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In the development of intravascular ultrasound (IVUS), a serious emphasis has been given to the improvement of the image quality in terms of resolution. The image quality is indeed a very important issue, but there is a lot more information hidden in the ultrasound signals than is currently exploited by commercially available IVUS equipment. For several years, at the Thorax Centre, we have been exploring the possibilities of analysing sequences of radiofrequency (RF) traces to extend the functionality of the IVUS machines. It gives possibilities for local elasticity assessment, flow estimation and enhanced lumen detection. This paper is an up to date report of where RF-data analysis has taken us.

ObjectivesTo assess the influence of smoking on restenosis after coronary angioplasty.Design and patientsThe incidence of smoking on restenosis was investigated in 2948 patients. They were prospectively enrolled in four major restenosis trials in which quantitative angiography was used before and immediately after successful angioplasty and again at six months.ResultsWithin the study population there were 530 current smokers, 1690 ex-smokers, and 728 non-smokers. Smokers were more likely to be men (85.9% v 87.5% v 65.3%, current v ex- v non-, p < 0.001), to be younger (54.0 (9.0) v 57.0 (9.1) v 59.9 (9.4) years, p < 0.001), to have peripheral vascular disease (7.2% v 5.5% v 2.3%, p < 0.001), and have sustained a previous myocardial infarction (42.9% v 43.9% v 37.9%, p = 0.022), but were less likely to be diabetic (9.1% v 9.5% v 12.6%, p = 0.043) or hypertensive (24.9% v 29.3% v 37.2, p < 0.001). There was no significant difference in the categorical restenosis rate (> 50% diameter stenosis) at six months (35.28% v 35.33% v 37.09%, current v ex- v non-), or the absolute loss (0.29 (0.54) v 0.33 (0.52) v 0.35 (0.55) mm, respectively; p = 0.172).ConclusionsAlthough smokers have a lower incidence of known predisposing risk factors for atherosclerosis, they require coronary intervention almost six years earlier than non-smokers and three years earlier than ex-smokers. Once they undergo successful coronary angioplasty, there appears to be no evidence that smoking influences their short term (six month) outcome, but because of the known long term effects of smoking, patients should still be encouraged to discontinue the habit.

ObjectiveTo improve the biocompatibility of stents using a phosphorylcholine coated stent as a form of biomimicry. InterventionsImplantation of phosphorylcholine coated (n = 20) and non-coated (n = 21) stents was performed in the coronary arteries of 25 pigs. The animals were killed after five days (n = 6), four weeks (n = 7), and 12 weeks (n = 8), and the vessels harvested for histology, scanning electron microscopy, and morphometry. Main outcome measuresStent performance was assessed by studying early endothelialisation, neointima formation, and vessel wall reaction to the synthetic coating. ResultsStent thrombosis did not occur in either group. Morphometry showed no significant differences between the two study groups at any time point. At five days both the coated and non-coated stents were equally well endothelialised (91% v 92%, respectively). At four and 12 weeks there was no difference in intimal thickness between the coated and non-coated stents. Up to 12 weeks postimplant the phosphorylcholine coating was still discernible in the stent strut voids, and did not appear to elicit an adverse inflammatory response. ConclusionIn this animal model the phosphorylcholine coating showed excellent blood and tissue compatibility, unlike a number of other polymers tested in a similar setting. Given that the coating was present up to 12 weeks postimplant with no adverse tissue reaction, it may be a potential candidate polymer for local drug delivery.

ObjectiveTo evaluate the healing of balloon induced coronary artery dissection in individuals who have received β radiation treatment and to propose a new intravascular ultrasound (IVUS) dissection score to facilitate the comparison of dissection through time. DesignRetrospective study. SettingTertiary referral centre. Patients31 patients with stable angina pectoris, enrolled in the beta energy restenosis trial (BERT-1.5), were included. After excluding those who underwent stent implantation, the evaluable population was 22 patients. InterventionsBalloon angioplasty and intracoronary radiation followed by quantitative coronary angiography (QCA) and IVUS. Repeat QCA and IVUS were performed at six month follow up. Main outcome measuresQCA and IVUS evidence of healing of dissection. Dissection classification for angiography was by the National Heart Lung Blood Institute scale. IVUS proven dissection was defined as partial or complete. The following IVUS defined characteristics of dissection were described in the affected coronary segments: length, depth, arc circumference, presence of flap, and dissection score. Dissection was defined as healed when all features of dissection had resolved. The calculated dose of radiation received by the dissected area in those with healed versus non-healed dissection was also compared. ResultsAngiography (type A = 5, B = 7, C = 4) and IVUS proven (partial = 12, complete = 4) dissections were seen in 16 patients following intervention. At six month follow up, six and eight unhealed dissections were seen by angiography (A = 2, B = 4) and IVUS (partial = 7, complete = 1), respectively. The mean IVUS dissection score was 5.2 (range 3-8) following the procedure, and 4.6 (range 3-7) at follow up. No correlation was found between the dose prescribed in the treated area and the presence of unhealed dissection. No change in anginal status was seen despite the presence of unhealed dissection. Conclusionβ radiation appears to alter the normal healing process, resulting in unhealed dissection in certain individuals. In view of the delayed and abnormal healing observed, long term follow up is indicated given the possible late adverse effects of radiation. Although in this cohort no increase in cardiac events following coronary dissections was seen, larger populations are needed to confirm this phenomenon. Stenting of all coronary dissections may be warranted in patients scheduled for brachytherapy after balloon angioplasty.

AimsTo classify atherosclerotic coronary lesions on the basis of adequate or inadequate compensatory vascular enlargement, and to examine changes in lumen, plaque, and vessel volumes during balloon optimised directional coronary atherectomy procedures in relation to the state of adaptive remodelling before the intervention. Design29 lesion segments in 29 patients were examined with intravascular ultrasound before and after successful balloon optimised directional coronary atherectomy procedures, and a validated volumetric intravascular ultrasound analysis was performed off-line to assess the atherosclerotic lesion remodelling and changes in plaque and vessel volumes that occurred during the intervention. Based on the intravascular ultrasound data, lesions were classified according to whether there was inadequate (group I) or adequate (group II) compensatory enlargement. ResultsThere was no significant difference in patient and lesion characteristics between groups I and II (n = 10 and 19), including lesion length and details of the intervention. Quantitative coronary angiographic data were similar for both groups. However, plaque and vessel volumes were significantly smaller in group I than in II. In group I, 9 (4)% (mean (SD)) of the plaque volume was ablated, while in group II 16 (11)% was ablated (p = 0.01). This difference was reflected in a lower lumen volume gain in group I than in group II (46 (18) mm³ v 80 (49) mm³ (p < 0.02)). ConclusionsPreintervention lesion remodelling has an impact on the operative mechanisms of balloon optimised directional coronary atherectomy procedures. Plaque ablation was found to be particularly low in lesions with inadequate compensatory vascular enlargement.

Background Tranilast is a unique drug in clinical development for the prevention of restenosis after percutaneous transluminal coronary revascularization (PTCR). Tranilast interferes with proliferation and migration of vascular medial smooth muscle cells induced by platelet-derived growth factor and transforming growth factor @b1. Collagen synthesis in vascular medial smooth muscle cells is inhibited by tranilast, which also inhibits the release or production of cyclooxygenase-2 and restores cytokine-induced nitric oxide production. These mechanisms may contribute to the reduction of angiographic restenosis after coronary intervention previously reported in clinical studies. Methods The primary objective of this multicenter study of 11,500 patients is to compare the composite clinical event rate of death, myocardial infarction, or the need for ischemia-driven target vessel revascularization of tranilast (300 and 450 mg twice daily) for 1 or 3 months with that of placebo in patients undergoing PTCR with or without stenting for single or multiple vessels over a 9-month period. The lesions can be de novo or restenotic. All revascularization procedures and the use of glycoprotein IIb/IIIa agents are permitted. The inclusion criteria are meant to allow an ''all comer'' approach for generalization of results to the broadest possible PTCR population. A subset population (n = 2000) will undergo 9-month follow-up angiography, 1000 of which will also undergo intravascular ultrasound (n = 1000). This study is the first tranilast trial to be conducted in a Western population to confirm the improved angiographic findings reported in Japanese patients and to determine if the clinical sequelae of restenosis are also reduced. Conclusion This multicenter study is the largest restenosis trial planned to date. It will test whether tranilast, a drug with multiple actions aimed at affecting proliferation and migration of vascular smooth muscle cells, can reduce clinical, angiographic, and intravascular ultrasound assessments of restenosis. (Am Heart J 2000;139:23-31.)

Two strategies for treatment of acute myocardial infarction were compared in a randomised trial of 533 patients admitted within 4 h of the onset of symptoms. 264 patients were allocated to conventional treatment and 269 patients to a strategy aimed at rapid recanalisation of the occluded coronary artery. At first, intracoronary streptokinase (up to 250 000 U) was given immediately after angiography. In the last 117 patients intracoronary administration was preceded by intravenous streptokinase (500 000 U). No angiography was done in 35 patients allocated to thrombolytic therapy. Among the 234 patients who underwent angiography the infarct-related coronary artery was patent on admission or recanalised in 198 (85%). The median time between onset of symptoms and angiographic confirmation of a patent infarct-related artery was 200 min. Mortality was lower in patients randomised to thrombolysis than in controls at 28 days (16 v31 patients) and at 8 months (23 v42); 1-year survival was higher after thrombolysis (91%) than conventional treatment (84%). The clinical course in hospital was more favourable in patients allocated to thrombolysis, with a lower incidence of ventricular fibrillation (38 v61), pericarditis (19 v46), and cardiogenic shock (13 v24), although they had a higher frequency of bleeding episodes (53 v7). Non-fatal reinfarction was commoner after thrombolysis than after conventional therapy (36 v16 patients). In both groups reinfarctions occurred predominantly in the same area as the initial infarct.

Background Patients with symptomatic myocardial ischemia from a chronic totally occluded coronary (TOC) artery are usually referred for coronary artery bypass surgery. Because guide wire technology has improved considerably in recent years, percutaneous coronary angioplasty has become a useful technique in opening chronic TOC arteries. We evaluated the early functional results of successful percutaneous recanalization by performing dobutamine stress echocardiography (DSE). Methods Fifteen patients with a chronic TOC artery who underwent a successful recanalization were prospectively studied. Each patient had a DSE within 24 hours before and 48 hours after the procedure. Wall motion was scored according to a 16-segment/5-point model. A clinical and angiographic follow-up of 6 months was obtained. Results The wall motion score index at rest improved from 1.26 +/- 0.23 before to 1.22 +/- 0.21 after the procedure (P < .05). Of those 10 segments that improved at rest, 7 were collateral recipients and 3 were collateral donors. The number of ischemic segments decreased from 46 before to 4 after the procedure (P < .0001). Wall motion score index at peak stress improved from 1.34 +/- 0.20 before to 1.15 +/- 0.12 after the procedure (P < .05). DSE was positive for ischemia in 15 patients before and 2 patients after the procedure (P < .0001). Angina was present in 12 patients before and in 2 patients after recanalization (P < .0001). Two patients (13%) had angiographic reocclusion and 5 (33%) restenosis after 6 months of follow-up. Conclusions Successful percutaneous recanalization of chronic TOC artery results in an early improvement of both clinical status and resting or stress-induced wall motion abnormalities, as detected by DSE. (Am Heart J 1998;136:831-6.)

Objectives To compare clinical outcome in patients with complex coronary lesions treated with either excimer laser coronary angioplasty (ELCA) or balloon angioplasty. Patients and design 308 patients with stable angina and a coronary lesion of more than 10 mm in length were randomised to ELCA (151 patients, 158 lesions) or balloon angioplasty (157 patients, 167 lesions). The primary clinical end points were death, myocardial infarction, coronary bypass surgery, or repeated coronary angioplasty of the randomised segment during six months of follow up. Subanalysis was performed to identify a subgroup of patients with a beneficial clinical outcome following ELCA or balloon angioplasty. Setting Two university hospitals and one general hospital. Results There were no deaths. Myocardial infarction, coronary bypass surgery, and repeated angioplasty occurred in 4.6, 10.6, and 21.2%, respectively, of patients treated with ELCA compared with 5.7, 10.8, and 18.5%, respectively, of those treated with balloon angioplasty. ELCA did not yield a favourable clinical outcome in subgroups of patients with long (more than 20 mm) coronary lesions, calcified lesions, small diseased vessels (≤2.5 mm reference diameter), or total coronary occlusions. There was a worse clinical outcome in patients with tandem lesions treated with ELCA compared with balloon angioplasty (9/18 v 3/26 lesions; p = 0.01); while a trend towards an unfavourable clinical outcome was found in patients with vessels with a reference diameter of more than 2.5 mm (23/66 v 13/63 lesions, p = 0.07) and left circumflex coronary lesions (12/41 v 6/42 lesions, p = 0.08). Conclusions The findings indicate a worse clinical outcome in patients with lesions of more than 10 mm treated with ELCA compared with balloon angioplasty who have tandem coronary lesions and in those with vessels with a reference diameter of more than 2.5 mm and left circumflex coronary lesions.

Coronary stents were developed to overcome the two main limitations of balloon angioplasty, acute occlusion and long-term restenosis. Coronary stents can tack back intimal flaps and seal the dissected vessel wall, thereby treating acute or threatened vessel closure after unsuccessful balloon angioplasty. After successful balloon angioplasty, stents can prevent late vessel remodeling (chronic vessel recoil) by mechanically enforcing the vessel wall and resetting the vessel size, resulting in a low incidence of restenosis. All currently available stents are composed of metal, and the long-term effects of their implantation in the coronary arteries are still not clear. Because of the metallic surface, they are also thrombogenic; therefore, rigorous antiplatelet or anticoagulant therapy is theoretically required. Furthermore, they have an imperfect compromise between scaffolding properties and flexibility, resulting in an unfavorable interaction between stents and unstable or thrombus-laden plaque. Finally, they still induce substantial intimal hyperplasia that may result in restenosis. Future stents can be made less thrombogenic by modifying the metallic surface or coating it with an antithrombotic agent or a membrane eluting an antithrombotic drug. The unfavorable interaction with the unstable plaque and the thrombus burden can be overcome by covering the stent with a biological conduit, such as a vein, or a biodegradable material that can be endogenous, such as fibrin, or exogenous, such as a polymer. Finally, the problem of persisting induction of intimal hyperplasia may be overcome with the use of either a radioactive stent or a stent eluting an antiproliferative drug.

To determine whether metallic stent implantation within a coronary artery modifies the accuracy of angina or exercise test results in predicting stenosis, we studied 172 patients assigned to stent implantation and 153 patients assigned to balloon angioplasty enrolled in the Benestent trial comparing de novo stenting with conventional balloon angioplasty. Sensitivity and specificity curves were constructed for the prediction of percentage diameter stenosis and minimal lumen diameter. Receiver-operator curves were constructed for comparison of diagnostic accuracy. Identical exercise load and duration were achieved in the two groups, despite a better angiographic result in patients treated with a stent. Similarly, the diagnostic accuracy of clinical symptoms or exercise test results as a function of the angiographic results were similar in patients with and patients without a stent. The intersection points of the sensitivity and specificity curves for recurrent angina or ST-segment depression were 72% to 77%. The corresponding cut-off points for percentage diameter stenosis were, respectively, 52% and 50% for patients with and without a stent (1.35 and 1.50 mm for minimal lumen diameter). We conclude that the presence of an intracoronary stent does not affect the diagnostic accuracy of recurrent angina or exercise-induced ST depression in predicting residual stenosis. We also conclude that exercise tolerance is similar after balloon angioplasty, with or without stenting, despite a better angiographic outcome in the group receiving a stent, suggesting a minimal threshold beyond which the patient is no longer at risk for ischemia during exercise. (Am Heart J 1997;133:240-8.)

Objective To compare vessel, lumen, and plaque volumes in atherosclerotic coronary lesions with inadequate compensatory enlargement versus lesions with adequate compensatory enlargement. Design 35 angiographically significant coronary lesions were examined by intravascular ultrasound (IVUS) during motorised transducer pullback. Segments 20 mm in length were analysed using a validated automated three dimensional analysis system. IVUS was used to classify lesions as having inadequate (group I) or adequate (group II) compensatory enlargement. Results There was no significant difference in quantitative angiographic measurements and the IVUS minimum lumen cross sectional area between groups I (n = 15) and II (n = 20). In group I, the vessel cross sectional area was 13.3 (3.0) mm ² at the lesion site and 14.4 (3.6) mm ² at the distal reference (p &lt; 0.01), whereas in group II it was 17.5 (5.6) mm ² at the lesion site and 14.0 (6.0) mm ² at the distal reference (p &lt; 0.001). Vessel and plaque cross sectional areas were significantly smaller in group I than in group II (13.3 (3.0) v 17.5 (5.6) mm ², p &lt; 0.01; and 10.9 (2.8) v 15.2 (4.9) mm ², p &lt; 0.005). Similarly, vessel and plaque volume were smaller in group I (291.0 (61.0) v 353.7 (110.0) mm ³, and 177.5 (48.4) v 228.0 (92.8) mm ³, p &lt; 0.05 for both). Lumen areas and volumes were similar. Conclusions In lesions with inadequate compensatory enlargement, both vessel and plaque volume appear to be smaller than in lesions with adequate compensatory enlargement.