scholarly journals Comparing effect estimates in randomized trials and observational studies from the same population: an application to percutaneous coronary intervention

2021 ◽  
Author(s):  
Anthony A Matthews ◽  
Karolina Szummer ◽  
Issa J Dahabreh ◽  
Bertil Lindahl ◽  
David Erlinge ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Percutaneous Coronary Intervention ◽  
Observational Studies ◽  
Randomized Trials ◽  
Coronary Intervention ◽  
Term Effect ◽  
Target Trial ◽  
Real World Data ◽  
Risk Of Death ◽  
Percutaneous Coronary

AbstractBackgroundThe ability for real world data to deliver similar results as a trial that asks the same question about the risks or benefits of a clinical intervention can be restricted not only by lack of randomization, but also limited information on eligibility criteria and outcomes. To understand when results from observational studies and randomized trials are comparable, we carried out an observational emulation of a target trial designed to ask similar questions as the VALIDATE randomized trial. VALIDATE compared the effect of bivalirudin and heparin during percutaneous coronary intervention on the risk of death, myocardial infarction, and bleeding across Sweden.MethodsWe specified the protocol of a target trial similar to the VALIDATE trial protocol, then emulated the target trial in the period before the trial took place using data from the SWEDEHEART registry; the same registry in which the trial was undertaken.ResultsThe target trial emulation and the VALIDATE trial both estimated no difference in the effect of bivalirudin and heparin on the risk of death or myocardial infarction by 180 days: emulation risk ratio for death 1.21 (0.88, 1.54); VALIDATE hazard ratio for death 1.05 (0.78, 1.41). The observational data, however, could not capture less severe cases of bleeding, resulting in an inability to define a bleeding outcome like the trial, and could not account for intractable confounding early in follow-up (risk ratio for death by 14 days 1.85 (0.95, 3.63)).ConclusionUsing real world data to emulate a target trial can deliver accurate long-term effect estimates. Yet, even with rich observational data, it is not always possible to estimate the short-term effect of interventions, or the effect on outcomes for which data are not routinely collected. If registries included information on reasons for treatment decisions, researchers may be better positioned to identify important confounders.

scholarly journals Comparing Effect Estimates in Randomized Trials and Observational Studies From the Same Population: An Application to Percutaneous Coronary Intervention

2021 ◽  
Author(s):  
Anthony A. Matthews ◽  
Karolina Szummer ◽  
Issa J. Dahabreh ◽  
Bertil Lindahl ◽  
David Erlinge ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Percutaneous Coronary Intervention ◽  
Observational Data ◽  
Observational Studies ◽  
Randomized Trials ◽  
Coronary Intervention ◽  
Target Trial ◽  
Risk Of Death ◽  
St Segment ◽  
Percutaneous Coronary

Background To understand when results from observational studies and randomized trials are comparable, we performed an observational emulation of a target trial designed to ask similar questions as the VALIDATE (Bivalirudin Versus Heparin in ST‐Segment and Non–ST‐Segment Elevation Myocardial Infarction in Patients on Modern Antiplatelet Therapy) randomized trial. The VALIDATE trial compared the effect of bivalirudin and heparin during percutaneous coronary intervention on the risk of death, myocardial infarction, and bleeding across Sweden. Methods and Results We specified the protocol of a target trial similar to the VALIDATE trial, then emulated the target trial in the period before the VALIDATE trial took place using data from the SWEDEHEART (Swedish Web System for Enhancement and Development of Evidence‐Based Care in Heart Disease Evaluated According to Recommended Therapies) registry—the same registry in which the trial was undertaken. The target trial emulation and the VALIDATE trial both estimated little or no effect of bivalirudin versus heparin on the risk of death or myocardial infarction by 180 days (target trial emulation risk ratio for death, 1.21 [95% CI, 0.88 – 1.54]; VALIDATE trial hazard ratio for death, 1.05 [95% CI, 0.78 – 1.41]). The observational data, however, could not capture less severe cases of bleeding, resulting in an inability to define a bleeding outcome like the trial, and could not accurately estimate the comparative risk of death by 14 days, which may be the result of intractable confounding early in follow‐up or the inability to precisely emulate the trial’s eligibility criteria. Conclusions Using real‐world data to emulate a target trial can deliver accurate effect estimates. Yet, even with rich observational data, it is not always possible to estimate the short‐term effect of interventions or the effect on outcomes for which data are not routinely collected.

scholarly journals The effect of de-escalation of P2Y12 receptor inhibitor therapy after acute myocardial infarction in patients undergoing percutaneous coronary intervention: A nationwide cohort study

PLoS ONE ◽  
2021 ◽  
Vol 16 (1) ◽  
pp. e0246029
Author(s):  
Jong-Shiuan Yeh ◽  
Chien-Yi Hsu ◽  
Chun-Yao Huang ◽  
Wan-Ting Chen ◽  
Yi-Chen Hsieh ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Percutaneous Coronary Intervention ◽  
Cox Regression ◽  
Coronary Intervention ◽  
Bleeding Complications ◽  
Major Adverse Cardiovascular Events ◽  
Real World Data ◽  
Risk Of Death ◽  
Percutaneous Coronary

To examine the effect of de-escalation of P2Y12 inhibitor in dual antiplatelet therapy (DAPT) on major adverse cardiovascular events (MACE) and bleeding complications after acute myocardial infarction (AMI) in Taiwanese patients undergoing percutaneous coronary intervention (PCI). Patients who had received PCI during hospitalization for AMI (between 2013 and 2016) and were initially treated with aspirin and ticagrelor and without adverse events after 3 months of treatment were retrospectively evaluated. In total, 1,901 and 8,199 patients were identified as “de-escalated DAPT” (switched to aspirin and clopidogrel) and “unchanged DAPT” (continued on aspirin and ticagrelor) cohorts, respectively. With a mean follow-up of 8 months, the incidence rates (per 100 person-year) of death, AMI readmission and MACE were 2.89, 3.68, and 4.91 in the de-escalated cohort and 2.42, 3.28, and 4.72 in the unchanged cohort, respectively, based on an inverse probability of treatment weighted approach that adjusting for baseline characteristics of the patients. Multivariate Cox regression analyses showed the two groups had no significant differences in the hazard risk of death, AMI admission, and MACE. Additionally, there was no observed difference in the risk of bleeding, including major or clinically relevant non-major bleeding. The real-world data revealed that de-escalation of P2Y12 inhibitor in DAPT was not associated with a higher risk of death or AMI readmission in Taiwanese patients with AMI undergoing successful PCI.

scholarly journals The effect of unguided de-escalation of P2Y12 receptor inhibitor therapy after acute myocardial infarction in patients undergoing percutaneous coronary intervention: a nationwide cohort study

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J.S Yeh ◽  
C.Y Hsu ◽  
C.Y Huang ◽  
W.T Chen ◽  
Y.C Hsieh ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Percutaneous Coronary Intervention ◽  
Coronary Intervention ◽  
Bleeding Complications ◽  
Funding Source ◽  
P2y12 Inhibitor ◽  
Risk Of Death ◽  
Percutaneous Coronary ◽  
Significant Difference

Abstract Aims To examine the effect of de-escalation of P2Y12 inhibitor in dual antiplatelet therapy (DAPT) on major adverse cardiovascular events (MACE) and bleeding complications after acute myocardial infarction (AMI) in Taiwanese patients undergoing percutaneous coronary intervention (PCI). Methods and results We retrospectively evaluated patients who had received PCI during AMI hospitalisation and were initially on aspirin and ticagrelor and without adverse events at 3 months between 2013 and 2016. In total, 1,901 and 8,199 patients were identified as switched DAPT (switched to aspirin and clopidogrel) and unswitched DAPT (continued on aspirin and ticagrelor) cohorts, respectively. With a mean follow-up of 8 months, the incidence rates (per 100 person-year) of death, AMI readmission and MACE were 2.89, 3.68 and 4.91 in the switched cohort and 2.42, 3.28 and 4.72 in the unswitched cohort, respectively based on an inverse probability of treatment weighted method. (Table) After adjustment for patients' clinical variables, two groups were no significant difference in death (A), AMI admission (B) and MACE (C). Additionally, there was no difference in the risk of major (D) or non-major clinically relevant bleeding (E) (Figure 1). Conclusions Unguided de-escalation of P2Y12 inhibitor in DAPT was not associated with higher risk of death, MACE, AMI readmission in Taiwanese patients with AMI undergoing PCI. Figure 1 Funding Acknowledgement Type of funding source: Private hospital(s). Main funding source(s): Taipei Medical University

scholarly journals Glycoprotein IIb/IIIa Receptor Inhibitors in Patients with ST-Segment Elevation Myocardial Infarction and Primary Percutaneous Coronary Intervention

2020 ◽  
Vol 15 (6) ◽  
pp. 918-927 ◽  
Author(s):  
A. S. Tereshchenko ◽  
Е. V. Merkulov ◽  
A. M. Samko
Keyword(s):  
Myocardial Infarction ◽  
Blood Flow ◽  
Percutaneous Coronary Intervention ◽  
Randomized Trials ◽  
Coronary Intervention ◽  
Thrombus Aspiration ◽  
St Segment Elevation ◽  
Segment Elevation Myocardial Infarction ◽  
St Segment ◽  
Percutaneous Coronary

Recently, there has been a positive trend to reduce mortality from myocardial infarction. One of the reasons for such dynamics is the development of angiographic service in our country and the increase in the number of primary percutaneous coronary interventions. One of the most serious complications of endovascular interventions affecting the prognosis is the development of the phenomenon of slow or unrecoverable blood flow (≪slow/no-reflow≫ phenomenon). The reason for the development of this phenomenon is associated, first of all, with distal embolization by thrombotic masses and fragments of atherosclerotic plaque. In order to prevent this complication, manual thromboextraction was developed – the aspiration of thrombotic masses from the infarct-related artery. The manual thrombus aspiration has not been proven effective in a number of large randomized trials. In addition to the lack of influence on the prognosis, the method of manual thrombus aspiration significantly more often led to the development of ischemic strokes and currently should not be routinely carried out. Another method of preventing the phenomenon of delayed or unrecoverable blood flow is the use of glycoprotein IIb/IIIa receptor inhibitors which is, in contrast to the instrumental method, effective and relatively safe. According to a number of large randomized trials, drug treatment of this complication influences life expectancy in patients with ST-elevation myocardial infarction. At a time when there is already a meta-analysis on the routine use of glycoprotein IIb/IIIa receptor inhibitors during primary percutaneous coronary intervention and their positive impact on survival, in our country, unfortunately, the importance of these drugs is underestimated and according to the register they are used only in 3% of patients with ST-segment elevation myocardial infarction. This review presents studies and comparisons of glycoprotein IIb/IIIa receptor inhibitors existing on the market.

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