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. 1998 Mar;79(3):234–241. doi: 10.1136/hrt.79.3.234

Procedural and follow up results with a new balloon expandable stent in unselected lesions

M di 1, B Reimers 1, Y Almagor 1, I Moussa 1, F Di 1, M Ferraro 1, M Leon 1, K Richter 1, A Colombo 1
PMCID: PMC1728636  PMID: 9602655

Abstract

Objective—To assess the clinical and angiographic results of the first clinical application of a new balloon expandable stent, the NIR stent, characterised by high longitudinal flexibility and low profile before expansion, and by high radial support and minimal recoil and shortening after expansion.
Design—Single centre survey of unselected lesions in consecutive patients.
Setting—Tertiary referral centre.
Patients and lesions—93 stents of various length (9, 16, and 32 mm) were implanted in 64 lesions in 41 patients. Twenty lesions (31%) were longer than 15 mm, and 17 lesions (27%) were located in vessels with a diameter smaller than 2.5 mm. Extreme tortuosity of the proximal vessel was present in 15 lesions (23%). All patients were treated with aspirin and ticlopidine. All lesions were evaluated before and after treatment by quantitative angiography, and in 47 lesions (75%) the stent expansion was also controlled by intracoronary ultrasound. Clinical follow up was available in all patients and angiographic follow up was performed in 53 lesions (84%), at a mean (SD) interval of 5.4 (1.7) months.
Results—Deployment of the stent failed in two lesions (3%). Minimum lumen diameter increased from 1.01 (0.54) mm to 2.94 (0.49) mm, and diameter stenosis decreased from 66(15)% to 7(11)%. There was one in-hospital non-Q wave myocardial infarction, one sudden death after 40 days, and 17 target lesion revascularisations (27%). Angiographic restenosis (⩾ 50% diameter stenosis) was documented in 19 lesions (36% of all lesions with angiographic follow up), with an average residual diameter stenosis of 43(21)% and minimum lumen diameter of 1.63 (0.74) mm. Restenosis was more common in vessels with a reference diameter < 2.5 mm (45%) and for lesions longer than 15 mm (46%).
Conclusions—The NIR stent could be used successfully in most lesions, achieving optimal angiographic results with very few in-hospital or subacute cardiac events. The angiographic restenosis rate and need for target lesion revascularisation remained high in this unfavourable lesion subset, especially in small vessels and long lesions.

 Keywords: coronary stenting;  quantitative angiography;  intravascular ultrasound;  restenosis

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Figure 1  .

Figure 1  

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Example of a long lesion of the mid-distal segment of the left anterior descending coronary artery treated with 3 × 32 mm NIR stents. MLD, minimum lumen diameter.

Figure 2  .

Figure 2  

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Example of very tortuous shepherd's crook proximal segment of a right coronary artery treated with two NIR stents. Note that a large lumen (minimum lumen diameter (MLD) = 2.05 mm) is still maintained at six months' follow up (FU).

Figure 3  .

Figure 3  

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Magnified photograph of the NIR stent before (upper panel) and after (lower panel) expansion with a balloon inside a transparent plastic tube. Note the flexibility before expansion and the conformability to the curved tube after expansion. The line connects the junction of the segment that elongates during expansion with the segment that shortens during expansion, maintaining the total stent length almost unchanged during the expansion. Note the regular cellular design of the stent after expansion.

Figure 4  .

Figure 4  

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Quantitative angiographic measurements of a proximal lesion of the left anterior descending coronary artery before treatment and after high pressure expansion of a 32 mm NIR stent. MLD, minimum lumen diameter.

Figure 5  .

Figure 5  

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(A) Example of a bifurcational lesion of the left circumflex-obtuse marginal branch treated with directional atherectomy followed by implantation of a long 32 mm NIR stent in the left circumflex and a 9 mm NIR stent subsequently inserted through the struts of the previously implanted stent at the ostium of the obtuse marginal branch. (B) Left and mid-panel: Example of a bifurcational lesion of the left circumflex-posterolateral branch treated with the implantation of two 9 mm NIR stents, expanded side by side at high pressure in the segment between the two arrows. Right panels: Cross sectional ultrasound (IVUS) image obtained proximal to the bifurcation (arrowhead in the mid-panel) showing the two stents well apposed to the vessel wall on both sides and merging in a central, regular metallic carina in the centre of the artery.

Figure 6  .

Figure 6  

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Bar graphs showing the quantitative ultrasound measurements after stent implantation.

Selected References

These references are in PubMed. This may not be the complete list of references from this article.

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