Comparison of Acute Vessel Wall Injury After Self-Expanding Stent and Conventional Balloon-Expandable (FULL TITLE BELOW)

Comparison of Acute Vessel Wall Injury After Self-Expanding Stent and Conventional Balloon-Expandable (FULL TITLE BELOW)
Comparison of Acute Vessel Wall Injury After Self-Expanding Stent and Conventional Balloon-Expandable (FULL TITLE BELOW)
Comparison of Acute Vessel Wall Injury After Self-Expanding Stent and Conventional Balloon-Expandable (FULL TITLE BELOW)
Comparison of Acute Vessel Wall Injury After Self-Expanding Stent and Conventional Balloon-Expandable (FULL TITLE BELOW)
Pages: 
435 - 439
Author(s): 

Eun-Seok Shin, MD, PhD*, Hector M. Garcia-Garcia, MD, PhD, Takayuki Okamura, MD, PhD, Joanna J. Wykrzykowska, MD, Nieves Gonzalo, MD, Zu Jun Shen, MD, PhD, Robert Jan van Geuns, MD, PhD, Evelyn Regar, MD, PhD, Patrick W. Serruys, MD, PhD

FULL TITLE: Comparison of Acute Vessel Wall Injury After Self-Expanding Stent and Conventional Balloon-Expandable Stent Implantation: A Study with Optical Coherence Tomography


ABSTRACT: Background. The acute impact in vivo from a self-expanding stent on the vessel wall has not been sufficiently evaluated. Objectives. We sought to compare acute in vivo injury on the vessel wall and the clinical impact between a self-expanding coronary stent and conventional balloon-expandable stents immediately after stent implantation. Methods. We included 40 patients (45 vessels) with stable or unstable angina who were assigned to either the self-expanding stent (vProtect® Luminal Shield) group (n = 9; Group 1) or the conventional balloon-expandable stent group (n = 36; Group 2). Optical coherence tomography (OCT) was performed after stent deployment, as were qualitative and quantitative assessments of tissue prolapse, intrastent dissection, edge dissection and incomplete stent apposition. Results. Tissue prolapse was visible in all vessels in both groups. The corrected tissue prolapse area by stent length was larger in Group 2 than in Group 1 (0.06 ± 0.06 vs. 0.02 ± 0.01 mm²; p < 0.001). Intrastent dissection was more frequently seen in Group 2 (33/36 vs. 4/9 vessels; p = 0.004) and the mean length of the dissection flap was greater in Group 2 than in Group 1 (277.6 ± 110.0 vs. 76.9 ± 103.7 µm; p < 0.001). Although edge dissection was not detected in Group 1, it was visible in 19/36 vessels (52.8%) in Group 2. The frequency of incomplete stent apposition was not significantly different between Group 2 and Group 1 (23/36 vs. 7/9 vessels, p = 0.7), but the mean depth of incomplete stent apposition was greater in Group 2 than in Group 1 (268.2 ± 72.1 vs. 178.2 ± 156.7 µm, p = 0.03). Conclusions. A self-expanding stent was associated with less intrastent dissection and edge dissection than conventional balloon-expandable stents with OCT.

J INVASIVE CARDIOL 2010;22:435–439

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Although balloon-expandable stenting techniques with high pressure have proved to be useful for optimal stent implantation to reduce the risks of restenosis and subacute thrombosis, this stent deployment strategy may also increase the risk of creating vessel damage in the stented segment or at its edges.1 As a stent is expanded with high pressure, immediate injury occurs deep in the vessel wall within the stented segment as well as in the unscaffolded persistent margins.2 Importantly, several stent trials have drawn our attention to the problem of accelerated lumen loss at stent margins, which accounts for up to one-third of target-vessel revascularization (TVR) in patients treated with balloon-expandable stents.3–5 On the other hand, a self-expanding stent allows deployment at lower pressures, resulting in less intimal trauma. Late loss was significantly smaller at the persistent margins in the self-expanding stent than it was in the balloon-expandable stent.2

Optical coherence tomography (OCT) is a high-resolution technique that allows very detailed assessment of the relationship between the stent and the vessel wall.

The objective of the present study was to qualitatively and quantitatively compare with OCT the stent implantation-associated vessel wall injury between a self-expanding stent (vProtect® Luminal Shield, Prescient Medical, Inc., Doylestown, Pennsylvania) and conventional balloon-expandable stents, and to compare their clinical impact during the hospitalization period.

Methods

Study population. This study was conducted in a single center of the Netherlands (Thoraxcenter, Erasmus MC). All 89 consecutive patients who underwent OCT after stent implantation in native coronary arteries between May 2007 and March 2009 were included. Patients with acute myocardial infarction and long lesions that needed over 50 mm of stent length (n = 33) were excluded. We also excluded 16 patients due to poor OCT images. Finally, 40 patients (45 vessels) with stable angina or unstable angina were included in the study. During the same period of time, 9 patients enrolled in the SECRITT trial were included for evaluation of vProtect® Luminal Shield.6 All patients gave informed consent.

OCT acquisition. OCT acquisition was performed using a commercially available system for intracoronary imaging (ImageWire, LightLab Imaging, Inc, Westford, Massachusetts). In 5 cases, the occlusive technique was used in which a proximal, low-pressure (0.4 atm) occlusion balloon (Helios, Goodman, Inc., Nagoya, Japan) was inflated with simultaneous distal flush delivery (lactated ringer; flow rate 0.8 mL/sec) to remove blood from the vessel lumen. Images were acquired during a pullback rate of 1.0 mm/sec. In 40 cases, OCT was acquired with the nonocclusive technique. In this case, the ImageWire was positioned distal to the region of interest using a double-lumen catheter (Twin-Pass Catheter, Vascular Solutions, Inc., Minneapolis, Minnesota) that had been previously placed in the artery over a conventional guidewire. The automated pullback was performed at 3 mm/sec (n = 39) or 20 mm/sec (n = 1,C7XR: Lightlab Imaging) while blood was removed by the continuous injection of iso-osmolar contrast (iodixanol 370, Visipaque™, GE Healthcare) at 37°C through the guiding catheter. Data were stored on CD for offline analysis.

Definitions. The acute impact of stent implantation in OCT are given in Figure 1. Tissue prolapse was defined as protrusion of tissue between the stent struts without disruption of the continuity of the vessel luminal surface.7 Protrusion of tissue between struts was considered tissue prolapse only if the distance from the arc connecting adjacent stent struts to the greatest extent of protrusion was > 50 µm.8 Intrastent dissection was defined as disruption of the vessel lumen surface in the stent segment with a visible dissection flap.8

Edge dissection was defined as disruption of the vessel lumen surface in the stent edge within the 5 mm proximal and distal segments. Incomplete stent apposition (ISA) was defined as at least one stent strut with detachment from the wall > 1 thickness of the strut for the respective stent and unrelated with a side branch.9 Thrombus was defined as an irregular mass protruding into the lumen or an intraluminal mass unconnected from the surface of the vessel wall that had single-free shadowing in the OCT image.10

Quantitative OCT analysis of the acute impact of stent implantation.8 The analyzed region comprised the stented segment and the 5 mm proximal and distal persistent segments. The lumen and stent areas were measured at 1 mm intervals. In the case of tissue prolapse, the number of sites with tissue prolapse and the area were measured. Tissue prolapse length was defined as the distance from the arc connecting the adjacent stent struts to the greatest extent of protrusion. The area of tissue protruding between the stent struts was also measured. When there were signs of intrastent dissection, the number of dissection flaps was counted and the length of the flap from its tip to the joint point with the vessel wall was measured. When edge dissection was present, the length of the dissection flap was measured in a similar way as described for the intrastent dissection flap. At sites of ISA, maximum depth in a single cut was measured and the average length was reported. The presence of thrombus was qualitatively assessed and maximum length of thrombus was measured. To account for differences in stent length, the number and total area of tissue prolapse and the number of dissection flaps were corrected according to the stent length and expressed on a per-millimeter basis. Image analysts were blinded to the clinical and procedural characteristics.

Clinical follow up. The presence of events (death, myocardial infarction, target-lesion revascularization [TLR], TVR and stent thrombosis) during the hospitalization period following stent implantation was registered in both groups. Myocardial infarction (MI) is defined as chest pain together with ST-elevation or new left bundle branch block and an increase in cardiac enzymes (i.e., creatine kinase-MB fraction of 3 times the upper limit of normal).8

Statistical analysis. Continuous variables are expressed as mean ± standard deviation. Categorical variables are expressed as percentages. Comparisons between groups were performed with the χ2 test for categorical variables. Continuous variables were compared with the Student t-test when they had a normal distribution and with nonparametric test (Mann-Whitney) when their distribution was not normal. A p-value < 0.05 was considered statistically significant.

Results

Table 1 shows clinical and procedural characteristics. There were no significant differences between the two groups. Group 2 had different stent types: 6 balloon-expandable bare-metal stents, 1 paclitaxel-eluting stent, 3 zotarolimus-eluting stents and 26 everolimus-eluting stents. The frequency of ACC/AHA Type B2 or C lesions was not significantly different, and the frequencies of predilatation and postdilatation did not differ significantly. However, stent length was significantly larger in Group 2 than in Group 1 (26.2 ± 8.8 and 17.1 ± 5.2 mm, respectively; p = 0.001).

Acute impact of stent implantation assessed by OCT (Figure 2). After stenting, the lumen area was 7.9 ± 2.3 mm² in Group 1 and 7.3 ± 1.7 mm² in Group 2 (p = 0.3). The mean and minimum stent areas were 8.0 ± 2.3 and 6.3 ± 2.3 mm² in Group 1 and 7.6 ± 1.9 and 6.0 ± 1.7 mm² in Group 2, respectively. Although all vessels in both groups showed tissue prolapse, the corrected number of tissue prolapse and corrected area by stent length were larger in Group 2 than in Group 1 (Table 2). The vProtect® Luminal Shield had less intrastent dissection than balloon-expandable stents and the corrected number of dissections and average length of intrastent dissection flaps were all lower (Table 2). In addition, there was no edge dissection in Group 1, while in Group 2 the distal and proximal edges presented edge dissection in 14/36 (38.9%) and 10/36 (27.8%) vessels, respectively. Among patients in Group 2, five vessels (14%) showed both proximal and distal edge dissection. The average length of the dissection flap was 515 ± 403 µm. Regarding ISA, 7/9 vessels in Group 1 and 23/36 vessels in Group 2, respectively, showed at least 1 malapposed stent strut; the maximum depth of ISA was 178 ± 156 µm in Group 1 and 267 ± 72 µm in Group 2 (p = 0.03). Images suggestive of thrombus were visible in 2 vessels in Group 1, and 16 in Group 2. The maximum length of visible thrombus was 131 ± 30 µm and 298 ± 122 µm, respectively.

In-hospital events. There were no events (death, MI, TLR, TVR or stent thrombosis) during the hospitalization period in either group.

Discussion

In a case report,22 a self-expanding stent showed excellent apposition of the stent to the vessel wall, with no signs of tissue prolapse or edge dissections by IVUS and OCT. This is the first study using OCT to compare the acute impact on the vessel wall between a self-expanding stent and balloon-expandable stents.


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