Full Length ArticleSafety and efficacy of drug eluting stents vs bare metal stents in patients with atrial fibrillation: A systematic review and meta-analysis
Introduction
Current generations of drug-eluting stents (DES) reduce the risk of in-stent restenosis and stent thrombosis compared with bare-metal stents (BMS) [1], but longer duration of dual antiplatelet therapy (DAPT) was believed to be required [2]. Patients undergoing percutaneous coronary intervention (PCI), with atrial fibrillation (AF) are at high risk for bleeding [3], and are usually excluded from trials evaluating stents or adjunctive therapies. Although current US guidelines recommend avoiding DES in patients at high bleeding risk on the basis of BMS having lower bleeding rates, the updated European guidelines indicate that second generation DES should be the default choice, coupled with shorter DAPT duration [4,5]. Moreover, the last European guidelines on myocardial revascularization recommend using DES in any PCI. Of interest, these recommendations include patients with high bleeding risk and clinical indication for oral anticoagulation [6]. If current DES are actually safer than BMS, patients fulfilling these untoward characteristics – a classical niche for BMS – would actually benefit from new-generation DES implantation. However, there are limited data in patients with AF, with a high number of comorbidities [7,8].
Triple antithrombotic therapy (TAT) has been the cornerstone of treatment in patients with AF undergoing PCI irrespective of the type of stent used but its safety has been questioned [4,5,9]. Five randomized controlled trials (RCTs) demonstrated reductions in bleeding events by shortening TAT duration or by skipping aspirin, using dual antithrombotic therapy (DAT) with clopidogrel plus vitamin K antagonists (VKA) or direct oral anticoagulants agents (DOAC) [[10], [11], [12], [13], [14]] More recently, a systematic review found that, compared with TAT, DAT shows a 47% relative lower risk of TIMI major or minor bleeding without differences in major adverse cardiovascular events (MACE) rates. However, the interaction between type of stent and DAT vs TAT has not been evaluated yet [15].
Therefore, we performed a systematic review to evaluate the safety and efficacy of DES vs BMS in patients with AF, in both RCTs and cohorts. We stratified our analyses by type and duration of antithrombotic therapy.
Section snippets
Methods
This systematic review was reported in accordance to the PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analysis) guidelines [16].
We searched PubMed, EMBASE, Scopus, The Web of Science, the Cochrane Library and www.clinicaltrials.gov until May 31, 2019 for cohorts and RCTs in AF patients undergoing PCI with stent placement for acute coronary syndromes (ACS) or stable coronary artery disease. Our searches included all languages. The PubMed search strategy is available in the
Results
Our search identified 1551 publications. After removing duplicates, 1025 articles were screened by title and abstract. Overall, 96 articles were selected for full-text review based (Fig. 1). Three RCTs [[11], [12], [13]] and 7 cohort studies [[21], [22], [23], [24], [25], [26], [27]] involving 10,624 patients were included in our study. Of these, 9353 patients had primary outcome and secondary outcome data of interest (DES: n = 6180; 66.1%). Reasons for exclusion of 86 articles are listed in
Discussion
Our meta-analysis showed that DES did not show higher major bleeding risk than BMS in patients with AF undergoing PCI overall or after stratification by type of antithrombotic strategy and duration of treatment. This meta-analysis could not find differences in risk of MACE between both types of stents; however, in patients who received DES, a trend of a lower risk of TVR and a similar risk of stent thrombosis were observed in comparison to those who received BMS. Regarding antithrombotic
Conclusions
Our meta-analysis showed that BMS was not safer than DES decreasing bleeding events in patients with AF undergoing PCI either overall or after stratifying by type of antithrombotic strategy and duration of treatment. Regarding major bleeding, long-term DAT was found to be safer than TAT regardless of stent type. New scales and tools open new venues to escape from “one size fits all” strategies such as DAT, shifting to a new paradigm of “personalized medicine” able to select the optimal
Funding
This study was not supported by specific funding.
Declaration of competing interest
Dr. Sambola reports personal fees from: Boehringer-Ingelheim, Bristol-Myers and Pfizer, outside the submitted work.
Dr. Rello has nothing to disclose.
Dr. Soriano has nothing to disclose.
Dr. Bhatt discloses the following relationships - Advisory Board: Cardax, Elsevier Practice Update Cardiology, Medscape Cardiology, Regado Biosciences; Board of Directors: Boston VA Research Institute, Society of Cardiovascular Patient Care, TobeSoft; Chair: American Heart Association Quality Oversight Committee;
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