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Background The 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase inhibitors competitively inhibit biosynthesis of mevalonate, a precursor of non-sterol compounds involved in cell proliferation. Experimental evidence suggests that fluvastatin may, independent of any lipid lowering action, exert a greater direct inhibitory effect on proliferating vascular myocytes than other statins. The FLARE (Fluvastatin Angioplasty Restenosis) Trial was conceived to evaluate the ability of fluvastatin 40mg twice daily to reduce restenosis after successful coronary balloon angioplasty (PTCA). Methods Patients were randomized to either placebo or fluvastatin 40mg twice daily beginning 2–4 weeks prior to planned PTCA and continuing after a successful PTCA (without the use of a stent), to follow-up angiography at 26±2 weeks. Clinical follow-up was completed at 40 weeks. The primary end-point was angiographic restenosis, measured by quantitative coronary angiography at a core laboratory, as the loss in minimal luminal diameter during follow-up. Clinical end-points were death, myocardial infarction, coronary artery bypass graft surgery or re-intervetion, up to 40 weeks after PTCA. Results Of 1054 patients randomized, 526 were allocated to fluvastatin and 528 to placebo. Among these, 409 in the fluvastatin group and 427 in the placebo group were included in the intention-to-treat analysis, having undergone a successful PTCA after a minimum of 2 weeks of pre-treatment. At the time of PTCA, fluvastatin had reduced LDL cholesterol by 37% and this was maintained at 33% at 26 weeks. There was no difference in the primary end-point between the treatment groups (fluvastatin 0·23±0·49mm vs placebo 0·23±0·52mm,P=0·95) or in the angiographic restenosis rate (fluvastatin 28%, placebo 31%, chi-squareP=0·42), or in the incidence of the composite clinical end-point at 40 weeks (22·4% vs 23·3%; logrankP=0·74). However, a significantly lower incidence of total death and myocardial infarction was observed in six patients (1·4%) in the fluvastatin group and 17 (4·0%) in the placebo group (log rankP=0·025). Conclusion Treatment with fluvastatin 80mg daily did not affect the process of restenosis and is therefore not indicated for this purpose. However, the observed reduction in mortality and myocardial infarction 40 weeks after PTCA in the fluvastatin treated group has not been previously reported with statin therapy. Accordingly, a priori investigation of this finding is indicated and a new clinical trial with this intention is already underway. [ABSTRACT FROM PUBLISHER]

The Cordis tantalum coil stent was assessed in a nonrandomized multicenter trial: 275 patients with stable or unstable angina were entered. Clinical follow-up was for 1 year, with repeat angiography at 6 months. The major adverse cardiac event rates (MACE) were 3%, 14%, and 17% at 1, 7, and 13 months, respectively. The procedural success rate was 96% and the subacute occlusion rate 1.5%, in a group of patients over 60% of whom had ACC/AHA type B2 or C lesions. The binary restenosis rate at 6 months was 17.3%. Minimum lumen diameter increased from 1.07 +/- 0.28 mm preprocedure to 2.93 +/- 0.34 mm poststenting and at 6 months was 1.99 +/- 0.69 mm. These results demonstrate that the Cordis tantalum stent can be used to treat complex lesions with good procedural success and low rates of subacute thrombosis and restenosis at 6 months.

Aims: A randomized trial was performed to assess the safety and efficacy of a laser guidewire, in the treatment of chronic coronary occlusions., Methods and Results: In 18 European centres, 303 patients with a chronic coronary occlusion were randomized to treatment with either the laser guidewire (n=144) or conventional guidewires (mechanical guidewire, n=159). The primary end-point of the study was treatment success, defined as reaching the true lumen distal to the occlusion by the allocated wire within 30 min of fluoroscopic time: laser guidewire vs mechanical guidewire; 52.8% (n=76) vs 47.2% (n=75), P=0.33. Serious adverse events following the initial guidewire attempt were 0% (laser guidewire) and 0.6% (mechanical guidewire), respectively. Angioplasty (performed following successful guidewire crossing) was successful in 179 patients (91%, laser guidewire n=79, mechanical guidewire n=100), followed by stent implantation in 149 (79%). At the 6-month angiographic follow-up, the difference in binary restenosis rate (laser guidewire vs mechanical guidewire; 45.5% vs 38.3 %, P=0.72) or reocclusion rate (25.8% vs 16.1%, P=0.15) did not reach statistical significance. At 1, 6 and 12 months, angina and event-free survival were 69%, 35% and 24% (laser guidewire) vs 74%, 40% and 31% (mechanical guidewire)., Conclusion: Although laser guidewire technology was safe, the increase in crossing success did not reach statistical significance.

Background: In addition to its known properties as a competitive, nonselective beta and alpha-1 receptor blocker, carvedilol directly inhibits vascular myocyte migration and proliferation and exerts antioxidant effects that are considerably greater than those of vitamin E or probucol. This provides the basis for an evaluation of carvedilol for the prevention of coronary restenosis., Methods and Results: In a prospective, double-blind, randomized, placebo-controlled trial, 25 mg of carvedilol was given twice daily, starting 24 hours before scheduled directional coronary atherectomy and continuing for 5 months after a successful procedure. The primary end point was the minimal luminal diameter as determined during follow-up angiography 26+/-2 weeks after the procedure. Of 406 randomized patients, 377 underwent attempted atherectomy, and in 324 (88.9%), a

Objectives: This study was performed to assess whether angiography six months after coronary balloon angioplasty or stent implantation has an influence on clinical management and one-year outcome., Background: The Benestent II study randomized 827 patients to balloon angioplasty or stent implantation. A subrandomization was undertaken allocating patients to six-month clinical follow-up (CF) or clinical and angiographic follow-up (AF)., Methods: Seven hundred and six patients (349 CF and 357 AF) had no intercurrent angiography, so that restenosis and disease progression elsewhere remained unknown until the time of six-month follow-up. These two groups, which were well matched at enrolment, were compared with respect to symptoms, medication and major cardiac events defined as death, myocardial infarction and need for revascularization at six and 12 months., Results: At six-month follow-up, 53 (15%) of the CF and 76 (21%) of the AF patients had stable angina (p = 0.041), while 5 (1%) and 4 (1%) had symptoms of unstable angina. At 12-month follow-up, 44 (13%) patients in both groups had stable angina, and only 1 patient in the CF group had unstable angina. Seventy-seven patients (27 CF and 50 AF; p < 0.01) had major cardiac events between 6 and 12 months. Of the 349 patients in the CF group, 21 underwent repeat percutaneous transluminal coronary angioplasty or coronary artery bypass graft surgery between 6 and 12 months, compared with 44 of the 357 patients in the AF group (relative risk 2.05 [1.24 to 3.37], p = 0.003)., Conclusions: Patients who had AF six months after balloon angioplasty or stent implantation experienced more repeat revascularization procedures than those who had CF. They also had significantly more angina at six-month follow-up but this may be due to bias.

Background: In the CAPTURE (c7E3 Fab Anti Platelet Therapy in Unstable REfractory angina) trial, 1265 patients with refractory unstable angina were treated with abciximab or placebo, in addition to standard treatment from 16 to 24 hours preceding coronary intervention through 1 hour after intervention. To investigate the incidence of recurrent ischemia and the ischemic burden, a subset of 332 patients (26%) underwent continuous vector-derived 12-lead ECG-ischemia monitoring., Methods and Results: Patients were monitored from start of treatment through 6 hours after coronary intervention. Ischemic episodes were detected in 31 (18%) of the 169 abciximab and in 37 (23%) of the 163 placebo patients (NS). Only 9 (5%) of abciximab versus 22 (14%) of placebo patients had >/=2 ST episodes (P<0.01). In patients with ischemia, abciximab significantly reduced total ischemic burden (P<0.02), which was calculated alternatively as the total duration of ST episodes per patient, the area under the curve of the ST vector magnitude during episodes, or the sum of the areas under the curves of 12 leads during episodes. Twenty-one patients (6%) suffered a myocardial infarction (MI) (18) or died (3) within 5 days of treatment. The presence of asymptomatic and symptomatic ST episodes during the monitoring period preceding coronary intervention was associated with an increased relative risk of these events of 3.2 (95% CI 1.4, 7.4) and 4.1 (95% CI 1.4, 12.2), respectively., Conclusions: Recurrent ischemia predicts MI or death within 5 days of follow-up. Treatment with abciximab is associated with a reduction of frequent ischemia and a reduction of total ischemic burden in patients with refractory unstable angina. As such, patients with ischemia derive particularly high benefit from abciximab.

Background: Clinical restenosis after balloon angioplasty can be categorized by use of dichotomous terms based on the presence or absence of recurrent myocardial ischemia. In contrast, recent investigations have concluded that late luminal renarrowing, documented through angiographic imaging, occurs to a variable extent in nearly all stenoses. This process has been characterized by a gaussian or normal frequency distribution, with restenosis simply representing an extreme form of this delayed remodeling. In the current study, frequency distribution analysis was used to examine the process of coronary restenosis in a large cohort of patients at risk., Methods and Results: Quantitative coronary angiographic analysis was applied to 9279 cineangiograms obtained in 3093 patients before and immediately after angioplasty and after 6-month follow-up. Late loss, defined as the change in minimum lumen diameter of the target stenosis from postdilation to follow-up, did not statistically conform to a normal distribution (P<.0001 by both chi2 statistic and Kolmogorov-Smirnov test), even after the exclusion of the 236 stenoses that displayed total occlusions at follow-up angiography. Examination of deviation from a normal curve revealed an excessively high frequency of stenoses that experienced either little change (0.0+/-0.3 mm) or marked change (1.0 to 2.0 mm) in late loss, with a low frequency of stenoses with intermediate values (0.3 to 1.0 mm). Similarly, although the distribution of percent diameter stenosis of the target lesion was statistically normal immediately after dilation, this gaussian distribution disappeared during the follow-up period. Other angiographic indexes of restenosis also failed to approximate a normal curve. In an attempt to improve the goodness of fit, a probabilistic model of late loss was created on the basis of deconvolution of the observed data distribution. Two theoretical, discrete populations of stenoses were identified, one with and one without overall late luminal narrowing. Unlike the gaussian distribution, this model provided a good representation of the observed data (P=NS for lack of fit)., Conclusions: The frequency distributions of angiographic indexes of restenosis often superficially resemble a gaussian curve, an appearance that is artifactually enhanced by the measurement imprecision of current quantitative techniques. Nevertheless, standard indexes of coronary restenosis fail to conform statistically to a normal distribution. The pattern of deviations observed supports the possible existence of discrete subpopulations of lesions, each with a different propensity toward the development of restenosis after coronary intervention.

Background: Experimental studies suggest that mural thrombus may be involved in postangioplasty restenosis. The aim of our study was to examine the role of angiographically identifiable thrombus in the clinical situation., Methods and Results: The study population comprised 2950 patients (3583 lesions). The presence of angiographically identifiable thrombus either before or after the procedure was defined as the presence of a generalized haziness or filling defect within the arterial lumen. Restenosis was assessed by both a categorical (> 50% diameter stenosis at follow-up) and a continuous approach (absolute and relative losses). The study population included 160 lesions with and 3423 lesions without angiographically identifiable thrombus. The categorical restenosis rate was significantly higher in lesions containing angiographically identifiable thrombus: 43.1% versus 34.4%, P < .01; relative risk, 1,449; CI, 1.051 to 1.997. The absolute and relative losses were also higher in lesions containing angiographically identifiable thrombus (absolute loss, 0.43 +/- 0.66 versus 0.32 +/- 0.52; relative loss, 0.16 +/- 0.26 versus 0.13 +/- 0.21; both P < .05). The higher restenosis in these lesions was due primarily to an increased incidence of occlusion at follow-up angiography in this group: 13.8% versus 5.7%, P < .001. When lesions that went on to occlude by the time of follow-up angiography were excluded from the analysis, the restenosis rate between the two groups was similar by both the categorical (34.1% versus 30.4%, P=NS; relative risk, 1.183; CI, 0.824 to 1.696) and continuous (absolute loss, 0.23 +/- 0.46 versus 0.24 +/- 0.42, P=NS; relative loss, 0.09 +/- 0.17 versus 0.09 +/- 0.16, P=NS) approaches., Conclusions: Our results indicate that the presence of angiographically identifiable thrombus at the time of the angioplasty is associated with higher restenosis. The mechanism by which this occurs is through vessel occlusion at follow-up angiography. Measures aimed at improving outcome in this group of patients should be focused in this direction.

Objectives: This study sought to compare acute lumen changes and late lumen narrowing during and after excimer laser-assisted balloon angioplasty, measured by quantitative coronary angiography, with the immediate and long-term outcome of balloon angioplasty alone., Background: Although excimer laser coronary angioplasty is used as an adjunct or alternative to balloon angioplasty, limited comparative data exist regarding the immediate and long-term efficacy of excimer laser-assisted balloon angioplasty versus balloon angioplasty alone., Methods: A series of 53 lesions in 47 consecutive patients successfully treated with excimer laser-assisted balloon angioplasty were individually matched after completion of 6-month follow-up angiography with 53 successfully treated balloon angioplasty lesions according to vessel location, preprocedural minimal lumen diameter and reference diameter. Immediate and long-term angiographic results were assessed by an automated lumen contour detection algorithm., Results: Before intervention in the laser and balloon angioplasty groups, respectively, minimal lumen diameter (mean +/- SD) was 0.73 +/- 0.47 and 0.74 +/- 0.46 mm, and reference diameter was 2.71 +/- 0.42 and 2.72 +/- 0.41 mm. Laser angioplasty was followed by adjunctive balloon dilation in 50 lesions. Mean balloon diameter at maximal inflation was similar in both treatment groups (2.61 +/- 0.32 and 2.65 +/- 0.38 mm, respectively), resulting in similar minimal lumen diameters after intervention of 1.77 +/- 0.41 and 1.78 +/- 0.34 mm, respectively. At follow-up angiography, minimal lumen diameter after excimer laser-assisted balloon angioplasty was 1.17 +/- 0.63 mm, and that after balloon angioplasty alone was 1.46 +/- 0.67 mm (p = 0.02). The angiographic restenosis rates at follow-up using the 50% diameter stenosis cutoff criterion were 57% and 34%, respectively (p = 0.02)., Conclusions: Quantitative angiographic analysis of a matched group of 106 successfully treated coronary lesions showed a similar immediate outcome but reduced long-term efficacy of excimer laser-assisted balloon angioplasty compared with that after balloon angioplasty alone.

Background: The long-term angiographic outcome after successful dilatation of coronary occlusions remains unclear. The objective of this study was to examine long-term restenosis after successful balloon dilatation of coronary occlusions at a predetermined time interval with quantitative angiography and compare this with a control population of stenoses., Methods and Results: The study population comprised 2950 patients (3583 lesions) prospectively enrolled in and successfully completing four major restenosis trials (86% quantitative angiographic follow-up). Cineangiographic films were processed and analyzed at a central core laboratory with the use of an automated interpolated edge detection technique. The study population comprised 266 occlusions (7%) defined as total when there was absent anterograde filling beyond the lesion (109 lesions) and functional (157 lesions) when faint, late anterograde opacification of the distal segment was seen in the absence of a discernible luminal continuity; 3317 lesions were defined as stenoses (93%). Restenosis was significantly higher after successful dilatation of occlusions than of stenoses. With the categorical (> 50% diameter stenosis at follow-up) approach, the restenosis rate was 44.7% in occlusions compared with 34.0% in stenoses (P < .001; relative risk, 1.575; CI, 1.224 to 2.027). Similarly, the absolute loss (defined as the change in minimal lumen diameter between post coronary angioplasty and follow-up; in millimeters, mean +/- SD) (0.43 +/- 0.68) in occlusions was significantly higher than in stenoses (0.31 +/- 0.51, P < .001), as was the relative loss, defined as the change in minimal lumen diameter between postangioplasty and follow-up, adjusted for the vessel size (0.17 +/- 0.28 versus 0.12 +/- 0.20, P < .001). The higher restenosis rate in the occlusions group was due predominantly to an increased number of occlusions at follow-up angiography in this group (19.2% compared with 5.0% for stenoses, P < .001). Within the occlusions group, there were no significant differences in long-term outcome between total and functional occlusions (restenosis rate, 45.0% versus 44.6%; reocclusion rate, 23.9% versus 15.9%; absolute loss, 0.53 +/- 0.69 versus 0.36 +/- 0.67; relative loss, 0.21 +/- 0.28 versus 0.15 +/- 0.28; P = NS)., Conclusions: These results indicate that successfully dilated coronary occlusions, both total and functional, have a higher rate of angiographic restenosis at 6 months than stenoses. This is due chiefly to a higher rate of occlusion at follow-up angiography in this group of lesions. Measures aimed at reducing restenosis after successful dilatation of coronary occlusion should be focused in this direction.

Objectives: Coronary lumen changes during and after excimer laser-assisted balloon angioplasty were measured by quantitative coronary angiography, and the results were compared with the effects of balloon angioplasty alone., Background: Reduction of atherosclerotic tissue mass by laser ablation in the treatment of coronary artery disease may be more effective in enlarging the lumen than balloon angioplasty alone., Methods: A series of 57 consecutive coronary lesions successfully treated by xenon chloride excimer laser-assisted balloon angioplasty were individually matched with 57 coronary artery lesions successfully treated by balloon angioplasty alone. The following variables were measured by quantitative coronary analysis: 1) ablation by laser, 2) stretch by balloon dilation, 3) elastic recoil, and 4) acute gain., Results: Matching by stenosis location, reference diameter and minimal lumen diameter resulted in two comparable groups of 57 lesions with identical baseline stenosis characteristics. Minimal lumen diameter before excimer laser-assisted balloon angioplasty and balloon angioplasty alone were (mean +/- SD) 0.73 +/- 0.44 and 0.74 +/- 0.43 mm, respectively. Laser ablation significantly improved minimal lumen diameter by 0.56 +/- 0.44 mm before adjunctive balloon dilation. In both treatment groups, similar-sized balloon catheters (2.59 +/- 0.35 and 2.56 +/- 0.40 mm, respectively) were used. After laser-assisted balloon angioplasty, elastic recoil was 0.84 +/- 0.30 mm (32% of balloon size), which was identical to that after balloon angioplasty alone, namely, 0.82 +/- 0.32 mm (32%). Consequently, both interventions resulted in similar acute gains of 1.02 +/- 0.52 and 1.00 +/- 0.56 mm, respectively. Minimal lumen diameter after intervention was equal in both groups: 1.75 +/- 0.35 and 1.75 +/- 0.34 mm, respectively. The statistical power of this study in which a 25% difference in elastic recoil (0.2 mm) between groups was considered clinically important was 95%., Conclusions: In matched groups of successfully treated coronary lesions, xenon chloride excimer laser ablation did not reduce immediate elastic recoil after adjunctive balloon dilation or improve the final angiographic outcome compared with balloon angioplasty alone using similar-sized balloon catheters.

Objectives: This study was designed to examine whether restenosis is related to the extent or mechanism of lumen improvement and to explore angiographic determinants of optimal atherectomy., Background: Directional atherectomy induces a greater extent of immediate gain and late loss but has not been found to yield a better late angiographic lumen than angioplasty in randomized trials. The difference in lumen renarrowing may be related to either the extent or the mechanism of immediate gain. The design of previous studies has precluded the detection of a device-specific effect on restenosis., Methods: A retrospective analysis was based on matching a prospectively collected series of 80 native coronary arteries successfully treated with atherectomy with a prospectively collected series of 80 native coronary arteries successfully treated with balloon angioplasty. Angiographic analysis was performed in 160 lesions to explore whether a specific device-related effect exists. Multivariate analyses were performed to determine the correlates of minimal lumen diameter at follow-up and late lumen loss and to identify the procedural characteristics for optimal atherectomy., Results: Matching resulted in two comparable groups with equivalent baseline clinical and stenosis characteristics. By study design, atherectomy and angioplasty resulted in similar mean (+/- SD) immediate lumen gain (1.15 +/- 0.44 vs. 1.10 +/- 0.40 mm, p = 0.50). However, lumen loss was more pronounced after atherectomy, and, thus, the minimal lumen diameter at follow-up differed significantly between the two groups (1.78 +/- 0.57 vs. 2.00 +/- 0.56 mm, p = 0.001). Device type was retained in the multivariate analysis as an independent predictor of late minimal lumen diameter and lumen loss. Multivariate analysis identified vessel size and immediate gain as determinants of optimal atherectomy., Conclusions: Restenosis is a consequence not only of the extent of lumen improvement but also of the mechanism of vessel wall injury (debulking vs. dilating). While performing atherectomy, the operator should strive for an optimal procedural result to accommodate an increased intimal hyperplastic response.

Background: Previous reports have suggested that hyperlipidemia may be associated with increased restenosis after successful coronary angioplasty. These studies have been compromised, however, by their retrospective nature, the small numbers involved, differences in the definition of restenosis, and inadequate quantitative angiographic follow-up at a prespecified time interval. The objective of the study was to examine the relation between serum cholesterol and long-term restenosis after coronary angioplasty, using quantitative angiography, at a predetermined time interval., Methods and Results: The study population comprised 2753 patients (3336 lesions) prospectively enrolled and successfully completing four major restenosis trials. Cineangiographic films were processed and analyzed at a central angiographic core laboratory with the use of an automated interpolated edge-detection technique. Serum total cholesterol was measured at trial entry and at 6 months. Hypercholesterolemia was defined as total cholesterol > 7.8 mmol.L-1 at trial entry. Two approaches were used to assess restenosis: first, a categorical approach using the cutoff point of > 50% diameter stenosis at follow-up and second, a continuous approach examining changes in minimal luminal dimensions, the absolute loss (change in minimum luminal diameter after PTCA to follow-up, in mm) and relative loss (absolute loss corrected for vessel size), which may give a better understanding of the underlying pathological process involved. One hundred sixty patients with 191 lesions (5.73%) had hypercholesterolemia (total cholesterol, > 7.8 mmol.L-1; mean +/- SD, 8.46 +/- 0.75 mmol.L-1) and 2593 patients with 3145 lesions (94.27%) normal cholesterol (5.67 +/- 1.06 mmol.L-1). The restenosis rate was similar in patients with and without hypercholesterolemia (31.9% versus 33.7%, respectively; relative risk, 0.975; 95% CI, 0.882 to 1.077; P = .68). Similarly, there was no difference in either the absolute or relative loss between patients with and without hypercholesterolemia (0.31 +/- 0.53 versus 0.32 +/- 0.53 mm and 0.12 +/- 0.20 versus 0.13 +/- 0.21, respectively, P = NS for both). Conversely, the total serum cholesterol in patients with restenosis (using the categorical definition) was similar to those without restenosis (5.84 +/- 1.24 versus 5.81 +/- 1.22 mmol/L, respectively, P = NS). Dividing the population into deciles according to total cholesterol and examining the categorical restenosis rate (by chi 2) as well as the absolute and relative loss by ANOVA again revealed no significant differences between deciles. Subgroup analysis of 579 patients (667 lesions) with HDL and LDL cholesterol levels available again revealed no differences in the categorical restenosis rate (by chi 2) or the absolute or relative loss between deciles according to LDL, HDL, or LDL:HDL ratio, suggesting no influence of these cholesterol subfractions on restenosis., Conclusions: Our results indicate that there is no association between cholesterol and restenosis by either a categorical or continuous approach, suggesting that measures aimed at reducing total cholesterol are unlikely to significantly influence postangioplasty restenosis.

Background: Long term luminal renarrowing after successful coronary balloon angioplasty is a major limitation of the technique. Knowledge of factors which influence long term luminal re-narrowing could be very valuable in selecting appropriate patients or lesions for the procedure and may therefore improve the medium term prognosis after angioplasty. Furthermore, modification or control of the identified risk factors could reduce overall restenosis. Additionally, identification of such factors would assist in the selection of high risk patients, who could then constitute the target population for pharmacological intervention studies. Thus the aims of the present study were to find independent patient, lesion and procedural related risk factors for the restenosis process., Methods and Results: Quantitative angiography was performed on 742 successfully dilated lesions at angioplasty and 6 months follow-up. Long-term luminal re-narrowing was defined as the absolute change in minimal luminal diameter (MLD) from post PTCA to follow up. Univariate and multiple linear regression analysis of all available clinical, lesion and procedural variables was performed to identify variables with a significant contribution to the prediction of change in MLD. Gain in MLD at angioplasty, pre PTCA MLD, total inflation time and male sex were positively related to change in MLD while a positive smoking history, vessel and maximum balloon size were negatively related. The overall prediction of the model was poor (R2-0.14) suggesting that many factors influencing the process are still outside our understanding., Conclusions: These results indicate that re-narrowing after successful PTCA is a process which can be influenced by a number of clinical, angiographic and procedural characteristics but cannot yet be accurately predicted by these.

Pulmonary function tests were performed in 78 patients who had been curatively treated for Hodgkin's disease with mantle field irradiation 10-18 years ago. Mean values of the total lung capacity (95.2%), vital capacity (VC) (95.9%), forced expiratory volume in 1 s (FEV1) (90.6%), and carbon monoxide diffusing capacity per unit alveolar volume (82.7%) showed significant deviations from the predicted normal values, standardised for age, sex, race and height. In a multiple regression analysis the normalised total dose of irradiation, the field of irradiation, and the interval since irradiation had independent negative effects on the test results. Patients reported more coughing, wheezing and dyspnoea on exertion in comparison with hospital-visitors. Their smoking habits and reported pulmonary disease were not different. It is concluded that small, but significant impairment of pulmonary function exists after a follow-up of 14 (2) years [mean (S.D.)]. The clinical impact of these findings seems, however, minimal. Further avoidance of pulmonary toxicity requires a careful quantitative study of the effects of the radiation dose and irradiated volume.