The optimal duration of dual antiplatelet therapy (DAPT) after implantation of newer-generation drug-eluting stents (DES) remains uncertain. Similarly, questions remain about the role of DAPT in ...long-term therapy of stable post-myocardial infarction (MI) patients.
Our objective was to compare the incidence of death, major hemorrhage, MI, stent thrombosis, and major adverse cardiac events in patients randomized to prolonged or short-course DAPT after implantation of newer-generation DES and in secondary prevention after MI.
We used traditional frequentist statistical and Bayesian approaches to address the following questions: Q1) What is the minimum duration of DAPT required after DES implantation? Q2) What is the clinical benefit of prolonging DAPT up to 18 to 48 months? Q3) What is the clinical effect of DAPT in stable patients who are >1 year past an MI?
We reviewed evidence from 11 randomized controlled trials (RCTs) that enrolled 33 051 patients who received predominantly newer-generation DES to answer: A1) Use of DAPT for 12 months, as compared with use for 3 to 6 months, resulted in no significant differences in incidence of death (odds ratio OR: 1.17; 95% confidence interval CI: 0.85 to 1.63), major hemorrhage (OR: 1.65; 95% CI: 0.97 to 2.82), MI (OR: 0.87; 95% CI: 0.65 to 1.18), or stent thrombosis (OR: 0.87; 95% CI: 0.49 to 1.55). Bayesian models confirmed the primary analysis. A2) Use of DAPT for 18 to 48 months, compared with use for 6 to 12 months, was associated with no difference in incidence of all-cause death (OR: 1.14; 95% CI: 0.92 to 1.42) but was associated with increased major hemorrhage (OR: 1.58; 95% CI: 1.20 to 2.09), decreased MI (OR: 0.67; 95% CI: 0.47 to 0.95), and decreased stent thrombosis (OR: 0.45; 95% CI: 0.24 to 0.74). A risk-benefit analysis found 3 fewer stent thromboses (95% CI: 2 to 5) and 6 fewer MIs (95% CI: 2 to 11) but 5 more major bleeds (95% CI: 3 to 9) per 1000 patients treated with prolonged DAPT per year. Post hoc analyses provided weak evidence of increased mortality with prolonged DAPT. We reviewed evidence from 1 RCT of 21 162 patients and a post hoc analysis of 1 RCT of 15 603 patients to answer: A3): Use of DAPT >1 year after MI reduced the composite risk of cardiovascular death, MI, or stroke (hazard ratio: 0.84; 95% CI: 0.74 to 0.95) but increased major bleeding (hazard ratio: 2.32; 95% CI: 1.68 to 3.21). A meta-analysis and a post hoc analysis of an RCT in patients with stable cardiovascular disease produced similar findings.
The primary analysis provides moderately strong evidence that prolonged DAPT after implantation of newer-generation DES entails a tradeoff between reductions in stent thrombosis and MI and increases in major hemorrhage. Secondary analyses provide weak evidence of increased mortality with prolonged DAPT after DES implantation. In patients whose coronary thrombotic risk was defined by a prior MI rather than by DES implantation, the primary analysis provides moderately strong evidence of reduced cardiovascular events at the expense of increased bleeding.
Interventional cardiologists who treat malfunctioning hemodialysis accesses play an important role in the life of patients with end-stage kidney disease (ESKD). By collaborating with interventional ...nephrologists who currently perform the bulk of routine access angiographic procedures, interventional cardiologists can fill an important gap in the care of ESKD patients by performing urgent or emergent procedures that fall outside the schedule of an outpatient interventional nephrology laboratory to ensure that hemodialysis patients will not miss a hemodialysis session or get a temporary catheter. This paper reviews the pathophysiology of dialysis access failure and illustrates the catheter-based approaches used by interventional cardiologists to treat malfunctioning dialysis accesses.
Bayesian analysis is firmly grounded in the science of probability and has been increasingly supplementing or replacing traditional approaches based on
values. In this review, we present gradually ...more complex examples, along with programming code and data sets, to show how Bayesian analysis takes evidence from randomized clinical trials to update what is already known about specific treatments in cardiovascular medicine. In the example of revascularization choices for diabetic patients who have multivessel coronary artery disease, we combine the results of the FREEDOM trial (Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease) with prior probability distributions to show how strongly we should believe in the new Class I recommendation ("should be done") for a preference of bypass surgery over percutaneous coronary intervention. In the debate about the duration of dual antiplatelet therapy after drug-eluting stent implantation, we avoid a common pitfall in traditional meta-analysis and create a network of randomized clinical trials to compare outcomes after specific treatment durations. Although we find no credible increase in mortality, we affirm the tradeoff between increased bleeding and reduced myocardial infarctions with prolonged dual antiplatelet therapy, findings that support the new Class IIb recommendation ("may be considered") to extend dual antiplatelet therapy after drug-eluting stent implantation. In the decision between culprit artery-only and multivessel percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction, we use hierarchical meta-analysis to analyze evidence from observational studies and randomized clinical trials and find that the probability of all-cause mortality at longest follow-up is similar after both strategies, a finding that challenges the older ban against noninfarct-artery intervention during primary percutaneous coronary intervention. These examples illustrate how Bayesian analysis integrates new trial information with existing knowledge to reduce uncertainty and change attitudes about treatments in cardiovascular medicine.
The optimal duration of dual antiplatelet therapy (DAPT) after implantation of newer-generation drug-eluting stents (DES) remains uncertain. Similarly, questions remain about the role of DAPT in ...long-term therapy of stable post-myocardial infarction (MI) patients.
Our objective was to compare the incidence of death, major hemorrhage, MI, stent thrombosis, and major adverse cardiac events in patients randomized to prolonged or short-course DAPT after implantation of newer-generation DES and in secondary prevention after MI.
We used traditional frequentist statistical and Bayesian approaches to address the following questions: Q1) What is the minimum duration of DAPT required after DES implantation? Q2) What is the clinical benefit of prolonging DAPT up to 18 to 48 months? Q3) What is the clinical effect of DAPT in stable patients who are >1 year past an MI?
We reviewed evidence from 11 randomized controlled trials (RCTs) that enrolled 33 051 patients who received predominantly newer-generation DES to answer: A1) Use of DAPT for 12 months, as compared with use for 3 to 6 months, resulted in no significant differences in incidence of death (odds ratio OR: 1.17; 95% confidence interval CI: 0.85 to 1.63), major hemorrhage (OR: 1.65; 95% CI: 0.97 to 2.82), MI (OR: 0.87; 95% CI: 0.65 to 1.18), or stent thrombosis (OR: 0.87; 95% CI: 0.49 to 1.55). Bayesian models confirmed the primary analysis. A2) Use of DAPT for 18 to 48 months, compared with use for 6 to 12 months, was associated with no difference in incidence of all-cause death (OR: 1.14; 95% CI: 0.92 to 1.42) but was associated with increased major hemorrhage (OR: 1.58; 95% CI: 1.20 to 2.09), decreased MI (OR: 0.67; 95% CI: 0.47 to 0.95), and decreased stent thrombosis (OR: 0.45; 95% CI: 0.24 to 0.74). A risk-benefit analysis found 3 fewer stent thromboses (95% CI: 2 to 5) and 6 fewer MIs (95% CI: 2 to 11) but 5 more major bleeds (95% CI: 3 to 9) per 1000 patients treated with prolonged DAPT per year. Post hoc analyses provided weak evidence of increased mortality with prolonged DAPT. We reviewed evidence from 1 RCT of 21 162 patients and a post hoc analysis of 1 RCT of 15 603 patients to answer: A3): Use of DAPT >1 year after MI reduced the composite risk of cardiovascular death, MI, or stroke (hazard ratio: 0.84; 95% CI: 0.74 to 0.95) but increased major bleeding (hazard ratio: 2.32; 95% CI: 1.68 to 3.21). A meta-analysis and a post hoc analysis of an RCT in patients with stable cardiovascular disease produced similar findings.
The primary analysis provides moderately strong evidence that prolonged DAPT after implantation of newer-generation DES entails a tradeoff between reductions in stent thrombosis and MI and increases in major hemorrhage. Secondary analyses provide weak evidence of increased mortality with prolonged DAPT after DES implantation. In patients whose coronary thrombotic risk was defined by a prior MI rather than by DES implantation, the primary analysis provides moderately strong evidence of reduced cardiovascular events at the expense of increased bleeding.
Evidence from studies published more than 10 years ago suggested that patients receiving first-generation drug-eluting stents (DES) needed dual antiplatelet therapy (DAPT) for at least 12 months. ...Current evidence from randomised controlled trials (RCT) reported within the past five years suggests that patients with stable ischaemic heart disease who receive newer-generation DES need DAPT for a minimum of three to six months. Patients who undergo stenting for an acute coronary syndrome benefit from DAPT for at least 12 months, but a Bayesian network meta-analysis confirms that extending DAPT beyond 12 months confers a trade-off between reduced ischaemic events and increased bleeding. However, the network meta-analysis finds no credible increase in all-cause mortality if DAPT is lengthened from three to six months to 12 months (posterior median odds ratio OR 0.98; 95% Bayesian credible interval BCI: 0.73-1.43), from 12 months to 18-48 months (OR 0.87; 95% BCI: 0.64-1.17), or from three to six months to 18-48 months (OR 0.86; 95% BCI: 0.63-1.21). Future investigation should focus on identifying scoring systems that have excellent discrimination and calibration. Although predictive models should be incorporated into systems of care, most decisions about DAPT duration will be based on clinical judgement and patient preference.
PDF
