Reduction of restenosis by vessel size adapted percutaneous transluminal coronary angioplasty using intravascular ultrasound

doi:10.1016/S0002-9149(98)01069-8

The American Journal of Cardiology

Volume 83, Issue 6, 15 March 1999, Pages 875-879

https://doi.org/10.1016/S0002-9149(98)01069-8 Get rights and content

Abstract

Restenosis following percutaneous transluminal coronary angioplasty (PTCA) remains a serious problem in interventional cardiology. Recent trials using stent implantation have proposed a reduction in restenosis, presumably due to a higher initial luminal gain. This study was conducted to evaluate if the short- and long-term results following conventional PTCA may be favorable, if balloon dilation was performed according to measurements gained by intravascular ultrasound (IVUS) (vessel size adapted PTCA). The use of intracoronary stents might be omitted if comparable long-term results could be achieved by this modified technique of balloon angioplasty. This unicenter and nonrandomized pilot trial was initiated in January 1995 with 252 patients who had 271 lesions. IVUS was performed before and after intervention to determine the external elastic membrane (EEM) diameter at the lesion site. The balloon catheter was sized according to the EEM diameter measured by IVUS (EEM 10%). The mean balloon diameter was 4.1 ± 0.5 mm, the dilation time 130 ± 60 seconds with a balloon pressure of 7.0 ± 2.0 atm. Clinical acute and 1-year long-term follow-up were obtained for all patients and follow-up angiography in 71% of patients. Acute events occurred postinterventionally in 5 patients (2%). The cumulative event rate during long-term follow-up was 14%. The angiographic restenosis rate (diameter stenosis >50%) after 1 year was 19%. Vessel size adapted PTCA using IVUS led to favorable acute and long-term results with a low restenosis rate and a low 1-year clinical event rate. Despite dissections that occur frequently using large balloon sizes, an increased rate of major complications did not occur, indicating a safe procedure and substantiating the philosophy of “therapeutic dissections.” The results need to be verified in a randomized trial.

Section snippets

Patients and study protocol

From January 1995 to December 1996, 252 patients with 271 lesions were included in this study. All patients gave their informed consent before the intervention. The study protocol was approved by the local ethical committee. The study population consisted of consecutive patients with typical angina pectoris, documented myocardial ischemia, or both, who were assigned to undergo IVUS-guided PTCA. The angiographic criteria for enrollment in the study included a lesion with a stenosis of ≥70% and

Study population

Two hundred fifty-two patients (202 men and 50 women, age 60 ± 9 years) were included. Cardiovascular risk factors were distributed as follows: hyperlipidemia 154 patients (61%), currently smoking 23 patients (9%), ever smoked 154 patients (61%), diabetes mellitus 51 patients (20%), and hypertension 147 patients (58%). Exertional angina pectoris was classified according to the Canadian Cardiovascular Society (CCS): class I: 90 patients (36%), class II: 106 patients (42%), class III: 48 patients

Discussion

The main conclusions of this study are (1) vessel size adapted PTCA using IVUS leads to favorable “stent-like” long-term results with a low restenosis rate (19%); and (2) dissections that occur frequently using “big balloons” do not lead to an increase of acute complications if at least TIMI flow 3 is present.

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Cited by (28)

Intravascular Ultrasound: Principles and Clinical Applications
2008, Practice of Clinical Echocardiography, Thrid Edition
Evidence and characterization of occlusive coronary artery thrombus by multislice-computed tomography
2007, European Journal of Radiology Extra
Citation Excerpt :
On the contrary, the intermediate and calciphic coronary plaques are less prone to fissuration and hence to the development of ACS [7,8]. Although ICUS is considered the gold standard for coronary plaque characterization [9–11], tissue density determined within atherosclerotic lesions using MSCT might prove to be a useful surrogate for ICUS when evaluating plaque morphology and composition [5]. Leber et al. [12] in an in vivo study showed that lesion echogenicity correlates well with MSCT attenuation measurements in coronary plaques.
In recent years, multislice-computed tomography has been shown to be a reliable tool for non-invasive assessment of atherosclerotic coronary artery plaque, particularly with regard to the location, dimension, morphology, severity and composition of the lesion.
In this report, we describe a case of acute coronary syndrome in which multislice-computed tomography showed evidence of a coronary occluding thrombus which probably dissolved spontaneously, as indicated by emergency coronary angiography.
This was made possible by analyzing retrospectively multislice-computed tomography density values at the site of the occluded vessel, which were ∼50 Hounsfield Units, and comparing them with subsequent coronary angiography which revealed an open coronary vessel.
Although this report needs to be confirmed by more extensive studies, it would seem to indicate that acute coronary syndrome frequently occurs as a consequence of the disruption of slightly occluding, mainly fibro-lipidic coronary plaques.
We conclude that density values of ∼50 Hounsfield Units detected by multislice-computed tomography at the site of an occluded vessel should be interpreted in the first instance as a thrombus of recent formation.
Routine intravascular ultrasound scanning guidance of coronary stenting is not associated with improved clinical outcomes
2004, American Heart Journal
Citation Excerpt :
However, after adoption of the aforementioned interventional strategy, it has proven difficult to demonstrate a durable benefit with aggressive IVUS-guided balloon sizing. Two single-center, nonrandomized studies of aggressive balloon sizing (on the basis of the IVUS-derived media-to-media dimension) and provisional stenting failed to show any differences in the rates of major adverse clinical events or target-vessel revascularization.14,15 Although initially introduced as a “bail-out” option after complicated balloon angioplasty, routine placement of stents during PCI is now recognized as an effective means of reducing restenosis and target-vessel revascularization when compared with balloon angioplasty alone.16,17
The purpose of the current study was to determine whether there is any incremental benefit to routine intravascular ultrasound (IVUS) guidance of percutaneous coronary intervention.
We compared the outcome of 796 patients who underwent an IVUS study (IVUS group) during the index stent procedure with 8274 patients who did not have an IVUS study (angiography group). The primary end point was the composite end point of death, myocardial infarction, or ischemia-driven target vessel revascularization within 9 months of the index stent procedure. There were statistically significant differences in multiple procedural characteristics. Most importantly, those patients who underwent an IVUS study had a larger postprocedural minimal lumen diameter and smaller postprocedural percent diameter stenosis. However, there was no significant difference between the IVUS group and the angiography group with respect to the primary end point (RR 1.10, 95% CI 0.91, 1.32) or any of the individual clinical end points. Adjustment for multiple clinical and procedural characteristics did not significantly alter these findings.
These data suggest that the routine performance of IVUS during stent placement influences the performance of the procedure, as judged by differences in procedural characteristics, but does not improve clinical outcome at 9 months.
Accuracy and reliability of quantitative measurements in coronary arteries by multi-slice computed tomography: Experimental and initial clinical results
2001, Clinical Radiology
AIM: To evaluate the accuracy of non-invasive measurements within coronary arteries by multi-slice computed tomography (MSCT). We present experimental as well as clinical data. MATERIALS AND METHODS: Silicon tubes simulating coronary arteries (outer diameter 6 mm, lumen diameter within stenotic area 2 mm) were used for experimental studies. Clinical data were derived from 15 patients in whom vessel diameters were assessed by MSCT, intracoronary ultrasound (ICUS) and quantitative coronary angiography (QCA). MSCT were performed in a Somatom Volume Zoom^™CT system (Siemens, Forchheim, Germany) at 2 collimated slice widths (2.5 mm, 1.0 mm). RESULTS: Outer silicon tube diameters were overestimated by MSCT (6.56 mm ± 0.32 mm). All measurements revealed significantly better results on 1.0 collimation compared to 2.5 mm collimation (outer diameter: 6.36 mm ± 0.22 mm vs 6.76 mm ± 0.27 mm, P < 0.0001; lumen diameters: 1.83 mm ± 0.14 mm vs 1.51 mm ± 0.19 mm,P < 0.0001). The comparison of vessel diameters within human coronary arteries revealed comparable results between ICUS and MSCT (4.89 mm ± 0.67 mm vs 4.91 mm ± 0.71 mm, P = 0.79,r = 0.79, P < 0.0001). QCA-measurements showed significantly lower results (3.67 ± 0.71, P < 0.0001,r = 0.62, P < 0.001). CONCLUSIONS: Experimental as well as initial clinical results indicate acceptable reliability and accuracy of quantitative measurements by MSCT, when using thin collimated slice widths. Partial volume effects lead to a systematic overestimation of vessel size. MSCT has the potential to become an important non-invasive diagnostic tool in patients with coronary artery disease. Schroeder, S.et al. (2001). Clinical Radiology56, 466–474.
Noninvasive detection and evaluation of atherosclerotic coronary plaques with multislice computed tomography
2001, Journal of the American College of Cardiology
Citation Excerpt :
Only those plaques were analyzed that could be clearly identified and in which plaque burden could be visualized in its total extension. Plaque configuration was classified according to ICUS criteria as recently reported (17–20). Briefly, the classification consists of three groups.
OBJECTIVES
The aim of the present study was to evaluate the accuracy in determining coronary lesion configuration by multislice computed tomography (MSCT). The results were compared with the findings of intracoronary ultrasound (ICUS).
BACKGROUND
The risk of acute coronary syndromes caused by plaque disruption and thrombosis depends on plaque composition rather than stenosis severity. Thus, the reliable noninvasive assessment of plaque configuration would constitute an important step forward for risk stratification in patients with known or suspected coronary artery disease. Just recently, MSCT scanners became available for general purpose scanning. Due to improved spatial and temporal resolution, this new technology holds promise to allow for differentiation of coronary lesion configuration.
METHODS
The ICUS and MSCT scans (Somatom Volume Zoom, Siemens, Forchheim, Germany) were performed in 15 patients. Plaque composition was analyzed according to ICUS (plaque echogenity: soft, intermediate, calcified) and MSCT criteria (plaque density expressed by Hounsfield units [HU]).
RESULTS
Thirty-four plaques were analyzed. With ICUS, the plaques were classified as soft (n = 12), intermediate (n = 5) and calcified (n = 17). Using MSCT, soft plaques had a density of 14 ± 26 HU (range −42 to +47 HU), intermediate plaques of 91 ± 21 HU (61 to 112 HU) and calcified plaques of 419 ± 194 HU (126 to 736 HU). Nonparametric Kruskal-Wallis test revealed a significant difference of plaque density among the three groups (p < 0.0001).
CONCLUSIONS
Our results indicate that coronary lesion configuration might be correctly differentiated by MSCT. Since also rupture-prone soft plaques can be detected by MSCT, this noninvasive method might become an important diagnostic tool for risk stratification in the near future.
Self-rated health and clinical status after PTCA: Results of a 4-year follow-up in 500 patients
2001, European Journal of Internal Medicine
Background: Data on the clinical long-term outcome of patients with coronary artery disease in the years following percutaneous interventions are rare. We therefore decided to conduct a study to: (1) analyze the efficiency of a retrospective inquiry using a questionnaire and (2) perform a clinical long-term follow-up of our patients. Methods and results: Some 45±7 months after PTCA, a questionnaire was sent to 549 patients who had been treated at our institution from July 1, 1989, to June 30, 1991. The response rate was 91.1%, with 49 patients (8.9%) lost to follow-up. A total of 115/500 patients (23%) had reinterventions due to severe angina (69 patients (13.8%) undergoing re-PTCA and 46 (9.2%) CABG). Sixteen patients (3.2%) had a myocardial infarction and 35 patients (7.0%) died. Multivariate analysis revealed that patients who were asymptomatic 3 months after PTCA were likely to have a good long-term outcome. This was not found when comparing the clinical status immediately after PTCA to follow-up. Medical therapy with β-blockers/aspirin/lipid-lowering drugs decreased from 75.2/82.2/35.4% at hospital discharge to 54.6/76.7/25.2% at follow-up. Conclusions: The present study provided important quality data for our institution. The response rate to the questionnaire was surprisingly high (91.1%), indicating that retrospective inquiries may also be efficient. The rate of reinterventions during long-term follow-up (23%) was acceptably low. Good self-rated health 3 months after the intervention turned out to be a strong predictor for a good clinical long-term outcome. Furthermore, we observed an underuse of cardiac medication, something that will be the subject of further quality improvement measures.

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Coronary Artery DiseaseReduction of restenosis by vessel size adapted percutaneous transluminal coronary angioplasty using intravascular ultrasound

Abstract

Section snippets

Patients and study protocol

Study population

Discussion

J Am Coll Cardiol

J Am Coll Cardiol

Am J Cardiol

J Am Coll Cardiol

Am J Cardiol

Acute and one year follow-up results after vessel size adapted PTCA using intracoronary ultrasound

Europ Heart J

Prevention of restenosis

Cardioscop

Porous balloon delivery of low molecular weight heparin in the dog coronary artery

Eur Heart J

Effects of Octreotide treatment on restenosis after coronary angioplasty. Results of the VERAS study

Circulation

A comparison of balloon-expantable stent implantation with ballon angioplasty in the treatment of coronary artery disease

N Engl J Med

A randomized comparison of coronary stent placement and balloon angioplasty in the treatment of coronary artery disease

N Engl J Med

Coronary Artery Disease
Reduction of restenosis by vessel size adapted percutaneous transluminal coronary angioplasty using intravascular ultrasound