Impact of lesion preparation and stent optimisation on lesion-oriented events in PCI with drug-eluting stents: 5-year results from the AIDA trial.

Abstract

Background: Meticulous implantation strategies (i.e. lesion predilatation, stent sizing and postdilatation) are known to decrease lesion-oriented adverse events (LOCE) following percutaneous coronary intervention (PCI) with bioresorbable scaffolds. Their impact on PCI with drug-eluting stents remains unclear.

Objective: To assess the impact of meticulous implantation strategies on long-term LOCE in PCI with everolimus-eluting stents (EES).

Methods: This substudy of the AIDA trial (NCT01858077) focused on the evaluation of predilatation, stent sizing and postdilatation through analyses of vessel and device diameters at various locations around the lesion. Their interrelations were assessed using quantitative coronary angiography across various lesion locations. Logistic regression was used to evaluate how predictors influenced the primary outcome LOCE, which includes target lesion revascularisation (TLR), target-vessel myocardial infarction (TV-MI) and definite stent thrombosis (ST).

Results: LOCE occurred in 84 (7.7%) of 1098 lesions, mainly driven by TLR (63, 5.7%) and TV-MI (46, 4.2%), with ST occurring in 9 (0.8%) lesions. Predilatation and postdilatation were performed in 92 and 49% of lesions, respectively. The difference between the diameter of the predilatation balloon and the reference vessel diameter was significantly associated with an increased risk for LOCE (odds ratio 4.84, 95% confidence interval: 1.91-12.7) with significant interaction with diabetes (p for interaction = 0.04), thus disfavouring predilatation with oversized balloons.

Conclusion: The low LOCE rate (7.7%) over 5 years underscores the efficacy of PCI with EES. The use of 'oversized' balloons for predilatation was associated with an increased risk of LOCE by up to fivefold, a risk that was interestingly reduced in patients with diabetes mellitus.