Dataset Information

Randomized Comparison of Strut Coverage between Ticagrelor and Clopidogrel in Acute Myocardial Infarction at 3-Month Optical Coherence Tomography.

ABSTRACT: This study aimed to compare the effects of ticagrelor and clopidogrel on early neointimal healing assessed with optical coherence tomography (OCT) after drug-eluting stent (DES) implantation in patients with acute myocardial infarction (AMI).AMI patients were randomly assigned to either the ticagrelor or clopidogrel arm. After DES implantation, OCT was performed to assess the percentages of uncovered struts immediately after procedure and 3 months later.Due to early termination, 83 patients out of 106 initially enrolled patients (24% of planned participants) underwent 3-month OCT. Differences in vascular healing patterns between the two groups, including percentage of uncovered struts on 3-month OCT (9.6% vs. 11.7% in ticagrelor vs. clopidogrel, respectively; p=0.867), neointimal thickness, percentage of malapposed struts, and healing scores did not reach statistical significance. The predictors of uncovered strut on 3-month OCT included greater reference vessel diameter [odds ratio (OR)=1.96, p<0.001] and more malapposed struts (OR=1.12, p=0.003).The current study did not explore favorable effect of ticagrelor on 3-month vascular healing after DES implantation. Our findings should only be considered for generating hypothesis, due to insufficient power.

SUBMITTER: Kim C

PROVIDER: S-EPMC5990671 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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Randomized Comparison of Strut Coverage between Ticagrelor and Clopidogrel in Acute Myocardial Infarction at 3-Month Optical Coherence Tomography.

Kim Choongki C Kim Byeong Keuk BK Hong Sung Jin SJ Ahn Chul Min CM Kim Jung Sun JS Ko Young Guk YG Choi Donghoon D Hong Myeong Ki MK Jang Yangsoo Y

Yonsei medical journal 20180701 5

<h4>Purpose</h4>This study aimed to compare the effects of ticagrelor and clopidogrel on early neointimal healing assessed with optical coherence tomography (OCT) after drug-eluting stent (DES) implantation in patients with acute myocardial infarction (AMI).<h4>Materials and methods</h4>AMI patients were randomly assigned to either the ticagrelor or clopidogrel arm. After DES implantation, OCT was performed to assess the percentages of uncovered struts immediately after procedure and 3 months la ...[more]

PMID: 29869460

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Project description:Importance:The bleeding safety of ticagrelor in patients with ST-elevation myocardial infarction treated with fibrinolytic therapy remains uncertain. Objective:To evaluate the short-term safety of ticagrelor when compared with clopidogrel in patients with ST-elevation myocardial infarction treated with fibrinolytic therapy. Design, Setting and Participants:We conducted a multicenter, randomized, open-label with blinded end point adjudication trial that enrolled 3799 patients (younger than 75 years) with ST-segment elevation myocardial infarction receiving fibrinolytic therapy in 152 sites from 10 countries from November 2015 through November 2017. The prespecified upper boundary for noninferiority for bleeding was an absolute margin of 1.0%. Interventions:Patients were randomized to ticagrelor (180-mg loading dose, 90 mg twice daily thereafter) or clopidogrel (300-mg to 600-mg loading dose, 75 mg daily thereafter). Patients were randomized with a median of 11.4 hours after fibrinolysis, and 90% were pretreated with clopidogrel. Main Outcomes and Measures:The primary outcome was thrombolysis in myocardial infarction (TIMI) major bleeding through 30 days. Results:The mean (SD) age was 58.0 (9.5) years, 2928 of 3799 patients (77.1%) were men, and 2177 of 3799 patients (57.3%) were white. At 30 days, TIMI major bleeding had occurred in 14 of 1913 patients (0.73%) receiving ticagrelor and in 13 of 1886 patients (0.69%) receiving clopidogrel (absolute difference, 0.04%; 95% CI, -0.49% to 0.58%; P < .001 for noninferiority). Major bleeding defined by the Platelet Inhibition and Patient Outcomes criteria and by the Bleeding Academic Research Consortium types 3 to 5 bleeding occurred in 23 patients (1.20%) in the ticagrelor group and in 26 patients (1.38%) in the clopidogrel group (absolute difference, -0.18%; 95% CI, -0.89% to 0.54; P = .001 for noninferiority). The rates of fatal (0.16% vs 0.11%; P = .67) and intracranial bleeding (0.42% vs 0.37%; P = .82) were similar between the ticagrelor and clopidogrel groups, respectively. Minor and minimal bleeding were more common with ticagrelor than with clopidogrel. The composite of death from vascular causes, myocardial infarction, or stroke occurred in 76 patients (4.0%) treated with ticagrelor and in 82 patients (4.3%) receiving clopidogrel (hazard ratio, 0.91; 95% CI, 0.67-1.25; P = .57). Conclusions and Relevance:In patients younger than 75 years with ST-segment elevation myocardial infarction, delayed administration of ticagrelor after fibrinolytic therapy was noninferior to clopidogrel for TIMI major bleeding at 30 days. Trial Registration:clinicaltrials.gov Identifier: NCT02298088.

Project description:BackgroundData are lacking on the effects of the alternation of P2Y12 receptor antagonists (P2Y12) on bleeding and outcome in patients with myocardial infarction (MI) with cardiogenic shock (CS). We compared the effects of different P2Y12 and alternation of P2Y12 (combination) on bleeding and outcome in patients with MI and CS.MethodsData from 247 patients divided into four groups: clopidogrel, ticagrelor, prasugrel, and the combination group, were analyzed. The association between P2Y12 and bleeding as well as 30-day and one-year mortality was examined.ResultsThe highest bleeding rate was observed in patients in the combination group, followed by the clopidogrel, ticagrelor, and prasugrel groups [12(50%) patients, 22(28.2%), 21(18.3%) and 4(13.3%), respectively; p = 0.003]. Bleeding occurred with a similar frequency in the combination and clopidogrel groups (p = 0.081), but more frequently than in the ticagrelor and prasugrel groups (p = 0.002 and p = 0.006, respectively). Bleeding rates were similar in patients receiving P2Y12 alone (p = 0.13). Compared to clopidogrel, both ticagrelor and prasugrel had a lower bleeding risk (aOR: 0.40; 95% CI: 0.18-0.92; p = 0.032 and aOR: 0.20; 95% CI: 0.05-0.85; p = 0.029, respectively) and the combination had a similar bleeding risk (aOR: 2.31; 95% CI: 0.71-7.48; p = 0.16). The ticagrelor and prasugrel groups had more than an 80% and 90% lower bleeding risk than the combination group (aOR: 0.17; 95% CI: 0.06-0.55; p = 0.003 and aOR: 0.09; 95% CI: 0.02-0.44; p = 0.003, respectively). The unadjusted 30-day and one-year mortality were highest in the clopidogrel group, followed by the ticagrelor, prasugrel, and combination groups (44(56.4%) and 55(70.5%) patients died in the clopidogrel group, 53(46.1%) and 56(48.7%) in the ticagrelor group, 12(40%) and 14(46.7%) patients died in the prasugrel, and 6(25%) and 9(37.5%) patients died in the combination group; p = 0.045 and p < 0.0001. After adjustment for confounders, the P2Y12 groups were not independently associated with either 30-day (p = 0.23) or one-year (p = 0.17) mortality risk.ConclusionOur results suggest that the choice of P2Y12 was not associated with treatment outcome. The combination of P2Y12 increased bleeding risk compared with ticagrelor and prasugrel and was comparable to clopidogrel in patients with MI and CS. However, these higher bleeding rates did not result in worse treatment outcomes.

Dataset Information

Randomized Comparison of Strut Coverage between Ticagrelor and Clopidogrel in Acute Myocardial Infarction at 3-Month Optical Coherence Tomography.

Publications

Randomized Comparison of Strut Coverage between Ticagrelor and Clopidogrel in Acute Myocardial Infarction at 3-Month Optical Coherence Tomography.

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