Early time course of neointima formation and vascular remodelling following percutaneous coronary intervention and vascular brachytherapy of in-stent restenotic lesions as assessed by intravascular ultrasound analysis

Summary In-stent restenosis (ISR) represents the major limitation of stent implantation. Treatment, although of relative technical ease, is unsatisfactory due to a high incidence of recurrent restenosis. Vascular brachytherapy (VBT) has emerged as a powerful adjunct therapeutic modality to treat ISR. Inhibition of neointima formation has been regarded as the relevant mechanism of action. Yet, positive remodelling has been suspected as another contributing factor. Since only very few precise analyses of the extent, distribution and time course of the respective mechanims exist, the goal of the present study was to describe the changes of the vessel geometry at the target lesion and at the reference site following angioplasty and VBT of ISR in 42 patients by means of quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS) before and after the index procedure and at the 3 and 6 month follow-up.By QCA the acute lumen gain measured 2.2±0.8 mm, the late lumen loss at 3 months was 0.1±0.5 mm and at 6 months 0.4±0.7 mm. By IVUS luminal cross-sectional area increased from 1.5±1.2 mm² to 7.9±1.9 mm² (p<0.001). The intima hyperplasia cross-sectional area at 3 months was only 0.2±1.0 mm² (p=0.191), but increased to 0.7±0.6 mm² (p<0.001) at 6 months resulting in a lumen cross-sectional area of 7.1±1.7 mm². Stent dimensions did not show any significant changes over time. The external elastic membrane cross-sectional area at 3 months increased by 1.3±1.9 mm² (p<0.001), and showed a further increase by 0.7±2.9 mm² at 6 months. Positive remodelling could be demonstrated also at the reference segment.In conclusion the absolute amount of intima hyperplasia during a 6-month follow-up period after VBT of ISR is low and most pronounced between the third and sixth month. Besides this, predominantly within the first 3 months of follow-up, significant positive remodelling could be demonstrated at the target lesion and at the reference site. Both observed effects may contribute to the preservation of the vessel lumen.Diese Publikation enthält die Ergebnisse der Promotionsarbeit von Frau Andrea Zimmermann     

多聚物型可吸收冠状动脉支架的研究进展

新一代药物洗脱支架由可吸收多聚物为平台,具有与金属支架相当的的支撑力,以及良好的生物相容性.既可以暂时支撑管壁,抑制早期血栓形成及晚期新生内膜增生,还可作为良好的药物载体实现局部控制释放,达到有效防止支架置入后的血管急性闭塞和降低再狭窄率.     

Contribution of early lumen loss after balloon angioplasty for in-stent restenosis to lumen loss at follow-up.

The treatment of in-stent restenosis using balloon angioplasty alone often produces excellent early results, but is associated with high rate of recurrence. Previous studies have demonstrated significant tissue reintrusion shortly after the treatment of in-stent restenosis with balloon angioplasty. The study was designed to elucidate the contribution of early lumen loss 6 hr after balloon angioplasty to lumen loss at follow-up. We prospectively performed quantitative coronary angiography and intravascular ultrasound in 12 patients with in-stent restenosis before intervention, after the final procedure, 6 hr later (5.6 +/- 1.4 hr), and at follow-up (7.7 +/- 2.3 months). Compared with immediately after balloon angioplasty, by 6 hr postintervention, the minimum lumen diameter (MLD) and lumen cross-sectional area had decreased significantly (2.48 +/- 0.44 to 2.01 +/- 0.57 mm, P = 0.01, and 7.0 +/- 1.2 to 5.5 +/- 1.4 mm2, P = 0.004, respectively). Furthermore, the MLD decreased further between 6 hr postintervention and long-term follow-up (2.01 +/- 0.57 to 1.55 +/- 0.64 mm; P = 0.001). Patients who showed recurrence of restenosis at follow-up had greater early lumen loss than patients without recurrence of restenosis (0.71 +/- 0.31 vs. 0.23 +/- 0.13 mm; P = 0.006). Diffuse lesions had greater early lumen loss compared to focal lesions (0.75 +/- 0.35 vs. 0.28 +/- 0.13 mm; P = 0.008). Early lumen loss is common after the treatment of in-stent restenosis by balloon angioplasty. Within the first 6 hr postintervention, 32% +/- 29% of acute lumen gain is lost, and early lumen loss contributed to 42% +/- 18% of total lumen loss at follow-up.     

CT Perfusion Versus Coronary CT Angiography in Patients With Suspected In-Stent Restenosis or CAD Progression

ObjectivesThe goal of this study was to assess the diagnostic performance of coronary computed tomography angiography (CTA) alone, adenosine-stress myocardial perfusion assessed by computed tomography (CTP) alone, and coronary CTA + CTP by using a 16-cm Z-axis coverage scanner versus invasive coronary angiography (ICA) and fractional flow reserve (FFR) as the clinical standard.BackgroundDiagnostic performance of coronary CTA for in-stent restenosis detection is still challenging. Recently, CTP showed additional diagnostic power over coronary CTA in patients with suspected coronary artery disease. However, few data are available on CTP performance in patients with previous stent implantation.MethodsConsecutive stable patients with previous coronary stenting referred for ICA were enrolled. All patients underwent stress myocardial CTP and rest CTP + coronary CTA. Invasive FFR was performed during ICA when clinically indicated. The diagnostic rate and diagnostic accuracy of coronary CTA, CTP, and coronary CTA + CTP were evaluated in stent-, territory-, and patient-based analyses.ResultsIn the 150 enrolled patients (132 men; mean age 65.1 ± 9.1 years), the CTP diagnostic rate was significantly higher than that of coronary CTA in all analyses (territory based [96.7% vs. 91.1%; p < 0.0001] and patient based [96% vs. 68%; p < 0.0001]). When ICA was used as gold standard, CTP diagnostic accuracy was significantly higher than that of coronary CTA in all analyses (territory based [92.1% vs. 85.5%, p < 0.03] and patient based [86.7% vs. 76.7%, p < 0.03]). The concordant coronary CTA + CTP assessment exhibited the highest diagnostic accuracy values versus ICA (95.8% in the territory-based analysis). The diagnostic accuracy of CTP was significantly higher than that of coronary CTA (75% vs. 30.5%; p < 0.001). The radiation exposure of coronary CTA + CTP was 4.15 ± 1.5 mSv.ConclusionsIn patients with coronary stents, CTP significantly improved the diagnostic rate and accuracy of coronary CTA alone compared with both ICA and invasive FFR as gold standard.     

川芎嗪药物涂层支架预防猪冠状动脉再狭窄的实验研究

目的 探讨川芎嗪药物涂层支架(TES)预防冠状动脉再狭窄的作用机制及其有效性.方法 TES为金属管状支架经喷涂川芎嗪单体制成(含川芎嗪200μg).采用随机、双盲实验在14只小型猪的冠状动脉左前降支分别置入TES及金属裸支架(BMS)(实验组7只,对照组7只).支架置入前后均行定量冠状动脉造影(QCA)及血管内超声(IVUS)检查.术后第28天随访行QCA及ⅣUS观察支架内膜增殖及血栓形成情况.实验终点处死动物,获取支架置入段血管及支架前后5 cm处组织行病理学及免疫组化检查.结果 14只动物均成功置入支架,4只动物因手术意外死亡未列入统计.5只动物于左前降支置入TES,5只动物置入BMs.术后第28天随访,QCA检查支架段血管直径狭窄百分比两组分别为实验组(10.0±2.1)%和对照组(60.2±23.5)%(P=0.01).IVUS检查显示,两组支架内面积相似,均未见血栓形成.对照组内弹力膜面积较实验组明显减小(P=0.021),而新生内膜面积明显增大(P=0.004).术后处死动物组织形态学检查显示两组血管损伤评分和支架内面积相近(P>0.05),均无明显的炎症反应,但实验组管腔面积[(4.34±0.93)mm2]较对照组[(1.29±1.02)mm2]明显增加(P=0.011),新生内膜面积[(1.51±0.45)mm2]较对照组[(4.60±1.39)mm2]明显减少(P=0.004).组织病理学检查提示所有支架置入节段均完全内皮化,实验组增殖细胞核抗原染色阳性细胞核明显减少,凋亡细胞较对照组增多.结论 川芎嗪药物涂层支架能有效抑制血管内膜增殖及血栓形成,减少支架内再狭窄.     

Results of percutaneous transseptal mitral commissurotomy in patients 40 years and above with those under 40 years of age: immediate and 5-year follow-up results

Patients with mitral stenosis in Western countries are relatively old. It is anticipated that percutaneous transseptal mitral commissurotomy (PTMC) may have more complications and may not be as effective in this group of patient as in younger patients due to more calcification and fibrosis of the mitral valve. We analysed the clinical, hemodynamic, echocardiographic data in 296 consecutive patients divided prospectively into two groups; group 1 consisted of 184 patients ≥ 40 years and group 2 of 112 patients < 40 years coming mostly from developing countries. The immediate gain in valve area was 2.18 ± 0.61 cm² in group 1 vs. 2.31 ± 0.65 cm² in group 2 (P = ns). The incidence of acute regurgitation requiring surgical intervention was similar in both groups. Follow-up data up to 5 years after PTMC was available in 170 patients (92.4%) in group 1 (mean 20 ± 13 months) and 83 patients (74.1%) in group 2 (mean 29 ± 17 months). Restenosis by Doppler method (valve area less than 1.5 cm² with loss of at least 50% initial gain in valve area) was found in 33 patients in group 1 (29.2%) vs. 11 (14.9%) in group 2 (P < 0.05). Events free from death, need for mitral valve replacement or repeat PTMC at 5 year follow-up was 76% in group 1 vs. 87% in group 2 (P < 0.05). We conclude that the immediate effectiveness and acute complications of PTMC in patients 40 years and above are comparable to younger patients. Restenosis is clearly higher and there is a trend towards need for mitral valve replacement in patients 40 years and above at follow-up. However, the continuing benefit for the majority of the patients 40 years and above (76% free from adverse events) would suggest that PTMC is an appropriate treatment modality even in the older patients. © 1994 Wiley-Liss,Inc..     

Left internal mammary graft stenosis and restenosis following angioplasty and stenting

Coronary bypass grafts using the internal mammary artery usually have an excellent record of success and long term patency. We report a 42 year old man who initially presented with a history of atypical left sided chest pain, who had coronary artery bypass surgery for a severe stenosis in his proximal left anterior descending coronary artery (LAD) and moderate stenosis of his proximal circumflex artery, with his LIMA being grafted to his mid-LAD and a saphenous venous graft to the proximal LAD. He subsequently developed multiple stenoses in the LIMA graft which required coronary augioplasty and stenting, on more than one occasion, in view of very rapid restenosis within the LIMA graft.


Keywords: graft patency; left internal mammary artery grafts; restenosis; stenosis     

Immediate and chronic results of cutting balloon angioplasty: A matched comparison with conventional angioplasty

Background: At the initial stages of percutaneous transluminal coronary angioplasty (PTCA), several studies reported on the feasibility of coronary artery incision and dilatation leading to the extension of the PTCA technique. Hypothesis: This study was designed to determine the immediate and chronic results of cutting balloon (CB) angioplasty. Methods: This procedure was performed on 127 lesions in 110 patients (male 83%, age 61.8 ± 9.3 years). Results: The overall procedural success rates for the CB were 93.7% (119 lesions) and 92.7% (102 patients), while solitary CB without pre- and/or postdilatation was 76.4% (91 lesions). There was one major in-hospital complication (Q-wave myocardial infarction, 0.9%), but there were no deaths or emergency coronary artery bypass graftings. Significant angiographic dissections (≥ grade C) occurred in four patients, and coronary perforation occurred in one. The successfully treated CB group (95 lesions) was matched with the successful conventional angioplasty group (PTCA group) for chronic result assessment in regard to reference vessel size and lesion characteristics. In the CB group, postprocedural minimal luminal diameters were significantly larger and the percentage of stenosis at the stenotic site was significantly lower compared with the PTCA group. Restenosis occurred in 22 lesions (23.1%). This showed a significantly lower restenosis rate compared with the PTCA group (42.1%). In addition, the restenosis rate of the CB without inclusion of the pre- and/or postdilatation-treated lesions was 19.7%. Conclusions: (1) Cutting balloon angioplasty procedures can be performed with high success rates with few major in-hospital events. (2) The restenosis rate in the CB group was significantly lower compared with the PTCA group.     

Usefulness of multidetector CT imaging to assess vascular stents in children with congenital heart disease: An in vivo and in vitro study

Objective : To evaluate varying CT settings to visualize pediatric vascular stents in comparison to digital angiography (DA). Background : There is a great clinical interest in substituting noninvasive methods to follow up children with congenital heart disease after interventional treatment. Materials and Methods : CT studies in small children with transcatheter placed stents were reviewed, retrospectively. Furthermore, eight stents were implanted in tubes and partially obstructed. CT exams were performed on varying scanners (4 up to 64 slices) with corresponding tube settings. The effects of dose on image quality were evaluated regarding stent size, strut thickness, and in‐stent stenoses in comparison to DA. Results : Fourteen children with 28 implanted stents were identified. Significant differences between higher and lower radiation settings were not found, corresponding with the phantom, where moderate tube setting showed the best results. In vitro, there was an improvement with increasing number of detector rows, which resulted in a decrease of stent strut overestimation (295% down to 201%; P < 0.0001) and a better agreement with DA measurements for mild (78% up to 91%; P = 0.003) and moderate in‐stent stenoses (80% up to 99%; P = 0.0001). Conclusion : Higher radiation exposure settings did not improve image quality, suggesting that the exams could be performed at a lower radiation dose. © 2008 Wiley‐Liss, Inc.     

The NUGGET study: NIR ultra gold-gilded equivalency trial.

This study should clarify whether the gold-coated NIROYAL stent is equivalent to the stainless steel NIR stent. Patients were randomized to either NIR stent (n = 298) or a NIROYAL stent (n = 305). The primary endpoint was the minimum lumen diameter of the target lesion at 6 months postprocedure. Secondary endpoints focused on clinical events. At 30 days, adverse events were similar in both groups. At 6 months, the minimal lumen diameter was 1.83/1.64 mm (P < 0.001; 95% CI = 0.08-0.30) and the angiographic restenosis rate was 20.6%/37.7% (P < 0.001; 95% CI = -24.7 to -9.3) for NIR/NIROYAL. The 6-month MACE rates were NIR 7.4% and NIROYAL 10.5% (95% CI = -7.7 to 1.4). Compared to stainless steel stent, the NIROYAL stent demonstrated a smaller minimal lumen diameter, a higher late loss (i.e., higher neointimal hyperplasia in spite of a significantly better initial gain), with higher restenosis and similar MACE rates at 6 months.