The randomized, controlled BioSTEMI trial was the first direct comparison between the two drug-eluting stents in patients with acute ST-segment elevation myocardial infarction (STEMI). Biotronik announced the results at the European Society of Cardiology Congress in Paris. In 2016, Berlin-based Biotronik claimed the Orsiro device had the edge over Xience in a heart attack subgroup study.
The 12-month study at Geneva University Hospitals included 1,300 patients with acute myocardial infarction. Orsiro had an incidence of 4% target lesion failure (TLF) at 12 months compared to Xience’s 6%. The difference in TLF was caused by lower rates of clinically indicated target lesion revascularization in patients treated with Orsiro, compared to Xience. The results were published in The Lancet.
“The BioSTEMI trial proves what the Bioscience STEMI subgroup analysis had already suggested. Different platform designs can really make a difference,” said principal investigator Dr. Juan Fernando Iglesias in a news release. “Based on the data, compared to the Xience stent, Orsiro is a superior solution for STEMI patients. In this patient group, vascular healing is a challenge due to the complex pro-thrombotic and inflammatory milieu. With Orsiro, we can incrementally improve their care path.”
“At Biotronik we always aim to advance the standard of care,” added Biotronik spokesman Alexander Uhl. “The BioSTEMI results are groundbreaking. Our data demonstrates a 41% lower risk for TLF with Orsiro, delivering a significant benefit for interventionalists and their STEMI patients.”
Here are some other highlights from the conference.
Carmat (EPA:ALCAR) believes it can win CE Mark approval for its artificial heart next year, but is actively enrolling in just one of four designated countries for the device’s pivotal trial, according to a report in Vantage.
The study, which has been delayed twice, is set to be conducted in Denmark, France, the Czech Republic and Kazakhstan. Carmat has received approval for the trial from Denmark, is in discussions with authorities in the Czech Republic and Kazakhstan, but has not requested permission to restart enrollment, the Vantage article said.
Carmat retains plenty of confidence in its device, regardless of the timeline for the trials.
“If you compare our device to what has been achieved so far with other solutions, we are much better and we have no complications,” Carmat CEO Stéphane Piat told Vantage. “We are doing much better than anything ever.”
The heart pump used to treat heart attack patients in cardiogenic shock will be released through a controlled rollout at select sites, while the majority of Impella CP devices will be transitioned to SmartAssist over the next 12 months. The SmartAssist technology is designed to improve patient outcomes with advanced algorithms and simplified patient management.
“Impella CP with SmartAssist is fast and easy to set up and to manage. The positioning and repositioning of this device is extremely precise thanks to the signal of the optical pressure sensor, its measurement is very reliable,” said Dr. Karim Ibrahim, head of cardiology at Klinikum Chemnitz, in a news release. “If you have a patient in cardiogenic shock, every minute counts to unload the left ventricle. CP SmartAssist is in this respect a tremendous technical innovation which can save essential time.”
CellAegis’ AutoRIC device trial falls flat
CellAegis Devices was reportedly seeking U.S. approval for its AutoRIC device some time next year, but that may not be in the cards after an investigator-initiated trial failed, according to a report in Vantage.
The AutoRIC device is designed to treat heart attacks by reopening a blocked blood vessel in the heart, while also guarding against extreme ischemia and reperfusion injuries. However, the study showed that 239 of the 5,401 patients in the study (9.4%) experienced cardiac death and hospitalization for heart failure at one year.
“Our trial provides definitive evidence that remote ischemic conditioning offers no benefit on clinical outcome,” said Hans Erik Bøtker, investigator and professor at Aarhus University, in the Vantage report.
PCI in nonculprit lesions shows better results
A new trial has shown that STEMI patients benefit from complete revascularization of any other angiographically significant lesions using percutaneous coronary intervention (PCI) rather than intervention only in the culprit lesion.
The 4,041-person, international, randomized trial showed that, after three years, 158 patients in the complete revascularization group (7.8%) experienced cardiovascular death or myocardial infarction, while it occurred in 213 patients in the culprit-lesion only group (10.5%).
“For the first time we have definitive evidence that complete revascularization reduces hard clinical outcomes,” Dr. Shamir Mehta of Population Health and Research Institute, McMaster University and Hamilton Health Sciences told theheart.org/Medscape Cardiology. “We knew from prior trials that softer outcomes like urgent revascularization were lower, but we didn’t know whether or not it would prevent hard outcomes. This is important because it suggests that the nonculprit lesion is biologically active and can cause recurrent events in the future.”
J&J’s Biosense Webster touts catheter ablation study
Johnson & Johnson‘s (NYSE:JNJ) Biosense Webster touted data from a new study that showed catheter ablation may be up to 10 times more effective than standard drug therapy for delaying the progression of atrial fibrillation.
The catheter ablation, which creates small scars on heart tissue to block abnormal electrical signals that cause arrhythmia, was far more successful in the Attest study, as only 2.4% of patients receiving that treatment developed persistent atrial fibrillation. Meanwhile, 17.5% of the group receiving standard antiarrhythmic drugs experienced disease progression.
“We are dedicated to advancing the care of — and ultimately curing — AF through focusing on three main areas: innovating new technology solutions, investing in research and publications to advance clinical understanding – as demonstrated by Attest – and improving education and awareness of AF among clinicians and the general public,” Uri Yaron, worldwide president of Biosense Webster, said in a news release. “With approximately 150 electrophysiology (EP) centers involved in research with us globally and a heritage spanning 20 years of pioneering treatment in the field of EP, we are committed to driving progress and healing more hearts. We welcome the findings presented at this morning’s late-breaking session, which reinforce the significant benefits of RF catheter ablation in the treatment of AF and should support clinicians in recommending its early use as the gold-standard in AF patient care.”
pPCI beats fibrinolysis in STEMI treatment
A randomized, controlled trial for patients with STEMI showed that transferring to an invasive center for primary percutaneous coronary intervention provided better outcomes than fibrinolysis treatment at a local facility.
The DANish Acute Myocardial Infarction 2 (DANAMI-2) study came to the same conclusion in 2003, and 16 years on, the same reportedly rings true.
The study showed that primary PCI (pPCI) was associated with a 14% relative reduction in the original composite endpoint of all-cause death, clinical reinfarction or disabling stroke. That signals a 25% decrease in reinfarction rates and a 22% drop in cardiac deaths.
“Physicians should feel confident that primary PCI remains the best way to treat STEMI patients, even after 16 years of follow-up, if transport can be achieved within two hours,” Aarhus University Hospital’s Dr. Michael Maeng said at a press conference reported by Medscape.
Bypass surgery and coronary stenting show comparable 10-year survival
A study showed that 10-year survival rates are similar for bypass surgery and coronary stenting with drug-eluting stents in randomized patients with de novo three-vessel and left main coronary artery disease.
The individual, randomized 1,800-person Syntax trial compared percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG), finding no survival benefit for either therapy at the mid-term follow-up after five years. At 10 years, there was still no significant survival benefit for either therapy, with 244 deaths after PCI (out of 903 patients) and 211 after CABG (out of 897).
“The Syntax extended survival study presents robust, clinically relevant, and complete 10-year randomized survival data and can aid a multidisciplinary heart team discussion in the process of deciding on the optimal treatment strategy for a patient with coronary artery disease requiring revascularization,” said Dr. Daniel Thuijs of the Erasmus University Medical Centre.
Study touts home-based, personalized education for AF
Data revealed at ECS showed that home-based, personalized education keeps patients with atrial fibrillation out of the hospital.
The HELP-AF study enrolled 627 patients with AF, randomizing them to the HELP-AF program or usual care. After two years, unplanned hospitalizations totaled 233 in the HELP-AF group and 323 with usual care.
“The initiative was designed to empower patients to understand and take control of their atrial fibrillation, i.e. to improve self-management,” principal investigator professor Prash Sanders of the University of Adelaide said in a news release. “Its success in stopping hospital admissions has enormous implications for the delivery of care in atrial fibrillation. As healthcare costs grow due to hospitalizations, such programs are essential.”