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Long-term dual antiplatelet treatment and bleeding complications in diabetic patients treated with drug eluting stent implantation.

ABSTRACT: Dual antiplatelet treatment (DAPLT) for at least 12 months is recommended after drug eluting stent (DES) implantation, but concerns regarding the extended use of this treatment persist due to increased risk of bleeding. In this study are assessed the incidence, correlates, and clinical significance of bleeding complications in diabetic patients after long-term DAPLT post DES implantation.We studied 610 consecutive diabetic patients after DES implantation. The primary end point was the occurrence of any bleeding according to the BARC and TIMI definitions.The incidence of overall bleeding was higher in patients on DAPLT (21.1% vs. 4.4%, p < 0.001); minor/minimal according to the TIMI definition, and type 1 or 2 according to the BARC definition, were more frequently observed in patients on DAPLT (20.3% vs. 3.0%, p < 0.001, 15.6% vs. 2.0%, p < 0.001 and 4.4% vs. 0.5%, p = 0.034, respectively), whereas there was no effect on type 3 (3.5% vs. 2.0%, p = ns). DAPLT was an independent predictor for overall (HR 5.35, 95% CI: 2.69-10.67, p < 0.001), minor (HR 7.45, 95% CI: 3.25-17.12, p < 0.001, for TIMI classification) and type 1 or 2 bleeding (HR 8.17, 95% CI 3.29-20.25, p < 0.001); furthermore smoking was also predictor for overall bleeding (HR 1.65, 95% CI: 1.05-2.61, p = 0.030). Cardiovascular adverse events were not more frequent in patients with bleeding as compared with those without bleeding.Long-term DAPLT in diabetic patients after DES implantation is associated with higher risk of overall and minor but not major bleeding; smoking may have a significant role in the occurrence of bleeding complications.

SUBMITTER: Voudris V

PROVIDER: S-EPMC5497144 | biostudies-other | 2014 Dec

REPOSITORIES: biostudies-other

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Project description:BackgroundThe optimal duration of dual antiplatelet therapy (DAPT) in patients with diabetes mellitus (DM) admitted with acute coronary syndrome (ACS) and treated with a drug-eluting stent (DES) remains unclear. This is a prespecified sub-study from the Randomised Evaluation of short-term DUal antiplatelet therapy in patients with acute Coronary syndromE treated with a new generation DES (REDUCE) trial that was designed to determine the efficacy and safety of short-term versus standard 12 months DAPT in diabetic patients with ACS undergoing percutaneous coronary intervention (PCI) using the COMBO stent.MethodsIn this study we included ACS diabetic patients enroled in the REDUCE trial treated with the COMBO stent and randomly assigned to either 3 or 12 months of DAPT. The primary study endpoint was the composite of all-cause mortality, myocardial infarction (MI), stent thrombosis (ST), stroke, target vessel revascularisation (TVR), and bleeding complications at 12 and 24 months follow-up.ResultsA total of 307 diabetic patients were included, of which 162 (52.8%) in the 3 months DAPT group and 145 (47.2%) in the 12 months DAPT group. Patient characteristics, PCI success, and number of stents used were similar in the 3 and 12 months DAPT groups. Occurrence of the primary study endpoint at 12 and 24 months follow-up was comparable between the two groups (3.1 vs. 3.5%, p = 0.865, and 15.8 vs. 14.9%, p = 0.824, respectively). Moreover, the prevalence of the specific clinical outcome parameters (all-cause mortality), MI, ST, stroke, TVR, and bleeding was similar in both study groups.ConclusionsThis sub-analysis shows similar clinical outcomes following 3 months DAPT as compared to 12 months DAPT in diabetic patients undergoing PCI for ACS using the COMBO stent. These results suggest that, even in this particular subset of patients, short duration of DAPT might be considered safe. Future larger studies are warranted to provide more precise estimations in terms of safety and efficacy of short term DAPT in these high-risk patients.

Project description:BackgroundEnd-stage renal disease yields susceptibility to both ischemia and bleeding. The optimal duration of dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation is not established in dialysis patients, who are usually excluded from randomized studies. Since recent studies implied the benefits of prolonged DAPT >12 months in chronic kidney disease, we investigated the effectiveness and safety of prolonged DAPT in dialysis patients with higher cardiovascular risks.MethodsIn this nationwide population-based study, we analyzed dialysis patients who underwent DES implantation from 2008 to 2015. Continued DAPT was compared with discontinued DAPT using landmark analyses, including free-of-event participants at 12 (n = 2246), 15 (n = 1925) and 18 months (n = 1692) after DES implantation. The primary outcome was major adverse cardiovascular events (MACEs): a composite of mortality, nonfatal myocardial infarction, coronary revascularization and stroke. Major bleeding was a safety outcome. Inverse probability of treatment weighting Cox regression was performed.ResultsMean follow-up periods were 278.3-292.4 days, depending on landmarks. Overall, incidences of major bleeding were far lower than those of MACE. Continued DAPT groups showed lower incidences of MACE and higher incidences of major bleeding, compared with discontinued DAPT groups. In Cox analyses, continued DAPT reduced the hazards of MACE at the 12- [hazard ratio (HR) = 0.74, 95% confidence interval (CI) 0.61-0.90; P = 0.003], 15- (HR = 0.78, 95% CI 0.64-0.96; P = 0.019) and 18-month landmarks (HR = 0.79, 95% CI 0.63-0.99; P = 0.041), but without a significant increase in major bleeding at 12 (HR = 1.39, 95% CI 0.90-2.16; P = 0.14), 15 (HR = 1.13, 95% CI 0.75-1.70; P = 0.55) or 18 months (HR = 1.27, 95% CI 0.83-1.95; P = 0.27).ConclusionsProlonged DAPT reduced MACE without significantly increasing major bleeding in patients who were event-free at 12 months after DES implantation. In deciding on DAPT duration, prolonged DAPT should be considered in dialysis patients.

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Long-term dual antiplatelet treatment and bleeding complications in diabetic patients treated with drug eluting stent implantation.

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