Key result
While some trials demonstrated superiority of ultrathin-strut biodegradable polymer-coated DES, overall evidence remains mixed with other trials showing no significant clinical outcome improvement.
Why the study?
To review recently published clinical studies evaluating very thin or ultrathin-strut drug-eluting stents, focusing on major randomized clinical trials in broad patient populations.
Do very thin or ultrathin-strut drug-eluting stents improve clinical outcomes compared to other drug-eluting stents in broad patient populations?
Do very thin or ultrathin-strut drug-eluting stents improve clinical outcomes compared to other drug-eluting stents in broad patient populations?
While ultrathin-strut DES generally show noninferiority to existing DES, evidence for their superiority remains limited to specific trials and patient populations, with equivocal results in small-vessel disease.
Mixed evidence leaves ultrathin-strut DES superiority unresolved; does not support practice change over contemporary DES.
PURPOSE OF REVIEW: The current article will review recently published clinical studies that evaluate very thin or ultrathin-strut drug-eluting stents (DES), focusing on major randomized clinical trials in broad patient populations. RECENT FINDINGS: Multiple randomized trials recently assessed the clinical performance of novel very thin to ultrathin-strut DES. Most randomized trials established noninferiority of the novel device. To date, only one major randomized clinical trial (i.e., BIOFLOW V) showed superiority of an ultrathin-strut biodegradable polymer-coated sirolimus-eluting stent over a very thin-strut durable polymer-coated everolimus-eluting stent in a relatively broad patient population. There are signals that the same ultrathin-strut biodegradable polymer-coated sirolimus-eluting stent may improve clinical outcome in specific patient populations. For example, in the randomized BIOSTEMI trial, 1-year superiority of the ultrathin-strut DES was found in patients presenting with an acute ST-segment elevation myocardial infarction. Yet, substudies of large randomized trials that assessed patients with small-vessel treatment showed equivocal results. SUMMARY: Although two randomized trials showed advantages for ultrathin-strut DES, other clinical trials provided no significant evidence that ultrathin-strut DES improve clinical outcome. The question whether ultrathin-strut DES may reduce the repeat revascularization risk following implantation in small vessels is a matter of further debate and future research.
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Buiten et al. (2020) conducted a review in Coronary artery disease requiring stenting. Very thin or ultrathin-strut drug-eluting stents vs. Other drug-eluting stents was evaluated. While some trials demonstrated superiority of ultrathin-strut biodegradable polymer-coated DES, overall evidence remains mixed with other trials showing no significant clinical outcome improvement.
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