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

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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. http://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.