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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
Author(s) -
Jaguszewski Milosz,
Dörig Manuela,
Frangieh Antonio H.,
Ghadri JelenaRima,
Cammann Victoria Lucia,
Diekmann Johanna,
Napp L. Christian,
D'Ascenzo Fabrizio,
Imori Yoichi,
Obeid Slayman,
Maier Willibald,
Lüscher Thomas F.,
Templin Christian
Publication year - 2016
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.26617
Subject(s) - medicine , clinical endpoint , zotarolimus , myocardial infarction , stent , acute coronary syndrome , conventional pci , everolimus , percutaneous coronary intervention , revascularization , cardiology , surgery , drug eluting stent , randomized controlled trial
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.