Dataset Information

Comparison of First- and Second-Generation Drug-Eluting Stents in Patients with ST-Segment Elevation Myocardial Infarction Based on Pre-Percutaneous Coronary Intervention Thrombolysis in Myocardial Infarction Flow Grade.

ABSTRACT: This study aims to investigate the two-year clinical outcomes between first-generation (1G) and second-generation (2G) drug-eluting stents (DES) based on pre-percutaneous coronary intervention (PCI) thrombolysis in myocardial infarction (TIMI) flow grade (pre-TIMI) in patients with ST-segment elevation myocardial infarction (STEMI). Overall, 17,891 STEMI patients were classified into two groups: pre-TIMI 0/1 group (n = 12,862; 1G-DES (n = 4318), 2G-DES (n = 8544)) and pre-TIMI 2/3 group (n = 5029; 1G-DES (n = 2046), 2G-DES (n = 2983)). During a two-year follow-up period, major adverse cardiac events (MACEs) defined as all-cause death, recurrent myocardial infarction (re-MI), or any repeat revascularization and stent thrombosis (ST) were considered as the primary and the secondary outcomes. In the pre-TIMI 0/1 and 2/3 groups, the cumulative incidences of MACEs (adjusted hazard ratio (aHR): 1.348, p < 0.001, and aHR: 1.415, p = 0.02, respectively) and any repeat revascularization (aHR: 1.938, p < 0.001, and aHR: 1.674, p = 0.001, respectively) were significantly higher in the 1G-DES than in the 2G-DES. However, sirolimus-eluting stent showed similar cumulative incidence of any repeat revascularization compared with zotarolimus-eluting stent and biolimus-eluting stent in both pre-TIMI 0/1 and 2/3 groups. The cumulative incidences of all-cause death, re-MI, and ST were similar between the 1G-DES and 2G-DES groups. In this study, 2G-DES showed better clinical outcomes than 1G-DES concerning MACEs and any repeat revascularization regardless of pre-TIMI. However, more research is needed to support these results.

SUBMITTER: Kim YH

PROVIDER: S-EPMC7835978 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Comparison of First- and Second-Generation Drug-Eluting Stents in Patients with ST-Segment Elevation Myocardial Infarction Based on Pre-Percutaneous Coronary Intervention Thrombolysis in Myocardial Infarction Flow Grade.

Kim Yong Hoon YH Her Ae-Young AY Jeong Myung Ho MH Kim Byeong-Keuk BK Hong Sung-Jin SJ Kim Seunghwan S Ahn Chul-Min CM Kim Jung-Sun JS Ko Young-Guk YG Choi Donghoon D Hong Myeong-Ki MK Jang Yangsoo Y

Journal of clinical medicine 20210119 2

This study aims to investigate the two-year clinical outcomes between first-generation (1G) and second-generation (2G) drug-eluting stents (DES) based on pre-percutaneous coronary intervention (PCI) thrombolysis in myocardial infarction (TIMI) flow grade (pre-TIMI) in patients with ST-segment elevation myocardial infarction (STEMI). Overall, 17,891 STEMI patients were classified into two groups: pre-TIMI 0/1 group (n = 12,862; 1G-DES (n = 4318), 2G-DES (n = 8544)) and pre-TI ...[more]

PMID: 33478003

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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:BACKGROUND:Use of everolimus-eluting stents (EES) has proven to be clinically effective and safe in patients with ST-segment elevation myocardial infarction but it remains unclear whether it is cost-effective compared to bare-metal stents (BMS) in the long-term. We sought to assess the cost-effectiveness of EES versus BMS based on the 5-year results of the EXAMINATION trial, from a Spanish health service perspective. METHODS:Decision analysis of the use of EES versus BMS was based on the patient-level clinical outcome data of the EXAMINATION trial. The analysis adopted a lifelong time horizon, assuming that long-term survival was independent of the initial treatment strategy after the end of follow-up. Life-expectancy, health-state utility scores and unit costs were extracted from published literature and publicly available sources. Non-parametric bootstrapping was combined with probabilistic sensitivity analysis to co-assess the impact of patient-level variation and parameter uncertainty. The main outcomes were total costs and quality-adjusted life-years. The incremental cost-effectiveness ratio was expressed as cost per quality-adjusted life-years gained. Costs and effects were discounted at 3%. RESULTS:The model predicted an average survival time in patients receiving EES and BMS of 10.52 and 10.38 undiscounted years, respectively. Over the life-long time horizon, the EES strategy was €430 more costly than BMS (€8,305 vs. €7,874), but went along with incremental gains of 0.10 quality-adjusted life-years. This resulted in an average incremental cost-effectiveness ratio over all simulations of €3,948 per quality-adjusted life-years gained and was below a willingness-to-pay threshold of €25,000 per quality-adjusted life-years gained in 86.9% of simulation runs. CONCLUSIONS:Despite higher total costs relative to BMS, EES appeared to be a cost-effective therapy for ST-segment elevation myocardial infarction patients due to their incremental effectiveness. Predicted incremental cost-effectiveness ratios were below generally acceptable threshold values.

Project description:AimsThere are limited contemporary data on the use of initial fibrinolysis in ST-segment elevation myocardial infarction cardiogenic shock (STEMI-CS). This study sought to compare the outcomes of STEMI-CS receiving initial fibrinolysis vs. primary percutaneous coronary intervention (PPCI).MethodsUsing the National (Nationwide) Inpatient Sample from 2009 to 2017, a comparative effectiveness study of adult (>18 years) STEMI-CS admissions receiving pre-hospital/in-hospital fibrinolysis were compared with those receiving PPCI. Admissions with alternate indications for fibrinolysis and STEMI-CS managed medically or with surgical revascularization (without fibrinolysis) were excluded. Outcomes of interest included in-hospital mortality, development of non-cardiac organ failure, complications, hospital length of stay, hospitalization costs, use of palliative care, and do-not-resuscitate status.ResultsDuring 2009-2017, 5297 and 110 452 admissions received initial fibrinolysis and PPCI, respectively. Compared with those receiving PPCI, the fibrinolysis group was more often non-White, with lower co-morbidity, and admitted on weekends and to small rural hospitals (all P < 0.001). In the fibrinolysis group, 95.3%, 77.4%, and 15.7% received angiography, PCI, and coronary artery bypass grafting, respectively. The fibrinolysis group had higher rates of haemorrhagic complications (13.5% vs. 9.9%; P < 0.001). The fibrinolysis group had comparable all-cause in-hospital mortality [logistic regression analysis: 28.8% vs. 28.5%; propensity-matched analysis: 30.8% vs. 30.3%; adjusted odds ratio 0.97 (95% confidence interval 0.90-1.05); P = 0.50]. The fibrinolysis group had comparable rates of acute organ failure, hospital length of stay, rates of palliative care referrals, do-not-resuscitate status use, and lesser hospitalization costs.ConclusionsThe use of initial fibrinolysis had comparable in-hospital mortality than those receiving PPCI in STEMI-CS in the contemporary era in this large national observational study.

Dataset Information

Comparison of First- and Second-Generation Drug-Eluting Stents in Patients with ST-Segment Elevation Myocardial Infarction Based on Pre-Percutaneous Coronary Intervention Thrombolysis in Myocardial Infarction Flow Grade.

Publications

Comparison of First- and Second-Generation Drug-Eluting Stents in Patients with ST-Segment Elevation Myocardial Infarction Based on Pre-Percutaneous Coronary Intervention Thrombolysis in Myocardial Infarction Flow Grade.

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