Effect of Adjunct Balloon Dilation after Long Everolimus-eluting Stent Deployment on Major Adverse Cardiac Events

Abstract

Background and objectives: The effectiveness of adjunct balloon dilation after drug-eluting stent (DES) deployment has not been sufficiently evaluated. We evaluated whether adjunct balloon dilation was associated with a reduction in major adverse cardiac events (MACEs) after long everolimus-eluting stents (EESs) implantation.

Subjects and methods: Drawing from 2 randomized trials, a total of 1,672 patients treated with long EES were analyzed. Of 1,672 patients, 1,061 patients (64%) received post-stent adjunct balloon dilation. MACE, defined as a composite of cardiac death, myocardial infarction, and target-lesion revascularization (TLR), was compared between patients who received post-stent adjunct balloon dilation and patients who did not in 595 propensity score-matched pairs.

Results: For the matched population, MACE occurred in 29 patients (4.9%) who received adjunct balloon dilation and in 29 patients (4.9%) who did not (hazard ratio [HR], 1.01; 95% confidence interval [CI], 0.60-1.69; p=0.972). However, significant interactions were observed among the subgroups for clinical presentation and vessel size. Adjunct balloon dilation was more favored within the subset of patients with stable angina vs. the subset of patients with acute coronary syndrome (p for interaction=0.037), and within the subset of lesions with small vessel diameter (reference vessel diameter [RVD] <3 mm) vs. the subset of lesions with larger vessel diameter (RVD ≥3 mm; p for interaction=0.027).

Conclusion: Adjunct balloon dilation was not associated with MACE reduction at 1 year among patients requiring long EES implantation. However, post-stent adjunct balloon dilation may be necessary for patients requiring long EES implantation who present with stable angina or for lesions with small vessel diameters.

Keywords: Coronary artery disease; Drug-eluting stents; Treatment outcome.

Figure 1

Kaplan-Meier estimates of occurrence of MACEs for total population (A) and matched population (B). Cumulative incidence curves for MACEs of cardiac death, target lesion-related myocardial infarction, and TLR. CI = confidence interval; HR = hazard ratio; MACE = major adverse cardiac event; TLR = target-lesion revascularization.

Figure 2

Subgroup analyses of the rates of MACEs at 1-year post-procedure. CI = confidence interval; DM = diabetes mellitus; HR = hazard ratio; IVUS = intravascular ultrasound; IVUS-XPL = Impact of intraVascular UltraSound guidance on outcomes of Xience Prime stents in Long lesions; LAD = left anterior descending; LCX = left circumflex; MACE = major adverse cardiac event; RCA = right coronary artery; RESET = REal Safety and Efficacy of 3-month dual antiplatelet Therapy following Endeavor zotarolimus-eluting stent implantation; RVD = reference vessel diameter.

Figure 3

MACEs at 1-year post-procedure according to clinical presentation. Arrow indicates cardiac death and arrow head indicates myocardial infarction, and other events are TLR. CI = confidence interval; HR = hazard ratio; MACE = major adverse cardiac event; TLR = target-lesion revascularization.

Figure 4

MACEs at 1-year post-procedure according to vessel size. Arrow indicates cardiac death and arrow head indicates myocardial infarction, and other events are TLR. CI = confidence interval; HR = hazard ratio; MACE = major adverse cardiac event; RVD = reference vessel diameter; TLR = target-lesion revascularization.