A subset analysis from 1,236 diabetic patients from the e-HEALING clinical registry presented at the EuroPCR meeting showed positive clinical outcomes in diabetic patients who have a high prevalence of comorbidities.
Peter Damman, Academic Medical Center, Amsterdam, The Netherlands, presented the subset analysis from 1,236 diabetic patients, including 273 insulin dependent diabetics and 963 non-insulin dependent diabetics, from the e-HEALING clinical registry and found a target vessel failure (TVF) rate of 10% for diabetic patients, compared to 7.9% for non-diabetics at 12 months. Specifically, the target vessel failure rate in insulin dependent diabetics was 13.4%, compared to 9% in non-insulin dependent diabetics. The higher target vessel failure rates in diabetic patients were mainly driven by a higher mortality hazard. The target lesion revascularisation rate (TLR) was 6.4% in diabetics, which is comparable to a reported 5.4% in non-diabetic patients, and the definite or probable stent thrombosis rate at 12 months was similar with 1.2% in diabetics compared to 1.1% in non-diabetics.
“The Genous Bio-engineered R stent shows positive clinical outcomes in diabetic patients who have a high prevalence of comorbidities,” said Robbert de Winter, Academic Medical Center in Amsterdam and a co-principal investigator of the study. “We see in the data that the stent thrombosis in all diabetic patients was comparable to non-diabetics. The growing prevalence of diabetes worldwide underscores the need for advanced treatment options for this challenging high-risk patient group.”
The main composite outcome of the diabetic sub-study was target vessel failure, defined as target vessel-related cardiac death or myocardial infarction and target vessel revascularisation. The mean age of the e-HEALING diabetic population was 64 years, and the mean body mass index of patients was 28.3. Seventy-three per cent of patients were male. An average of 1.4 lesions per patient was treated with an average of 1.1 stents. For the lesions treated, 97% were de novo lesions, and 48% were type B2/C lesions.
Michael Kutryk, clinician scientist and an interventional cardiologist at St Michael’s Hospital as well as an assistant professor at the University of Toronto, Canada, added, “The endothelial progenitor cells (EPCs) of diabetics exhibit an impaired capacity for vascular repair. The dysfunctional homing and adhesive abilities of EPCs of diabetics result in delayed endothelialisation and subsequent heightened smooth muscle cell proliferation, leading to higher restenosis rates in diabetics. We believe that the unique EPC capture technology of the Genous Bio-engineered R stent mitigates these deficiencies and restores the natural healing ability that is impaired in diabetics.”
e-HEALING is a multicentre, worldwide (outside of the United States) prospective clinical registry conducted in 31 countries at 144 clinical centres.
Genous is OrbusNeich’s patented endothelial progenitor cell (EPC) capture technology that promotes the accelerated natural healing of the vessel wall after the implantation of blood-contact devices such as stents. The technology consists of an antibody surface coating that attracts EPCs circulating in the blood to the device to form an endothelial layer that provides protection against thrombosis and modulates restenosis.
The Genous Bio-engineered R stent has been commercially available in over 60 countries since 2005. The Genous stent has been proven as a safe, effective alternative to drug-eluting stents and is supported by data from more than 5,000 patients in company-sponsored clinical studies. There is a growing body of evidence from multiple clinical studies that the Genous stent is effective for patients who are non-responsive to or cannot tolerate long-term dual antiplatelet therapy.
Quick 3 with Kamran Baig
Kamran Baig, interventional cardiologist, Trent Cardiac Centre, Nottingham, UK, spoke to Cardiovascular News about the Genous stent at the EuroPCR congress.
Were you surprised that the Genous stent seems to be effective in diabetic patients?
I am not sure that I am surprised is the right answer, because one could always think of theoretical mechanisms via which it would be advantageous to have early vascular endothelisation in such people who are particularly at risk of stent thrombosis or at risk of premature stent restenosis. I do not think it is unsurprising either, but the Genous EPC stent seems to be an advantage in an established special risk group of people that will always have a special vascular risk; so any technology that promotes rapid vascular healing with low rates of restenosis is likely to result in a beneficial clinical outcome.
What are the particular problems with treating diabetic patients?
Diabetic patients with vascular disease and coronary disease have a tendency to accelerated atherosclerosis. In addition to having an early, aggressive and widespread coronary disease, they also tend to tolerate intravascular mechanical treatments – standard PCI treatments – for cardiovascular disease less well than non-diabetic people’s vessels. So for example, diabetic coronary vessels are more fragile and so tend to rupture/dissect much more easily than normal vessels. In addition, there is a tendency toward a much more aggressive rate of restenosis within implanted coronary stents also.
Will these results change practice?
If we can be confident that the Genous stent provides a significantly lower restenosis rate, a lower thrombosis rate in diabetic people, with a lower need for adjunctive pharmacological therapy, it is a great advantage. What is interesting about the Genous stent is the fact that it is a new direction of technology; and as with all new technologies to some degree, it is a question of finding an appropriate place for its use in the armamentarium of medical treatment.
Logically and scientifically the Genous stent is very attractive because what we want to do, of course, is to maintain the endothelium at all times. The fact that the EPC coating on the stent promotes a more rapid endothelisation therefore seems a great advantage. Data so far seem to suggest that, as you might logically expect, a lower (early and late) stent thrombosis rate, a restenosis rate comparable to the better non- drug-eluting stent products, and a minimum need for antithrombotic/antiplatelet treatment which provides a major advantage in certain clinical settings.