Promising Outcomes of Overlapping Stents in Patients Undergoing Bioresorbable Scaffold (BRS) Implantation

Courtesy of Dr. Guillermo Migliaro.

In regular clinical practice, overlapping stents are reported in up to 30% of patients undergoing coronary angioplasty, especially due to very long lesions requiring implantation of multiple stents or dissection after the implantation of a first stent.

In bare metal stent era, overlapping was associated with unfavorable clinical outcomes because of an increased rate of restenosis. With drug-eluting stents (DES), results were contradictory: whereas overlapping first-generation DES were associated with higher rates of death and infarction (due to double metal layer, double drug and polymer dose, and higher arterial injury), these effects were not present with second-generation DES, with which overlapping seems to be safe and effective.

As regards everolimus-eluting bioresorbable scaffolds (BRS), which present struts thicker than those in second-generation DES, few data are available on the impact of overlapping on clinical outcomes, since this patient group has been left out of most randomized trials.

The objective of this study was to analyze the clinical impact of BRS overlapping in the GHOST-EU registry.

The GHOST-EU (Gauging coronary Healing with biOresorbable Scaffolding plaTforms in EUrope) registry is a multicenter registry (conducted at 11 European sites) that included 1477 consecutive patients who underwent single or multivessel angioplasty with at least one BRS device (Absorb) between 2011 and 2014. The primary endpoint was a composite of all-cause death, myocardial infarction, and the need for new revascularisation within a one-year follow-up.

Patients were divided in two groups, depending on whether they underwent overlapping or not. Among them, 21.7% of patients (n = 320) were treated with overlapping BRS, whereas the remaining 78.3% (n = 1157) were not. The overlap group (composed mostly by male patients) had significantly higher frequency of diabetes, chronic stable angina, B2/C lesion type, SYNTAX score >22, lesion length >34 mm, higher use of intracoronary imaging guidance in the procedure, pre- and postdilatation. Procedures in this study were performed by experienced operators and following strict implantation protocols for this scaffold type.

At 1-year, there were no differences in the primary endpoint between the overlap versus the no-overlap group (18.4% vs. 18.2%; hazard ratio [HR]: 1.07, [0.80-1.44]; p = 0.636). Even after variable adjustment, there were no significant differences. The scaffold thrombosis rate did not differ either at 1 month (1.3% vs. 1.5%; p = 0.769) or at 1 year (1.9% vs. 2.1%; p = 0.823).

The study concluded that in habitual clinical practice, overlapping BRS did not appear to have an impact on clinical outcomes as compared to no-overlapping BRS.

Editorial

Even with the limitations inherent to its design, this registry presents the advantage of being a multicenter registry with wide inclusion criteria (“real world”). Furthermore, it offers the first safety and efficacy data on clinical outcomes at 1 year for everolimus-eluting bioresorbable scaffolds overlapping.

While there were differences in baseline population characteristics and procedure-related variables (such us a higher use of optical coherence tomography [OCT] in the overlap group, which might explain these results), variable adjustment did not alter results.

This study lacks statistical power for endpoint assessment, but it generates hypotheses that should be confirmed in large-scale randomized studies. The next generation of bioresorbable scaffolds with thinner struts could further improve scaffold performance in BRS overlapping.

Courtesy of Dr. Guillermo Migliaro.

Original title: Impact of Overlapping on 1-Year Clinical Outcomes in Patients Undergoing Everolimus Eluting Bioresorbable Scaffolds Implantation in Routine Clinical Practice: Insights from the European Multicenter GHOST-EU Registry. 

Reference: Ortega Paz L, et al. Catheterization and Cardiovascular Interventions 89:812-818(2016).

We are interested in your opinion. Please, leave your comments, thoughts, questions, etc., below. They will be most welcome.