Stent wars at TCT 2012: Drug-eluting stents maintain lead over bare-metal

October 23, 2012 By MassDevice staff Leave a Comment

With new and next-generation stents gaining ground over their forebears, the stent wars don’t look to be letting up anytime soon.

The battle continued at the Transcatheter Cardiovascular Therapeutics meeting this week, where pooled results from a pair of studies further affirmed that next-generation drug-eluting stents demonstrate better safety and efficiency at 1 year compared to bare-metal stents.

Researchers combined data from the Examination and Comfortable AMI studies, which comprised a total of more than 2,600 patients, to look for larger trends in the DES vs. BMS battle.

The Examination study compared Abbott’s (NYSE:ABT) Xience V everolimus-eluting stent to a bare-metal stent, and the Comfortable AMI study compared Biosensors’ BioMatrix against a bare-metal stent.

Researchers reported that patients with the newer DES implants had lower risks of target lesion revascularization, definite stent thrombosis and acute stent thrombosis at 1 year.

"Most would agree that DES are more efficacious than BMS, namely in that they reduce restenosis," investigator Dr. Manel Sabaté told TCT Daily. "Data from this pooled analysis are reassuring and clearly indicate that 2nd-generation DES are not only efficacious but safe in a highly prothrombotic context such as STEMI, at least up to 1-year follow-up."

It’s not the 1st time DES and BMS have entered the ring.

Earlier this year Biosensors released data comparing its BioMatrix Flex to Johnson & Johnson’s (NYSE:JNJ) bare metal Cypher Select in a randomized single-blinded trial of more than 1,100 patients. That study concluded that the drug-eluting semi-resorbable BioMatrix Flex cut adverse events in half at 1 year in patients with ST-segment elevation myocardial infarction.

Last December Biosensors 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 BioMatrix Flex 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.

In January DES came out on top with lower rates of adverse events in patients over 85.

The battle continues, however, as some raise eyebrows about the increased cost of DES devices. 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.

DES use decreased from 92% to 68% between 2004 and 2007, according to the study, but adverse events related to stent procedures remained largely unchanged.

More results from the Examination study should be unveiled during the TCT conference this week.

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