Drug-eluting biodegradable stents cut adverse events in half when compared with bare-metal stents in patients with ST-segment elevation myocardial infarction, according to a new study.
The study, dubbed the Comfortable AMI trial, reported 24 adverse cardiac events at 1 year of follow-up in STEMI patients treated with DES, compared with 49 events in patients treated with BMS, providing more fuel to the ongoing controversy over whether the more expensive DES devices are worth the price.
Researchers compared Biosensors International’s biodegradable BioMatrix Flex drug-eluting stent against Cordis’ bare metal Cypher Select in a randomized single-blinded trial of more than 1,100 patients.
They concluded that Biosensors’ biolimus-eluting stent resulted in a 51% relative reduction in risk of major cardiac adverse events and prevention of 4.2% of events, defined as cardiac death, target vessel-related reinfarction, and ischemia-driven target-lesion revascularization at 1 year.
"The efficacy and safety of drug-eluting stents compared with bare-metal stents remains controversial in patients with STEMI undergoing primary PCI," according to the study’s authors. "Our results suggest better clinical outcomes in terms of major adverse cardiac events of a stent releasing biolimus from a biodegradable polymer compared with a bare-metal stent for the treatment of patients with STEMI."
The biodegradable stents also ameliorate the delayed vessel healing often seen in traditional drug-eluting stents, the authors added.
It’s not Biosensors’ 1st study affirming its BioFlex stent. Last December the company became the 1st to demonstrate the “proof of concept” that a drug-eluting stent with biodegradable polymer coating can outperform a DES with durable coating. That study, which also compared the BioFlex to the Cypher Select, found that the devices delivered comparable results at 9 months but that the BioFlex showed better adverse events results out to 4 years.
Drug-eluting stents have slowly been gaining ground on their bare metal forebears in recent years. In January DES came out on top with lower rates of adverse events in patients over 85.
Patient with drug-eluting stents in that study showed a 29% mortality risk, compared with a 38% risk in patients with bare-metal stents, with the difference narrowing with increasing age.
However, a study published in the journal Circulation last August called bare-metal stents a more cost-efficient treatment option, offering an average of about $400 in savings per patient without significantly increasing adverse health outcomes.
"The bottom-line was that using drug-eluting stents in a relatively unselected way was only resulting in marginal improvement compared to more selective use," according to that study’s senior author David Cohen.
