Background Randomized studies have shown that the use of coronary-arterystenting as the initial treatment for coronary stenosis is associatedwith a lower risk of restenosis than is standard coronary angioplasty.We prospectively investigated the efficacy of these two approachesin selected patients with isolated stenosis of the proximalleft anterior descending coronary artery.
Methods A total of 120 patients with isolated stenosis of theproximal left anterior descending coronary artery were randomlyassigned to stent implantation or standard coronary angioplasty.The primary clinical end points were the rate of proceduralsuccess (defined as residual stenosis of less than 50 percentand the absence of death, myocardial infarction, and the needfor coronary-artery bypass surgery during the hospital stay)and the rate of event-free survival (defined as freedom fromdeath, myocardial infarction, and the recurrence of angina)at 12 months. The angiographic end point was the rate of restenosis12 months after the procedure.
Results The two treatment groups did not differ significantlywith respect to demographic, clinical, or angiographic characteristics.The rates of procedural success were similar in the two groupsof patients (95 percent in the stenting group vs. 93 percentin the angioplasty group, P = 0.98). The 12-month rates of event-freesurvival were 87 percent after stenting and 70 percent afterangioplasty (P = 0.04). The rates of restenosis were 19 percentafter stent implantation and 40 percent after angioplasty (P= 0.02).
Conclusions In patients with symptomatic isolated stenosis ofthe proximal left anterior descending coronary artery, stentinghad advantages over standard coronary angioplasty in that itwas associated with both a lower rate of restenosis and a betterclinical outcome.
Percutaneous transluminal coronary angioplasty (PTCA) is moreeffective in improving symptoms, exercise performance, and thequality of life than medical treatment in patients with single-vesselcoronary artery disease.1,2 Two recent randomized, multicenterstudies of patients with single-vessel and multivessel diseasehave shown that primary stent implantation in large coronaryarteries results in a lower risk of restenosis and less frequentneed for subsequent interventions than does PTCA.3,4 As a consequence,stent implantation appears to be a better therapeutic optionthan PTCA. However, both studies enrolled a heterogeneous groupof patients with different patterns of coronary artery disease,different clinical manifestations of ischemic heart disease,and different prognoses — a fact that makes it difficultto apply the results to the care of individual patients.
We carried out a prospective, randomized study comparing theefficacy of primary stent implantation with that of PTCA inthe treatment of highly selected patients with symptomatic isolatedstenosis of the proximal left anterior descending coronary artery.
Methods
Selection of Patients
The study population consisted of patients with the followingcharacteristics: typical angina pectoris, documented myocardialischemia, or both; a newly diagnosed, isolated stenosis of theproximal portion of the left anterior descending coronary artery(defined as a reduction of more than 50 percent of the luminaldiameter, as measured by quantitative computerized angiography,extending less than 15 mm in length in a vessel more than 3mm in diameter); and a left ventricular ejection fraction of40 percent or more on left ventricular angiography. Exclusioncriteria were a myocardial infarction within the previous month;a contraindication to oral anticoagulation, antiplatelet therapy,or both; and anatomical contraindications, including ostiallesions, major branching of the vessel within the target lesion,total occlusion, and severe tortuosity of the proximal portionof the left anterior descending coronary artery. Patients wererandomly assigned to undergo either primary stent implantationor PTCA. Before randomization could be performed, a consensusthat both procedures were feasible had to be reached by twophysicians experienced in invasive cardiology who were not involvedin the study. The study protocol was approved by the institutionalethics committee. Written, informed consent was obtained forevery patient.
Clinical Evaluation
Exertional angina was classified according to the system ofthe Canadian Cardiovascular Society.5 Patients were classifiedas having unstable angina according to Braunwald's criteria.6Patients were classified as having had a myocardial infarctionif they had definite electrocardiographic changes and documentationof abnormal cardiac-enzyme levels. Conventional risk factorswere examined by direct questioning of patients and by a reviewof hospital records, as previously described.7
Stent Implantation and PTCA
Both procedures were performed in the presence of a standbysurgical team. Patients received aspirin (Ascriptin, Rhone–PoulencRorer, Milan, Italy) and diltiazem (Dilzene, Sigma-Tau, Rome)on the day before the procedure. At the beginning of the procedure,10,000 IU of heparin was administered intraarterially; supplementaldoses were then given to maintain an activated clotting timeof more than 300 seconds.
Stent Implantation
A premounted stent-delivery system (Johnson & Johnson InterventionalSystems, Warren, N.J.) was used after predilation in the first40 patients. In the remaining patients, the stent was manuallymounted on a balloon that matched the angiographically determinedreference diameter of the lumen; a PS 153 stent was used inseven cases, a PS 104 in three, a PS 084 in one, and a PS 154Ain six. All the stents were overdilated at high pressure. Afterthe procedure, arterial and venous sheaths were removed whenthe activated clotting time fell to 150 seconds or less. Heparintherapy was begun again two to four hours after the removalof the cannula. Therapy with warfarin sodium (Coumadin, DupontMerck, Wilmington, Del.) was begun within 24 hours after theprocedure. Patients continued to receive heparin infusions untilan international normalized ratio of 2.5 to 3.5 was achieved.After discharge, warfarin was continued for three months andaspirin and diltiazem indefinitely.
Coronary Angioplasty
Monorail balloon catheters (Advanced Cardiovascular Systems,Temecula, Calif.; Scimed, Maple Grove, Minn.; and Cordis, Miami)were used in all patients. The management of acute or threatenedclosure was left to the discretion of the operator, and crossoverto stent implantation was permitted in the case of abrupt orthreatened closure or suboptimal results. After discharge, aspirinand diltiazem were given indefinitely.
Clinical and Angiographic Assessment
Patients were seen in the outpatient clinic at 1, 3, 6, and12 months. The primary clinical end points were the rate ofprocedural success (defined as residual stenosis of less than50 percent in the worse of two orthogonal views, as assessedby quantitative analysis, and the absence of death, myocardialinfarction, and the need for coronary-artery bypass surgeryduring the hospital stay) and the rate of event-free survivalat 12 months (defined as freedom from death, myocardial infarction,and recurrence of angina during the follow-up period). Secondaryclinical end points were the incidence of in-hospital complicationsat the puncture sites necessitating major interventions andthe duration of the hospital stay.
Angiography was performed in two orthogonal views after theintracoronary injection of 200 µg of nitroglycerin. Inall patients, ioversol (Optiray 320, Mallinckrodt Medical, St.Louis) was used as a contrast agent. Angiographic variableswere assessed before the procedure, immediately after it, andat follow-up; the same two orthogonal views were always obtained.Quantitative analysis was performed with the use of the AutomatizedCoronary Analysis System (Philips, Best, the Netherlands). Measurementsincluded the minimal luminal diameter at the point of stenosisin the projection showing the greatest narrowing and the diameterof the proximal reference segment; both were measured at end-diastole.The severity of stenosis was also expressed as the percentagereduction of the internal luminal diameter as compared withthe angiographically normal proximal coronary-artery referencesegment. All angiograms were analyzed by two observers who wereblinded to the patients' treatment assignments; measurementswere highly reproducible (r > 0.97), and there was no significantdifference between the observers (P = 0.24). The average ofthe two measurements was used for statistical analysis. Follow-upcoronary angiography was performed 12 months after the initialprocedure or if symptoms suggestive of coronary restenosis developedbefore that time. The angiographic end point was the rate ofrestenosis (defined as stenosis of 50 percent or more) at 12months.
Statistical Analysis
We calculated the size of the sample necessary to achieve 80percent statistical power at an alpha level of 0.05. The accrualgoal was based on previous reports of the effects of stent implantationand PTCA on the angiographic end point (the 12-month rate ofrestenosis).3,4,8 On the basis of the assumption that 15 percentof the patients assigned to stent implantation and 40 percentof those assigned to PTCA would have restenosis, 55 patientswere required in each cohort. Assuming a 10 percent dropoutrate, we set a goal of 120 patients for the study.
All analyses were performed according to the intention-to-treatprinciple. Continuous data are expressed as means ±SDand were compared by the unpaired Student's t-test. Discretevariables were compared by the Mann–Whitney U test. Thechi-square test with a continuity correction was used to compareproportions. Differences between the groups were consideredto be statistically significant when the P value was below 0.05.All statistical tests were two-tailed.
Results
Characteristics of the Patients
Between March 1992 and July 1995, 3918 consecutive patientswere referred to our hospital for coronary angiography; 1293patients had single-vessel disease, and 120 (105 men and 15women; mean age, 57±10 years; range, 34 to 84) had stenosisof the proximal left anterior descending coronary artery thatmet the inclusion criteria. Sixty patients were randomly assignedto undergo stent implantation, and 60 to undergo PTCA. Fourpatients dropped out of the study after randomization: two patients,one assigned to stent implantation and one to PTCA, withdrewtheir consent before the procedure and were treated medically;the other two patients (one assigned to each group) underwentsurgical revascularization. There were no significant differencesin base-line clinical or angiographic characteristics betweenthe two groups (Table 1).
Table 1. Base-Line Clinical and Angiographic Characteristics of 120 Patients Included in the Intention-to-Treat Analysis, According to Treatment Group.
Early Clinical Outcomes
The success rate was similar whether patients were treated withstenting or with PTCA (95 percent vs. 93 percent, P = 0.98).Stent implantation was successful in 55 patients. In one patient,the stent could not be deployed because the lesion could notbe predilated, and in one patient the stent was deployed tooclose to the stenosis. Both patients were in clinically andhemodynamically stable condition and underwent successful surgicalrevascularization. Another patient, in whom the stent had beensuccessfully implanted, had subacute stent thrombosis two daysafter the procedure and underwent coronary bypass grafting.This patient had a Q-wave myocardial infarction.
PTCA was successful in 54 patients. Two patients assigned toundergo PTCA crossed over to stent implantation; in one patientthere was residual stenosis of more than 50 percent, and inthe other there was clear angiographic evidence of flow-limitingdissection (grade 1 on the scale described in the Thrombolysisin Myocardial Infarction [TIMI] trial10). In two other patientsPTCA was unsuccessful. In one the lesion could not be crossedwith the guide wire; this patient underwent successful coronarybypass surgery two days later. The other patient underwent urgentsurgical revascularization for refractory occlusion during theprocedure; this patient had a non–Q-wave myocardial infarction.
The incidence of bleeding and vascular complications at thepuncture sites that resulted in pseudoaneurysm was higher afterstent implantation than after PTCA (7 percent vs. 0, P = 0.12).Three patients were treated surgically, and one was treatedwith prolonged compression. The median hospital stay was 6.5days (range, 3 to 26) in the stent group and 5.0 days (range,2 to 19) in the PTCA group (P = 0.04). Data on the in-hospitalevents are shown in Table 2.
Table 2. Clinical Outcomes in the Hospital and during Follow-up, According to Treatment Group.
Early Angiographic Results
After the procedure, patients who underwent stent implantationhad a greater immediate gain in luminal diameter than thosewho underwent PTCA (2.0±0.6 vs. 1.4±0.5 mm, P= 0.001), resulting in a greater minimal luminal diameter (2.8±0.6vs. 2.1±0.5 mm, P = 0.001) and in less severe residualstenosis (17±14 percent vs. 34±13 percent, P =0.001). Early angiographic results are shown in Table 3.
Table 3. Procedural Characteristics and Initial Angiographic Results, According to Treatment Group.
Clinical Outcomes at 12 Months
Late clinical follow-up data were available for all patients.The rate of event-free survival at 12 months was 87 percentin the stenting group and 70 percent in the PTCA group (P =0.04) (Table 2). In the stenting group, one patient had an acutemyocardial infarction two months after discharge from the hospitaland died. All the remaining patients were alive at the lastfollow-up visit. Symptoms developed in seven patients duringthe 12-month follow-up period, and one of these patients hada documented non–Q-wave myocardial infarction. All sevenof these patients underwent repeated angiography. One patienthad progression of the disease in the circumflex coronary arteryand underwent successful PTCA; five patients had restenosisat the level of the stent; and the remaining patient had totalocclusion of the left anterior descending coronary artery ata point proximal to the stent. In three patients it was possibleto recanalize the artery by PTCA; one patient underwent coronarybypass grafting because he declined to undergo a second PTCAprocedure, and in three patients the dosage of antianginal agentswas increased to control symptoms. Data on events during follow-upare shown in Table 2.
In the PTCA group, one patient had an anterior Q-wave myocardialinfarction three months after the procedure and died. All theremaining patients were alive at the last follow-up visit. Seventeenpatients became symptomatic during the 12-month follow-up period.Non–Q-wave myocardial infarction was documented in 2 ofthese 17 patients. The other 15 underwent repeated angiography,and all had evidence of restenosis. In six patients a stentwas successfully implanted. Seven patients underwent repeatedPTCA, which was successful in three. In one patient the resultsof PTCA were considered suboptimal; the patient underwent coronarysurgery because he refused stent implantation. Three patientswere treated medically with increasing dosages of antianginaldrugs; one of the three declined repeated angiography. In thispatient, thallium-201 scintigraphy strongly indicated exercise-inducedischemia in the territory of the left anterior descending coronaryartery, thus suggesting restenosis; he was treated medically.
Angiographic Results at 12 Months
Coronary angiography was repeated at 12 months in 49 patientsassigned to stenting and in 46 patients assigned to PTCA whowere eligible for follow-up (P = 0.14). All patients in whomcoronary angiography was not repeated were free of symptoms.The rate of restenosis was 19 percent after stent implantationand 40 percent after PTCA (P = 0.02). At 12 months, the stentinggroup had a greater mean reduction in the luminal diameter fromthe value immediately after the procedure (0.7±0.6 mm,vs. 0.4±0.4 mm in the PTCA group, P = 0.035) but alsoa greater net gain over the base-line value (1.4±0.7vs. 1.0±0.5 mm, P = 0.012), resulting in a greater minimalluminal diameter (1.8±1.0 vs. 1.4±0.9 mm, P =0.028). Data on the results of follow-up angiography are shownin Table 4.
Table 4. Angiographic Outcome at 12 Months, According to Treatment Group.
Discussion
Our findings indicate that in symptomatic patients with isolatedstenosis of the proximal left anterior descending coronary artery,primary stent implantation, as compared with PTCA, resultedin a similar rate of immediate procedural success, superiorearly and late angiographic results, a more favorable clinicaloutcome at 12 months, and a lower 12-month rate of restenosis.
The treatment of symptomatic patients with isolated stenosisof the proximal left anterior descending coronary artery isdifficult.11,12,13,14 Epidemiologic and investigational dataindicate that disease of the proximal left anterior descendingcoronary artery is a "high-risk" lesion because this arterysupplies 40 to 50 percent of the total left ventricular myocardium;thus, an occlusion at this site results in ischemia in a largeportion of the myocardium.15,16 This high-risk stenosis canbe treated medically, by PTCA, by stenting, or by surgery. Thebest therapeutic approach is still being debated.
In the Angioplasty Compared to Medicine Study,17 69 of the 212patients with single-vessel disease who were randomly assignedto PTCA or medical therapy had stenosis of the proximal leftanterior descending coronary artery. After six months of follow-up,the patients who underwent PTCA had greater exercise toleranceand fewer symptoms than the medically treated patients.17
Coronary-artery bypass grafting with the left internal thoracicartery is an excellent alternative treatment for isolated stenosisof the proximal left anterior descending coronary artery.18,19The Lausanne study, designed to compare PTCA and grafting withthe left internal thoracic artery for the treatment of isolatedstenosis of the left anterior descending coronary artery, founda similar survival rate in the two groups, but PTCA was associatedwith a greater risk of restenosis and more frequent need forreintervention.20 A report from a recent trial in which patientswere randomly assigned to surgery, PTCA, or medical therapyindicated that, among patients who underwent surgery with agraft from the left internal thoracic artery, the incidenceof cardiac events during follow-up was significantly lower thanamong patients assigned to PTCA or medical treatment.21
Recent randomized, prospective, multicenter studies have shownthat in patients with coronary artery disease, primary stentimplantation, on average, is associated with a lower incidenceof restenosis, defined both angiographically and clinically,than PTCA.3,4 Furthermore, a retrospective analysis of the StentRestenosis Study showed that although stenting, as comparedwith PTCA, provided a better average net gain in luminal diameter,the gain was greater in patients who had stents implanted inthe left anterior descending coronary artery than in patientswho had stents implanted in other coronary arteries.22 On thebasis of these data, we postulated that primary stent implantationfor the treatment of isolated stenosis of the proximal leftanterior descending coronary artery could be a better therapeuticoption than PTCA.
In this study, primary stent implantation resulted in a betterlong-term angiographic and clinical outcome than PTCA, mainlybecause of a reduced need for additional interventions. After12 months of follow-up, 87 percent of the patients treated withstenting, as compared with 70 percent of those treated withPTCA, were asymptomatic and free of cardiac events (definedas death, myocardial infarction, and recurrence of angina).The greater clinical benefit in patients treated with stentingis unlikely to be due to anticoagulant therapy, since previousstudies have shown that anticoagulation does not improve theclinical outcome after PTCA.23,24
In contrast to previous studies in which very heterogeneousgroups of patients were randomly assigned to stenting or PTCA,our study compared the two approaches in a well-characterizedcohort of symptomatic patients who had reasonably good leftventricular function and isolated stenosis of the proximal leftanterior descending coronary artery in a vessel at least 3 mmin diameter. Interestingly, the rate of recurrence of anginaafter one year of follow-up was similar to that observed inthe Benestent trial, which enrolled a much more heterogeneousgroup of patients.25
The incidence of major peripheral vascular complications washigher in the stenting group than in the PTCA group in our study.Furthermore, the duration of hospitalization was longer forthe patients treated with stenting than for those treated withPTCA, confirming a previous report from other European institutions.26However, in the present study we used a very aggressive antithromboticand anticoagulant regimen. It is likely that by using an antithromboticregimen only, as recently proposed, the incidence of peripheralcomplications and the hospital stay could be significantly reducedwithout affecting the long-term patency of the stented vessel.26,27The hospital stay in our study was, on average, longer thanthat reported in the United States.4 This difference is probablydue to a longer time lag in our hospital between admission andthe revascularization procedure.
Clinical follow-up was based only on the clinical examination,electrocardiography at rest, and the interview. We did not systematicallyperform noninvasive testing to assess functional capacity objectively.Moreover, although primary stent implantation, as compared withPTCA, resulted in a more favorable clinical outcome at 12 months,our study did not show a significant difference between thegroups in mortality due to cardiac causes. This could be dueto the low rate of mortality among patients with single-vesseldisease and good left ventricular function, the small numberof patients studied, the short duration of follow-up, or a combinationof these factors.13
In symptomatic patients with isolated, uncomplicated stenosisof the proximal left anterior descending coronary artery ina vessel at least 3 mm in diameter, primary stent implantation,as compared with PTCA, resulted in better immediate and lateangiographic results, reduced the incidence of restenosis, andwas associated with a more favorable clinical outcome at 12months. Since this study showed that in highly selected patientswith isolated disease of the proximal left anterior descendingcoronary artery, primary stent implantation resulted in a betterlong-term outcome than PTCA, a comparison of the results ofstenting with those of the best surgical therapy is now warranted.
Presented in part at the 45th Annual Scientific Session of theAmerican College of Cardiology, Orlando, Fla., March 24–27,1996.
Source Information
From the Servizio Speciale di Diagnosi e Cura di Emodinamica, Divisione di Cardiochirurgia, Università di Roma Tor Vergata (F.V., A.G., F.T., L.C., P.A.G.); and the Istituto di Cardiologia, Università Cattolica del Sacro Cuore (F.C.) — both in Rome.
Address reprint requests to Professor Gioffrè at the Servizio Speciale di Diagnosi e Cura di Emodinamica, Divisione di Cardiochirurgia, Università di Roma Tor Vergata, via Portuense 700, 00149 Rome, Italy.
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