Drug-Coated Balloons for Acute Myocardial Infarction: A Metaanalysis of Randomized Clinical Trials
Yuxuan Zhang1, Delong Chen1, Qichao Dong1
1Department of Cardiology, Second Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.
Insights
Drug-coated balloons (DCB) show comparable clinical outcomes to stents in treating acute myocardial infarction (AMI). While not reducing major adverse cardiac events, DCB lowered myocardial infarction incidence and late lumen loss.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- The clinical efficacy of drug-coated balloons (DCB) for acute myocardial infarction (AMI) requires further elucidation.
- Current treatment paradigms for AMI primarily involve stenting, with limited data on alternative approaches like DCB.
Purpose of the Study:
- To evaluate the effectiveness and safety of drug-coated balloons (DCB) compared to traditional stents in patients with acute myocardial infarction (AMI).
- To synthesize evidence from randomized controlled trials (RCTs) to inform clinical practice regarding DCB use in AMI.
Main Methods:
- A systematic review and meta-analysis of RCTs comparing DCB with stents for AMI treatment.
- Searched five databases up to July 30, 2021, focusing on major adverse cardiac events (MACEs) as the primary endpoint.
- Included 4 RCTs with 485 patients, analyzing outcomes using fixed-effects models.
Main Results:
- DCB demonstrated no significant difference in MACEs compared to control interventions (RR 0.59; P=0.11).
- DCB showed a reduced incidence of myocardial infarction (RR 0.16; P=0.04) and significantly lower late lumen loss (MD -0.20; P<0.00001).
- No differences were observed in mortality, stent thrombosis, or target lesion revascularization between DCB and control groups.
Conclusions:
- Drug-coated balloons (DCB) represent a potentially feasible interventional option for acute myocardial infarction (AMI), offering comparable clinical outcomes to standard treatments.
- Further large-scale, well-designed randomized controlled trials are necessary to definitively establish the role of DCB in AMI management.
Background:
The role of a drug-coated balloon (DCB) in the treatment of acute myocardial infarction (AMI) is not well established.
Methods:
Five databases were searched for randomized controlled trials that compared DCB with stents in the treatment of AMI from their inception to 30 July 2021. The primary clinical endpoint was major adverse cardiac events (MACEs). Summary estimations were conducted using fixed-effects analysis complemented by several subgroups. The protocol was registered with PROSPERO (https://clinicaltrials.gov/ct2/show/CRD42021272886).
Results:
A total of 4 randomized controlled trials with 485 patients were included. On routine clinical follow-up, DCB was associated with no difference in the incidence of MACEs compared with control (risk ratio [RR] 0.59 [0.31 to 1.13]; P=0.11). DCB was associated with similar MACEs compared with drug-eluting stent and lower MACEs compared with bare-metal stent. There was no difference between DCB and control in terms of all-cause mortality, cardiovascular mortality, stent thrombosis, target lesion revascularization, and minimal lumen diameter during follow-up. However, DCB was associated with a lower incidence of myocardial infarction (RR 0.16 [0.03 to 0.90]; P=0.04) and lower late lumen loss (mean difference -0.20 [-0.27 to -0.13]; P < 0.00001).
Conclusions:
In treatment of patients with AMI, DCB might be a feasible interventional strategy versus control as it associated with comparable clinical outcomes. Future large-volume, well-designed randomized controlled trials to evaluating the role of the DCB in this setting are warranted.
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