scholarly journals Safety and Efficacy of Second-Generation Drug-Eluting Stents in Real-World Practice: Insights from the Multicenter Grand-DES Registry

2020 ◽  
Vol 2020 ◽  
pp. 1-9 ◽  
Author(s):  
You-Jeong Ki ◽  
Kyung Woo Park ◽  
Jeehoon Kang ◽  
Chee-Hoon Kim ◽  
Jung-Kyu Han ◽  
...  
Keyword(s):  
Propensity Score ◽  
Stent Thrombosis ◽  
Real World ◽  
Coronary Intervention ◽  
Drug Eluting Stents ◽  
Drug Eluting Stent ◽  
Safety And Efficacy ◽  
Drug Eluting ◽  
Composite Outcomes

Objective. In this study, we sought to compare the efficacy and safety of the Xience Prime/Xience V/Promus EES and Biomatrix/Biomatrix Flex/Nobori BES with resolute integrity/resolute ZES using the grand drug-eluting stent (Grand-DES) registry. Background. Currently, new-generation drug-eluting stents (DESs) are used as the standard of care in patients undergoing percutaneous coronary intervention. No study has simultaneously compared everolimus-eluting stent (EES), biolimus-eluting stent (BES), and zotarolimus-eluting stent (ZES). Methods. Stent-related composite outcomes (target lesion failure) and patient-related composite outcomes were compared in crude and propensity score-matched analysis. Results. Of the 17,286 patients in the Grand-DES group, 5,137, 2,970, and 4,990 patients in the EES, BES, and ZES groups completed a three-year follow-up. In the propensity score-matched cohort, the stent-related outcome (EES vs. BES vs. ZES; 5.9% vs. 6.7% vs. 7.1%, P=0.226) and patient-related outcomes (12.7% vs. 13.5% vs. 14.3%, P=0.232) were similar among the three groups, at 3 years. The rate of definite or probable stent thrombosis (0.6% vs. 0.8% vs. 0.5%, P=0.549) was similar. In the multivariate analysis, chronic kidney disease was the strongest predictor of stent thrombosis (adjusted hazard ratio 3.178; 95% confidence interval 1.621–6.229; P<0.001). Conclusions. In this robust real-world registry with unrestricted use of EES, BES, and ZES, the three stent groups showed comparable safety and efficacy at the 3-year follow-up.

Abstract 12989: Generalizability of Quantitative Angiographic In-Segment Late Lumen Loss Imaging in Eastern and Western Populations: Can We Facilitate Global Drug Eluting Stent Evaluation?

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Vaishnavi Radhakrishnan ◽  
John C Allen ◽  
Rebecca Fisher ◽  
Weng Kit Lye ◽  
Robert W Harrison ◽  
...  
Keyword(s):  
Coronary Angiography ◽  
Propensity Score ◽  
Quantitative Coronary Angiography ◽  
Drug Eluting Stents ◽  
Drug Eluting Stent ◽  
Meaningful Difference ◽  
Late Lumen Loss ◽  
Drug Eluting ◽  
East And West

Background: Regulators require mechanistic observations of late lumen loss (LLL) in evaluating new drug eluting stents (DES). Redundant requirements for follow-up catheterization across regulatory jurisdictions worldwide could be reduced if independent core laboratory quantitative coronary angiography (QCA) findings were generalizable. Our study aim was to assess comparability of QCA LLL in East (Japan, China) and West (N. America, Europe) pts using the world’s largest compilation of late follow-up QCA data. Hypothesis: The propensity adjusted mean difference in QCA in-segment LLL between East and West is ≤0.4mm, with 95% confidence. Methods: All available data from 4 manufacturers (7157 pts, 29 trials) reporting 6-12mo QCA LLL were compiled. East vs West were compared unadjusted and via propensity score (PS) quartiles that adjusted for 26 clinical descriptive and anatomic variables affecting QCA LLL. Of the 7157 pts, 6163 (86%) had complete covariable profiles and comprised the analysis set. Based on consensus of experts and regulators, a clinically meaningful difference between East and West mean IS-LLL was prospectively set at 0.4mm. Results: Of 6163 pts, 4134 were West and 2029 East, including 2304 paclitaxel, 1455 everolimus, 1562 zotarolimus, 440 sirolimus and 402 biolimus exposures. Unadjusted and adjusted IS-LLL (Mean±SD) was 0.25±0.47 (W) and 0.08±0.41 (E), and 0.24±0.45 (W) and 0.13±0.45 (E), respectively; differences (95% CI) were 0.17 (0.15, 0.19) and 0.12 (0.08, 0.16), respectively. PS-adjusted IS-LLL is shown the Figure. All differences were ≤ 0.4mm. Conclusion: In the world’s largest compilation of protocol follow-up across multiple DES platforms, QCA LLL appears generalizable and sufficiently predictive across East and West pts in both unadjusted and adjusted comparisons. This suggests that global DES evaluations can be facilitated by reducing the need for redundant invasive late catheterization across regulatory jurisdictions.

scholarly journals DEFINITE STENT THROMBOSIS UP TO 8 YEARS FOLLOW-UP IN REAL-WORLD PATIENTS UNDERGOING DRUG-ELUTING STENT IMPLANTATION

2011 ◽  
Vol 57 (14) ◽  
pp. E1727
Author(s):  
Ricardo A. Costa ◽  
Amanda Sousa ◽  
Adriana Moreira ◽  
J. Ribamar Costa ◽  
Manuel Cano ◽  
...  
Keyword(s):  
Stent Thrombosis ◽  
Real World ◽  
Stent Implantation ◽  
Drug Eluting Stent ◽  
Drug Eluting ◽  
Definite Stent Thrombosis

BioMime – A Sirolimus-eluting Coronary Stent System for the Treatment of Patients with De Novo Coronary Lesions – meriT-1 Report

2011 ◽  
Vol 6 (1) ◽  
pp. 39
Author(s):  
Keyword(s):  
Stent Thrombosis ◽  
Time Course ◽  
De Novo ◽  
Drug Eluting Stent ◽  
Cobalt Chromium ◽  
Cardiac Events ◽  
End Points ◽  
Safety And Efficacy ◽  
Binary Restenosis

Background:Since the first reported use of percutaneous transluminal coronary angioplasty, advances in the interventional cardiology arena have been fast paced. Developers and clinicians are adapting from the learning curve awarded by the time-course of drug-eluting stent (DES) evolution. BioMime™ sirolimus-eluting stent (SES) is a step towards biomimicry. The stent is built on a strut of ultra-low thickness (65μm), a cobalt–chromium platform using an intelligent hybrid of closed and open cells allowing for morphology-mediated expansion. It employs a well-known antiproliferative – sirolimus – that elutes from a known biodegradable copolymer formulation within 30 days. The resultant stent demonstrates almost 100% endothelialisation at 30 days in preclinical models.Methods:The meriT-1 was a prospective, single-arm, single-centre trial to evaluate the safety and efficacy of BioMime SES in 30 patients with a single de novo lesion in native coronary arteries. The primary safety and efficacy end-points were major adverse cardiac events (MACE) at 30 days and in-stent late lumen loss at eight months, as measured using quantitative coronary angiographic (QCA) method. Secondary safety and efficacy end-points included MACE at one and two years and angiographic binary restenosis at eight-month angiographic follow-up. Other end-points included the occurrence of stent thrombosis at acute, subacute, late and very late periods and the percentage of diameter stenosis by QCA.Results:No MACE were observed and the median in-stent late luminal loss in 20 (67%) subjects studied by QCA was 0.15mm, with 0% binary restenosis at eight-month follow-up. No stent thrombosis was observed up to one-year follow-up.Conclusions:In comparison to currently available DES, BioMime SES appears to have a considerable scientific basis for prevention of neointimal proliferation, restenosis and associated clinical events.

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