Dataset Information

Ranolazine After Incomplete Percutaneous Coronary Revascularization in Patients With Versus Without Diabetes Mellitus: RIVER-PCI Trial.

ABSTRACT: BACKGROUND:Chronic angina is more common in patients with diabetes mellitus (DM) with poor glucose control. Ranolazine both treats chronic angina and improves glucose control. OBJECTIVES:This study sought to examine ranolazine's antianginal effect in relation to glucose control. METHODS:The authors performed a secondary analysis of the RIVER-PCI (Ranolazine in Patients with Incomplete Revascularization after Percutaneous Coronary Intervention) trial, a clinical trial in which 2,604 patients with chronic angina and incomplete revascularization following percutaneous coronary intervention were randomized to ranolazine versus placebo. Mixed-effects models were used to compare the effects of ranolazine versus placebo on glycosylated hemoglobin (HbA1c) at 6- and 12-month follow-up. Interaction between baseline HbA1c and ranolazine's effect on Seattle Angina Questionnaire angina frequency at 6 and 12 months was tested. RESULTS:Overall, 961 patients (36.9%) had DM at baseline. Compared with placebo, ranolazine significantly decreased HbA1c by 0.42 ± 0.08% (adjusted mean difference ± SE) and 0.44 ± 0.08% from baseline to 6 and 12 months, respectively, in DM patients, and by 0.19 ± 0.02% and 0.20 ± 0.02% at 6 and 12 months, respectively, in non-DM patients. Compared with placebo, ranolazine significantly reduced Seattle Angina Questionnaire angina frequency at 6 months among DM patients but not at 12 months. The reductions in angina frequency were numerically greater among patients with baseline HbA1c ?7.5% than those with HbA1c <7.5% (interaction p = 0.07). CONCLUSIONS:In patients with DM and chronic angina with incomplete revascularization after percutaneous coronary intervention, ranolazine's effect on glucose control and angina at 6 months was proportionate to baseline HbA1c, but the effect on angina dissipated by 12 months.

SUBMITTER: Fanaroff AC

PROVIDER: S-EPMC5784418 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature

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Ranolazine After Incomplete Percutaneous Coronary Revascularization in Patients With Versus Without Diabetes Mellitus: RIVER-PCI Trial.

Fanaroff Alexander C AC James Stefan K SK Weisz Giora G Prather Kristi K Anstrom Kevin J KJ Mark Daniel B DB Ben-Yehuda Ori O Alexander Karen P KP Stone Gregg W GW Ohman E Magnus EM

Journal of the American College of Cardiology 20170501 18

<h4>Background</h4>Chronic angina is more common in patients with diabetes mellitus (DM) with poor glucose control. Ranolazine both treats chronic angina and improves glucose control.<h4>Objectives</h4>This study sought to examine ranolazine's antianginal effect in relation to glucose control.<h4>Methods</h4>The authors performed a secondary analysis of the RIVER-PCI (Ranolazine in Patients with Incomplete Revascularization after Percutaneous Coronary Intervention) trial, a clinical trial in whi ...[more]

PMID: 28473136

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Project description:ImportanceMany studies have compared outcomes for incomplete revascularization (IR) among patients undergoing percutaneous coronary interventions (PCI), but little is known about whether outcomes are related to the nature of the IR.ObjectiveTo determine whether some coronary vessel characteristics are associated with worse outcomes in patients with PCI with IR.Design, setting, and participantsNew York's PCI registry was used to examine mortality (median follow-up, 3.4 years) as a function of the number of vessels that were incompletely revascularized, the stenosis in those vessels, and whether the proximal left anterior descending artery was incompletely revascularized after controlling for other factors associated with mortality for patients with and without ST-elevation myocardial infarction (STEMI). This was a multicenter study (all nonfederal PCI hospitals in New York State) that included 41 639 New York residents with multivessel coronary artery disease undergoing PCI in New York State between January 1, 2010, and December 31, 2012.ExposuresPercutaneous coronary interventions, with complete and incomplete revascularization.Main outcomes and measuresMedium-term mortality.ResultsFor patients with STEMI, the mean age was 62.8 years; 26.2% were women, 11.9% were Hispanic, and 81.5% were white. For other patients, the mean age was 66.6 years, 29.1% were women, 11.3% were Hispanic, and 79.1% were white. Incomplete revascularization was very common (78% among patients with STEMI and 71% among other patients). Patients with IR in a vessel with at least 90% stenosis were at higher risk than other patients with IR. This was not significant among patients with STEMI (17.18% vs 12.86%; adjusted hazard ratio [AHR], 1.16; 95% CI, 0.99-1.37) and significant among patients without STEMI (17.71% vs 12.96%; AHR, 1.15; 95% CI, 1.07-1.24). Similarly, patients with IR in 2 or more vessels had higher mortality than patients with completely revascularization and higher mortality than other patients with IR among patients with STEMI (20.37% vs 14.39%; AHR, 1.35; 95% CI, 1.15-1.59) and among patients without STEMI (20.10% vs 12.86%; AHR, 1.17; 95% CI, 1.09-1.59). Patients with proximal left anterior descending artery vessel IR had higher mortality than other patients with IR (20.09% vs 14.67%; AHR, 1.31; 95% CI, 1.04-1.64 for patients with STEMI and 20.78% vs 15.62%; AHR, 1.11; 95% CI, 1.01-1.23 for patients without STEMI). More than 20% of all PCI patients had IR of 2 or more vessels and more than 30% had IR with more than 90% stenosis.Conclusions and relevancePatients with IR are at higher risk of mortality if they have IR with at least 90% stenosis, IR in 2 or more vessels, or proximal left anterior descending IR.

Project description:BackgroundThe Triglyceride-glucose (TyG) index, as a surrogate marker of insulin resistance, is independently associated with the severity of coronary artery lesions and the prognosis of coronary heart disease. The investigation aimed to explore the relationship between the TyG index and recurrent revascularization in individuals with type 2 diabetes mellitus (T2DM) resulting from the progression of lesions or in-stent restenosis (ISR) after percutaneous coronary intervention (PCI).MethodA total of 633 patients who met the inclusion and exclusion criteria were enrolled and divided into three groups based on the tertiles of the TyG index. The primary endpoint was recurrent revascularization resulting from the progression of lesions or ISR. All-cause death was considered as the competing risk event. Competing risk analysis and Cox regression analysis for predicting recurrent revascularization after PCI were conducted stepwise. Variables were standardized to make the hazard ratio (HR), subdistribution hazard ratio (SHR) and corresponding 95% CI more consistent prior to being used for fitting the multivariate risk model. The predictive ability of the TyG index was evaluated using several measures, including the ROC curve, likelihood ratio test, Akaike's information criteria, category-free continuous net reclassification improvement (cNRI > 0), and integrated discrimination improvement (IDI). Internal validation was conducted through bootstrapping with 1000 resamples.ResultsDuring a median follow-up period of 18.33 months, a total of 64 (10.11%) patients experienced recurrent revascularization, including 55 cases of lesion progression and 9 cases of in-stent restenosis. After controlling for competitive risk events, the TyG index was independently associated with a higher risk of recurrent revascularization [SHR:1.4345, (95% CI 1.1458-1.7959), P = 0.002]. The likelihood ratio test and Akaike's information criteria showed that the TyG index significantly improves the prognostic ability. Additionally, adding the TyG index improved the ability of the established risk model in predicting recurrent revascularization, indicated by a C-index of 0.759 (95% CI 0.724-0.792, P < 0.01), with a cNRI > 0 of 0.170 (95% CI 0.023-0.287, P < 0.05), and an IDI of 0.024 (95% CI 0.009-0.039, P = 0.002). These results remained consistent when the models containing TyG index were confirmed using an internal bootstrap validation method.ConclusionThe findings highlight the potential of the TyG index as a predictor of recurrent revascularization. Lesion progression emerged as the primary contributor to recurrent revascularization instead of in-stent restenosis. The incorporation of the TyG index into risk prediction models is likely to be beneficial for accurate risk stratification in order to improve prognosis.

Project description:OBJECTIVE:To evaluate the clinical utility of individualising dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in an all-comers population, including ST-elevation myocardial infarction (STEMI) patients. SETTING:Tertiary care single centre registry. PARTICIPANTS:1008 consecutive PCI patients with stent implantation, without exclusion criteria. INTERVENTION:Peri-interventional individualisation of DAPT, guided by multiple electrode aggregometry (MEA), to overcome high on-treatment platelet reactivity (HPR) to ADP-induced (?50 U) and arachidonic acid (AA)-induced aggregation (>35 U). OUTCOME MEASURES:The primary efficacy end point was definite stent thrombosis (ST) at 30 days. The primary safety end point was thrombolysis in myocardial infarction (TIMI) major and minor bleeding. Secondary end points were probable ST, myocardial infarction, cardiovascular death and the combined end point: major cardiac adverse event (MACE). RESULTS:53% of patients presented with acute coronary syndrome (9% STEMI, 44% non-ST-elevation). HPR to ADP after 600 mg clopidogrel loading occurred in 30% of patients (73±19 U vs 28±11 U; p<0.001) and was treated by prasugrel or ticagrelor (73%), or clopidogrel (27%) reloading (22±12 U; p<0.001). HPR to ADP after prasugrel loading occurred in 2% of patients (82±26 U vs 19±10 U; p<0.001) and was treated with ticagrelor (34±15 U; p=0.02). HPR to AA occurred in 9% of patients with a significant higher proportion in patients with HPR to ADP (22% vs 4%, p<0.001) and was treated with aspirin reloading. Definite ST occurred in 0.09% of patients (n=1); probable ST, myocardial infarction, cardiovascular death and MACE occurred in 0.19% (n=2), 0.09% (n=1) and 1.8% (n=18) of patients. TIMI major and minor bleeding did not differ between patients without HPR and individualised patients (2.6% for both). CONCLUSIONS:Individualisation of DAPT with MEA minimises early thrombotic events in an all-comers PCI population to an unreported degree without increasing bleeding. A randomised multicentre trial utilising MEA seems warranted. TRIAL REGISTRATION NUMBER:http://www.clinicaltrials.gov; NCT01515345.

Dataset Information

Ranolazine After Incomplete Percutaneous Coronary Revascularization in Patients With Versus Without Diabetes Mellitus: RIVER-PCI Trial.

Publications

Ranolazine After Incomplete Percutaneous Coronary Revascularization in Patients With Versus Without Diabetes Mellitus: RIVER-PCI Trial.

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