One year cost effectiveness of sirolimus eluting stents compared with bare metal stents in the treatment of single native de novo coronary lesions: an analysis from the RAVEL trial.

OBJECTIVE: To assess the balance between costs and effects of the sirolimus eluting stent in the treatment of single native de novo coronary lesions in the RAVEL (randomised study with the sirolimus eluting Bx Velocity balloon expandable stent in the treatment of patients with de novo native coronary artery lesions) study. DESIGN: Multicentre, double blind, randomised trial. SETTING: Percutaneous coronary intervention for single de novo coronary lesions. PATIENTS: 238 patients with stable or unstable angina. INTERVENTIONS: Randomisation to sirolimus eluting stent or bare stent implantation. MAIN OUTCOME MEASURES: Patients were followed up to one year and the treatment effects were expressed as one year survival free of major adverse cardiac events (MACE). Costs were estimated as the product of resource utilisation and Dutch unit costs. RESULTS: At one year, the absolute difference in MACE-free survival was 23% in favour of the sirolimus eluting stent group. At the index procedure, sirolimus eluting stent implantation had an estimated additional procedural cost of 1286. At one year, however, the estimated additional cost difference had decreased to 54 because of the reduction in the need for repeat revascularisations in the sirolimus group (0.8% v 23.6%; p < 0.01). After adjustment of actual results for the consequences of angiographic follow up (correction based on data from the BENESTENT (Belgium Netherlands stent) II study), the difference in MACE-free survival was estimated at 11.1% and the additional one year costs at 166. CONCLUSIONS: The one year data from RAVEL suggest an attractive balance between costs and effects for sirolimus eluting stents in the treatment of single native de novo coronary lesions. The cost effectiveness of drug eluting stents in more complex lesion subsets remains to be determined.

Elevated troponin T and C-reactive protein predict impaired outcome for 4 years in patients with refractory unstable angina, and troponin T predicts benefit of treatment with abciximab in combination with PTCA.

AIMS: Treatment with the glycoprotein IIb/IIIa receptor antagonist abciximab before and during coronary intervention in refractory unstable angina improves early outcome. We collected 4-year follow-up data to assess whether this benefit is sustained. Additionally, we investigated the predictive value of baseline troponin T and CRP for long-term cardiovascular events. METHODS AND RESULTS: Of 1265 patients enrolled in the CAPTURE trial follow-up was available in 94% of the patients alive after 6 months (median 48 months). Survival was similar in both groups. Both elevated troponin T and CRP were associated with impaired outcome, independently of other established risk factors, but with a different time course. Elevated troponin was associated with increased procedure related risk, and elevated CRP with increased risk for subsequent events. Lower rates of the composite end-point of death or myocardial infarction with abciximab vs. placebo were sustained during long-term follow up: 15.7% vs 17.2% at 4 years (P=ns), particularly in patients with elevated troponin T: 16.9% with abciximab vs 28.4% with placebo: P=0.015. Elevated CRP was not associated with specific benefit of abciximab. CONCLUSION: Troponin T as a marker of thrombosis and CRP as a marker of inflammation are independent predictors of impaired outcome at 4 years follow-up. The initial benefit from abciximab with regard to death and myocardial infarction was preserved at 4 years. No specific benefit with abciximab was observed for patients with elevated CRP, suggesting that a chronic inflammatory process is not affected by abciximab. In contrast the benefit of treatment in patients with elevated troponin T implies that the acute thrombotic process in refractory unstable angina is treated effectively.

Platelet GP IIb/IIIa receptor blockers for failed thrombolysis in acute myocardial infarction, alone or as adjunct to other rescue therapies; single centre retrospective analysis of 548 consecutive patients with acute myocardial infarction.

In order to study the safety of 'rescue' strategies in the treatment of patients with failed thrombolysis, all 548 patients admitted with evolving myocardial infarction to the Thoraxcenter, Rotterdam, from January 1997 until April 1999 were reviewed. Of these patients, 49% had received thrombolysis. Of patients treated with thrombolysis and not referred from other hospitals (n = 154) 36% received rescue therapy for failed thrombolysis. Three rescue therapies were used after failed thrombolysis: percutaneous coronary intervention (74%), retreatment with thrombolysis (39%) and platelet glycoprotein (GP) IIb/IIIa receptor blockers (53%), often in combination. Platelet GP IIb/IIIa receptor blockers were administered in 64% of patients treated with rescue percutaneous coronary intervention. Major bleeding occurred in 14% of all thrombolysis treated patients, and in 30% of patients who received multiple rescue therapies. Bleeding was related to heparin usage and platelet GP IIb/IIIa receptor blockers, as was the insertion of catheters for percutaneous coronary intervention or intra-aortic balloon pumps. Major bleeding resulted in one death due to a ruptured ventricle, one haemorrhagic stroke, and three cases of tamponade for which surgery was needed. Four of these patients had received combination rescue therapy. Rescue therapy is a widely used strategy for failed thrombolysis, but is associated with a high bleeding rate. Alternative reperfusion strategies to avoid failed thrombolysis should be considered in high risk patients.

Coronary restenosis elimination with a sirolimus eluting stent: first European human experience with 6-month angiographic and intravascular ultrasonic follow-up.

AIMS: Coronary stenting is limited by a 10%-60% restenosis rate due to neointimal hyperplasia. Sirolimus is a macrocyclic lactone agent that interacts with cell-cycle regulating proteins and inhibits cell division between phases G1 and S1. The hypothesis tested in this study is that local delivery of sirolimus with an eluting stent can prevent restenosis. METHODS AND RESULTS: Fifteen patients were treated with 18 mm sirolimus eluting BX VELOCITY stents. Quantitative angiography and three-dimensional quantitative intravascular ultrasound were performed at implantation and at the 6 months follow-up. All stent implantations were successful. One patient died on day 2, of cerebral haemorrhage and one patient suffered a subacute stent occlusion due to edge dissection (re-PTCA, CKMB 42). At 9 months no further adverse events had occurred and all patients were angina free. Quantitative coronary angiography revealed no change in minimal lumen diameter and percent diameter stenosis and hence no in-lesion or in-stent restenosis. Quantitative intravascular ultrasound showed that intimal hyperplasia volume and percent obstruction volume at follow-up were negligible at 5.3 mm(3)and 1.8%, respectively. No edge effect was observed in the segments proximal and distal to the stents. CONCLUSION: Implantation of a sirolimus-eluting stent seems to effectively prevent intimal hyperplasia.

Feelings of being disabled as a predictor of mortality in men 10 years after percutaneous coronary transluminal angioplasty.

OBJECTIVE: To examine the independent prognostic value of the four subscales of the Heart Patients Psychological Questionnaire (HPPQ) on mortality in male and female patients 10 years following percutaneous transluminal coronary angioplasty (PTCA). METHODS: The HPPQ, which measures well-being, feelings of being disabled, despondency, and social inhibition, was administered to 356 patients (23% women) post-PTCA. The patients were followed for a median of 10 years. Clinical and demographic variables were sampled from medical records. RESULTS: During the follow-up period, 104 patients (29%) had died. Women scored significantly worse on all psychological subscales compared with men. Fifty-nine (72%) women and 92 (34%) men had a score indicating at least mild to moderate feelings of being disabled. Men scoring high on feelings of being disabled were at increased risk of mortality compared with men having a low score, adjusted for other cardiac risk factors (chi(2)=7; P=.008). No differences were found between women with low or high scores on feelings of being disabled (relative risk (RR): 1.2; 95% confidence interval (CI): 0.5-3.3). None of the other HPPQ subscales were related to mortality. CONCLUSION: Feelings of being disabled measured at least 1 year after hospital discharge is a significant predictor of mortality in men 10 years post-PTCA, but not in women. This finding adds to the increasing knowledge that psychosocial variables influence morbidity and mortality in cardiac patients.

Long-term clinical outcome after coronary balloon angioplasty: identification of a population at low risk of recurrent events during 17 years of follow-up.

AIMS: This study reports the clinical outcome, up to 17 years, of the first 856 consecutive patients treated by coronary angioplasty at a single centre and attempts to identify a subgroup of patients at low risk of adverse events. METHODS AND RESULTS: Follow-up status was established via hospital and general practitioner records and the civil registry. Median follow-up was 16 years. The overall 5-, 10-, 15- and 17-year survival was 90%, 78%, 64% and 58%, respectively and corresponding event-free survival was 53%, 33%, 22% and 19%. After 32% of patients had experienced a major adverse cardiac event in the first year, the annual coronary re-intervention incidence thereafter and, even beyond year 10, remained at 2%--3%. Using multivariable Cox regression, significant independent predictors of mortality were advanced age, diabetes, multivessel disease and impaired left ventricular function at the time of PTCA. A subgroup of 26% of the patients with none of these risk factors had a survival rate similar to the general Dutch population matched for age and gender (at 5 years: 96%, at 10 years: 89% and at 15 years: 83%). CONCLUSION: Although the majority of patients (>80%) experienced a further cardiac event during the 17 years after their first angioplasty procedure, in those non-diabetics under 60 years with single-vessel disease and good left ventricular function, prognosis was similar to the general population.

Comparison of coronary-artery bypass surgery and stenting for the treatment of multivessel disease.

BACKGROUND: The recent recognition that coronary-artery stenting has improved the short- and long-term outcomes of patients treated with angioplasty has made it necessary to reevaluate the relative benefits of bypass surgery and percutaneous interventions in patients with multivessel disease. METHODS: A total of 1205 patients were randomly assigned to undergo stent implantation or bypass surgery when a cardiac surgeon and an interventional cardiologist agreed that the same extent of revascularization could be achieved by either technique. The primary clinical end point was freedom from major adverse cardiac and cerebrovascular events at one year. The costs of hospital resources used were also determined. RESULTS: At one year, there was no significant difference between the two groups in terms of the rates of death, stroke, or myocardial infarction. Among patients who survived without a stroke or a myocardial infarction, 16.8 percent of those in the stenting group underwent a second revascularization, as compared with 3.5 percent of those in the surgery group. The rate of event-free survival at one year was 73.8 percent among the patients who received stents and 87.8 percent among those who underwent bypass surgery (P<0.001 by the log-rank test). The costs for the initial procedure were $4,212 less for patients assigned to stenting than for those assigned to bypass surgery, but this difference was reduced during follow-up because of the increased need for repeated revascularization; after one year, the net difference in favor of stenting was estimated to be $2,973 per patient. CONCLUSION: As measured one year after the procedure, coronary stenting for multivessel disease is less expensive than bypass surgery and offers the same degree of protection against death, stroke, and myocardial infarction. However, stenting is associated with a greater need for repeated revascularization.

Pharmacodynamics and safety of lefradafiban, an oral platelet glycoprotein IIb/IIIa receptor antagonist, in patients with stable coronary artery disease undergoing elective angioplasty.

OBJECTIVE: Lefradafiban is the orally active prodrug of fradafiban, a glycoprotein IIb/IIIa receptor antagonist. The present phase II study aimed to determine the dose of lefradafiban that provides 80% blockade of the glycoprotein IIb/IIIa receptors by fradafiban, and to study the pharmacodynamics and safety of different doses in patients with stable angina undergoing angioplasty. DESIGN: A double blind, placebo controlled, dose finding study. SETTING: Four academic and community hospitals in the Netherlands. PATIENTS: 64 patients with stable coronary artery disease undergoing elective percutaneous transluminal coronary angioplasty. INTERVENTIONS: 30 mg, 45 mg, and 60 mg of lefradafiban three times daily or placebo was given for 48 hours. MAIN OUTCOME MEASURES: The primary safety end point was the occurrence of bleeding, classified as major, minor, or insignificant according to the thrombolysis in myocardial infarction (TIMI) criteria. Efficacy indices included per cent fibrinogen receptor occupancy (FRO), ex vivo platelet aggregation, and plasma concentrations of fradafiban. RESULTS: Administration of lefradafiban 30, 45, and 60 mg three times daily resulted in a dose dependent increase in median FRO levels of 71%, 85%, and 88%, respectively. Inhibition of platelet aggregation was closely related to FRO. There were no major bleeding events. The 60 mg lefradafiban group had a high (71%) incidence of minor and insignificant bleeding. The incidence of bleeding was 44% in the 30 mg and 45 mg groups, compared with 9% in placebo patients. Puncture site bleeding was the most common event. The odds of bleeding increased by 3% for every 1% increase in FRO. CONCLUSIONS: Lefradafiban is an effective oral glycoprotein IIb/IIIa receptor blocker. The clinical effectiveness of doses up to 45 mg three times daily should be investigated.

Three dimensional intravascular ultrasonic assessment of the local mechanism of restenosis after balloon angioplasty.

OBJECTIVE: To assess the mechanism of restenosis after balloon angioplasty. DESIGN: Prospective study. PATIENTS: 13 patients treated with balloon angioplasty. INTERVENTIONS: 111 coronary subsegments (2 mm each) were analysed after balloon angioplasty and at a six month follow up using three dimensional intravascular ultrasound (IVUS). MAIN OUTCOME MEASURES: Qualitative and quantitative IVUS analysis. Total vessel (external elastic membrane), plaque, and lumen volume were measured in each 2 mm subsegment. Delta values were calculated (follow up - postprocedure). Remodelling was defined as any (positive or negative) change in total vessel volume. RESULTS: Positive remodelling was observed in 52 subsegments while negative remodelling occurred in 44. Remodelling, plaque type, and dissection were heterogeneously distributed along the coronary segments. Plaque composition was not associated with changes in IVUS indices, whereas dissected subsegments had a greater increase in total vessel volume than those without dissection (1.7 mm(3) v -0.33 mm(3), p = 0.04). Change in total vessel volume was correlated with changes in lumen (p < 0.05, r = 0.56) and plaque volumes (p < 0.05, r = 0.64). The site with maximum lumen loss was not the same site as the minimum lumen area at follow up in the majority (n = 10) of the vessels. In the multivariate model, residual plaque burden had an influence on negative remodelling (p = 0.001, 95% confidence interval (CI) -0.391 to -0.108), whereas dissection had an effect on total vessel increase (p = 0.002, 95% CI 1.168 to 4.969). CONCLUSIONS: The mechanism of lumen renarrowing after balloon angioplasty appears to be determined by unfavourable remodelling. However, different patterns of remodelling may occur in individual injured coronary segments, which highlights the complexity and influence of local factors in the restenotic process.

Completeness of revascularisation by percutaneous coronary intervention.

OBJECTIVE: To evaluate the relationship between the completeness of revascularisation by percutaneous coronary intervention and the one-year occurrence of adverse cardiac events in patients with multivessel disease. PATIENTS: Patients with stable or unstable angina pectoris, or with exercise-induced ischaemia, were enrolled in the Coronary Angioplasty versus Bypass Revascularisation Investigation (CABRI). METHODS: In CABRI, patients were randomised to coronary bypass grafting (CABG; n=513) or angioplasty (PTCA; n=541). Revascularisation in patients randomised to PTCA was defined as complete if no lesions with a diameter stenosis <50% remained post-procedure. Patients with complete revascularisation were distinguished from those with one, two, and three or more remaining lesions, respectively. Differences in baseline characteristics and in the one-year occurrence of death, myocardial infarction, (re)CABG, and (re)PTCA between these subgroups were evaluated. Comparisons were made with patients randomised to CABG. RESULTS: Complete revascularisation was obtained in 148 patients randomised to PTCA (27%). In 147 (27%) cases one lesion remained, while there were 122 (23%) and 119 (22%) patients with two and three or more remaining lesions, respectively. Five (1%) patients could not be classified. The one-year rates of either death or MI were 9.5%, 5.4%, 8.2%, and 12.6% in the respective PTCA subgroups (p=0.225), and 6.2% in patients randomised to CABG (comparison with three or more remaining lesions after PTCA: p=0.017). The percentages of repeat interventions during one-year follow-up were 29.7%, 29.3%, 39.3%, and 51.3% (p<0.001), much higher than after CABG (3.5%; p<0.001). CONCLUSION: Complete revascularisation by PTCA in multivessel coronary disease did not result in a lower death or MI rate compared with incomplete revascularisation. Overall the patient's prognosis after PTCA is similar to CABG, but patients with three or more remaining lesions after PTCA had a worse prognosis than CABG patients.

Corneal arcus: indicator for severity of coronary atherosclerosis?

BACKGROUND: The occurrence of a corneal arcus before the age of 60 years has been associated with the presence of atherosclerosis and the occurrence of hypercholesterolemia. The aim of this observational study was to assess the correlation between the presence of a corneal arcus and the severity of coronary artery disease. METHODS: A consecutive group of 200 Caucasian patients aged 40-60 years were studied. All patients were scheduled for diagnostic coronary angiography in a tertiary referral center. RESULTS: The severity of coronary disease was assessed by coronary angiography. A corneal arcus was observed in 38% of the patients. The prevalence of multivessel disease on a coronary angiogram was significantly higher in the group of patients with corneal arcus (p < 0.02). Patients with a corneal arcus compared to patients without a corneal arcus were slightly older (p < 0.05). Corrected for age, patients with an arcus has a relative risk for multivessel disease of 3.3 (CI 1.1-12.1, p < 0.05). CONCLUSION: In Caucasian patients with symptoms of coronary disease, the presence of a corneal arcus below 60 years of age indicates a high risk for multivessel coronary atherosclerosis.

Spontaneous dissections of all three coronary arteries in a 33-week-pregnant woman.

The clinical course and angiographic follow-up of a woman with spontaneous coronary dissections in all three coronary arteries during the third trimester of pregnancy is described. Mother and child survived and subsequent clinical course was uneventful. At 6-month follow-up, dissections in the right and circumflex coronary artery had healed completely. At the site of the dissection in the LAD, an aneurysm had formed. This is to our knowledge the first report of antepartum and antemortem diagnosis of pregnancy related coronary dissections in all three coronary arteries. Cathet. Cardiovasc. Intervent. 48:207-210, 1999.

Angiographic findings in patients with refractory unstable angina according to troponin T status.

BACKGROUND: The CAPTURE (C7E3 fab AntiPlatelet Therapy in Unstable REfactory angina) trial enrolled patients with refractory unstable angina and documented a therapeutic benefit for abciximab, a platelet glycoprotein IIb/IIIa receptor antagonist, that was particularly evident in patients with elevated troponin T (TnT) levels. In the current study, we related the angiographic data to the TnT status of the CAPTURE patients. METHODS AND RESULTS: In 853 patients, angiographic data at baseline and 18 to 24 hours after treatment were available and assessed by an Angiographic Committee with respect to TIMI flow, lesion severity, and visibility of thrombus. TnT levels >0.1 microg/L were found in 30.9% of the patients. Before randomization, thrombus was visible in 14.6% of TnT-positive patients (TnT levels >0.1 microg/L) and 4.2% of TnT-negative patients (P=0.004). Complex lesion characteristics B2+/C (72.0% versus 53.9%; P<0.001) and TIMI flow <2 (15.6% versus 5. 1%; P<0.001) were more frequent in TnT-positive patients. Abciximab was effective with respect to reduction of visible thrombus, increase of TIMI flow, and reduction of cardiac events in TnT-positive patients only. Multivariate analysis identified TnT status, but not angiographic findings, as an independent predictor for both outcome and efficacy of treatment with abciximab. CONCLUSIONS: Complex lesion characteristics and visible thrombus formation at baseline were significantly linked to TnT elevation. However, TnT status was a more powerful predictor of increased cardiac risk and efficacy of treatment with abciximab than either. Relative to the angiogram, TnT can thus be considered a more sensitive marker for the underlying pathology, identifying patients with unstable angina who will particularly benefit from antiplatelet treatment.

Abciximab in the treatment of acute myocardial infarction eligible for primary percutaneous transluminal coronary angioplasty. Results of the Glycoprotein Receptor Antagonist Patency Evaluation (GRAPE) pilot study.

OBJECTIVES: We sought to study the effect of early infusion of abciximab on coronary patency before primary angioplasty in patients with acute myocardial infarction. BACKGROUND: Glycoprotein IIb/IIIa antagonists have proved to be effective in reducing ischemic events associated with coronary angioplasty. The present study explores whether abciximab alone, without administration of thrombolytic therapy, may induce reperfusion in patients with acute myocardial infarction. METHODS: In the Glycoprotein Receptor Antagonist Patency Evaluation pilot study 60 patients with less than 6 h signs and symptoms of acute myocardial infarction eligible for primary angioplasty received in the emergency room a bolus of abciximab 250 microg/kg followed by a 12-h infusion of 10 microg/min. All patients were also treated with an oral dose of 160 mg aspirin and 5,000 IU of heparin intravenously. As soon as possible a diagnostic angiography was performed to evaluate the patency of the infarct-related artery. RESULTS: The median time between onset of symptoms and the administration of the abciximab bolus was 150 min (range 45 to 345), and the median time between abciximab bolus and first contrast injection in the infarct-related artery was 45 min (range 10 to 150). In 24 patients (40%, 95% confidence interval 28% to 52%) Thrombolysis in Myocardial Infarction (TIMI) flow grade 2 or 3 was observed at a median time of 45 min (range 10 to 150) after abciximab bolus; TIMI flow grade 3 was observed in 11 patients (18%, 95% confidence interval 9% to 28%). There was no difference in percentage of TIMI flow grade 2 or 3 between patients who received abciximab within 2.5 h after onset of symptoms or thereafter. CONCLUSIONS: Abciximab therapy given in the emergency room in patients awaiting primary angioplasty is associated with full reperfusion (TIMI flow grade 3) in about 20% and with TIMI flow grade 2 or 3 in about 40% of the patients at a median time of 45 min. These figures are higher than those in primary angioplasty trials without such pretreatment. Randomized controlled trials of very early infusion of abciximab, either prehospital or in-hospital, in patients eligible for angioplasty are warranted.

The ARTS study (Arterial Revascularization Therapies Study).

The rising costs of health care have forced policy makers to make choices, and new treatments are increasingly assessed in terms of the balance between additional costs and additional effects. The recent recognition that stenting has a major and long-lasting effect enhancing balloon PTCA procedure has made it imperative to compare in patients with multivessel disease the standard surgical procedure with multiple stenting in a large scale multinational and multicentre approach (19 countries, 68 sites). Selection and inclusion of patients is based on a consensus of the cardiac surgeon and interventional cardiologist on equal 'treatability' of patients by both techniques with analysis of clinical follow-up (event-free survival) on the short (30 day), medium (1 year), and long-term (3 and 5 year) with analysis of cost-effectiveness and quality of life (EuroQol and SF-36). Of the entire trial, the primary null hypothesis which needs to be rejected is that there will be no difference in event-free survival or effectiveness (E), at 1 year and also that the direct and indirect costs (C) per event-free year are not different between surgery or stenting. For this to become significant with a power of 90% one needs 1200 patients. Between April 97 and June 98, 1205 patients have been randomized with a monthly recruitment of 83 patients. Expected costs, effects and cost-effectiveness ratio (CE ratio) are: Stent high costs 2 VDStent high costs 3 VDStent low costs 2 VDStent low costs 3 VDCABG costs (C)$19.297$24.566$16.638$20.456$21.350 effects (E)81%81%81%81%88% CE ratio$23.876$30.397$20.586$25.322$24.348 Clinically, stenting is not expected to be more effective than CABG, but should be cost effective in both the 2- and 3-VD group when using the lower cost estimate and in the 2 VD group when using the higher cost assumptions.

[Abciximab: a new antiplatelet agent for use in coronary angioplasty]. / Abciximab: een nieuwe plaatjesaggregatieremmer voor toepassing bij coronaire angioplastiek.

Angioplasty of coronary arteries (PTCA) is an accepted treatment modality for patients with symptomatic coronary artery disease. Despite technological improvements it is still plagued by (mainly thrombotic) complications in around 10% of all patients. A number of new antithrombotic and antiplatelet agents have been tried in the setting of angioplasty. The monoclonal glycoprotein IIb-IIIa receptor blocker abciximab appears to control the thrombotic process most effectively before, during and after the procedure. Three large randomized trials with abciximab in patients with stable, unstable or refractory unstable angina pectoris were conducted. All three showed a relative reduction by 35% to 56% in the primary combined endpoint, consisting of mortality, myocardial infarction or urgent intervention, at 30 days. Severe bleeding, which affected 14.0% of patients on abciximab in the first trial, was reduced, after adjusting heparin dosing and issuing sheath removal guidelines, to 3.8% in the second and 2.0% in the final study. In the placebo groups the percentages of severe bleeding were 6.6, 1.9, and 3.1, respectively. Abciximab appears to reduce the thrombotic complications of PTCA substantially. The extent of this reduction and the severity of complications prevented justifies its more general use during angioplasty.

Women fare no worse than men 10 years after attempted coronary angioplasty.

A retrospective review of cardiac events occurring in all patients who underwent attempted coronary angioplasty in the first 5 years of our experience (1980-1985) was undertaken. Follow-up data were obtained from the civil registry, hospital records, patient, family, and referring physician. Patient survival curves were constructed and the outcome of women and men was compared. Eight hundred fifty-six patients, 172 women and 684 men with a mean age of 60.0 and 55.3 years, respectively, underwent attempted coronary angioplasty with an overall procedural success rate of 82%, 77.7% in women and 83.1% in men. Follow-up data were obtained in 837 patients (97.8%) with a mean period of 9.6 years (range 0-13.3 years). The estimated 10 year survival in women was identical to men [79%, 95% confidence interval (CI) 72.6-85.4% vs. 78%, 95% CI 74.6-81.4%] as was the 10 year event-free survival (men 36%, 95% CI 32.0-40.0% vs. women 37%, 95% CI 29.2-44.8%), with a similar proportion of major cardiac events-death, myocardial infarction, coronary artery bypass surgery, and repeat angioplasty. When women were matched to men for age and previous myocardial infarction, factors found to be associated with an adverse outcome, there was no significant difference. Additionally, outcome was compared after patients were matched for maximum nominal balloon size as an estimate of vessel size, with no significant difference between women and men. At follow-up, women complained of significantly more anginal symptoms than men (59.2% vs. 44.0%, P < 0.05) and took significantly more antianginal medication.

Long-term clinical outcome after stent implantation in saphenous vein grafts.

OBJECTIVES: We sought to determine the role of stent implantation in vein grafts by evaluating the long-term clinical outcome and estimated event-free survival at 5 years in 62 patients and by comparing our data with those of other treatment modalities previously reported. BACKGROUND: Patients with recurrent angina after coronary artery bypass graft surgery pose a problem. Stent implantation has been advocated in an effort to avoid repeat operation and to address the limitations of balloon angioplasty. METHODS: Patients undergoing stenting of a vein graft were entered into a dedicated data base. They were screened for death, infarction, bypass surgery and repeat angioplasty. Procedure-related events were included in the follow-up analysis. Survival and event-free survival curves were constructed by the Kaplan Meier method. RESULTS: A total of 93 stents (84 Wallstent and 9 Palmaz-Shatz) were implanted in 62 patients. During the in-hospital period seven patients (11%) sustained a major cardiac event: two deaths (3%), two myocardial infarctions (3%) and three urgent bypass surgeries (5%). The clinical success rate, therefore, was 89%. During the follow-up period (median 2.5 years, range 0 to 5.9), another five patients (8%) died, 14 (23%) sustained a myocardial infarction, 12 (20%) underwent bypass surgery, and 14 (23%) underwent angioplasty. The estimated 5-year survival and event-free survival rates (free from infarction, repeat surgery and repeat angioplasty) were (mean +/- SD) 83 +/- 5% (95% confidence interval [CI] 73% to 93%) and 30 +/- 7% (95% CI 16% to 44%), respectively. CONCLUSIONS: The in-hospital outcome of patients who underwent stent implantation in a vein graft is acceptable, but the long-term clinical outcome is poor. It is unlikely that mechanical intervention alone will provide a satisfactory or definite answer for the patient with graft sclerosis over the long term.

Clinical outcome 10 years after attempted percutaneous transluminal coronary angioplasty in 856 patients.

OBJECTIVES: This study reports the 10-year outcome of 856 consecutive patients who underwent attempted coronary angioplasty at the Thoraxcenter during the years 1980 to 1985. BACKGROUND: Coronary balloon angioplasty was first performed in 1977, and this procedure was introduced into clinical practice at the Thoraxcenter in 1980. Although advances have been made, extending our knowledge of the long-term outcome in terms of survival and major cardiac events remains of interest and a valuable guide in the treatment of patients with coronary artery disease. METHODS: Details of survival, cardiac events, symptoms and medication were retrospectively obtained from the Dutch civil registry, medical records or by letter or telephone or from the patient's physician and entered into a dedicated data base. Patient survival curves were constructed, and factors influencing survival and cardiac events were identified. RESULTS: The procedural clinical success rate was 82%. Follow-up information was obtained in 837 patients (97.8%). Six hundred forty-one patients (77%) were alive, of whom 334 (53%) were symptom free, and 254 (40%) were taking no antianginal medication. The overall 5- and 10-year survival rates were 90% (95% confidence interval [CI] 87.6% to 92.4%) and 78% (95% CI 75.0% to 81.0%), respectively, and the respective freedom from significant cardiac events (death, myocardial infarction, coronary artery bypass surgery and repeat angioplasty) was 57% (95% CI 53.4% to 60.6%) and 36% (95% CI 32.4% to 39.6%). Factors that were found to adversely influence 10-year survival were age > or = 60 years (> or = 60 years [67%], 50 to 59 years [82%], < 50 years [88%]), multivessel disease (multivessel disease [69%], single-vessel disease [82%]), impaired left ventricular function (ejection fraction < 50% [57%], > or = 50% [80%]) and a history of previous myocardial infarction (previous myocardial infarction [72%], no previous infarction [83%]). These factors were also found to be independent predictors of death during the follow-up period by a multivariate stepwise logistic regression analysis. Other factors tested, with no influence on survival, were gender, procedural success and stability of angina at the time of intervention. CONCLUSIONS: The long-term prognosis of patients after coronary angioplasty is good, particularly in those <60 years old with single-vessel disease and normal left ventricular function. The majority of patients are likely to experience a further cardiac event in the 10 years after their first angioplasty procedure.