Predictors and Long‐Term Clinical Impact of Acute Stent Malapposition: An Assessment of Dual Antiplatelet Therapy With Drug‐Eluting Stents (ADAPT‐DES) Intravascular Ultrasound Substudy

Abstract

BackgroundThe impact of acute stent malapposition (ASM) on long‐term clinical outcomes in patients undergoing percutaneous coronary intervention is still controversial. We sought to evaluate predictors and long‐term clinical outcomes of ASM.Methods and Results ADAPT‐DES (Assessment of Dual Antiplatelet Therapy With Drug‐Eluting Stents) was a prospective multicenter study of 8663 patients undergoing percutaneous coronary intervention using drug‐eluting stents. In a prespecified intravascular ultrasound–guided substudy, 2072 patients with 2446 culprit lesions had post–percutaneous coronary intervention intravascular ultrasound and were classified according to the presence or absence of ASM. After intravascular ultrasound–guided percutaneous coronary intervention, the overall prevalence of ASM after successful drug‐eluting stents implantation was 14.4% per patient and 12.6% per lesion. Compared to lesions without ASM, lesions with ASM had larger in‐stent lumen areas, larger stent areas, and larger in‐stent vessel areas. A larger mean plaque area along with more attenuated plaque was observed in lesions with ASM versus lesions without ASM. Lesions with ASM had greater proximal and distal reference lumen areas and more distal, but not proximal, reference calcium compared to lesions without ASM. At 2‐year follow‐up, there was no significant difference in the incidence of cardiac death; myocardial infarction; early, late, or very late stent thrombosis; or clinically driven target lesion revascularization in patients with ASM versus those without ASM. Furthermore, ASM was not an independent predictor of 2‐year major adverse cardiac events or target lesion revascularization even when forced into the multivariate model.ConclusionsIn patients treated with intravascular ultrasound–guided drug‐eluting stents implantation, ASM was not associated with adverse clinical events during long‐term follow‐up including, but not limited to, stent thrombosis.Clinical Trial Registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT00638794.

Clinical Implications of Acute Stent Mal-Apposition in the Left Main Coronary Artery

“…In vitro analyses [ 26 ], coupled with intravascular imaging examinations [ 9 , 28 ], suggest the theoretical association between exposed mal-apposed struts and an elevated likelihood for localized thrombus development, potentially due to induced flow disruptions and protracted healing. Nevertheless, across varied studies involving different patient demographics, stent categories, and imaging modalities, the results found no correlation between ASM and unfavorable cardiac incidents following DES placement, similar to the results from our study [ 5 , 7 , 8 , 16 , 18 , 21 , 29 ]. The IVUS-oriented sub-analysis of 2072 patients encompassing 2446 lesions from the ADAPT-DES study revealed no discernible link between ASM and major adverse cardiovascular events (MACE) during a 2-year post-intervention observation [ 18 ].…”

“…Nevertheless, across varied studies involving different patient demographics, stent categories, and imaging modalities, the results found no correlation between ASM and unfavorable cardiac incidents following DES placement, similar to the results from our study [ 5 , 7 , 8 , 16 , 18 , 21 , 29 ]. The IVUS-oriented sub-analysis of 2072 patients encompassing 2446 lesions from the ADAPT-DES study revealed no discernible link between ASM and major adverse cardiovascular events (MACE) during a 2-year post-intervention observation [ 18 ]. Presently, there is no universally accepted criteria to assess ASM severity linked to adverse cardiovascular events.…”

Clinical Implications of Acute Stent Mal-Apposition in the Left Main Coronary Artery

“…In vitro analyses [ 26 ], coupled with intravascular imaging examinations [ 9 , 28 ], suggest the theoretical association between exposed mal-apposed struts and an elevated likelihood for localized thrombus development, potentially due to induced flow disruptions and protracted healing. Nevertheless, across varied studies involving different patient demographics, stent categories, and imaging modalities, the results found no correlation between ASM and unfavorable cardiac incidents following DES placement, similar to the results from our study [ 5 , 7 , 8 , 16 , 18 , 21 , 29 ]. The IVUS-oriented sub-analysis of 2072 patients encompassing 2446 lesions from the ADAPT-DES study revealed no discernible link between ASM and major adverse cardiovascular events (MACE) during a 2-year post-intervention observation [ 18 ].…”

“…Nevertheless, across varied studies involving different patient demographics, stent categories, and imaging modalities, the results found no correlation between ASM and unfavorable cardiac incidents following DES placement, similar to the results from our study [ 5 , 7 , 8 , 16 , 18 , 21 , 29 ]. The IVUS-oriented sub-analysis of 2072 patients encompassing 2446 lesions from the ADAPT-DES study revealed no discernible link between ASM and major adverse cardiovascular events (MACE) during a 2-year post-intervention observation [ 18 ]. Presently, there is no universally accepted criteria to assess ASM severity linked to adverse cardiovascular events.…”

Consensus of National Heart Center and the Saudi Arabian Cardiac Interventional Society on the Current Landscape of the Management of Intracoronary Calcification in Saudi Arabia

“…This was seen in studies such as OPUS-CLASS which showed 14% for IVUS and 39% for OCT [ 39 ], and ILUMIEN III [ 30 ], with 19.3% for IVUS versus 38.5% for OCT. Consistent findings were seen in large cross-sectional studies using IVUS and OCT, with prevalence rates for acute malapposition being 8%–15% with IVUS and 39%–62% with OCT [ 40 , 41 ]. Therefore, IVUS and OCT, in combination with quantitative coronary angiography, play a critical role in ensuring optimal stent implantation and patient outcomes.…”

Long-term consequences of optical coherence tomography findings during percutaneous coronary intervention: the Centro Per La Lotta Contro L’infarto – Optimization Of Percutaneous Coronary Intervention (CLI-OPCI) LATE study

“…According to the one-year data of previous CLI-OPCI registries [6][7][8] , and also as seen in the present study, acute residual SM, vari ably observed in over 50% of stents, was not significantly related to the risk of long-term stent failure (HR 0.92). Albeit the lack of an OCT follow-up is a limitation in discussing the role of acute SM as a potential cause of stent thrombosis due to incomplete stent coverage 20,21 , the present OCT findings (consistent with the ADAPT-DES IVUS data 22 ), seem to suggest a safe management of acute residual SM with single antiplatelet therapy after the first year 23 .…”

Clinical Implications of Acute Stent Mal-Apposition in the Left Main Coronary Artery

“…In vitro analyses [ 26 ], coupled with intravascular imaging examinations [ 9 , 28 ], suggest the theoretical association between exposed mal-apposed struts and an elevated likelihood for localized thrombus development, potentially due to induced flow disruptions and protracted healing. Nevertheless, across varied studies involving different patient demographics, stent categories, and imaging modalities, the results found no correlation between ASM and unfavorable cardiac incidents following DES placement, similar to the results from our study [ 5 , 7 , 8 , 16 , 18 , 21 , 29 ]. The IVUS-oriented sub-analysis of 2072 patients encompassing 2446 lesions from the ADAPT-DES study revealed no discernible link between ASM and major adverse cardiovascular events (MACE) during a 2-year post-intervention observation [ 18 ].…”

“…Nevertheless, across varied studies involving different patient demographics, stent categories, and imaging modalities, the results found no correlation between ASM and unfavorable cardiac incidents following DES placement, similar to the results from our study [ 5 , 7 , 8 , 16 , 18 , 21 , 29 ]. The IVUS-oriented sub-analysis of 2072 patients encompassing 2446 lesions from the ADAPT-DES study revealed no discernible link between ASM and major adverse cardiovascular events (MACE) during a 2-year post-intervention observation [ 18 ]. Presently, there is no universally accepted criteria to assess ASM severity linked to adverse cardiovascular events.…”

Consensus of National Heart Center and the Saudi Arabian Cardiac Interventional Society on the Current Landscape of the Management of Intracoronary Calcification in Saudi Arabia

“…This was seen in studies such as OPUS-CLASS which showed 14% for IVUS and 39% for OCT [ 39 ], and ILUMIEN III [ 30 ], with 19.3% for IVUS versus 38.5% for OCT. Consistent findings were seen in large cross-sectional studies using IVUS and OCT, with prevalence rates for acute malapposition being 8%–15% with IVUS and 39%–62% with OCT [ 40 , 41 ]. Therefore, IVUS and OCT, in combination with quantitative coronary angiography, play a critical role in ensuring optimal stent implantation and patient outcomes.…”

Long-term consequences of optical coherence tomography findings during percutaneous coronary intervention: the Centro Per La Lotta Contro L’infarto – Optimization Of Percutaneous Coronary Intervention (CLI-OPCI) LATE study

“…According to the one-year data of previous CLI-OPCI registries [6][7][8] , and also as seen in the present study, acute residual SM, vari ably observed in over 50% of stents, was not significantly related to the risk of long-term stent failure (HR 0.92). Albeit the lack of an OCT follow-up is a limitation in discussing the role of acute SM as a potential cause of stent thrombosis due to incomplete stent coverage 20,21 , the present OCT findings (consistent with the ADAPT-DES IVUS data 22 ), seem to suggest a safe management of acute residual SM with single antiplatelet therapy after the first year 23 .…”

Clinical Implications of Acute Stent Mal-Apposition in the Left Main Coronary Artery

“…In vitro analyses [ 26 ], coupled with intravascular imaging examinations [ 9 , 28 ], suggest the theoretical association between exposed mal-apposed struts and an elevated likelihood for localized thrombus development, potentially due to induced flow disruptions and protracted healing. Nevertheless, across varied studies involving different patient demographics, stent categories, and imaging modalities, the results found no correlation between ASM and unfavorable cardiac incidents following DES placement, similar to the results from our study [ 5 , 7 , 8 , 16 , 18 , 21 , 29 ]. The IVUS-oriented sub-analysis of 2072 patients encompassing 2446 lesions from the ADAPT-DES study revealed no discernible link between ASM and major adverse cardiovascular events (MACE) during a 2-year post-intervention observation [ 18 ].…”

“…Nevertheless, across varied studies involving different patient demographics, stent categories, and imaging modalities, the results found no correlation between ASM and unfavorable cardiac incidents following DES placement, similar to the results from our study [ 5 , 7 , 8 , 16 , 18 , 21 , 29 ]. The IVUS-oriented sub-analysis of 2072 patients encompassing 2446 lesions from the ADAPT-DES study revealed no discernible link between ASM and major adverse cardiovascular events (MACE) during a 2-year post-intervention observation [ 18 ]. Presently, there is no universally accepted criteria to assess ASM severity linked to adverse cardiovascular events.…”

Consensus of National Heart Center and the Saudi Arabian Cardiac Interventional Society on the Current Landscape of the Management of Intracoronary Calcification in Saudi Arabia

“…This was seen in studies such as OPUS-CLASS which showed 14% for IVUS and 39% for OCT [ 39 ], and ILUMIEN III [ 30 ], with 19.3% for IVUS versus 38.5% for OCT. Consistent findings were seen in large cross-sectional studies using IVUS and OCT, with prevalence rates for acute malapposition being 8%–15% with IVUS and 39%–62% with OCT [ 40 , 41 ]. Therefore, IVUS and OCT, in combination with quantitative coronary angiography, play a critical role in ensuring optimal stent implantation and patient outcomes.…”

Long-term consequences of optical coherence tomography findings during percutaneous coronary intervention: the Centro Per La Lotta Contro L’infarto – Optimization Of Percutaneous Coronary Intervention (CLI-OPCI) LATE study

“…According to the one-year data of previous CLI-OPCI registries [6][7][8] , and also as seen in the present study, acute residual SM, vari ably observed in over 50% of stents, was not significantly related to the risk of long-term stent failure (HR 0.92). Albeit the lack of an OCT follow-up is a limitation in discussing the role of acute SM as a potential cause of stent thrombosis due to incomplete stent coverage 20,21 , the present OCT findings (consistent with the ADAPT-DES IVUS data 22 ), seem to suggest a safe management of acute residual SM with single antiplatelet therapy after the first year 23 .…”