Late thrombosis after double versus single drug-eluting stent in the treatment of coronary bifurcations: a meta-analysis of randomized and observational Studies

Abstract

Objectives: This study sought to hypothesize that the higher risk of myocardial infarction (MI) documented after a routine double drug-eluting stent (DES) strategy (DDS) compared with a single DES strategy (SDS) with provisional stenting in percutaneous coronary interventions (PCI) of bifurcation lesions is driven by an increased rate of DES thrombosis.

Background: The results of currently available randomized, controlled trials (RCTs) were inconclusive in the choice between SDS and DDS. Meta-analyses have shown an increased risk of MI in the DDS group, without identifying the underlying mechanism(s).

Methods: We performed a meta-analysis of 12 major (>100 patients) studies of bifurcation DES PCI: 5 RCTs and 7 nonrandomized observational studies, for a total of 6,961 patients. Random-effects models were used to calculate summary risk ratios (RRs). As a primary endpoint, we assessed the RRs and 95% confidence intervals (CIs) of definite DES thrombosis; death, MI, and target vessel revascularization (TVR) were evaluated as secondary endpoints.

Results: Compared with SDS, DDS had an increased risk of DES thrombosis (RR: 2.31; 95% CI: 1.33 to 4.03) and MI (RR: 1.86; 95% CI: 1.34 to 2.60). Mortality (RR: 1.18; 95% CI: 0.85 to 1.65) and TVR (RR: 1.02; 95% CI: 0.80 to 1.30) were similar. The RRs of MI and DES thrombosis were associated (p = 0.040).

Conclusions: In PCI of coronary bifurcations, SDS should be the preferred approach, as DDS is associated with an increased risk of MI, likely driven by DES thrombosis.

Keywords: CI; DDS; DES; MI; PCI; RCT; RR; SDS; TVR; confidence interval; coronary bifurcation; double drug-eluting stent strategy; drug-eluting stent thrombosis; drug-eluting stent(s); myocardial infarction; nROS; nonrandomized, observational study; percutaneous coronary intervention; randomized, controlled trial; relative risk; single drug-eluting stent strategy; target vessel revascularization.