Optimal solution for coronary bifurcation lesions, a comparison between bioresorbable scaffolds and dedicated bifurcation stents

Abstract

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Coronary bifurcation lesions (CBL) constitute 15-20% of all coronary lesions and they constitute a challenge both technically and prognostically.(1) Bioresorbable scaffolds (BRS) represent a novel invention in the realm of coronary stenting.(2) They have a degradable structure that survives for 12-24 months,(3) allowing enough time for re-endothelialisation while they gradually disappear leaving the artery geometrically intact. The use of BRS is potentially beneficial in the treatment of CBLs because of these lesions’ complex geometry.(4) Purpose The aim of this study was to assess the effectiveness and safety of BRS in CBL when compared to dedicated bifurcation stents (DBS) by comparing the 12-months clinical outcomes including rates of cardiac death (CD), myocardial infarction (MI), target lesion revascularisation (TLR), and stent thrombosis (ST). Methods This study was conducted using PRISMA guidelines (figure 1). (5) a systematic literature review was made by searching ScienceDirect, EMBASE, MEDLINE, NIH, TRIP database, PUBMED, and ClinicalTrials.gov. Eligibility criteria included studies published since 2013 in English language. They must be designed to study bifurcation lesions and reporting clinical outcomes rather than procedural results. Studies must have either studied BRS or DBS. Risk of bias was assessed through a combined score consisting of MINORS and modified Cowley’s criteria. (6) Qualitative synthesis of results is performed through Microsoft Excel 365. Tests of heterogeneity were conducted using Q statistic, and between-study heterogeneity was assessed with the I2 statistic; also, publication bias was investigated graphically using funnel plots.(7) Meta-analysis was performed using the "meta" package in R software application. Results 14 studies were included with 1742 participants: eight studies of BRS (n=1038) and six studies for DBS (n=704), with an average follow-up period of 12 months. The mean age of participants was 60 years for the BRS arm and 65.6 years for DBS arm (p-value < 0.001). Almost 80% of participants are male (p-value= 0.148) and around two-thirds who are smokers or suffer from hypercholesterolemia (p-value: 0.202, 0.094 respectively) (Figure-2). There were six cardiac deaths in the BRS group compared to seven CDs in the DBS group (p-value = 0.56) . Meta-analysis was performed for MI, TLR, major adverse cardiac events (MACE), and ST; showing statistically nonsignificant difference for the aforementioned outcomes with a slight trend favouring BRS except in stent thrombosis. Conclusion There was no statistical difference between BRS and DBS in the treatment of CBL in terms of MI, ST, TLR or MACE. There was, however, a trend for a more favourable outcome on all measures for BRS other than stent thrombosis. this study showed a lack of randomised controlled trials in this subject which may be an area for researchers to investigate further in the future.