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Published on: February 18, 2020
Deferred versus conventional stent implantation in patients with ST-segment elevation myocardial infarction (DANAMI
Henning Kelbæk1, Dan Eik Høfsten2, Lars Køber2
1Department of Cardiology, Roskilde Hospital, Roskilde, Denmark.
Insights
Deferred stent implantation in ST-segment elevation myocardial infarction (STEMI) did not reduce major adverse cardiovascular events compared to standard percutaneous coronary intervention (PCI). This study found no significant difference in outcomes between the two PCI strategies for STEMI patients.
Area of Science:
- Cardiology
- Interventional Cardiology
- Clinical Trials
Background:
- Thrombotic embolisation post-primary percutaneous coronary intervention (PCI) with stent implantation can negatively impact prognosis in ST-segment elevation myocardial infarction (STEMI) patients.
- Assessing alternative PCI strategies is crucial for improving outcomes in STEMI management.
Purpose of the Study:
- To evaluate the clinical outcomes of deferred stent implantation compared to standard primary PCI in patients diagnosed with STEMI.
- To determine if a delayed stenting approach offers improved prognosis following successful culprit artery treatment.
Main Methods:
- An open-label, randomized controlled trial conducted across four primary PCI centers in Denmark.
- 1215 eligible STEMI patients were randomized to either standard PCI with immediate stenting or deferred stenting 48 hours post-procedure.
- The primary endpoint was a composite of all-cause mortality, heart failure admission, recurrent infarction, and unplanned revascularization within 2 years.
Main Results:
- No significant difference was observed in the primary endpoint between standard PCI (18%) and deferred stent implantation (17%) groups (HR 0.99, 95% CI 0.76-1.29; p=0.92).
- Rates of procedure-related myocardial infarction, bleeding, contrast-induced nephropathy, and stroke were similar between the two groups.
- Median follow-up was 42 months, with 1215 patients randomized between March 2011 and February 2014.
Conclusions:
- Routine deferred stent implantation does not appear to reduce the incidence of major adverse cardiovascular events in STEMI patients compared to conventional primary PCI.
- Further research from ongoing randomized trials is needed to fully elucidate the role of deferred stenting in STEMI management.
Background:
Despite successful treatment of the culprit artery lesion by primary percutaneous coronary intervention (PCI) with stent implantation, thrombotic embolisation occurs in some cases, which impairs the prognosis of patients with ST-segment elevation myocardial infarction (STEMI). We aimed to assess the clinical outcomes of deferred stent implantation versus standard PCI in patients with STEMI.
Methods:
We did this open-label, randomised controlled trial at four primary PCI centres in Denmark. Eligible patients (aged >18 years) had acute onset symptoms lasting 12 h or less, and ST-segment elevation of 0·1 mV or more in at least two or more contiguous electrocardiographic leads or newly developed left bundle branch block. Patients were randomly assigned (1:1), via an electronic web-based system with permuted block sizes of two to six, to receive either standard primary PCI with immediate stent implantation or deferred stent implantation 48 h after the index procedure if a stabilised flow could be obtained in the infarct-related artery. The primary endpoint was a composite of all-cause mortality, hospital admission for heart failure, recurrent infarction, and any unplanned revascularisation of the target vessel within 2 years' follow-up. Patients, investigators, and treating clinicians were not masked to treatment allocation. We did analysis by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01435408.
Findings:
Between March 1, 2011, and Feb 28, 2014, we randomly assigned 1215 patients to receive either standard PCI (n=612) or deferred stent implantation (n=603). Median follow-up time was 42 months (IQR 33-49). Events comprising the primary endpoint occurred in 109 (18%) patients who had standard PCI and in 105 (17%) patients who had deferred stent implantation (hazard ratio 0·99, 95% CI 0·76-1·29; p=0·92). Procedure-related myocardial infarction, bleeding requiring transfusion or surgery, contrast-induced nephopathy, or stroke occurred in 28 (5%) patients in the conventional PCI group versus 27 (4%) patients in the deferred stent implantation group, with no significant differences between groups.
Interpretation:
In patients with STEMI, routine deferred stent implantation did not reduce the occurrence of death, heart failure, myocardial infarction, or repeat revascularisation compared with conventional PCI. Results from ongoing randomised trials might shed further light on the concept of deferred stenting in this patient population.
Funding:
Danish Agency for Science, Technology and Innovation, and Danish Council for Strategic Research.
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