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Long-Term Data

Long-Term Data

 YUKON Choice PC has long term safety data upto 4 years for MACE and shows 78% less Very Late Stent Thrombosis(VLST) compared to first generation DES. In ISAR TEST -4, YUKON has shown non-inferiority to Xience and Cypher in a prospective randomized trial in over 2600 patients done in Europe over a period of 4 years.

The performance parameters of DES have considerably changed in the last few years and with increased safety concerns,9-12 months evaluation may not be enough to prove efficacy and safety of a DES.It is important to have atleast a 24 months angiographic and clinical evaluation for the newer DES Technology.

The rationale behind biodegradable polymer coated DES is intuitively attractive: loading and elution of the lipophilic active-drug is facilitated by a biocompatible polymer, which after completion of its useful function, is slowly degraded to inert organic monomers such as lactic acid and glycolic acid. These metabolites are ultimately converted to carbon dioxide and water in the Krebs cycle and are removed from the body by normal metabolic processes, thereby eliminating the risk associated with the long-term presence of polymer in the coronary vessel wall. The promise inherent in this model has prompted a large number of investigations with novel biodegradable polymer platforms in recent years.

The pooled individual patient data from three large-scale multicentre randomized clinical trials (ISAR-TEST 3, ISAR-TEST 4, and LEADERS) comparing biodegradable polymer DES with durable polymer SES and assessed clinical outcomes during follow-up through 4 years was published in European Heart Journal(March 2012). The efficacy endpoint of interest was target lesion revascularization and the safety endpoint of interest was definite stent thrombosis. Out of 4062 patients included in the present analysis, 2358 were randomly assigned to treatment with biodegradable polymer DES (YUKON Choice PC, n ¼ 1501; BIOMATRIX, n ¼ 857) and 1704 patients to durable polymer SES. No heterogeneity across the trials was observed in analyses of the primary and secondary endpoints. At 4 years, Treatment with the biodegradable-polymer drug-eluting stents significantly reduced the risk of TLR 18% and stent thrombosis 44% compared with the SES stent with permanent polymers, with the reduction in stent thrombosis driven by a significant 78% reduction in the risk of very late stent thrombosis the risk of target lesion revascularization was significantly lower among patients treated with biodegradable polymer DES vs. durable polymer SES (hazard ratio 0.82, 95% CI 0.68–0.98, P ¼ 0.029). In addition, the risk of stent thrombosis was significantly reduced with biodegradable polymer DES vs. durable polymer SES (hazard ratio 0.56, 95% CI 0.35–0.90, P ¼ 0.015), driven by a lower risk of very late stent thrombosis (hazard ratio 0.22, 95% CI 0.08–0.61, P ¼ 0.004). In keeping with this, in landmark analysis between 1 and 4 years, the incidence of myocardial infarction was lower for patients treated with biodegradable polymer DES vs. durable polymer SES (hazard ratio 0.59, 95% CI 0.73–0.95, P ¼ 0.031).

Stent thrombosis is the most severe complication of percutaneous intervention with coronary stents. A large proportion of patients with this complication dies or incurs myocardial infarction. Several factors have been attributed a role in the aetiology of this event including, but not restricted to, suboptimal procedural results, stent malapposition, delayed healing and re-endothelialization of the treated segment, enhanced platelet reactivity, hypercoagulability, impaired response to antiplatelet drugs induced by genetic susceptibility, drug-drug interactions and other unknown factors.

The risk of stent thrombosis was very significant in the era of oral anticoagulation. Better understanding of underlying mechanisms led to the introduction of dual antiplatelet therapy as a replacement for oral anticoagulation with considerable reduction in the risk of stent thrombosis. This enabled an explosive increase in the use of stenting for the treatment of patients with coronary artery disease.

The advent of drug-eluting stents has been a great success for interventional cardiology in the fight against restenosis. However, new concerns have arisen that drug-eluting stents may be associated with exacerbated inflammatory reaction, failed reendothelialization and exaggerated delayed arterial healing, all factors that may increase the risk of stent thrombosis.

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