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Assessment of Outcomes after Implantation of Bioabsorbable Stents at Long term Follow up in Indian Patients

Nagaraju A S. , Nagaraju A S , Anshul Patodia , Manojkumar Rohit ,

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Journal of Cardiovascular Medicine and Surgery 6(3):p 189-194, July – September 2020. | DOI: http://dx.doi.org/10.21088/jcms.2454.7123.6320.4

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Nagaraju A S, Anshul Patodia, Manojkumar Rohit. Assessment of Outcomes after Implantation of Bioabsorbable Stents at Long
term Follow up in Indian Patients. J Cardiovasc Med Surg. 2020;6(3):189-194.
 

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Received : N/A         Accepted : N/A          Published : N/A

Abstract

Background: Bioresorbable drug-eluting vascular scaffolds were developed to overcome the limitations of metallic drug eluting stents. Several studies have shown the non inferiority of the bioresorbable vascular scaffold (Absorb, Abott Vascular) compared to metallic DES with added advantages of stent resorption. However recent studies
have reported higher rates of major adverse cardiac events and scaffold thrombosis in patients receiving Absorb bioresorbable vascular scaffold. The product has been withdrawn by the manufacturers since 14 september 2017 in view of ‘low commercial sales’ and ‘safety concerns’ raised by US FDA and European medical agency. However long term follow up of patients with implanted Absorb stents will be continued. We have evaluated long term outcomes in Indian patients after implantation of bioresorbable stents as there is no such study till date.

Methods: This was a prospective, open label, single-center, observational clinical study. A total of 30 patients who had undergone PCI with bioresorbable stent (ABSORB) were reassessed at 3 years of follow up. These patients were evaluated for their functional status, stent thrombosis, in-stent restenosis (ISR), target vessel revascularization
(TVR), myocardial infarction and death. Primary clinical endpoint was a composite of cardiac death, myocardial infarction or ischemia-driven target vessel revascularization at 3 years of follow up.

Results: The study population comprised of 87% males, 43% diabetics, 73% hypertensives and 20% smokers.  Mean age was 60 years. Over 3 years of follow up, one patient (3.3%) expired due to noncardiovascular cause. Clinical ISR was seen in 2 patients (6.7%) and angiographic ISR in 4 patients (13.3%). Revascularization rate was3.3% with target vessel revascularization of 3.3% and non target vessel revascularization of 0%. All target vessel revascularizations were due to restenosis related TLR. Primary composite endpoint of target vessel failure was seen
in 3.3%. There was no incidence of stent thrombosis, non fatal MI and cardiac death during 3 years of follow up.

Conclusions: Long term clinical outcomes of our study are acceptable. There was no incidence of cardiovascular death, nonfatal MI or stent thrombosis during 3 years of follow up. Clinical restenosis was seen in 6.7% and angiographic restenosis in 13.3% of patients. Target lesion revascularization rate was 3.3%. Primary composite end point of target vessel failure was seen in 3.3% of patients.

 

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Cite this article

Nagaraju A S, Anshul Patodia, Manojkumar Rohit. Assessment of Outcomes after Implantation of Bioabsorbable Stents at Long
term Follow up in Indian Patients. J Cardiovasc Med Surg. 2020;6(3):189-194.
 

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Received Accepted Published
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DOI: http://dx.doi.org/10.21088/jcms.2454.7123.6320.4

Keywords

Bioabsorbable stents; Coronary artery disease; Stent thrombosis; In stent restenosis.

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