Early Follow-Up Optical Coherence Tomographic Findings of Significant Drug-Eluting Stent Malapposition: Results From the DETECT-OCT Trial

Background: Using optical coherence tomography, we evaluated early follow-up findings of significant stent malapposition (SSM) in patients treated with second-generation drug-eluting stent. Methods and Results: From the DETECT-OCT randomized trial (Determination of the Duration of the Dual Antiplatelet Therapy by the Degree of the Coverage of the Struts on Optical Coherence Tomography From the Randomized Comparison Between Everolimus- Versus Biolimus-Eluting Stent), a total of 386 patients (390 lesions) who underwent both postintervention and 3-month follow-up optical coherence tomography examinations were included for the present analysis. SSM was defined as a stent that had a strut with a maximal wall-to-strut distance of ≥200 &mgr;m. Postintervention, SSM was detected in 175 lesions (44.9%), including 117 lesions with a maximal wall-to-strut distance of ≥200 to <400 &mgr;m and 58 lesions with a maximal wall-to-strut distance of ≥400 &mgr;m. As the implanted stent diameter-to-reference vessel diameter ratio grew, the risk of postintervention SSM dropped (odds ratio, 0.587; 95% CI, 0.367–0.941; P=0.0398). The optimal value that best separated SSM from non-SSM postintervention was a stent diameter-to-reference vessel diameter ratio of 1.0. At 3 months follow-up, the frequency of SSM decreased from 44.9% to 33.6% (131 lesions; P=0.0001), mainly driven by the decrease in lesions with a maximal wall-to-strut distance of ≥200 to <400 &mgr;m. As the maximal wall-to-strut distance on postintervention optical coherence tomography was larger, the risk of 3-month SSM increased (odds ratio, 1.607; 95% CI, 1.131–2.286; P=0.0284). The optimal value that best separated SSM from non-SSM at 3 months follow-up was a maximal wall-to-strut distance postintervention of 230 &mgr;m. Conclusions: A spontaneous decrease in SSM was observed early in this qualified study with a large number of study patients treated with second-generation drug-eluting stent. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01752894.

[1]  P. Serruys,et al.  The fate of incomplete stent apposition with drug-eluting stents: an optical coherence tomography-based natural history study. , 2010, European heart journal.

[2]  Y. Jang,et al.  Impact of Coronary Plaque Characteristics on Late Stent Malapposition after Drug-Eluting Stent Implantation , 2015, Yonsei medical journal.

[3]  Antonio Colombo,et al.  Clinical use of intracoronary imaging. Part 1: guidance and optimization of coronary interventions. An expert consensus document of the European Association of Percutaneous Cardiovascular Interventions , 2018, European heart journal.

[4]  Y. Jang,et al.  Incidences, Predictors, and Clinical Outcomes of Acute and Late Stent Malapposition Detected by Optical Coherence Tomography After Drug-Eluting Stent Implantation , 2014, Circulation. Cardiovascular interventions.

[5]  Gregg W Stone,et al.  One-Year Clinical Results With the Slow-Release, Polymer-Based, Paclitaxel-Eluting TAXUS Stent: The TAXUS-IV Trial , 2004, Circulation.

[6]  Ryo Torii,et al.  Incomplete Stent Apposition Causes High Shear Flow Disturbances and Delay in Neointimal Coverage as a Function of Strut to Wall Detachment Distance: Implications for the Management of Incomplete Stent Apposition , 2014, Circulation. Cardiovascular interventions.

[7]  Francesco Versaci,et al.  Clinical Impact of OCT Findings During PCI: The CLI-OPCI II Study. , 2015, JACC. Cardiovascular imaging.

[8]  L. Räber,et al.  Clinical use of intracoronary imaging. Part 1: guidance and optimization of coronary interventions. An expert consensus document of the European Association of Percutaneous Cardiovascular Interventions. , 2018, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[9]  Y. Jang,et al.  Mini-Focus Issue: Second-Generation DESEvaluation in 3 Months Duration of Neointimal Coverage After Zotarolimus-Eluting Stent Implantation by Optical Coherence Tomography: The ENDEAVOR OCT Trial , 2009 .

[10]  P. Serruys,et al.  Vascular Tissue Reaction to Acute Malapposition in Human Coronary Arteries: Sequential Assessment With Optical Coherence Tomography , 2012, Circulation. Cardiovascular interventions.

[11]  T. Akasaka,et al.  Outcomes of everolimus-eluting stent incomplete stent apposition: a serial optical coherence tomography analysis. , 2015, European heart journal cardiovascular Imaging.

[12]  Y. Jang,et al.  Comparison of early strut coverage between zotarolimus- and everolimus-eluting stents using optical coherence tomography. , 2013, American Journal of Cardiology.

[13]  Akiko Maehara,et al.  Consensus standards for acquisition, measurement, and reporting of intravascular optical coherence tomography studies: a report from the International Working Group for Intravascular Optical Coherence Tomography Standardization and Validation. , 2012, Journal of the American College of Cardiology.

[14]  Y. Jang,et al.  Early Strut Coverage in Patients Receiving Drug-Eluting Stents and its Implications for Dual Antiplatelet Therapy: A Randomized Trial. , 2018, JACC. Cardiovascular imaging.

[15]  K. Hirata,et al.  Natural consequence of post-intervention stent malapposition, thrombus, tissue prolapse, and dissection assessed by optical coherence tomography at mid-term follow-up , 2013, European heart journal cardiovascular Imaging.

[16]  L. Tavazzi,et al.  Clinical Impact of Suboptimal Stenting and Residual Intrastent Plaque/Thrombus Protrusion in Patients With Acute Coronary Syndrome: The CLI-OPCI ACS Substudy (Centro per la Lotta Contro L’Infarto-Optimization of Percutaneous Coronary Intervention in Acute Coronary Syndrome) , 2016, Circulation. Cardiovascular interventions.

[17]  N. Bruining,et al.  Expert review document part 2: methodology, terminology and clinical applications of optical coherence tomography for the assessment of interventional procedures , 2012, European heart journal.

[18]  Seung‐Jung Park,et al.  Incidence and Clinical Significance of Post-Stent OCT Findings: One Year Follow-Up Study From a Multicenter Registry , 2015 .

[19]  Seung‐Jung Park,et al.  Incidence and Clinical Significance of Poststent Optical Coherence Tomography Findings: One-Year Follow-Up Study From a Multicenter Registry. , 2015, Circulation.

[20]  Y. Jang,et al.  Optical coherence tomography analysis of strut coverage in biolimus- and sirolimus-eluting stents: 3-month and 12-month serial follow-up. , 2013, International journal of cardiology.