login
  Password reminder
Cardiovascular News
Contact the editor Visit Cardiovascular News Twitter feed Visit Cardiovascular News Facebook page
 

Resolute stent shows positive outcomes in diabetic and non-diabetic heart disease patients


Monday, 28 May 2012 16:49
Resolute drug-eluting stent
Resolute drug-eluting stent

The Resolute drug-eluting stent (Medtronic) yields strong performance in coronary artery disease (CAD) patients both with and without diabetes through two years of follow-up, according to results from the RESOLUTE clinical study presented by Scott W Lee, Los Angeles, USA, at a late-breaking clinical trials session at the American Association of Clinical Endocrinologists (AACE) 21stAnnual Meeting & Clinical Congress (23–27 May, Philadelphia, USA).


Research shows that people with diabetes have a two- to three-fold increased risk for CAD and two- to four-fold higher CAD morbidity and mortality rates.1 Historically it’s been difficult to treat CAD patients with diabetes because they tend to have smaller coronary arteries and persistently elevated blood-sugar levels, which can increase the rate of procedural complications and long-term safety risks. As a result, CAD patients with diabetes have commonly undergone open heart surgery, which is more invasive and requires longer hospital stays and recovery time compared with stent procedures.

Within RESOLUTE, roughly 30% of the patients had diabetes—a proportion that mirrors current clinical practice. The study compared the clinical outcomes associated with the Resolute drug-eluting stent in 878 standard risk2 diabetes patients to 1,903 patients without diabetes enrolled in the clinical programme.

The analysis showed consistently low event rates out to two years for both groups, despite the higher-risk nature of the diabetes patient population. At two years of follow-up, rates of target lesion failure (TLF)—defined as cardiac death, target vessel myocardial infarction (heart attack due to a blockage in the stented vessel) and target lesion revascularisation—are 7.1% for the patients without diabetes and 9.6% for patients with diabetes.


“Clinically-validated and minimally-invasive treatment options for patients with both coronary artery disease and diabetes has represented a significant unmet clinical need for the diabetes community for quite some time,” said Lee, clinical professor of medicine at Loma Linda University Medical Center near Los Angeles and medical director of global clinical research for Medtronic Diabetes. “Considering the challenges that are presented when treating diabetes patients with CAD, physicians can have confidence in the consistently low event rates in both patients with and without diabetes when using this device.”

The analysis also features additional outcomes for important safety measures, comparing insulin-dependent- and non-insulin-dependent diabetes patients to patients without diabetes. Rates are similar among non-insulin-dependent diabetes patients and patients without diabetes.


RESOLUTE pooled diabetes analysis: Two-year outcomes

 


Insulin-dependent

Non-insulin dependent

Patients without

Endpoint*

diabetes patients

diabetes patients

diabetes

N=250

N=628

N=1,903

TLR

6.5%

4.3%

3.4%

CD/TVMI

8.6%

3.9%

4.1%

Def/Prob ST

0.80%

0.16%

0.43%


* Endpoint Key

• TLR = target lesion revascularisation

• CD/TVMI = cardiac death/target vessel myocardial infarction

• Def/Prob ST = definite/probable stent thrombosis as defined by the Academic Research Consortium (ARC)


The Resolute Integrity drug-eluting stent was approved by the FDA in February 2012 with a first-of-its-kind indication for CAD patients who also have diabetes.



References:


1
Tan, Meng Hee. From Research to Practice Diabetes and Coronary Heart Disease. Diabetes Spectrum1999; 12: 80-83. journal.diabetes.org/diabetesspectrum/99v12n2/pg81.htm


2
Standard risk was defined as excluding the following characteristics: bifurcation, saphenous vein graft (SVG), in-stent restenosis (ISR), acute myocardial infarction (AMI) within 72 hours, left ventricular ejection fraction (LVEF) of less than 30%, unprotected left main disease, atherosclerosis in three or more vessels, renal impairment, total lesion length per vessel of greater than 27mm, two or more lesions per vessel, lesion with thrombus, or lesion with total occlusion.





Add New Comment

Most popular


Medtronic completes acquisition of Covidien
Tuesday, 27 Jan 2015
Under the terms of the acquisition agreement, Medtronic Inc and Covidien plc are now combined under Medtronic plc. Medtronic completes acquisition of Covidien

Transapical TAVI can be performed with comparable results to transfemoral TAVI in high-volume centres
Friday, 16 Jan 2015
Results from a registry of 1,000 patients undergoing transcatheter aortic valve implantation (TAVI) in a high-volume centre do not indicate a significant difference in the rates of short- and long-... Transapical TAVI can be performed with comparable results to transfemoral TAVI in high-volume centres

Arteriovenous anastomosis creation brings blood pressure down
Friday, 06 Feb 2015
The ROX CONTROL HTN, an international randomised controlled trial, published online ahead of print in The Lancet in late January, has demonstrated that creation of a central arteriovenous anastomosis ... Arteriovenous anastomosis creation brings blood pressure down

Features


Exploring new transcatheter options for the mitral valve
Thursday, 19 Feb 2015
Anson Cheung (University of British Columbia, St. Paul’s Hospital, Vancouver, Canada) speaks to Cardiovascular News about the potential benefits of transcatheter mitral valve implantation. Exploring new transcatheter options for the mitral valve

Tailoring dual antiplatelet therapy duration for an individual patient
Tuesday, 03 Feb 2015
Guillaume Cayla explores how the duration of DAPT may be tailored after careful evaluation of both bleeding and ischaemic risk, taking into consideration the type of the device implanted. Tailoring dual antiplatelet therapy duration for an individual patient

Profiles


Flavio Ribichini
Thursday, 05 Mar 2015
Flavio Ribichini speaks to Cardiovascular News about being involved in the first use of primary ... Flavio Ribichini

Sunil Rao
Thursday, 23 Oct 2014
Sunil Rao speaks to Cardiovascular News about his career highlights, including his research into ... Sunil Rao

Cardiac Rhythm News Vascular News Cardiovascular News Interventional News Spinal News NeuroNews
BIBA Medical BIBA MedTech Insights CX Symposium ilegx
 
Password Reminder

BIBA Medical, 526 Fulham Road, Fulham, London, SW6 5NR.
TEL: +44 (0)20 7736 8788 FAX: +44 (0)20 7736 8283 EMAIL: 
info@bibamedical.com
© BIBA Medical Ltd is a company registered in England and Wales with company number 2944429.
VAT registration number 730 6811 50.
Site Map | Terms and Conditions