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Safety and efficacy profile of bioresorbable-polylactide-polymer-biolimus-A9-eluting stents versus durable-polymer-everolimus- and zotarolimus-eluting stents in patients with acute coronary syndrome.
Catheterization and Cardiovascular Interventions 2016 November 16
BACKGROUND: Comparative data on long-term safety and efficacy of bioresorbable-polymer-BES versus durable-polymer-EES/ZES in ACS setting have hitherto been lacking. We sought to assess the safety and efficacy of bioresorbable-polymer-biolimus-A9-eluting stents (BES) compared with thin-strut-durable-polymer-everolimus- and zotarolimus-eluting stents (EES/ZES) in patients with acute coronary syndrome (ACS) undergoing PCI.
METHODS AND RESULTS: Between 2007 and 2012, 1,547 patients were implanted with new-generation drug-eluting stents (DES). Out of these, 369 received BES and 1,178 EES/ZES. The primary endpoint was probable/definite stent thrombosis (ST) while the secondary endpoint was a composite of all-cause death, myocardial infarction (MI), target vessel revascularization (TVR) and definite ST up to 5 years. As stent assignment was not random, we performed a propensity score matching (PSM), with 1:3 ratio, to account for potential confounders. Primary analysis demonstrated no significant differences between both groups for the primary endpoint of ST (BES vs.
EES/ZES: 1.6% vs. 1.9%; mean-event-time = 1,797 days vs. 1,795 days, respectively; P = 0.75) and composite safety endpoint (BES vs.
EES/ZES: 12.5% vs. 12.9%; mean-event-time = 1,631 days vs. 1,620 days, respectively; P = 0.88). Results regarding the 5-year-ST- and safety endpoint remained non-significant after PSM (P = 0.85, P = 0.56; respectively). After stratification based on cardiovascular risk, no difference regarding ST and composite outcome measure has been documented between both stent groups in high-risk- and low-risk patients. The type of stent did neither predict ST (HR 1.11, 95%CI 0.45-2.74, P = 0.82) nor composite safety endpoint (HR 0.93, 95%CI 0.67-1.30, P = 0.69).
CONCLUSIONS: Long-term safety and efficacy of bioresorbable-polymer-BES and durable-polymer-EES/ZES appear comparable in patients with ACS. © 2016 Wiley Periodicals, Inc.
METHODS AND RESULTS: Between 2007 and 2012, 1,547 patients were implanted with new-generation drug-eluting stents (DES). Out of these, 369 received BES and 1,178 EES/ZES. The primary endpoint was probable/definite stent thrombosis (ST) while the secondary endpoint was a composite of all-cause death, myocardial infarction (MI), target vessel revascularization (TVR) and definite ST up to 5 years. As stent assignment was not random, we performed a propensity score matching (PSM), with 1:3 ratio, to account for potential confounders. Primary analysis demonstrated no significant differences between both groups for the primary endpoint of ST (BES vs.
EES/ZES: 1.6% vs. 1.9%; mean-event-time = 1,797 days vs. 1,795 days, respectively; P = 0.75) and composite safety endpoint (BES vs.
EES/ZES: 12.5% vs. 12.9%; mean-event-time = 1,631 days vs. 1,620 days, respectively; P = 0.88). Results regarding the 5-year-ST- and safety endpoint remained non-significant after PSM (P = 0.85, P = 0.56; respectively). After stratification based on cardiovascular risk, no difference regarding ST and composite outcome measure has been documented between both stent groups in high-risk- and low-risk patients. The type of stent did neither predict ST (HR 1.11, 95%CI 0.45-2.74, P = 0.82) nor composite safety endpoint (HR 0.93, 95%CI 0.67-1.30, P = 0.69).
CONCLUSIONS: Long-term safety and efficacy of bioresorbable-polymer-BES and durable-polymer-EES/ZES appear comparable in patients with ACS. © 2016 Wiley Periodicals, Inc.
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