(Circulation. 1999;99:3255-3259.)
© 1999 American Heart Association, Inc.
Clinical Investigation and Reports |
From the Division of Cardiology (J.-J.G., E.E., C.M., P.V., J.-C.S., P.U., L.K.), Service of Cardiovascular Surgery (M.H., F.S., P.R., L.v.S.), and Institute of Social and Preventive Medicine (B.B.), Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.
Correspondence to Professeur Jean-Jacques Goy, Division of Cardiology, BH-10, CHUV, Rue du Bugnon 46, 1011 Lausanne, Switzerland. E-mail jean-jacques.goy{at}chuv.hospvd.ch
| Abstract |
|---|
|
|
|---|
Methods and ResultsWe monitored 134 patients randomized to PTCA
(n=68) or CABG (n=66) for
5 years. End points were death, myocardial
infarction, need for additional revascularization,
clinical status, and medical treatment. At 5 years, 6 patients (9%)
had died in the PTCA group versus 2 (3%) in the CABG group
(P=0.12). One patient in each group died of a cardiac
cause. Myocardial infarction was more frequent after PTCA (15% versus
4%; P=0.0001), but Q-wave infarction was not (6% in
the PTCA group versus 3% in the CABG group; P=0.8).
Additional revascularization was required in 38%
of patients in the PTCA group versus 9% in the CABG group
(P=0.0001). Functional status was comparable, with 6%
of patients after PTCA and 3% after CABG in functional class III or
IV. Finally, after PTCA or CABG, 62% and 91% of patients,
respectively, were free of events (P=0.0001).
ConclusionsThe 5-year prognosis of patients with isolated proximal left anterior descending coronary artery stenosis is good. Both PTCA and CABG improve clinical status, but revascularization was needed more frequently after PTCA. There is an excess incidence of nonQ-wave myocardial infarction in the PTCA group that does not affect the vital or symptomatic outcome.
Key Words: angioplasty bypass stenosis prognosis revascularization
| Introduction |
|---|
|
|
|---|
| Methods |
|---|
|
|
|---|
Patients
Patients with isolated proximal LAD stenosis and an
ejection fraction >0.50 were eligible for the trial provided they had
documented clinical or silent ischemia; we excluded patients
with refractory unstable angina or previous anterior Q-wave myocardial
infarction. The study protocol was approved by the hospital ethics
committee. A consensus on the feasibility of PTCA or CABG had to be
obtained from 2 cardiologists and 2 cardiac surgeons before
randomization.
Randomization was performed according to Zelen's design.9 The standard treatment was CABG. Patients allocated this treatment were not informed of the PTCA option. Patients in the PTCA group were fully informed about the trial and were requested to provide informed consent. However, the patients in the CABG arm who requested PTCA because they were aware of this technique underwent PTCA after having been fully informed of the trial. CABG had to be performed within 30 days after randomization and PTCA within 10 days.
Percutaneous Revascularization
PTCA was performed by the right or left femoral route with an 8F
guiding catheter. Adjunct medication consisted of 500 mg of aspirin and
15 000 U of heparin. Standard angioplasty techniques with
over-the-wire or monorail balloons were used. Inflation was performed
as recommended by the manufacturer. PTCA was performed until an
acceptable result (<50% residual stenosis) was obtained. The
management of threatened or acute closure was left to the discretion of
the operator, with the knowledge that stents were available (Wallstent;
Schneider). After the procedure, patients were placed in an
intensive care unit. Creatine kinase (CK) activity and ECG monitoring
were performed after the procedure, at 6 hours, and the
following day.
Surgical Revascularization
Surgery was performed by median sternotomy.
Cardiopulmonary bypass was established by means of a single
canula. St Thomas II cardioplegia and cooled Ringer's solution
were used to induce cardiac arrest. The left internal mammary artery
(LIMA) pedicle was transferred into the surgical field through a
lateral incision in the pericardium. The LAD was incised for 0.5 to 1.0
cm. Vessel anastomosis was assured by means of 2 double-armed 7.0
polypropylene wires sutured in continuous stitches. The pedicle was
tacked to the heart surface with 2 interrupted 6.0 polypropylene
sutures to prevent twisting of the pedicle and tension of the suture
line. Visual assessment was assured by the use of 4 to 5x magnifying
glasses.
Follow-Up
Data were collected by direct contact with the patient and his
or her home physician. Repeat cardiac investigations and angiography
were not mandatory at 6 months but were highly encouraged in case of
recurrence of typical or atypical symptoms. Repeat PTCA was
recommended for patients in the PTCA group who had restenosis,
but CABG was presented as a possible alternative. For patients
allocated CABG who needed additional
revascularization, both approaches were
presented, but the final choice was left to the patient and his
or her physician.
End Points
The primary end points were cardiac-related death, myocardial
infarction, and the need for additional
revascularization. Standard clinical, biochemical,
and ECG criteria were used to define myocardial infarction. A CK rise
at twice the normal value without new Q wave on the ECG was considered
a nonQ-wave infarction. Secondary end points were angina functional
status and antianginal drug regimen. An interim analysis was
done at 2 years and the final analysis at 5 years after
inclusion in the trial. Clinical status was assessed by means of the
Canadian Cardiovascular Society classification, and the
need for antianginal treatment was documented. Reinterventions were
classified as (1) target-vessel revascularization
(LAD) or (2) revascularization in a vessel other
than the LAD.
Statistical Analysis
The sample size to achieve 95% statistical power (
=0.01,
ß=0.05) was calculated based on previous reports of the effects of
PTCA and CABG on patients with single-artery coronary disease.
We assumed, based on the composite primary end point, that 35% of
patients treated by PTCA would reach an end point compared with only
5% for the CABG group; we calculated that a total of 132 patients were
required for the study.
All analyses were made according to the intention-to-treat
principle. All tests of significance were 2-tailed (Fisher's and
2 test for discrete variables and
Mann-Whitney, Friedman, and Kruskal-Wallis tests for continuous
variables). The proportions of patients without any primary end
points or repeat angiography were estimated by the Kaplan-Meier method
and compared by means of a log-rank test. These primary end points were
also compared by means of odds ratios and a simultaneous
Fisher's test. A statistical probability of <0.05 was considered to
indicate significance.
| Results |
|---|
|
|
|---|
|
Late Follow-Up
The incidence of adverse events at 5 years is shown in Table 2
. Six patients (9%) died in the
PTCA group versus 2 in the CABG group (2%). However, cardiac death was
equally frequent, with only 1 death in each group (1%). The cause of
noncardiac death was cancer in 4 patients (3 patients in the PTCA group
and 1 in the CABG group), pulmonary embolism (1 patient in the
PTCA group), and mesenteric infarction (1 patient in the PTCA
group). Myocardial infarction was more frequent after PTCA and occurred
in 10 patients (15%) compared with 3 (4%) in the CABG group
(P=0.0001). However, the incidence of Q-wave infarction was
not significantly different: 6% for the PTCA group versus 3% for the
CABG group (P=0.8). Six (9%) of the PTCA patients suffered
a nonQ-wave infarction due to an acute closure during the procedure
or unstable angina with CK rise related to restenosis; these
infarctions were documented by CK rise only. Finally, taken
together, cardiac death and myocardial infarction were more frequent
after PTCA (P=0.0004), with a relative risk of 2.6 (95% CI,
1.1 to 5.4) (Figure 1
and Table 2
).
|
|
There were significantly more repeat interventions (Table 2
) in
the PTCA group, with an incidence of 36% versus 9% in the CABG group
(P=0.002; relative risk, 4.2; 95% CI, 2.8 to 5.6). In the
PTCA group, 26% of the patients had a repeat
revascularization on the LAD and 12% on another
vessel compared with 4.5% and 4.5%, respectively, in the CABG group
(P=0.002) (Table 3
). Finally,
the LAD did not require revascularization during
follow-up in 74% of the patients in the PTCA group compared with 95%
in the CABG group (P=0.04) (Table 3
). The proportion
of patients free of events was 62% in the PTCA group
(P=0.00001) (Figure 2
) and
91% in the CABG group.
|
|
Clinical Follow-Up
Clinical status revealed no difference between the 2 groups.
Seventy-four percent of patients in the PTCA group and 71% in the CABG
group were in functional class I. Only 6% in the PTCA group and 3% in
the CABG group were in class III or IV (Table 4
).
|
At 5 years, most of the patients were taking either no drug, aspirin
alone, or aspirin plus an antianginal drug (Table 5
). There were no differences in drug use
between the 2 groups.
|
Control of risk factors was encouraged, but only 22% of the patients in both groups were taking lipid-lowering drugs, and mean cholesterol blood level was similar at 5.9 mmol/L (95% CI, 5.6 to 6.2 mmol/L). In the PTCA group, 89% of the smokers had stopped smoking compared with 71% in the CABG group. Only 12% in the PTCA group and 6% in the CABG group were smoking after 5 years of follow-up.
| Discussion |
|---|
|
|
|---|
However, the overall incidence of myocardial infarction was higher after PTCA. This is mainly due to the higher number of nonQ-wave infarctions, most of which were due to periprocedural complications, although their incidence is comparable to those reported previously.14 A majority of the infarction cases that we observed only resulted in a CK rise, with no impact on left ventricular function; they are reported as myocardial infarctions, as defined in our initial protocol. Our data differ from those of the RITA I trial, in which no excess of myocardial infarction was noted in the angioplasty group.7 However, a more detailed analysis of the results of the present study shows that for patients with single-vessel disease, there was a clear trend toward more myocardial infarction in the angioplasty patients. The difference was not significant but probably would have been significant with the occurrence of just 1 more event. This makes our results and those of the RITA I trial very concordant. However, if we exclude patients with periprocedural infarction in our trial, there are no differences between the 2 strategies during follow-up with regard to myocardial infarction.
The need for additional revascularization was significantly higher in the PTCA group, which was mainly related to the occurrence of restenosis in 32% of patients. More than 75% of these procedures were performed on the LAD. In the CABG group, subsequent revascularization was rarely required (9%), and in half of the cases, it was related to progression of the disease in other vessels. Surprisingly, the incidence of non-LAD revascularization was significantly higher in the PTCA group (12% versus 4.5%). Patients in the PTCA group more often underwent control angiography and were therefore more prone to have revascularization because of a detection bias. Indeed, the progression of the disease cannot explain this difference; there is no obvious reason to have more rapid progression in the PTCA group. In particular, incidence and control of risk factors for ischemic heart disease were similar in both groups. Lipid-level control was insufficient compared with current standards but was comparable in both groups. Finally, only 4.5% of the initial cohort randomized to CABG underwent additional revascularization of the LAD. This confirms the high value of arterial conduits to revascularize the LAD. Our results are very similar to those reported recently by Hennessy et al.14 Very similar conclusions also arise from the Medicine, Angioplasty or Surgery Study (MASS),15 with a higher incidence of adverse events in the angioplasty and medical group owing to more additional revascularizations. The authors did not observe an increased incidence of myocardial infarction after angioplasty, but the true incidence of this event was not reported. They mention an 8% incidence of occluded LAD at 2 years, but whether these occlusions were silent or not is not indicated. In the present study, the proportion of asymptomatic patients was high, with no differences between treatment groups. This clinical improvement may also be due in part to the medical treatment, but again, this was similar in both groups, as was the quality of risk factor control.
Limitation of the Present Trial
One limitation of this study is its relatively low power to
demonstrate that a difference between the 2 groups for an event is
actually "statistically significant."
Clinical Implications
On the basis of the above-mentioned data, we suggest that patients
with isolated proximal LAD stenosis who need to be
revascularized should be fully informed about the various approaches.
The final choice should integrate the clinical status, morphology of
the stenosis, and expressed preference of a fully informed
patient. Indeed, there is an opportunity for a shared decision-making
process to assist physician and patients in making the decision.
Received December 7, 1998; revision received April 14, 1999; accepted April 14, 1999.
| References |
|---|
|
|
|---|
2. Hampton J, Henderson R, Julian D, Parker J, Pocock S, Sowton E, Wallwork J, and RITA participants. Coronary angioplasty versus coronary artery bypass surgery: the Randomized Intervention Treatment of Angina (RITA) trial. Lancet. 1993;341:573580.[Medline] [Order article via Infotrieve]
3.
King S III, Lembo NJ, Weintraub WS, Kosinski AS,
Barnhart HX, Kutner MH, Alazraki NP, Guyton RA, Zhao XQ. A randomized
trial comparing coronary angioplasty with coronary
bypass surgery: Emory Angioplasty versus Surgery Trial. N
Engl J Med. 1994;331:10441050.
4.
Hamm C, Reimers J, Ischinger T, Rupprecht H, Berger J,
Bleifeld W. A randomized study of coronary angioplasty compared
with bypass surgery in patients with symptomatic
multivessel coronary disease: German Angioplasty Bypass Surgery
Investigation. N Engl J Med. 1994;331:10371043.
5. CABRI Trial Participants. First-year results of CABRI (Coronary Angioplasty versus Bypass Revascularization Investigation). Lancet. 1995;346:11791184.[Medline] [Order article via Infotrieve]
6. Pocock S, Henderson R, Rickards A, Hampton J, King S III, Hamm C, Puel J, Hueb W, Goy J-J, Rodriguez A. A meta-analysis of randomised trials comparing coronary angioplasty with bypass surgery. Lancet. 1995;346:11841189.[Medline] [Order article via Infotrieve]
7. Henderson R, Pocock S, Sharp J, Nanchahal K, Sculpher M, Buxton M, Hampton H, for the Randomised Intervention Treatment of Angina (RITA I) trial participants. Long-term results of RITA-1 trial: clinical and cost comparisons of coronary angioplasty and coronary-artery bypass grafting. Lancet. 1998;352:14191425.[Medline] [Order article via Infotrieve]
8. Goy J-J, Eeckhout E, Burnand B, Vogt P, Stauffer J-C, Hurni M, Stumpe F, Ruchat P, Sadeghi H, Kappenberger L. Coronary angioplasty versus left internal mammary artery grafting for isolated proximal left anterior descending artery stenosis. Lancet. 1994;343:14491453.[Medline] [Order article via Infotrieve]
9. Zelen M. A new design for randomized clinical trials. N Engl J Med. 1979;300:12421245.[Abstract]
10. Klein L, Weintraub W, Agarwal J, Schneider R, Seelaus P, Katz R, Helfant R. Prognostic significance of severe narrowing of the proximal portion of the left anterior descending coronary artery. Am J Cardiol. 1986;58:4246.[Medline] [Order article via Infotrieve]
11. Mark D. Assessment of prognosis in patients with coronary artery disease. In: Roubin G, Califf R, O'Neil W. Interventional Cardiovascular Medicine: Principles and Practice. New York, NY: Churchill Livingstone; 1994:163166.
12. Webster J, Moberg C, Rincon G. Natural history of severe proximal coronary artery diseases as documented by coronary cineangiography. Am J Cardiol. 1974;33:195200.[Medline] [Order article via Infotrieve]
13.
Detre K, Holmes D, Holubkov R, Cowley M, Bourassa M,
Faxon D, Dorros G, Bentivoglio L, Kent K, Myler RK. Incidence of
consequences of periprocedural occlusion: the National Heart, Lung, and
Blood Institute Percutaneous Transluminal
Coronary Angiography registry. Circulation. 1990;82:739750.
14.
Hennessy T, Codd M, Donnelly S, Hartigan C, McCann H,
McCarthy C, Neligan M, Wood A, Luke D, McGovern E, Aherne T, Sugrue D.
Long term clinical outcome following coronary artery bypass
grafting for isolated stenosis of the left anterior descending
coronary artery. Eur Heart J. 1998;19:447457.
15. Hueb W, Bellotti G, Almeida De Olivera S, Shiguemituzo A, de Albuquerque C, Jatene A, Pileggi F. The Medicine, Angioplasty or Surgery Study (MASS): a prospective, randomized trial of medical therapy, balloon angioplasty or bypass surgery for single proximal left anterior descending artery stenoses. J Am Coll Cardiol. 1995;26:16001605.[Abstract]
This article has been cited by other articles:
![]() |
O. Soran, A. Manchanda, and S. Schueler Percutaneous coronary intervention versus coronary artery bypass surgery in multivessel disease: a current perspective Interactive CardioVascular and Thoracic Surgery, June 1, 2009; 8(6): 666 - 671. [Abstract] [Full Text] [PDF] |
||||
![]() |
L. K. von Segesser Clinical databases - a double-edged sword! Eur. J. Cardiothorac. Surg., May 1, 2009; 35(5): 749 - 750. [Full Text] [PDF] |
||||
![]() |
J. R. Kapoor, A. L. Gienger, R. Ardehali, R. Varghese, M. V. Perez, V. Sundaram, K. M. McDonald, D. K. Owens, M. A. Hlatky, and D. M. Bravata Isolated Disease of the Proximal Left Anterior Descending Artery: Comparing the Effectiveness of Percutaneous Coronary Interventions and Coronary Artery Bypass Surgery J. Am. Coll. Cardiol. Intv., October 1, 2008; 1(5): 483 - 491. [Abstract] [Full Text] [PDF] |
||||
![]() |
J.-H. Krannich, P. Weyers, S. Lueger, C. Schimmer, H. Faller, and O. Elert The effectiveness of a motivation programme for lifestyle change in the course of aortocoronary bypass graft surgery Clinical Rehabilitation, January 1, 2008; 22(1): 3 - 13. [Abstract] [PDF] |
||||
![]() |
M. L. Brown, T. M. Sundt III, and B. J. Gersh Indications for Revascularization Card. Surg. Adult, January 1, 2008; 3(2008): 551 - 572. [Full Text] |
||||
![]() |
D. M. Bravata, A. L. Gienger, K. M. McDonald, V. Sundaram, M. V. Perez, R. Varghese, J. R. Kapoor, R. Ardehali, D. K. Owens, and M. A. Hlatky Systematic Review: The Comparative Effectiveness of Percutaneous Coronary Interventions and Coronary Artery Bypass Graft Surgery Ann Intern Med, November 20, 2007; 147(10): 703 - 716. [Abstract] [Full Text] [PDF] |
||||
![]() |
D. M. Holzhey, S. Jacobs, M. Mochalski, T. Walther, H. Thiele, F. W. Mohr, and V. Falk Seven-Year Follow-up After Minimally Invasive Direct Coronary Artery Bypass: Experience With More Than 1300 Patients Ann. Thorac. Surg., January 1, 2007; 83(1): 108 - 114. [Abstract] [Full Text] [PDF] |
||||
![]() |
Authors/Task Force Members, K. Fox, M. A. A. Garcia, D. Ardissino, P. Buszman, P. G. Camici, F. Crea, C. Daly, G. De Backer, P. Hjemdahl, et al. Guidelines on the management of stable angina pectoris: executive summary: The Task Force on the Management of Stable Angina Pectoris of the European Society of Cardiology Eur. Heart J., June 1, 2006; 27(11): 1341 - 1381. [Full Text] [PDF] |
||||
![]() |
H. Thiele, S. Oettel, S. Jacobs, R. Hambrecht, P. Sick, J. F. Gummert, F. W. Mohr, G. Schuler, and V. Falk Comparison of Bare-Metal Stenting With Minimally Invasive Bypass Surgery for Stenosis of the Left Anterior Descending Coronary Artery: A 5-Year Follow-Up Circulation, November 29, 2005; 112(22): 3445 - 3450. [Abstract] [Full Text] [PDF] |
||||
![]() |
G. Dangas, S. G. Ellis, R. Shlofmitz, S. Katz, D. Fish, S. Martin, R. Mehran, M. E. Russell, G. W. Stone, and TAXUS-IV Investigators Outcomes of paclitaxel-eluting stent implantation in patients with stenosis of the left anterior descending coronary artery J. Am. Coll. Cardiol., April 19, 2005; 45(8): 1186 - 1192. [Abstract] [Full Text] [PDF] |
||||
![]() |
S. Fraund, G. Herrmann, A. Witzke, J. Hedderich, G. Lutter, M. Brandt, A. Boning, and J. Cremer Midterm Follow-Up After Minimally Invasive Direct Coronary Artery Bypass Grafting Versus Percutaneous Coronary Intervention Techniques Ann. Thorac. Surg., April 1, 2005; 79(4): 1225 - 1231. [Abstract] [Full Text] [PDF] |
||||
![]() |
D. J. Drenth, N. J.G.M. Veeger, J. G. Grandjean, M. A. Mariani, A. J. van Boven, and P. W. Boonstra Isolated high-grade lesion of the proximal LAD: a stent or off-pump LIMA? Eur. J. Cardiothorac. Surg., April 1, 2004; 25(4): 567 - 571. [Abstract] [Full Text] [PDF] |
||||
![]() |
A. Gimelli, M. Glauber, A. Giorgetti, G. Sambuceti, A. L'Abbate, and P. Marzullo Revascularization of dysfunctioning myocardium: differential prognostic effects of coronary artery bypass grafting and percutaneous transluminal coronary angioplasty in patients with three-vessel disease and mostly viable myocardium Interactive CardioVascular and Thoracic Surgery, September 1, 2003; 2(3): 301 - 306. [Abstract] [Full Text] [PDF] |
||||
![]() |
R. J. Dabal, J. R. Goss, C. Maynard, and G. S. Aldea The effect of left internal mammary artery utilization on short-term outcomes after coronary revascularization Ann. Thorac. Surg., August 1, 2003; 76(2): 464 - 470. [Abstract] [Full Text] [PDF] |
||||
![]() |
S. N. Hoffman, J. A. TenBrook Jr, M. P. Wolf, S. G. Pauker, D. N. Salem, and J. B. Wong A meta-analysis of randomized controlled trials comparing coronary artery bypass graft with percutaneous transluminal coronary angioplasty: one- to eight-year outcomes J. Am. Coll. Cardiol., April 16, 2003; 41(8): 1293 - 1304. [Abstract] [Full Text] [PDF] |
||||
![]() |
T. M. Sundt III, B. J. Gersh, and H. C. Smith Indications for Coronary Revascularization Card. Surg. Adult, January 1, 2003; 2(2003): 541 - 559. [Full Text] |
||||
![]() |
A. Diegeler, H. Thiele, V. Falk, R. Hambrecht, N. Spyrantis, P. Sick, K. W. Diederich, F. W. Mohr, and G. Schuler Comparison of Stenting with Minimally Invasive Bypass Surgery for Stenosis of the Left Anterior Descending Coronary Artery N. Engl. J. Med., August 22, 2002; 347(8): 561 - 566. [Abstract] [Full Text] [PDF] |
||||
![]() |
A. Diegeler, N. Spyrantis, M. Matin, V. Falk, R. Hambrecht, R. Autschbach, F. W. Mohr, and G. Schuler The revival of surgical treatment for isolated proximal high grade LAD lesions by minimally invasive coronary artery bypass grafting Eur. J. Cardiothorac. Surg., May 1, 2000; 17(5): 501 - 504. [Abstract] [Full Text] [PDF] |
||||
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Circulation Home | Subscriptions | Archives | Feedback | Authors | Help | AHA Journals Home | Search Copyright © 1999 American Heart Association, Inc. All rights reserved. Unauthorized use prohibited. |