August 2013
adverse events such as stent thrombosis.
Clinical News
are required to confirm these results, external ultrasound appears to have strong potential as an alternative to catheter based energy delivery for patients with hypertension.”
Resolute drug- eluting stent delivers durable clinical outcomes through two years in major studies According to new clinical data presented at ACC.12 – the 61st Annual Scientific Session & Expo of the American College of Cardiology (ACC) – the Resolute drug- eluting stent (DES) from Medtronic maintains a powerful and persistent treatment effect for a wide variety of patients with coronary artery disease, including those with diabetes mellitus, through two years of follow-up.
The latest data on this novel heart stent, which received approval from the FDA in February 2012 with a first-of-its- kind indication for the treatment of coronary artery disease in patients with diabetes, come from the RESOLUTE US clinical study and two pooled analyses of the entire Resolute clinical programme – one on safety measures for all patients (RESOLUTE Pooled Safety), the other for all patients with diabetes (RESOLUTE Pooled Diabetes). Highlights of the two-year data include low rates of target lesion failure, target lesion revascularisation and definite/probable stent thrombosis. Laura Mauri, Harvard Clinical Research Institute and Brigham and Women’s Hospital in Boston, presented the two-year results from RESOLUTE US; Jorge Belardi, Cardiovascular Institute of Buenos Aires, Argentina, the two-year update for RESOLUTE Pooled Safety; and Alan Yeung, of the Stanford University School of
Medicine in Palo Alto, the two-year update for RESOLUTE Pooled Diabetes.
“What is particularly striking about the two- year outcomes from the Resolute clinical programme is the device’s consistently strong performance and low event rates in such a wide variety and high number of patients,” explained Mauri, a national co- principal investigator of RESOLUTE US like Yeung and Martin Leon, of the Cardiovascular Research Foundation and
NewYork- Presbyterian Hospital/ Columbia University
Medical Center in New York.
“The Resolute DES yields excellent outcomes in patients with and without diabetes mellitus, and that’s a factor of significant clinical relevance given the large number of diabetes patients that undergo
percutaneous coronary intervention each year. Its safety and efficacy data at two years of patient follow-up continue to impress.” RESOLUTE US enrolled 1,402 patients across 128 US-based clinical trial sites. The two-year results among 1,359 patients include low rates of target lesion failure (7.3%), clinically- driven target lesion revas- cularisation (4.3%), and definite/probable stent thrombosis (0.2%). These powerful clinical results were achieved despite 34% of the patients having diabetes. Among the 474 patients with diabetes in RESOLUTE US, the Resolute DES showed consistently low two-year rates of target lesion failure (8.9%) and
clinically-driven target lesion revascularisation (5.7%) and no definite/ probable stent thrombosis. The global
RESOLUTE clinical programme consisted of a large randomised controlled trial and a series of confirmatory single-arm studies involving nearly 250 sites in 32 countries. In total, the programme enrolled 5,130 patients
The two-year update to RESOLUTE Pooled Safety showed very low rates of clinically- driven target lesion revascularisation (4.7%) and definite/probable stent thrombosis (0.9%), despite 46% of the patients in the RESOLUTE programme being considered complex.
The two-year update to RESOLUTE Pooled Diabetes, which presents clinical outcomes in patients with and without diabetes who received a
Integrity
aortic valve, in a subset of patients aged 60 or younger at the time of operation. A company press release reported that the study tracked patients over a nearly 25- year period, achieved follow-up of 3,299 valve years and determined that expected valve durability for this population was greater than 17 years. The data were presented at the Congress of the French Society for Thoracic and Cardiovascular Surgery by Thierry Bourguignon, from University Hospital of Tours, France. The valve, which was introduced into clinical use in 1981, is bioengineered with precisely- matched leaflets made from bovine pericardial tissue that are handsewn onto a stainless steel frame. The design of the valve, including its frame and leaflets, serves as the model for Edwards’ leading surgical products
who received a Resolute DES; about one third (n=1,535) of these patients had diabetes, a proportion that mirrors the US patient mix for percutaneous coronary intervention.
For the pooled
analyses related to safety and diabetes presented at ACC.12, two-year data on more than 5,000 patients from the RESOLUTE programme who received a Resolute DES were included. Individual trials, while powered for many composite endpoints, are often underpowered to show real differences for low-frequency but clinically important
Resolute DES, shows
consistently
low event rates out to two years despite the higher- risk nature of the diabetes patient population.
New data demonstrate long-term durability of Perimount aortic valve
Edwards Lifesciences has announced long- term durability results for bovine pericardial heart valves, based on a study of the Carpentier- Edwards Perimount
(Magna Ease and Magna Mitral Ease) are based. “Pericardial valve use has increased over time. These long-term data on the Perimount valve strengthen the evidence for surgeons to utilise Edwards’ pericardial tissue valves, including in selected patients of age 60 and under,” said Michel Aupart, head of the Department of Cardiovascular and Thoracic Surgery, University Hospital of Tours, France, and a paid consultant to Edwards.
Robotic-assisted stent placement device used for first time Corindus Vascular Robotics has announced that, at Sanford Aber- deen Medical Center, Aberdeen, USA, inter- ventional cardiologists have performed the first robotic-assisted stent
Studies
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placement in a STEMI patient with the com- pany’s CorPath robotic angioplasty device. According to a
company press release, use of the device was associated with a far better door-to-balloon time than the national standard. It added that using the FDA-cleared CorPath system, Puneet Sharma was able to perform the robotic- assisted angioplasty procedure and restore blood flow to the patient’s heart within 68 minutes of their arrival (the national door-to- balloon time standard is 90 minutes).
The CorPath system is the first and only FDA- cleared technology that enables precise, robotic- assisted angioplasties to open arteries and restore blood flow in patients with coronary artery disease. Seated in an interventional cockpit, the interventional cardiologist advances stents and guidewires via a joy stick with millimeter by millimeter precision. The system may also improve clinical outcomes by enabling precise measurement of the anatomy, which could potentially lead to better stent placements. “Timely access to
emergency cardiac care and survival is partly dependent on access to services and technology,” said Sharma. “Being able to perform a CorPath Robotic Angioplasty on a ST-segment elevation myocardial infarction (STEMI) patient within 68 minutes is a great benefit. As shown with the latest procedure, robotic-assisted angioplasties improve rural access and quality of care as more patients in this area will have access for advanced specialty care. The implementation of the CorPath system and its ability to precisely and rapidly execute an angioplasty procedure with only one stent in the patient heart is a great example of Sanford Health’s commitment to enhanced clinical outcome for our patients.”
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