Dataset Information

Two-Year Safety and Efficacy of Biodegradable Polymer Drug-Eluting Stent Versus Second-Generation Durable Polymer Drug-Eluting Stent in Patients With Acute Myocardial Infarction: Data from the Korea Acute Myocardial Infarction Registry (KAMIR).

ABSTRACT: BACKGROUND:Despite improved long-term safety of biodegradable polymer (BP) drug-eluting stents (DES) compared to first-generation durable polymer (DP) DES, data on the safety and efficacy of BP-DES compared with second-generation (2G) DP-DES in patients with acute myocardial infarction (AMI) are limited. HYPOTHESIS:To evaluate the safety and efficacy of BP-DES compared with 2G-DP-DES in the higher stent thrombosis (ST) risk setting of AMI. METHODS:A total of 3359 AMI patients who received either BP-DES (n = 261) or 2G-DP-DES (n = 3098) were included from the Korea Acute Myocardial Infarction Registry (KAMIR). Differences in baseline clinical and angiographic characteristics were adjusted using a 1:5 propensity score matching analysis (n = 261 for BP-DES and n = 1305 for 2G-DP-DES). The primary outcome was the incidence of major adverse cardiac events (MACE) including all-cause death, recurrent myocardial infarction (re-MI), and target vessel revascularization (TVR). The rate of definite or probable ST was also investigated. RESULTS:In adjusted analysis, there was no significant difference between the 2 groups in baseline clinical and angiographic characteristics; 2-year MACE (10.7% and 9.9% in the BP-DES group and 2G-DP-DES group, respectively, P = 0.679); ST incidence (0.8% vs 0.9%, respectively, P = 1.0), and rates of all-cause death, re-MI, and TVR. By multivariate analysis, old age, diabetes mellitus, renal dysfunction, and left ventricular dysfunction were the independent predictors of MACE after BP-DES or 2G-DP-DES implantation. CONCLUSIONS:BP-DES and 2G-DP-DES appear to have comparable 2-year safety and efficacy for the treatment of AMI. However, longer-term follow-up is needed.

SUBMITTER: Hur SH

PROVIDER: S-EPMC6490733 | biostudies-literature | 2016 May

REPOSITORIES: biostudies-literature

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Two-Year Safety and Efficacy of Biodegradable Polymer Drug-Eluting Stent Versus Second-Generation Durable Polymer Drug-Eluting Stent in Patients With Acute Myocardial Infarction: Data from the Korea Acute Myocardial Infarction Registry (KAMIR).

Hur Seung-Ho SH Kim In-Cheol IC Won Ki-Bum KB Cho Yun-Kyeong YK Yoon Hyuck-Jun HJ Nam Chang-Wook CW Kim Kwon-Bae KB Kim Min-Seok MS Park Jincheol J Rha Seung-Woon SW Chae Shung-Chull SC Kim Young-Jo YJ Kim Chong-Jin CJ Cho Myeong-Chan MC Jeong Myung-Ho MH Ahn Young-Keun YK Kim Hyo-Soo HS Ahn Tae-Hoon TH Seung Ki-Bae KB Jang Yangsoo Y Yoon Jung-Han JH Seong In-Whan IW Hong Taek-Jong TJ Bae Jang-Ho JH Park Seung-Jung SJ

Clinical cardiology 20160330 5

<h4>Background</h4>Despite improved long-term safety of biodegradable polymer (BP) drug-eluting stents (DES) compared to first-generation durable polymer (DP) DES, data on the safety and efficacy of BP-DES compared with second-generation (2G) DP-DES in patients with acute myocardial infarction (AMI) are limited.<h4>Hypothesis</h4>To evaluate the safety and efficacy of BP-DES compared with 2G-DP-DES in the higher stent thrombosis (ST) risk setting of AMI.<h4>Methods</h4>A total of 3359 AMI patien ...[more]

PMID: 27028303

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Project description:AimsPatients with ST-segment elevation myocardial infarction (STEMI) feature thrombus-rich lesions with large necrotic core, which are usually associated with delayed arterial healing and impaired stent-related outcomes. The use of bioresorbable vascular scaffolds (Absorb) has the potential to overcome these limitations owing to restoration of native vessel lumen and physiology at long term. The purpose of this randomized trial was to compare the arterial healing response at short term, as a surrogate for safety and efficacy, between the Absorb and the metallic everolimus-eluting stent (EES) in patients with STEMI.Methods and resultsABSORB-STEMI TROFI II was a multicentre, single-blind, non-inferiority, randomized controlled trial. Patients with STEMI who underwent primary percutaneous coronary intervention were randomly allocated 1:1 to treatment with the Absorb or EES. The primary endpoint was the 6-month optical frequency domain imaging healing score (HS) based on the presence of uncovered and/or malapposed stent struts and intraluminal filling defects. Main secondary endpoint included the device-oriented composite endpoint (DOCE) according to the Academic Research Consortium definition. Between 06 January 2014 and 21 September 2014, 191 patients (Absorb [n = 95] or EES [n = 96]; mean age 58.6 years old; 17.8% females) were enrolled at eight centres. At 6 months, HS was lower in the Absorb arm when compared with EES arm [1.74 (2.39) vs. 2.80 (4.44); difference (90% CI) -1.06 (-1.96, -0.16); Pnon-inferiority < 0.001]. Device-oriented composite endpoint was also comparably low between groups (1.1% Absorb vs. 0% EES). One case of definite subacute stent thrombosis occurred in the Absorb arm (1.1% vs. 0% EES; P = ns).ConclusionStenting of culprit lesions with Absorb in the setting of STEMI resulted in a nearly complete arterial healing which was comparable with that of metallic EES at 6 months. These findings provide the basis for further exploration in clinically oriented outcome trials.

Project description:ObjectiveTo compare the safety and effectiveness between biodegradable polymer drug-eluting stents (BP-DES) and durable polymer drug-eluting stents (DP-DES) in patients with acute coronary syndrome (ACS).DesignMeta-analysis of randomised controlled trials (RCTs).Primary and secondary outcome measuresMajor adverse cardiovascular events (MACEs) were considered the primary endpoint. Efficacy endpoints included target vessel revascularisation (TVR) and target lesion revascularisation (TLR). Safety endpoints included all-cause death, cardiac death, target vessel myocardial infarction and stent thrombosis (ST).MethodsWe searched PubMed, Medline, Embase and the Cochrane Controlled Register of Trials for comparative studies of BP-DES and DP-DES in patients with ACS from January 2000 to July 2021. Statistical pooling was performed to estimate incidence using a random-effects model with generic inverse-variance weighting. Risk estimates were computed with 95% CIs.ResultsEight articles with seven RCTs that compared BP-DES and DP-DES in patients with ACS were identified and included in the qualitative and quantitative analyses. There was no difference in the baseline characteristics, except for the number of smoking patients (OR: 1.13, 95% CI 1.03 to 1.24; p=0.008, I2=29%), which was significantly lower in the BP-DES group. The meta-analysis demonstrated that MACEs, efficacy endpoints and safety endpoints were similar between the groups at 1 year. However, the incidence of total ST was signiﬁcantly different between the BP-DES and DP-DES groups in the follow-up period (p=0.0001). Further analysis showed a statistically significant difference in MACEs (OR: 0.71, 95% CI 0.57 to 0.88; p=0.002, I2=0 %), TLR (OR: 0.71, 95% CI 0.51 to 1.01; p=0.05, I2=0%), TVR (OR: 0.70, 95% CI 0.52 to 0.94; p=0.002, I2=15%), total ST incidence (OR: 0.59, 95% CI 0.46 to 0.77; p=0.0001, I2=48%) and ST incidence (OR: 0.63, 95% CI 0.47 to 0.85; p=0.002, I2=0%) over 2 years.ConclusionThis meta-analysis revealed that both stent types demonstrated excellent safety and efficacy profiles at 12 months. However, a slight increase in MACEs, TLR, TVR and ST incidence was observed in the DP-DES group over the 2-year follow-up period, suggesting that BP-DES may be more favourable when treating patients with ACS.Trial registration numberNCT00389220.

Dataset Information

Two-Year Safety and Efficacy of Biodegradable Polymer Drug-Eluting Stent Versus Second-Generation Durable Polymer Drug-Eluting Stent in Patients With Acute Myocardial Infarction: Data from the Korea Acute Myocardial Infarction Registry (KAMIR).

Publications

Two-Year Safety and Efficacy of Biodegradable Polymer Drug-Eluting Stent Versus Second-Generation Durable Polymer Drug-Eluting Stent in Patients With Acute Myocardial Infarction: Data from the Korea Acute Myocardial Infarction Registry (KAMIR).

Similar Datasets

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