Stent makers came out in force for the Transcatheter Cardiovascular Therapeutics meeting in Miami this week, touting results of clinical studies of next-generation drug-eluting stents and new designs with bioresorbable polymers.
Medtech industry giants such as Medtronic (NYSE:MDT) and Abbott (NYSE:ABT) presented results alongside smaller players such as Biosensors International, with studies that pitted drug-versus-drug and permanent-versus-semi-permanent stents.
Pure-play device maker Medtronic touted its Resolute zotarolimus-eluting stent this week, releasing results from several arms of its Resolute trial.
Medtronic compared the Resolute DES to Abbott’s Xience V in a 3-year non-inferiority study, finding that the devices were clinically equivalent based on data from the Resolute All Comers study.
A separate 1-year analysis of more than 900 patients who either interrupted or discontinued use of dual anti-platelet therapy 1 month after stenting concluded that none had experienced definite or probable stent thrombosis after 1 year, based on data from the entire Resolute clinical program.*
Medtronic also released results from the long-lesion cohort of the Resolute studies, compiling data on 222 patients who received the 38 mm Resolute stent for treatment of coronary lesions no longer than 35 mm in length. Results showed a 1-year 5.4% rate of target lesion failure, a measure representing a composite of adverse events including clinically-driven target lesion revascularization, cardiac death and target-vessel myocardial infarction. There were no instances of late stent thrombosis.
Nearly 38% of patients involved in the long-lesion cohort had diabetes, Medtronic noted, and their results were similar to patients who did not have diabetes, with modestly higher rates of target lesion failure.
The company hopes the findings will contribute to an already-submitted bid to win FDA approval for the 38 mm Resolute stent, which currently only has investigational approval in the U.S., according to a company press release. Medtronic in February won FDA approval for the "core" sizes of the Resolute stent, which was the 1st device on the U.S. market indicated for patients with coronary artery disease as well as diabetes.
The Resolute stent also fared well among the nearly 2,000 patients in the study’s small-vessel cohort, the data from which was pooled from the The Resolute, Resolute All Comers, Resolute International, Resolute US and Resolute Japan trials.
That arm considered patients with coronary lesions no larger than 2.5 mm in diameter, showing a 2-year target lesion failure rate of 10.1%, according to a Medtronic statement.
Those rates compared fairly evenly with patients in the same studies who had larger vessels, and both groups had low rates of clinical events and stent thrombosis, according to Medtronic.
Healthcare goliath Abbott reported results from a pair of Compare trials for its Xience and Xience V stents .
At a 3-year follow-up, Xience V produced lower rates of adverse event rates, a composite measure including death, non-fatal myocardial infarction and target vessel revascularization, and advantage that may increase over time, according to TCT Daily.
The study found no significant 1-year differences in adverse event outcomes or rates of definite or probable stent thrombosis, demonstrating a level of non-inferiority between the 2 devices, TCT Daily reported.
The big dogs weren’t the only ones touting stent study results at the TCT conference.
Paris-based Biosensors International released findings from its Leaders study, which compared its BioMatrix Flex biolimus-eluting stent, which features a biodegradable polymer, to Johnson & Johnson’s (NYSE:JNJ) Cypher sirolimus-eluting stent.
The BioMatrix Flex DES proved non-inferior to Cypher at 5 years, but 2-year results found a nearly 75% reduction in late definite stent thrombosis, TCT Daily reported.
"The Leaders trial provides the 1st evidence of improved clinical outcomes vs. the ‘gold standard’ 1st-generation SES," study presenter Dr. Patrick Serruys told TCT attendees. "These findings provide the basis for the proof of concept of biodegradable polymer DES."
*Correction, October 24, 2012: This article mistakenly attributed the DAPT study results and the Xience V non-inferiority results to the same study data. The DAPT data was from the entire Resolute clinical program and the non-inferiority results were from the Resolute All Comers data.