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(Circulation. 2003;108:2870.)
© 2003 American Heart Association, Inc.

Clinical Investigation and Reports

Randomized Comparison Between Stenting and Off-Pump Bypass Surgery in Patients Referred for Angioplasty

Frank Eefting, MD; Hendrik Nathoe, MD; Diederik van Dijk, MD; Erik Jansen, MD; Jaap Lahpor, MD; Pieter Stella, MD; Willem Suyker, MD; Jan Diephuis, MD; Harry Suryapranata, MD; Sjef Ernst, MD; Cornelius Borst, PhD; Erik Buskens, PhD; Diederick Grobbee, PhD; Peter de Jaegere, MD

From the Department of Cardiology, Heart Lung Center Utrecht (F.E., H.N., P.S., C.B., S.E., P.J.), Departments of Anesthesiology (D.D., J.D.) and Cardiothoracic Surgery (E.J., J.L.), and The Julius Center for Health Science and Primary Care (E.B., D.G.), Utrecht, the Netherlands; and Isala Clinics, Department of Cardiothoracic Surgery (W.S., H.S.), Zwolle, the Netherlands.

Correspondence to Peter de Jaegere, HPN, E 01.207, PO Box 85500, 3508 GA, Utrecht, The Netherlands. E-mail p.p.t.dejaegere{at}hli.azu.nl

Received March 6, 2003; de novo received June 20, 2003; revision received September 4, 2003; accepted September 8, 2003.

	Abstract

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Background— Stenting improves cardiac outcome in comparison with balloon angioplasty. Compared with conventional surgery, off-pump bypass surgery on the beating heart without cardiopulmonary bypass may reduce morbidity, hospital stay, and costs. The purpose, therefore, was to compare cardiac outcome, quality of life, and cost-effectiveness 1 year after stenting and after off-pump surgery.

Methods and Results— Patients referred for angioplasty (n=280) were randomly assigned to stenting (n=138) or off-pump bypass surgery. At 1 year, survival free from stroke, myocardial infarction, and repeat revascularization was 85.5% after stenting and 91.5% after off-pump surgery (relative risk, 0.93; 95% CI, 0.86 to 1.02). Freedom from angina was 78.3% after stenting and 87.0% after off-pump surgery (P=0.06). Quality-adjusted lifetime was 0.82 year after stenting and 0.79 year after off-pump surgery (P=0.09). Hospital stay after the initial procedure was 1.43 and 5.77 days, respectively (P<0.01). Stenting reduced overall costs by $2933 (26.2%) per patient ($8276 versus $11 209; P<0.01). Stenting was more cost-effective in 95% of the bootstrap estimates.

Conclusions— At 1 year, stenting was more cost-effective than off-pump surgery while maintaining comparable cardiac outcome and quality of life. Stenting rather than off-pump surgery, therefore, can be recommended as a first-choice revascularization strategy in selected patients.

Key Words: bypass • stents • cost-benefit analysis

	Introduction

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Coronary revascularization by either bypass surgery or coronary angioplasty relieves angina and may improve the prognosis in patients with coronary artery disease.^1,2 Randomized comparisons reveal no difference in survival free from myocardial infarction (MI) between surgery and balloon angioplasty.^3,4 Stenting significantly improved the long-term outcome, but surgery is still associated with fewer reinterventions during follow-up.^5–9 Surgery, however, is more invasive and is associated with significant perioperative morbidity, which is attributed to the use of cardiopulmonary bypass.¹⁰

To improve outcome, enhance recovery, and reduce hospital stay and costs, off-pump surgery on the beating heart without cardiopulmonary bypass is advocated and was stimulated by the advent of tissue stabilizers.¹¹ Immobilization of the cardiac wall allows the safe construction of anastomoses on the beating heart, with patency rates comparable to conventional bypass surgery.¹² Also, in case of single-vessel disease, access to the heart can be obtained via a limited thoracotomy, which may reduce recovery time, hospital stay, and costs.¹³ Thus, off-pump bypass surgery may be an alternative for patients in whom stenting is considered the first-choice treatment. Better long-term clinical outcome may offset the still more invasive nature of off-pump surgery. The purpose of this randomized trial was to compare cardiac outcome, quality of life, and cost-effectiveness at 1 year between off-pump surgery and stenting in patients referred for angioplasty.

	Methods

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Subjects
Patients referred for coronary angioplasty were eligible provided they had stable or unstable angina (Braunwald class I–IIB) and/or documented ischemia, irrespective of the extent of vessel disease, provided that both stenting and off-pump surgery were considered technically feasible and expected to lead to a similar degree of revascularization.

Patients were excluded in case of left main stem stenosis, totally occluded artery supplying an akinetic myocardial area, in-stent restenosis, the need of >1 graft for complete revascularization of the left circumflex artery, and poor ventricular function. Clinical exclusion criteria consisted of emergency revascularization, Q-wave MI in the previous 6 weeks, angioplasty in the previous 6 months, previous bypass surgery, hemorrhagic disorder, hypercoagulability, or intolerance to acetylsalicylic acid or ticlopidine.

The study was performed according to the guidelines of the Declaration of Helsinki. The ethics committees of the 3 participating centers approved the study protocol. After patients had provided written informed consent, computerized randomization was performed by telephone.

Coronary Revascularization
The objective was to achieve complete functional revascularization of viable but ischemic myocardium by stenting or arterial grafting of the major coronary arteries. Stenting was performed by use of standard techniques. Balloon angioplasty without stenting was permitted in branch vessels. Off-pump surgery was performed by use of the "Octopus" tissue stabilizer described in detail elsewhere.¹¹

Primary End Point
The primary end point was freedom from all-cause death, stroke, acute MI, and repeat revascularization at 12 months. Stroke was defined by focal cerebral injury persisting >24 hours in combination with an increase in handicap of at least 1 grade on the Rankin scale.¹⁴ Acute MI within 7 days was defined by an increase in creatine kinase isoenzyme (CK-MB) exceeding 5 times the upper limit of the normal value after surgery or 3 times after stenting (non–Q-wave) and if concomitantly, new pathological Q waves appeared (Q-wave).¹⁵ After 7 days, a Q-wave acute MI was documented in case of new pathological Q waves and a non–Q-wave acute MI in case of isolated CK-MB elevation with a CK-MB/CK ratio >0.1. An independent committee blinded to the treatment allocation evaluated all events.

Secondary End Points
Secondary end points were survival free of stroke and acute MI, freedom from angina and medication, quality of life, and cost-effectiveness. Quality of life was assessed by use of the Short Form 36 (SF-36) and Euroqol questionnaires.¹⁶ The summary index of the Euroqol (EQ-5D) was used to weigh survival time and to analyze cost-effectiveness.¹⁷

Costs were estimated in 1999 Dutch florins (DFL) and were converted to US dollars ($1=2.5 DFL). Direct medical costs were assessed separately during the initial hospitalization and follow-up until 1 year. Costs per patient were calculated by multiplying resource use by the cost per unit. Costs of acute MI and stroke after hospitalization were calculated by use of overall costs.^18,19 The direct in-hospital costs were used as an estimate of unit costs of angioplasty or bypass surgery during follow-up. Sick leave was assessed over a period of 4 weeks at baseline and before every follow-up time. Indirect costs concern losses of productivity and were calculated by use of the "friction cost" method.²⁰

By use of linear extrapolation for the periods between measurements until 1 year after the intervention, quality-adjusted survival time was estimated by calculating the individual area under the curve of the EQ-5D. Effectiveness was expressed in terms of quality-adjusted life years (QALYs). Efficiency was addressed by calculating cost-effectiveness ratios by dividing the difference in overall costs by the difference in QALYs. The uncertainty surrounding costs and effects was evaluated by bootstrap techniques.²¹

Data Analysis
The sample size was based on the assumption that stenting and off-pump surgery result in event-free survival of 75% percent and 90%, respectively. With an error of 0.05 and ß error of 0.10 (power 90%), 125 patients per group were required. Anticipating a 10% loss to follow-up, this number was increased to 140.

All events from randomization onward were recorded and analyzed by intention-to-treat. Relative risks (RRs) with 95% CIs were used to express the difference in effect between the interventions. Dichotomous data were compared by use of the ² statistic. Means are presented with SDs and were compared by use of a 2-sample t test. Non–normally distributed continuous variables were compared by a Mann-Whitney test. Event-free survival was compared by use of Kaplan-Meier curves and log rank test. Overall change from baseline of the EQ-5D was analyzed by repeated measures ANOVA.

	Results

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Between March 1998 and August 2000, 280 patients were randomly assigned to stenting (n=138) and off-pump surgery (n=142; Table 1). Seven patients randomized to stenting did not undergo the assigned treatment; 5 underwent balloon angioplasty and 2 on-pump surgery. Six patients randomized to off-pump surgery did not undergo the assigned treatment; 2 underwent on-pump surgery and 4 angioplasty. Therefore, 131 patients (95%) randomized to stenting and 136 (96%) randomized to off-pump surgery received the assigned treatment.

View this table: [in this window] [in a new window]   TABLE 1. Baseline Characteristics

In the stent group, 1.44 stents with a mean length of 20.1 (SD, 10.2 mm) per patient were implanted. The majority of stents (88%) were implanted for a stenosis in the left anterior descending coronary artery located in segment 6 in 15 patients (12%), in segment 7 in 100 (83%), and in segment 8 in the remaining 6 (5%). In addition, a stent was implanted in the left circumflex artery and right coronary artery in 17% and 27% of patients, respectively. None had an ostial stenosis. A glycoprotein IIb/IIIa receptor blocker was administered in 16 patients (12.2%).

In the off-pump group, access to the heart was achieved via median sternotomy in 91 patients (67%) or a left anterior thoracotomy in 41 (30%). Left posterolateral, xyphoid laparotomy, or partial sternotomy was used in 5 (3.6%). All patients received at least 1 arterial graft. In total, 168 arterial grafts were used: in situ mammary artery in 147 patients, free mammary graft in 18, and a gastroepiploic artery in 3. Four patients (3.6%) also received a vein graft.

One-Year Outcome
There was no difference in event-free survival after stenting (85.5%) and off-pump surgery (91.5%) (RR, 0.93; 95% CI, 0.86 to 1.02; Table 2). In the off-pump group, 4 patients died: 2 of a perioperative acute MI and 2 during follow-up because of malignancy and primary pulmonary hypertension. An acute MI occurred in 6 patients in the stent group (Q-wave, 4; non–Q-wave, 2) and in 7 in the off-pump group (Q-wave, 5; non–Q-wave, 2). At least 1 repeat revascularization was performed in 17 patients (12.3%) in the stent group and in 5 patients (3.5%) in the bypass group (RR, 3.50; 95% CI, 1.33 to 9.22). Kaplan-Meier estimates of event-free survival are depicted in Figure 1.

View this table: [in this window] [in a new window]   TABLE 2. Clinical Events*

View larger version (14K): [in this window] [in a new window]   Figure 1. Kaplan-Meier estimates of survival free of stroke and MI (top, P=0.46) and free of stroke, MI, and repeat revascularization (bottom, P=0.11).

Freedom from angina at 1 year was 78.3% after stenting and 87.0% after off-pump surgery (P=0.06; Table 3). An exercise test was performed in 264 patients (94.3%) at 1 year. There was no difference in exercise capacity expressed by metabolic equivalents: 9.5 and 10.1 METS (P=0.20) after stenting and off-pump surgery, respectively. Absence of ischemia was documented in 99 patients (74.4%) in the stent group and in 104 (79.4%) in the off-pump group (P=0.34).

View this table: [in this window] [in a new window]   TABLE 3. Quality of Life, Symptoms, and Use of Medication

Quality of Life and Cost-Effectiveness
Stenting reduced the direct in-hospital costs by $2495 (33.2%) per patient ($5013 versus $7508; P<0.01; Table 4). The overall costs at 1 year were $2933 (26.2%) per patient lower after stenting ($8276 versus $11 209; P<0.01). The indirect costs at 1 year were comparable. Hospital stay after initial hospitalization was 1.43 days in the stent group and 5.77 days in the surgery group (P<0.01).

View this table: [in this window] [in a new window]   TABLE 4. Average Resource Use and Costs per Patient*

At 1 month, quality of life (EQ-5D) was significantly higher after stenting than after off-pump surgery but was comparable at 1 year. (Figure 2) Most scores of the individual domains of the SF-36 showed the same pattern as the EQ-5D (Table 3).

View larger version (15K): [in this window] [in a new window]   Figure 2. Quality of life after stenting and off-pump surgery (summary score of Euroqol EQ-5D). Controls indicates EQ-5D scores of age matched control subjects.

The number of QALYs was 0.82 after stenting versus 0.79 after off-pump surgery (P=0.09). The incremental cost-effectiveness ratio for stenting compared with off-pump surgery was -$97 767 (ie, -$2933/0.03), indicating cost savings of $97 767 for 1 QALY gained. The bootstrap simulation showed a similar result, ie, stenting dominated off-pump surgery in 95% of the 500 bootstrap estimates (less costly and more QALYs gained) (Figure 3).

View larger version (23K): [in this window] [in a new window]   Figure 3. Bootstrap estimates of expected costs and quality-adjusted life years (QALYs) after stenting and off-pump surgery. Stenting dominated off-pump surgery in 95% of 500 bootstrap estimates (less costly and more QALYs gained).

	Discussion

Top Abstract Introduction Methods Results Discussion References

 
Off-pump surgery was compared with stenting in patients referred for angioplasty. No difference in cardiac outcome at 1 year was found. Off-pump surgery, however, was associated with fewer repeat revascularizations, and these patients were more likely to be free of angina and medication. Yet, there was no difference in quality of life, and stenting was associated with lower costs.

With respect to the in-hospital events as a measure of safety, there was a trend toward fewer events in favor of stenting. Considering the differences in invasiveness of stenting and bypass surgery, irrespective of the precise surgical approach, stenting is still expected to be safer in less selected patients as well.^7,8

The limitation of angioplasty is the need for reintervention. Event-free survival has remained at 90% after surgery. It was 60% after balloon angioplasty but increased to 74% (ARTS study) and 86% (present study), which is explained by the reduction in reinterventions from 30% after balloon angioplasty to 8% to 13% after stent implantation.^3,7 In patients with an isolated left anterior descending coronary artery stenosis, Diegeler et al²² found a 6-month event-free survival of 85% after off-pump surgery but 69% after stenting. This is at variance with the 1-year event-free survival of 91.5% after off-pump surgery and 85.5% after stenting in this study.

Considering the absolute difference in the event free survival (6.0%) and direct medical costs ($2475 US) at 1 year, 17 patients need surgery for 1 additional patient to have an 1-year event-free survival. This implies an extra cost of $42 000 US. A significant cost saving was also observed after stenting in patients with multivessel disease.⁷

The safety and efficacy of stenting may be further enhanced by the use of a glycoprotein IIB/IIIA receptor blocker or drug-eluting stents.^23,24 Obviously, this will increase direct costs, but it may favorably affect cost-effectiveness, because absence of repeat revascularization is reported after implantation of a sirolimus-eluting stent.²⁴ As a result, event-free survival after stenting may equal that of bypass surgery. Novel surgical techniques, such as robotic surgery and single-shot anastomosis, are being developed.^25,26 Therefore, the comparison of cost-effectiveness between percutaneous and surgical revascularization needs periodic reevaluation.

Coronary angioplasty is the least invasive revascularization procedure and can be performed in an outpatient setting. In this study, most patients assigned to surgery underwent full midsternal split. Access to the heart via a limited thoracotomy could have been achieved in a larger proportion of patients, reducing hospital stay and costs. This is especially true for the patients with isolated right coronary artery disease, in whom an subxyphoidal access could have been used more often. In patients with 3-vessel disease, a midsternal split will remain mandatory until more advanced surgical techniques, such as robotic heart surgery, have proved to be safe and feasible. A limited surgical approach, however, may cause significant pain during the postoperative period and follow-up, which may negatively affect the quality of life. It is important to address and discuss these issues with the patient, who may have a different perception of the advantages and disadvantages of the various treatment modalities.

The point estimates of the (cost)-effectiveness may lack precision because of sample size, risk profile of the population, number of events, and duration of follow-up. Also, the open design may have affected the assessment of outcome, such as revascularization, angina, and quality of life. In addition, despite the computerized randomization procedure, subtle differences between the populations cannot be ruled out. With respect to the population, patients with in-stent restenosis were excluded because of the potentially refractory nature of this disorder, for which stent reimplantation was not considered an appropriate therapy. The exclusion of patients with complex circumflex pathology was related to the current limitations of off-pump surgery. In such patients, extensive luxation of the heart may lead to significant hemodynamic instability, rendering off-pump surgery a less attractive procedure.

Conclusions
In the present population, there is no difference in cardiac outcome between off-pump surgery and stenting. Off-pump surgery, however, was associated with fewer repeat revascularizations, but stenting was more cost-effective. Stenting rather than off-pump surgery therefore can be recommended as a first-choice revascularization strategy in selected patients.

	Acknowledgments

 
This study was supported by grant OG 98-026 from the Netherlands National Health Insurance Council.

	References

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This Article Abstract Full Text (PDF) All Versions of this Article: 108/23/2870    most recent 01.CIR.0000100723.50363.2Cv1 Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Eefting, F. Articles by de Jaegere, P. Search for Related Content PubMed PubMed Citation Articles by Eefting, F. Articles by de Jaegere, P. Related Collections Catheter-based coronary interventions: stents CV surgery: coronary artery disease