Biotech Values

[DewDiligence]

Cypher Tops Endeavor With Ease in Danish Study

[MDT’s Endeavor stent has held a distant fourth-place ranking among DES’s in all major jurisdiction (#msg-39762286), and this new study surely won’t help. The original premise for Endeavor—that modest efficacy in terms of late loss was outweighed by superior safety—now appears to be flawed.

The larger question is whether this new information is even material from a commercial standpoint. While Endeavor has been an also-ran from day one, Cypher, once the market leader, is steadily losing market share to the clearly superior Xience platform from ABT. JNJ’s hopes to become a significant player in drug-eluting stent would seem to rest on the Nevo platform. ]

http://www.reuters.com/article/idCNN1513785620100315

›Mon Mar 15, 2010 11:12am EDT
By Bill Berkrot and Debra Sherman

* Fewer major adverse events seen with J&J stent

* 4.5 pct event rate with Cypher vs 9.7 for Endeavor

* Medtronic critical of data, trial design

ATLANTA, March 15 (Reuters) - Johnson & Johnson's <JNJ.N> Cypher drug-coated stent led to significantly fewer heart attacks, deaths and need for repeat procedures than Medtronic Inc's <MDT.N> newer Endeavor stent using a different drug, according to a head-to-head study conducted by Danish researchers.

Eighteen months after the stents were placed, 9.7 percent of Endeavor patients suffered cardiac death, heart attacks or target vessel revascularizations compared with 4.5 percent of those who received J&J's Cypher, according to data presented at the American College of Cardiology scientific meeting in Atlanta.

Medtronic questioned the data and study's design, calling it biased toward Cypher. [Nice try, but see next sentence.] The study was supported by grants from both companies.

…Based on findings from a previous clinical trial of Endeavor, researchers said they believed the Medtronic stent would prove superior and provide strong protection against blood clots in the stented area and heart attacks.

"But we found there is a high risk of early stent thrombosis and early heart attack in the Endeavor," said Dr. Michael Maeng, lead researcher of the 2,332-patient study, from Aarhus University Hospital in Denmark.

Maeng speculated that the higher number of adverse events seen with Endeavor may have been related to faster delivery of the drug coating the device.

Cypher, the first drug eluting stent to reach the market, is coated with a medicine called sirolimus. Endeavor, the fourth entry into the increasingly competitive sector, is coated with zotarolimus.

"If you have to compare the two stents, the Cypher stent is a better stent," Maeng said.

Medtronic took exception to the results and issued a lengthy press release attempting to refute the data.

The study "uses an unconventional methodology, which raises questions about the reproducibility, viability and applicability of the results," Medtronic spokesman Joe McGrath said in a statement.

Maeng argued that his study was more meaningful as it was carried out in a real world setting on a variety of patients with coronary artery disease. The Danish study also included more than five times as many patients as the Endeavor trial cited by Medtronic in its defense.

"The Endeavor III trial was performed on 436 low-risk patients with a single non-complex lesion," Maeng said.

"If you want to assess clinically relevant differences between the various drug-eluting stents, you have to compare the stents in routine clinical care patients," Maeng said.

However, Medtronic's McGrath said the Danish study "produced unexpectedly low event rates and inconsistent data for the Cypher stent compared to nearly every other trial in which the device has been evaluated."‹