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Risk Factors and Outcomes of Recurrent Drug-Eluting Stent Thrombosis: Insights From the REAL-ST Registry.

ABSTRACT: Background Stent thrombosis (ST) after drug-eluting stent (DES) implantation remains a life-threatening complication. Recurrent ST (RST) is not a rare phenomenon, potentially contributing to high mortality after the index ST events. However, little evidence is available about the incidence, risk factors, and clinical outcomes of definite RST after DES thrombosis. Methods and Results From REAL-ST (Retrospective Multicenter Registry of ST After First- and Second- Generation DES Implantation), this study evaluated 595 patients with definite ST (first-generation DES thrombosis, n=314; second-generation DES thrombosis, n=281). During a median follow-up of 31 months, we identified 32 patients with definite RST after first-generation DES thrombosis (n=18) and second-generation DES thrombosis (n=15). Cumulative incidence of RST was 4.5% and 6.0% at 1 and 5 years, respectively, which did not significantly differ between first-generation DES thrombosis and second-generation DES thrombosis. Independent predictors of definite RST were early ST (hazard ratio [HR], 2.38; 95% CI, 1.06-5.35 [P=0.035]) and multivessel ST (HR, 3.47; 95% CI, 1.03-11.7 [P=0.044]). Definite RST was associated with a 2.8-fold increased risk of mortality (adjusted HR, 2.78; 95% CI, 1.35-5.73 [P=0.006]). Conclusions Cumulative incidence of definite RST did not significantly differ between first-generation DES thrombosis and second-generation DES thrombosis. Early ST and multivessel ST were risk factors of definite RST. Definite RST significantly increased mortality after DES thrombosis, highlighting the clinical importance of preventing RST to improve outcomes of patients with ST. Registration URL: https://www.clinicaltrials.gov; Unique identifier: UMIN000025181.

SUBMITTER: Enomoto S

PROVIDER: S-EPMC8200759 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundPatients with diabetes mellitus are at an increased risk for adverse clinical events following percutaneous coronary interventions (PCI). However, the clinical impact of diabetes mellitus (DM) on second-generation drug-eluting stent (DES) implantation is not well-known. The aim of the current analysis was to examine the clinical impact of DM on clinical outcomes and the time sequence of associated risks in patients treated with second-generation DES.MethodsUsing patient-level data from two stent-specific, all-comer, prospective DES registries, we evaluated 1,913 patients who underwent PCI with second-generation DES between Feb 2009 and Dec 2013. The primary outcomes assessed were two-year major cardiac adverse events (MACE), composite endpoints of death from any cause, myocardial infarction (MI), and any repeat revascularization. We classified 0-1 year as the early period and 1-2 years as the late period. Landmark analyses were performed according to diabetes mellitus status.ResultsThere were 1,913 patients with 2,614 lesions included in the pooled dataset. The median duration of clinical follow-up in the overall population was 2.0 years (interquartile range 1.9-2.1). Patients with DM had more cardiovascular risk factors than patients without DM. In multivariate analyses, the presence of DM and renal failure were strong predictors of MACE and target-vessel revascularization (TVR). After inverse probability of treatment weighting (IPTW) analyses, patients with DM had significantly increased rates of 2-year MACE (HR 2.07, 95% CI; 1.50-2.86; P <0.001). In landmark analyses, patients with DM had significantly higher rates of MACE in the early period (0-1 year) (HR 3.04, 95% CI; 1.97-4.68; P < 0.001) after IPTW adjustment, but these findings or trends were not observed in the late period (1-2 year) (HR 1.24, 95% CI; 0.74-2.07; P = 0.41).ConclusionsIn the second-generation DES era, the clinical impact of DM significantly increased the 2-year event rate of MACE, mainly caused by clinical events in the early period (0-1 year). Careful observation of patients with DM is advised in the early period following PCI with second-generation DES.

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Risk Factors and Outcomes of Recurrent Drug-Eluting Stent Thrombosis: Insights From the REAL-ST Registry.

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