dublin, Ireland. “[T]he comparator device … represents a high benchmark for comparison, potentially contributing to the efficacy gap observed.” [Circulation 2020;141:2064-2066]

The study comprised 3,151 patients (mean age 66 years) with 3,951 atherosclerotic coronary artery lesions. Participants were randomized 1:1 to receive either a BES or SES to manage the lesions. [Circulation 2020;141:2052-2063]

At 1 year, the rates of the composite endpoint MACE were similar between the BES and the SES arms (5.0 percent vs 3.7 percent; pnoninferiority=0.14). “[Although these reflect] low MACE rates in both stent groups … noninferiority of the BES [to SES] could not be demonstrated,” said the researchers.

There were also similar rates of all-cause mortality (2.0 percent vs 2.7 percent; p=0.16), cardiac death (1.0 percent vs 1.8 percent; p=0.05), and MI (2.4 percent vs 2.5 percent; p=0.73).

Rates of definite stent thrombosis were also similar between the two arms (0.7 percent for both; p=0.99). This finding aligns with those observed in other DES all-comer trials, [Lancet 2016;388:2607-2617; Lancet 2018;392:1235-1245] and was lower than the rates seen in another trial comparing a BES with a bare-metal stent. [N Engl J Med 2015;373:2038-2047]

 

The impact of TLR

“Failure to meet the noninferiority criteria was caused mainly by [the] higher rate of target lesion revascularization (TLR) in patients treated with the polymer-free BES,” the editorialists pointed out. TLR incidence was nearly threefold higher with BES vs SES (3.5 percent vs 1.3 percent; p=0.0001).

“The TLR curves started to diverge after 4 months and continued to do so throughout the study … The difference in TLR was driven by in-stent restenosis, where the mechanism probably is lesser efficacy on the inhibition of neo-intimal hyperplasia,” explained the researchers. They also attributed the high TLR rate with BES to strut thickness and rapid drug release.

The editorialists concurred, stating, “mechanistically, these design features provide a rationale for the differences in efficacy between the polymer-free BES and the comparator device.” The BES used in the study has faster drug release than other polymer-free devices, and is thicker than a majority of newer-generation DESs. [JACC Cardiovasc Interv 2016;9:51-64; Circulation 2001;103:2816-2821]

“DES efficacy is closely correlated with the release kinetics of the active drug in the first 30 days, especially in the first 10 days … The results provide further evidence that control of drug-release kinetics is critical to the clinical anti-restenotic efficacy of DES,” noted Byrne and Colleran. “[Strut thickness] is also of relevance because [it] is a known risk factor for in-stent restenosis.”

[Nonetheless, the findings] are highly relevant for clinical practice,” said Byrne and Colleran. The performance and safety of the stents shall be evaluated annually up to 5 years following stent implantation.

 

 

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Most Read Articles
04 Oct 2020
Obesity does not appear to be strongly correlated with an increased risk for febrile neutropaenia during levofloxacin prophylaxis in patients with haematological malignancies receiving intermediate-risk myelosuppressive chemotherapy, suggests a study.
Roshini Claire Anthony, 3 days ago

Initiation or switch to the single-tablet regimen of bictegravir/emtricitabine/tenofovir alafenamide (TAF) led to low HIV-1 RNA viral load in people living with HIV (PLHIV), according to the BICSTaR study presented at HIV Glasgow 2020.

09 Nov 2020
Use of corticosteroids appears to be an effective treatment for paediatric drug reaction with eosinophilia and systemic symptoms (DRESS), suggest the results of a recent study. In severe cases, corticosteroids used in conjunction with intravenous immunoglobulin result in fast clinical improvement.
07 Aug 2020
Concomitant treatment with a nonsteroidal anti-inflammatory drug (NSAID) following myocardial infarction (MI) is associated with a higher risk of cardiovascular and bleeding events, a study has shown.