Clinical outcomes, pharmacological treatment, and quality of life of patients with stable coronary artery diseases managed by cardiologists: 1-year results of the START study

Luca, Leonardo De; Temporelli, Pier Luigi; Riccio, Carmine; Gonzini, Lucio; Marinacci, Lina; Tartaglione, Sara; Costa, Paolo; Marino, Paolo; Senni, Michele; Colivicchi, Furio; Gulizia, Michele Massimo; Investigators, Start

doi:10.1093/ehjqcco/qcz002

Cited by 16 publications

(10 citation statements)

References 25 publications

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“…Finally, six rather than 12 month DAPT is recommended after percutaneous coronary intervention in patients with chronic coronary syndrome. However, 12 month DAPT remains the standard of care in many centres across the world in patients with chronic coronary syndrome, 32 and the results remained largely consistent for either ischaemic or bleeding endpoints when stratified on the basis of clinical presentation.…”

Section: Discussionmentioning

confidence: 97%

P2Y12 inhibitor monotherapy or dual antiplatelet therapy after coronary revascularisation: individual patient level meta-analysis of randomised controlled trials

Valgimigli

Gragnano

Branca³

et al. 2021

BMJ

168

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Objective To assess the risks and benefits of P2Y 12 inhibitor monotherapy compared with dual antiplatelet therapy (DAPT) and whether these associations are modified by patients’ characteristics. Design Individual patient level meta-analysis of randomised controlled trials. Data sources Searches were conducted in Ovid Medline, Embase, and three websites ( www.tctmd.com , www.escardio.org , www.acc.org/cardiosourceplus ) from inception to 16 July 2020. The primary authors provided individual participant data. Eligibility criteria Randomised controlled trials comparing effects of oral P2Y 12 monotherapy and DAPT on centrally adjudicated endpoints after coronary revascularisation in patients without an indication for oral anticoagulation. Main outcome measures The primary outcome was a composite of all cause death, myocardial infarction, and stroke, tested for non-inferiority against a margin of 1.15 for the hazard ratio. The key safety endpoint was Bleeding Academic Research Consortium (BARC) type 3 or type 5 bleeding. Results The meta-analysis included data from six trials, including 24 096 patients. The primary outcome occurred in 283 (2.95%) patients with P2Y 12 inhibitor monotherapy and 315 (3.27%) with DAPT in the per protocol population (hazard ratio 0.93, 95% confidence interval 0.79 to 1.09; P=0.005 for non-inferiority; P=0.38 for superiority; τ 2 =0.00) and in 303 (2.94%) with P2Y 12 inhibitor monotherapy and 338 (3.36%) with DAPT in the intention to treat population (0.90, 0.77 to 1.05; P=0.18 for superiority; τ 2 =0.00). The treatment effect was consistent across all subgroups, except for sex (P for interaction=0.02), suggesting that P2Y 12 inhibitor monotherapy lowers the risk of the primary ischaemic endpoint in women (hazard ratio 0.64, 0.46 to 0.89) but not in men (1.00, 0.83 to 1.19). The risk of bleeding was lower with P2Y 12 inhibitor monotherapy than with DAPT (97 (0.89%) v 197 (1.83%); hazard ratio 0.49, 0.39 to 0.63; P<0.001; τ 2 =0.03), which was consistent across subgroups, except for type of P2Y 12 inhibitor (P for interaction=0.02), suggesting greater benefit when a newer P2Y 12 inhibitor rather than clopidogrel was part of the DAPT regimen. Conclusions P2Y 12 inhibitor monotherapy was associated with a similar risk of death, myocardial infarction, or stroke, with evidence that this association may be modified by sex, and a lower bleeding risk compared with DAPT. Registration PROSPERO CRD42020176853.

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Section: Discussionmentioning

confidence: 97%

P2Y12 inhibitor monotherapy or dual antiplatelet therapy after coronary revascularisation: individual patient level meta-analysis of randomised controlled trials

Valgimigli

Gragnano

Branca³

et al. 2021

BMJ

168

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“…The design and main results of the START registry have been published previously [8, 9]. In brief, the START was a prospective observational nationwide study designed to evaluate, over a 3-month period, the current presentation, management, treatment, and quality of life of patients with CCS as seen by cardiologists in clinical practice in Italy [8].…”

Section: Methodsmentioning

confidence: 99%

“…The LV ejection fraction (LVEF) was assessed by conventional transthoracic echocardiography according to international standard criteria. Optimal medical therapy (OMT) has been defined as patients being prescribed aspirin or thienopyridine, β-blocker, and a statin at the maximum tolerated dosage [9]. To be categorized as receiving OMT, a patient must have been prescribed all medications in each category (or else have a reported contraindication to one or more).…”

Section: Methodsmentioning

confidence: 99%

Comparing the Prognostic Impact of Prediabetes with Diabetes in a Nationwide Cohort of Patients with Chronic Coronary Syndromes: An Analysis of the START Registry

et al. 2021

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Aims: Using data from the nationwide prospective START registry that enrolled a large cohort of patients with chronic coronary syndromes (CCS), we aimed to investigate whether the presence of diabetes mellitus (DM) and pre-DM independently affected the risk of cardiovascular events at 1-year follow-up. Methods: We assessed the impact of DM and pre-DM on all-cause mortality and a composite of all-cause mortality and hospitalization for cardiovascular causes at 1-year follow-up. Results: Among the 3,778 patients with available fasting plasma glucose data at study entry, 37% were classified as DM, 25% as pre-DM, and 38% as no DM. At 1 year, patients with DM had higher rates of all-cause death (p = 0.004) and death/cardiovascular hospitalization (p = 0.003) than those with pre-DM or without DM. Conversely, no significant differences in the adverse event rate were found between patients with pre-DM and those without DM. At unadjusted Cox analysis, DM resulted as a predictor of both death for any cause (hazard ratio [HR]: 2.41; 95% confidence intervals [CI]: 1.34–4.34; p = 0.003) and all-cause death/hospitalization for cardiovascular causes (HR: 1.29; 95% CI: 1.02–1.62; p = 0.03). However, DM did not result as an independent predictor of either endpoint at multivariate analysis. Conclusions: The risk of 1-year major events among patients with CCS and pre-DM is comparable to that of patients with CCS and normoglycemic status and is lower than that of patients with DM.

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“…Nevertheless, poor data are available on the predictive role of TG/HDL-C ratio in patients with established chronic coronary syndromes (CCS), particularly in those at very high risk (VHR). Therefore, using the data from the STable Coronary Artery Diseases RegisTry (START) study ( 10 , 11 ), an Italian nationwide registry, we sought to assess the association between the TG/HDL-C ratio and baseline clinical characteristics, pharmacological treatment, and major adverse cardio-cerebrovascular events (MACCE) at 1 year in a large cohort of CCS patients at VHR.…”

Section: Introductionmentioning

confidence: 99%

Clinical Impact and Prognostic Role of Triglyceride to High-Density Lipoprotein Cholesterol Ratio in Patients With Chronic Coronary Syndromes at Very High Risk: Insights From the START Study

Luca¹,

Temporelli

Colivicchi

et al. 2022

Front. Cardiovasc. Med.

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BackgroundSeveral studies have reported that the combination of high TG and low HDL-C, as simplified by the TG/HDL-C ratio, was a predictor of cardiovascular disease independent of LDL-C level. Nevertheless, poor data are available on the predictive role of TG/HDL-C ratio in very high risk (VHR) patients with chronic coronary syndromes (CCS).MethodsUsing the data from the STable Coronary Artery Diseases RegisTry (START) study, an Italian nationwide registry, we assessed the association between the TG/HDL-C ratio and baseline clinical characteristics, pharmacological treatment, and major adverse cardio-cerebrovascular events (MACCE) at 1 year in a large cohort of CCS patients at VHR.ResultsVHR patients with both TG and HDL-C levels available were grouped in tertiles of TG/HDL-C ratio: low (TG/HDL-C ratio <2, n = 967), middle (TG/HDL-C ratio 2–3.3, n = 1,071) and high (TG/HDL-C ratio >3.3, n = 1,028). At 1 year from enrolment, 232 (7.6%) patients presented a MACCE, with a higher incidence in the higher tertile, even though not statistically significant (6.0, 8.2, and 8.4% in the low, middle and high tertile, respectively; p = 0.08). At multivariable analysis, the TG/HDL-C ratio in tertiles did not result an independent predictor of the MACCE (p = 0.29) at 1-year follow-up (HR: 1.30; 95% CI: 0.93–1.82; p = 0.12 middle vs. lower tertile, and HR: 1.22; 95% CI: 0.87–1.72; p = 0.25 higher vs. lower).ConclusionsIn the present large, nationwide cohort of CCS patients at VHR a high TG/HD ratio did not emerge as independent predictor of MACCE at 1 year. Further studies with a longer follow-up are needed to better define the prognostic role of TG/HDL ratio in CCS.

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Clinical outcomes, pharmacological treatment, and quality of life of patients with stable coronary artery diseases managed by cardiologists: 1-year results of the START study

Cited by 16 publications

References 25 publications

P2Y12 inhibitor monotherapy or dual antiplatelet therapy after coronary revascularisation: individual patient level meta-analysis of randomised controlled trials

P2Y12 inhibitor monotherapy or dual antiplatelet therapy after coronary revascularisation: individual patient level meta-analysis of randomised controlled trials

Comparing the Prognostic Impact of Prediabetes with Diabetes in a Nationwide Cohort of Patients with Chronic Coronary Syndromes: An Analysis of the START Registry

Clinical Impact and Prognostic Role of Triglyceride to High-Density Lipoprotein Cholesterol Ratio in Patients With Chronic Coronary Syndromes at Very High Risk: Insights From the START Study

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