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Evaluation by Optical Coherence Tomography (OCT) of Neointimal Coverage of Sirolimus-Eluting Stent

Three Months After Implantation

Evaluation by Optical Coherence Tomography (OCT) of Neointimal Coverage of Sirolimus-Eluting Stent

Three Months After Implantation

Masamichi Takano, MD; Shigenobu Inami, MD; Masamichi Takano, MD; Shigenobu Inami, MD; Ik-Kyung Jang, MD, PhD; Masanori Yamamoto, MD; Ik-Kyung Jang, MD, PhD; Masanori Yamamoto, MD;

Daisuke Murakami, MD; Koji Seimiya, MD; Daisuke Murakami, MD; Koji Seimiya, MD; Takayoshi Ohba, MD; and Kyoichi Mizuno, MD, PhDTakayoshi Ohba, MD; and Kyoichi Mizuno, MD, PhD

Published in the Published in the Am J of Cardiol Am J of Cardiol 2007; 99:1033-10382007; 99:1033-1038


Evaluation by OCT of Neointimal Coverage of Sirolimus-Eluting Stent Three Months After Implantation: Background

Evaluation by OCT of Neointimal Coverage of Sirolimus-Eluting Stent Three Months After Implantation: Background

• The US FDA recommends that aggressive medical therapies with dual The US FDA recommends that aggressive medical therapies with dual antiplatelet drugs be continued antiplatelet drugs be continued >> 3 months after sirolimus-eluting stent 3 months after sirolimus-eluting stent (SES) implantation for the prevention of stent thrombotic occlusion.(SES) implantation for the prevention of stent thrombotic occlusion.

• Nevertheless, there is no evidence of completion of reendothelialization Nevertheless, there is no evidence of completion of reendothelialization after SES implantation at 3 months in living patients, and late stent after SES implantation at 3 months in living patients, and late stent thrombosis has been reported in patients with SES.thrombosis has been reported in patients with SES.

• Therefore, optical coherence tomographic (OCT) analysis at 3-month Therefore, optical coherence tomographic (OCT) analysis at 3-month follow-up, focusing on stent exposure and malapposition of a SES, follow-up, focusing on stent exposure and malapposition of a SES, might provide adequate information on the safety of discontinuation of might provide adequate information on the safety of discontinuation of dual antiplatelet therapy for patients.dual antiplatelet therapy for patients.

• The US FDA recommends that aggressive medical therapies with dual The US FDA recommends that aggressive medical therapies with dual antiplatelet drugs be continued antiplatelet drugs be continued >> 3 months after sirolimus-eluting stent 3 months after sirolimus-eluting stent (SES) implantation for the prevention of stent thrombotic occlusion.(SES) implantation for the prevention of stent thrombotic occlusion.

• Nevertheless, there is no evidence of completion of reendothelialization Nevertheless, there is no evidence of completion of reendothelialization after SES implantation at 3 months in living patients, and late stent after SES implantation at 3 months in living patients, and late stent thrombosis has been reported in patients with SES.thrombosis has been reported in patients with SES.

• Therefore, optical coherence tomographic (OCT) analysis at 3-month Therefore, optical coherence tomographic (OCT) analysis at 3-month follow-up, focusing on stent exposure and malapposition of a SES, follow-up, focusing on stent exposure and malapposition of a SES, might provide adequate information on the safety of discontinuation of might provide adequate information on the safety of discontinuation of dual antiplatelet therapy for patients.dual antiplatelet therapy for patients.

Takano, et al. Am J Cardiol 2007; 99: 1033-38Takano, et al. Am J Cardiol 2007; 99: 1033-38


Evaluation by OCT of Neointimal Coverage of Sirolimus-Eluting Stent Three Months After Implantation: Design

Evaluation by OCT of Neointimal Coverage of Sirolimus-Eluting Stent Three Months After Implantation: Design

• Evaluation of stent exposure and malapposition using OCT in different clinical Evaluation of stent exposure and malapposition using OCT in different clinical presentations, such as acute coronary syndrome (ACS) and non-ACS. presentations, such as acute coronary syndrome (ACS) and non-ACS.

• Performance of motorized optical coherence tomographic pullback (1 mm/s) to Performance of motorized optical coherence tomographic pullback (1 mm/s) to examine consecutive implanted 31 SESs in 21 lesions.examine consecutive implanted 31 SESs in 21 lesions.

• Measurement of NIH thickness inside each strut and percent neointimal Measurement of NIH thickness inside each strut and percent neointimal hyperplasia (NIH) area in each cross section.hyperplasia (NIH) area in each cross section.

• Evaluation of stent exposure and malapposition using OCT in different clinical Evaluation of stent exposure and malapposition using OCT in different clinical presentations, such as acute coronary syndrome (ACS) and non-ACS. presentations, such as acute coronary syndrome (ACS) and non-ACS.

• Performance of motorized optical coherence tomographic pullback (1 mm/s) to Performance of motorized optical coherence tomographic pullback (1 mm/s) to examine consecutive implanted 31 SESs in 21 lesions.examine consecutive implanted 31 SESs in 21 lesions.

• Measurement of NIH thickness inside each strut and percent neointimal Measurement of NIH thickness inside each strut and percent neointimal hyperplasia (NIH) area in each cross section.hyperplasia (NIH) area in each cross section.

21 patients (21 lesions) undergoing percutaneous coronary intervention (PCI) 21 patients (21 lesions) undergoing percutaneous coronary intervention (PCI)

with SESs for their native coronary arterieswith SESs for their native coronary arteries * *Three month follow-up (90 Three month follow-up (90 ± 10 days)± 10 days)

Exclusion Criteria: unprotected left main coronary artery disease, restenotic lesions, chronic renal failure Exclusion Criteria: unprotected left main coronary artery disease, restenotic lesions, chronic renal failure without regular hemodialysis, and severely decreased left ventricular systolic function.without regular hemodialysis, and severely decreased left ventricular systolic function.

21 patients (21 lesions) undergoing percutaneous coronary intervention (PCI) 21 patients (21 lesions) undergoing percutaneous coronary intervention (PCI)

with SESs for their native coronary arterieswith SESs for their native coronary arteries * *Three month follow-up (90 Three month follow-up (90 ± 10 days)± 10 days)

Exclusion Criteria: unprotected left main coronary artery disease, restenotic lesions, chronic renal failure Exclusion Criteria: unprotected left main coronary artery disease, restenotic lesions, chronic renal failure without regular hemodialysis, and severely decreased left ventricular systolic function.without regular hemodialysis, and severely decreased left ventricular systolic function.

3 mos. after SES implantation3 mos. after SES implantation 3 mos. after SES implantation3 mos. after SES implantation


* All patients received dual antiplatelet drugs (Ticlopidine 200mg/day and aspirin 100 mg/day)


Evaluation by OCT of Neointimal Coverage of Sirolimus-Eluting Stent Three Months After Implantation : Baseline CharacteristicsEvaluation by OCT of Neointimal Coverage of Sirolimus-Eluting

Stent Three Months After Implantation : Baseline Characteristics

• Study subjects consisted of 9 patients with ACS (3 with Study subjects consisted of 9 patients with ACS (3 with STEMI, 3 with non-STEMI, and 3 with unstable angina) STEMI, 3 with non-STEMI, and 3 with unstable angina) and 12 with non-ACS.and 12 with non-ACS.

• Patients’ characteristics were similar between the ACS Patients’ characteristics were similar between the ACS and non-ACS groups.and non-ACS groups.

• Study subjects consisted of 9 patients with ACS (3 with Study subjects consisted of 9 patients with ACS (3 with STEMI, 3 with non-STEMI, and 3 with unstable angina) STEMI, 3 with non-STEMI, and 3 with unstable angina) and 12 with non-ACS.and 12 with non-ACS.

• Patients’ characteristics were similar between the ACS Patients’ characteristics were similar between the ACS and non-ACS groups.and non-ACS groups.



• In total, 4516 struts in 567-mm single-stented segments In total, 4516 struts in 567-mm single-stented segments were analyzed.were analyzed.

• Overall, NIH thickness and percent NIH area were 29 Overall, NIH thickness and percent NIH area were 29 ± ± 41 41 μμm and 10 ± 4%, respectively.m and 10 ± 4%, respectively.

• Rates of exposed struts and exposed struts with Rates of exposed struts and exposed struts with malapposition were 15% and 6%, respectively. malapposition were 15% and 6%, respectively.

• These were more frequent in patients with ACS than in These were more frequent in patients with ACS than in those with non-ACS (18% vs. 13%, p < 0.0001; 8% vs. those with non-ACS (18% vs. 13%, p < 0.0001; 8% vs. 5%, p <0.005, respectively).5%, p <0.005, respectively).

Evaluation by OCT of Neointimal Coverage of Sirolimus-Eluting Stent Three Months After Implantation : Results

Evaluation by OCT of Neointimal Coverage of Sirolimus-Eluting Stent Three Months After Implantation : Results



Figure 1.Figure 1. OCT measurements in length and area. (A) Typical cross-sectional image of OCT measurements in length and area. (A) Typical cross-sectional image of single-stented segment. Six stent struts with shadowing are clearly recognized. single-stented segment. Six stent struts with shadowing are clearly recognized. Magnification of the image is displayed in the lower left. Numerals on vertical and Magnification of the image is displayed in the lower left. Numerals on vertical and horizontal axes indicate absolute length (millimeters). (B) Length between surfaces of horizontal axes indicate absolute length (millimeters). (B) Length between surfaces of the neointima and each stent strut (NIH thickness). Each NIH thickness is displayed on the neointima and each stent strut (NIH thickness). Each NIH thickness is displayed on the upper left. (C) Stent area (outer circle) and lumen area (inner circle) were measured the upper left. (C) Stent area (outer circle) and lumen area (inner circle) were measured by manual trace. Each area measurement is displayed on the upper left.by manual trace. Each area measurement is displayed on the upper left.

C

A CB

Evaluation by OCT of Neointimal Coverage of Sirolimus-Eluting Stent Three Months After Implantation




A



Figure 2. Figure 2. Different nonexposed strut types with malapposition. Although all struts were Different nonexposed strut types with malapposition. Although all struts were diagnosed as malapposed, there were intracoronary structures on them. (A) Struts diagnosed as malapposed, there were intracoronary structures on them. (A) Struts seem to float into the lumen compared with the extra-stent lumen (arrowheads). (B) A seem to float into the lumen compared with the extra-stent lumen (arrowheads). (B) A strut is surrounded by an intracoronary structure with an irregular surface. This OCT strut is surrounded by an intracoronary structure with an irregular surface. This OCT finding likely indicates that a part of the analyzed strut has fibrin deposition. (C) finding likely indicates that a part of the analyzed strut has fibrin deposition. (C) Maximum distance between the strut surface and the vessel wall is 200 Maximum distance between the strut surface and the vessel wall is 200 μμm. This strut m. This strut is completely buried under the intracoronary structure protruding into the lumen.is completely buried under the intracoronary structure protruding into the lumen.

A B C



Figure 2

A

Figure 3. Figure 3. Different exposed strut types. (A) An exposed strut without malapposition Different exposed strut types. (A) An exposed strut without malapposition has no structure inside the strut, which adheres to the vessel wall. (B, C) Exposed has no structure inside the strut, which adheres to the vessel wall. (B, C) Exposed struts with malapposition with a maximum distance < 160 struts with malapposition with a maximum distance < 160 μμm between the strut surface m between the strut surface and the vessel wall. (C) No filling space between the struts and adjacent vessel wall and the vessel wall. (C) No filling space between the struts and adjacent vessel wall was found.was found.

A B C





Figure 4. Figure 4. Intracoronary thrombus with an obvious protruding Intracoronary thrombus with an obvious protruding mass between 4 and 5 o’clock.mass between 4 and 5 o’clock.





• Findings were based on observations in a relatively small Findings were based on observations in a relatively small number of patients and stented segments.number of patients and stented segments.

• This study was not randomizedThis study was not randomized. Lesion characteristics such . Lesion characteristics such as reference diameter before PCI and stent and lumen as reference diameter before PCI and stent and lumen areas at follow-up differed between the two groups, and so areas at follow-up differed between the two groups, and so relative NIH area was compared.relative NIH area was compared.

Evaluation by OCT of Neointimal Coverage of Sirolimus-Eluting Stent Three Months After Implantation : Limitations

Evaluation by OCT of Neointimal Coverage of Sirolimus-Eluting Stent Three Months After Implantation : Limitations



• Although OCT was used, detection of very thin structures below its Although OCT was used, detection of very thin structures below its image resolution and certain distinctions between fibrin and NIH were image resolution and certain distinctions between fibrin and NIH were impossible. impossible.

• Occurrence of stent malapposition was unidentified because OCT Occurrence of stent malapposition was unidentified because OCT

examination was performed at a single time point.examination was performed at a single time point.

Evaluation by OCT of Neointimal Coverage of Sirolimus-Eluting Stent Three Months After Implantation : Limitations Cont.

Evaluation by OCT of Neointimal Coverage of Sirolimus-Eluting Stent Three Months After Implantation : Limitations Cont.



• In conclusion, the present study using optical coherence tomography In conclusion, the present study using optical coherence tomography demonstrated the existence of malapposed struts without neointimal demonstrated the existence of malapposed struts without neointimal coverage and incomplete neointimal proliferation at 3 mos. after SES coverage and incomplete neointimal proliferation at 3 mos. after SES implantation.implantation.

• However, it is not clear that these uncovered struts are associated However, it is not clear that these uncovered struts are associated with clinical events such as late stent thrombosis. with clinical events such as late stent thrombosis.

• This study suggests that dual antiplatelet therapy might be continued This study suggests that dual antiplatelet therapy might be continued

>3 months after SES implantation.>3 months after SES implantation.

Evaluation by OCTof Neointimal Coverage of Sirolimus-Eluting Stent

Three Months After Implantation: Summary

Evaluation by OCTof Neointimal Coverage of Sirolimus-Eluting Stent

Three Months After Implantation: Summary


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