The biggest names in the medical device world are busy touting the results of several clinical trials of their cardiovascular products, with more to come from the American College of Cardiology’s 59th annual scientific session.
Companies including Boston Scientific Corp. (NYSE:BSX), Johnson & Johnson (NYSE:JNJ), Abbott (NYSE:ABT) and Medtronic (NYSE:MDT) are making presentation after presentation at the Atlanta conference, hoping to drum up abuzz among the attending surgeons.
Boston Scientific touts Taxus Express, Element data
Boston Scientific said a study of the drug-eluting version of its Taxus Express stent in patients with diabetes who suffered heart attacks showed the drug-eluting device fared better than its bare-metal antecedent. That prompted it to apply to the Food & Drug Administration for expanded indications for the Express DES and Taxus Liberté stents for treating patients with acute myocardial infarctions, the medical term for heart attacks.
The Horizons AMI trial showed that the Express stent significantly reduced ischemia-driven target lesion revascularization by 54 percent in diabetic patients and 37 percent in non-diabetic patients a year after implantation. The safety of the device for diabetics, as measured by major adverse events, was comparable between the drug-eluting and bare-metal versions, as were rates of death or repeat heart attack.
The company also announced the completion of enrollment in the small vessel and long lesion phase of its Platinum trial, comparing its Promus Element platinum-chromium DES with the Taxus Express DES. Ninety-four patients with lesions between 2.25mm and 2.5mm in diameter and up to 28mm long enrolled in the small vessel study; 104 patients with lesions between 24mm and 34mm long and 2.5mm to 4.25mm in diameter signed on for the long lesion trial.
Yesterday, BSX cited results from its Perseus clinical trial, comparing the latest iteration of its Taxus drug-eluting stent platform with prior models, showed that the platinum chromium paclitaxel-eluting device was about as safe and effective as its forebears. The Natick, Mass.-based stents pioneer is hoping that the results will help it regain some market share from its rivals. Sales of its stable of older stents have slipped as its peers’ newer technologies hit the market.
The 1,611-subject Perseus study first compared patients treated with the Element stent to patients treated with the Taxus Express2 device. After 12 months, both treatment groups showed similar rates of ischemia-driven target lesion revascularization, myocardial infarction/cardiac death related to the target vessel. Patients in both groups also showed similar rates of major adverse events, including cardiac death, myocardial infarction and target vessel revascularization, as well as lower rates of stent thrombosis.
The study also compared the Element to the Express bare-metal stent in patients with small vessels. After nine months, Element-treated patients showed better rates of in-stent late loss than the bare-metal control group.
Boston Scientific plans to release results from other trials at the conference today, including data from various phases of the Spirit trial of its Xience V stent and the Syntax study comparing coronary artery bypass graft surgery with stenting using the Taxus Express.
Johnson & Johnson: Cordis’s Cypher tops Medtronic’s Endeavor
Johnson & Johnson took aim at Medtronic with data from the Sort Out III trial comparing its Cypher DES with MDT’s Endeavor device. The Cordis stent elutes the drug sirolimus, while the Medtronic device releases zotarolimus. The study of more than 2,300 patients showed lower rates of mortality, heart attack and major adverse events over 18 months.
The mortality rate for the Endeavor-implanted group was 4.4 percent, compared with 2.7 percent for patients implanted with the Cypher device. The incidence of heart attacks was 2.1 percent for Endeavor, versus 0.9 percent for the Cypher, and the major adverse event rate was 9.7 percent for Endeavor, compared with 4.5 percent for Cypher. The stents were about even when it came to late stent thrombosis, according to a press release, at 1.1 percent for Endeavor and 0.5 percent for Cypher, but the Cordis product showed much less ischemia-driven revascularization after 18 months: 1.7 percent for Cypher and 6.1 percent for the Endeavor.
Abbott’s MitraClip safer, less effective than open heart surgery
Abbott touted the Everest II study of its MitraClip atrial valve treatment, based on technology it snapped up in its $320 million Evalve acquisition last year. The device is designed to hold the flaps of the heart’s mitral valve in place to prevent blood from flowing backwards through the valve, a condition called mitral regurgitation. It is inserted into the heart via a catheter threaded from the groin through the femoral artery.
The study showed that although the device is far safer than open heart surgery, it is about 15 percent less effective than the surgical alternative. After 30 days, only 9.6 percent of patients receiving the clip suffered major adverse events, compared with 57 percent of patients who underwent surgery. But the surgery logged an 87.8 percent success rate over course of a year, compared with a 72.4 percent success rate for the clip recipients.
Abbott also touted new data from the second phase of the Absorb trial of its bioresorbable vascular scaffold. The Chicago-based conglomerate claims to be the sole player with long-term data on such a device, designed to be a fully absorbable alternative to metal stents.
The first 101 patients enrolled in the trial showed no cases of blood clots, no need for repeat procedures and a 2 percent rate of major adverse events at 30 days. Abbott said the trial’s first phase delivered data on 30 patients over three years.
Medtronic cites five-year data on Endeavor DES
Medtronic released five-year data from trials of its Endeavor drug-eluting stent it said showed the zotarolimus‐releasing device was safer and more effective than its Driver bare-metal stent. Specifically, patients treated with the Endeavor were about 10 percent less likely to experience a major adverse event and 1.5 percent less likely to die. Patients treated with the drug-eluting device also showed less incidence of late-stent thrombosis and lower rates of revascularization of the treated area.
The Fridley, Minn.-based devices giant also cited results from the Stop AF
trial of its Arctic Front system in treating paroxysmal atrial fibrillation. That technique involves killing the muscle cells causing a portion of the heart wall to flutter by freezing them. One year out, nearly 70 percent of the roughly 163 patients treated with the so-called "cryoablation" procedure stayed free of PAF, compared with 7.3 percent of patients treated using drugs.
And a trial of MDT’s CareLink wireless monitoring system showed that it significantly reduced the amount of time between a clinical event and a doctor’s decision on how to proceed. The system relays data on clinical events experienced by patients with implantable cardioverter defibrillator or cardiac resynchronization therapy implants. Subjects in the 1,997-patient Connect trial who were monitored using the system went 4.6 days from event to decision, compared with 22 days for patients monitored via office visits. The clinical events included episodes of arrhythmia, cardiovascular disease progression and device issues.
The study also showed shorter hospital stays for remotely-monitored patients of an average 3.3 days, compared with four days for patients in the office-monitored group. That means a savings of about $1,660 per visit, according to the company.