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Long Term Safety Data

Long Term Safety Data

Long Term Safety

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, ISARTEST 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 YUKON Choice PC 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 YUKON Choice PC 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).


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