Severe Acute Stent Malapposition After Drug‐Eluting Stent Implantation: Effects on Long‐Term Clinical Outcomes

BACKGROUND: The effects of severe acute stent malapposition (ASM) after drug‐eluting stent implantation on long‐term clinical outcomes are not clearly understood. We evaluated long‐term clinical outcomes of severe ASM using optical coherence tomography. METHODS AND RESULTS: We pooled patient‐ and lesion‐level data from 6 randomized studies. Five studies investigated follow‐up drug‐eluting stent strut coverage and one investigated ASM. In this data set, a total of 436 patients with 444 lesions underwent postintervention optical coherence tomography examination and these data were included in the analysis. Severe ASM was defined as lesions with ≥400 μm of maximum malapposed distance or ≥1 mm of maximum malapposed length. Composite events (cardiac death, target lesion–related myocardial infarction, target lesion revascularization, and stent thrombosis) were compared between patients with and without severe ASM. The postintervention optical coherence tomography findings indicated that 62 (14.2%) patients had lesions with ≥400 μm of maximum malapposed distance and 186 (42.7%) patients had lesions with ≥1 mm of maximum malapposed length. The 5‐year clinical follow‐up was completed in 371 (86.1%) of the eligible 431 patients. The cumulative rate of composite events was similar among the patients in each group during 5‐year follow‐up: 3.3% in patients with ASM ≥400 μm of maximum malapposed distance versus 3.1% in those with no ASM or ASM <400 μm of maximum malapposed distance (P=0.89), and 1.2% in patients with ASM ≥1 mm of maximum malapposed length versus 4.6% in those with no ASM or ASM <1 mm of maximum malapposed length (P=0.06). CONCLUSIONS: During the 5‐year follow‐up, ASM severity was not associated with long‐term clinical outcomes in patients treated with drug‐eluting stents.