EarlyResults,Complicationsand RestenosisRates After Multilesionand MultivesselPercutaneous TransluminalCoronaryAngioplasty MARC LAMBERT, MD, RAOUL BONAN, MD, GILLES COT6, MD, JACQUES CREPEAU, MD, PIERRE de GUISE, MD, JACQUES LESPCRANCE, MD, PAUL ROBERT DAVID, MD, and DAVID D. WATERS, MD
PTCA; however, lesions distal to proximal sites had a success rate of only 62% (54 of 87), worse than either those with proximal stenoses or multivessel PTCA (p <0.005). Arterial diameter, severity of stenosis or procedural variables did not account for this difference. Complication rates were similar in the 2 groups. Despite a poorer success rate among patients with multilesion PTCA, clinical improvement to functional class 0 or 1 occurred in more than 70% of patients in both groups and was equal in patients with and without successful distal dilatations. Restenosis rates per lesion in patients with multivessel (31% ) and multilesion (30 % ) PTCA were similar. Thus, multilesion PTCA has a lower primary success rate than multivessel angioplasty because of the difficulty in dilating lesions distal to other angioplasty sites; however, this is not reflected in differences in clinical outcome. (Am J Cardiol 1987;60:788-791)
initial results, complications, restenosis rates and clinical outcomes were compared in 78 patients undergoing multilesion and 128 patients undergoing multivessel percutaneous transluminal coronary angioplasty (PTCA). Multilesion PTCA was defined as a procedure in which a proximal PTCA site had to be crossed to dilate a distal severe narrowing and multivessel PTCA as multiple dilatations without having to cross 1 severe narrowing to dilate another. The clinical and angiographic features of the 2 groups were similar. More sites per patient were attempted among those who underwent multilesion PTCA. Primary success rate per lesion was 88% (236 of 274) among those who underwent multivessel and 73% (155 of 211) among those who underwent multilesion PTCA (p
P
ercutaneous transluminal coronary angioplasty (PTCA) is the treatment of choice for many patients with coronary artery disease (CAD]. Although originally limited to patients with l-vessel CAD,*r2 it is now administered to selected patients with multivessel CAD with excellent results.3-7 However, multivessel CAD is a heterogeneous disease. PTCA appears to be ideal for some combinations of lesions but relatively contraindicated for others. Further studies are re-
quired to determine which subgroups of patients with multivessel CAD respond best to this treatment and how outcomes can be improved in other candidates. We compared the results of “multivessel” and “multilesion” PTCA. We define multivessel PTCA as a procedure in which 2 or more severe narrowings are dilated, but without crossing one to reach the other. The dilated lesions may be in the same arterial system, e.g., the mid-left anterior descending and the first diagonal branch, or in different arteries entirely. In contrast, multilesion PTCA was defined as a situation in which a proximal stenosis was crossed to dilate a distal lesion. Both sites may be in the same artery or in a main trunk and a distal branch.
From the Department of Medicine, Montreal Heart Institute, and the University of Montreal Medical School, Montreal, Quebet, Canada. Manuscript received March 81987; revised manuscript received and accepted June 151987. Address for reprints: Raoul Bonan, MD, Montreal Heart Institute, 5000 East, Belanger Street, Montreal, Quebec HlT lC8, Canada.
Methods Patients: Between December 1981, when the first multiple PTCA was performed, and January 1986, 788
October
1,448 patients underwent a first elective PTCA at the Montreal Heart Institute. Using our definitions, 128 patients (8.8%) underwent multivessel PTCA and 78 (5.4%] multilesion PTCA. Patients who underwent multilesion PTCA who also had stenoses dilated in other arteries were still included in the multilesion group. Patients undergoing dilatation for restenosis or during acute myocardial infarction were excluded. Angioplasty procedure and adjunctive therapy: All dilated segments were studied prospectively by measuring arterial diameter proximal and distal to the stenosis to determine optimal balloon size. The degree of stenosis was measured with a caliper in the view showing the most severe stenosis and was expressed as a percent of luminal narrowing, as compared with the closest normal segment. All measurements were made by an independent experienced cardiovascular radiologist. Data related to the procedure were systematically collected using a standard protocol. All PTCAs were performed through a percutaneous femoral approache5 Steerable catheters have been used since April 1982. Since April 1983, based on our experience,*vg we usually use higher inflation pressures (8 to 12 atm] and balloons that when inflated are slightly larger in diameter than the adjacent normal coronary segment. The artery judged the most important with respect to the amount of myocardium at risk was usually dilated first. If this artery was providing collaterals to another vessel, the latter one was dilated first. In the multilesion group the proximal stenosis was sometimes dilated first to allow access to the distal lesion, but the usual procedure was to dilate the distal stenosis first if possible. Use of antianginal medication was continued up to the time of the procedure. Therapy with aspirin, 650 mg/day, and dipyridamole, 75 mg 3 times daily, was begun 1 day before PTCA and continued for 6 months after if the procedure was successful and the medication was tolerated. Diltiazem, 60 or 90 mg, was administered the evening before and the morning of angioplasty; in some patients diltiazem use was continued for 6 months.lO Follow-up: Patients were seen in a regular clinic at 2 and 6 months after angioplasty. Coronary arteriography was recommended to all patients at 6 months but was performed earlier in those with recurrent angina. Data analysis: Primary success was defined as a stenosis reduction of more than 2O%, with a residual stenosis diameter of less than 50% in the absence of major complications. Restenosis was considered present if a 50% or greater diameter narrowing was found at a site that had been successfully dilated. An angioplasty site in patients undergoing multilesion PTCA was considered distal if another site had to be crossed to reach it; other sites were considered proximal. Thus, distal lesions were not necessarily far from, or proximal sites close to, the coronary orifices. Values are expressed as mean f standard deviation. Univariate analysis was performed using the chi-square test for categorical data and the unpaired t test for continuous variables.
1, 1987
THE AfvlERiCAN
LE I
Clinical
JOURNAL
OF CARDIOLOGY
Characteristics
of the Study Multivessel
Age (yr) (mean f SD) Male Duration of angina (mo) Previous myocardial infarction Previous bypass surgery Systemic hypertension Diabetes mellitus Cigarette smoking LDL cholesterol (mgldl) HDL cholesterol (mgldl) Triglycerides (mgldl) CCVS functional class O-1 2 3-4 CCVS = Canadian Cardiovascular tein; LDL = low-density lipoprotein; deviation.
Volume
SO
76
Patients Multilesion
(n = 128)
(n = 78)
P Va!ue
54 103 18 33 6 42 16 92 171 39f 228
54 f 9 59 (76%) 22 f 32 23 (29%) 5 (6%) 28 (36%) 7 (9%) 57 (73%) 159 f 40 40f 12 184 f 80
NS NS NS NS NS NS NS NS NS NS <0.05
i: 9 (80%) f 27 (26%) (5%) (33%) (13%) (72%) f 69 10 f 140
6 (5%) 50 (39%) 72 (56%)
3 (4%) 24 (31%) 51 (65%)
NS
Society; HDL = high-density lipoproNS = not significant; SD = standard
Results Clinical and angiographic features: The clinical characteristics of patients who underwent multivessel and multilesion PTCA are listed in Table I. Triglyceride levels were inexplicably higher in patients with multivessel PTCA, but the 2 patient groups were otherwise quite similar. Mean age was 54 years; most patients were men. Fifty-six patients (27%) had a previous myocardial infarction and 123 (60%] were in Canadian Cardiovascular Society functional class 3 or 4.11 The number of arteries with at least a 50% diameter stenoses was 2.19 f 0.5 per patient among patients undergoing multivessel PTCA and 1.84 f 0.7 per patient among those undergoing multilesion PTCA (difference not significant). Angioplasty was attempted at 2 sites in 110 of the patients (86%) undergoing multivessel PTCA and 38 (49%) of those undergoing multilesion PTCA (p
790
MULTILESION
VERSUS
TABLE II Angioplasty
MULTIVESSEL
Comparison
ANGIOPLASTY
of Multivessel
and Multilesion
Percutaneous
Translumlnal
Coronary
Multilesion Multivessel,
No. of pts No. of sites attempted Primary success (% of sites) Failure to cross (% of sites) Failure to dilate (% of sites) Max inflation pressure (atm) Inflations per lesion Balloon artery ratio Arterial diameter (mm) Stenosis diameter (% ) Before PTCA After PTCA lntimal dissection (% of sites)
Myocardial Emergency Total
Complications Transluminal
infarction bypass surgery
Sites
Distal
Sites
All Sites
128 274 236 (86 %) 4 (1%) 34 (12%) 8.2 f 2.3 3.2 f 1.7 1.09 f 0.17 2.68 f 0.5
78 211 155 (73%)’ 10 (5%) 46 (22%) 8.2 f 2.1 3.9 i 2.5 1.05 f 0.20 2.90 f 0.5
78 124 101 (81%) 2 (2%) 21 (17%) 8.4 f 1.9 4.1 f 2.5 1.04 f 0.16 2.95 A 0.6
54 (ii%)+ 8 (9%) 25 (29%) 7.9 f 2.9 3.3 zk 2.3 1.06 f 0.10 2.88 f 0.5
74 f 14 33 f 20 124 (46%)
75 f 14 33 f 19 92 (44%)
77 f 12 30 f 18 55 (44%)
70 f 13 37f 16 37 (43%)
l p
TABLE Ill Percutaneous
Proximal
All Sites
vs proximal
sites
and vs multivessel
group;
78
all other
comparisons
angioplasty.
of Multivessel and Multilesion Coronary Angioplasty Multivessel (n = 128)
Multilesion (n = 78)
Total (n = 206)
8 (6%) 1 (1%) 9 (7%)
6 (8%) i(l%) 7 (9%)
14 (6.8%) 2 (0.9%) 16 (7.7%)
33 f 20% among those with multivessel PTCA and from 75 f 14% to 33 f 19% in those with multilesion PTCA. Distal stenoses were not more severe than proximal stenoses in those with multilesion PTCA and the adjacent normal vessel diameter was not significantly narrower. Eight patients with multivessel and 6 with multilesion PTCA had myocardial infarction as a complication of coronary angioplasty, and 1 other patient in each group underwent emergency coronary bypass surgery (Table III]. Follow-up: Six months after angioplasty, 81 of the 114 patients (71%] with multivessel PTCA available for follow-up were in Canadian Cardiovascular Society functional class 0 or 1. Similarly, 56 of 78 patients (72%) with multilesion PTCA were in class 0 or 1. The initial result with respect to the degree of revascularization was not predictive of the clinical outcome. All attempted lesions were dilated successfully in 89 of the 128 patients with multivessel PTCA (70%); among 81 of these “successes” available for follow-up, 57 (70%) were in class 0 or 1. However, 24 of the 33 patients (73%) in whom dilatation was incomplete and were available for follow-up were in class 0 or 1. A similar outcome was observed in the patients with multilesion PTCA: 27 of 38 patients (71%] with completely successful and 28 of 39 (72%) with incompletely successful PTCA were in functional class 0 or 1. Among 65 patients with multilesion PTCA in whom proximal lesions were dilated successfully, 36 had suc-
cessful PTCA of a distal lesion and 29 had an unsuccessful result. The outcome with respect to symptoms was identical at 6 months in these subgroups: 23 of 29 (79%] available for follow-up in the distal success group and 19 of 24 (79%) in the distal failure group were in class 0 or 1. From hospital discharge to 6month follow-up, 1 patient died, 33 required repeat PTCA, 5 underwent bypass surgery and 4 had myocardial infarctions (Table IV). The incidence of these events was similar in the multivessel and multilesion groups. Coronary arteriograms were recorded 5.8 f 3 months after PTCA in 75 patients (59%) with multivesse1 PTCA and in 46 (59%) with multilesion PTCA. Restenosis rates were not significantly different in the 2 groups. In patients with multivessel PTCA, restenosis had occurred at 42 of 135 sites (31%) and in those with multilesion PTCA restenosis had occurred at 32 of 105 sites (30%). At least 1 restenosis was present in 36 of 75 patients (48%) with multivessel PTCA and 21 of 46 (46701 with multilesion PTCA. Restenosis rates among those with multilesion PTCA were 23 of 68 (34%) for proximal sites and 9 of 37 (24%) for distal sites, a difference that was not statistically significant. The correlation between symptoms and the degree of restenosis is depicted in Table V.
Discussion This study confirms previous reports3-7 that PTCA can be performed at multiple sites in selected patients with excellent results. Our patients were classified into 1 of 2 groups: 1 with multivessel PTCA, in which 2 or more dilatations were done without having to cross 1 lesion to reach another, and 1 with multilesion PTCA, in which at least 1 proximal lesion had to be crossed to reach a distal stenosis. Primary success was significantly higher among those with multivessel PTCA, 86% vs 73% (p
October
TABLE IV Follow-Up
Clinical
Clinical follow-up Deaths Repeat PTCA Bypass surgery Myocardial infarction
Outcome
of Study
Patients
Multivessel (n = 128)
Multilesion (n = 78)
114 I 21 2 2
78 (100%) 0 12 (15%) 3 (3.8%) 2 (2.6%)
(89%) (0.9%) (18%) (1.8%) (1.8%)
at Six-Month
THE
ABLE atienb
Total (n = 206) 192 1 33 5 4
*, 3387
(93%) (0.5%) (17%) (2.6%) (2.1%)
Difference between groups not statistically significant. PTCA = percutaneous transluminal coronary angioplasty.
PTCA. The success rate for proximal lesions in this group was similar to the rate in those with multivessel PTCA. Potential explanations: The higher failure rate for lesions distal to another site was not due to more severe stenoses (mean 70 f 13% compared with 74 to 77% in the other groups], nor due to smaller arterial diameters (mean 2.88 f 0.5 mm, similar to the other groups]. Both an increase in failure to cross and an increase in failure to dilate contributed to the difference. Procedural variables were similar for proximal and distal sites in multilesion PTCA and for multivesse1 PTCA. These data suggest that either distal lesions are intrinsically less amenable to angioplasty or added complexity of crossing and dilating serial lesions decreases the primary success rate at the distal site. Other studies: The overall primary success rate in this study is within the range reported for similar patients undergoing angioplasty during these years.3-6 Other reports have not distinguished between multivessel and multilesion angioplasty as defined in this study. Dorros et aL3 using a reduction in stenosis diameter of at least 20% as their criterion, reported an angiographic success rate of 155 of 170 (91%) in “tandem” lesions, defined as 2 lesions in series in the same vess&l. This rate was similar to success rates for other combinations of multiple PTCA in their study. Multiple stenoses in the same artery were dilated in many patients in the study of Vandormael et aL4 but the success rates reported did not subdivide the results in this respect. Clinical significance: Before angioplasty, 60% of our patients were in functional class 3 or 4; after the procedure, more than 70% were angina-free or in class 1. Although the primary success rate was lower among patients with multilesion PTCA, the clinical outcome was identical to that in patients with multivessel PTCA. Similarly, patients with multilesion PTCA in whom the distal stenosis could not be dilated had a clinical outcome no worse than that in those in whom distal angioplasty was successful. Thus, PTCA of the distal lesion may not be essential in patients with several coronary lesions who undergo angioplasty. Other studies support this conclusion. Wohlgelernter et all2 reported that most unstable angina patients with multivessel disease became asymptomatic after angioplasty of the “culprit lesion” and that in
AERiCAN
V with
;OZWX
Correiation Angisgra
3F
tween
Group
Clinical
Status
Multivessel (n = 75) Multilesion (n = 46)
Asymptomatic Symptomatic Asymptomatic Symptomatic
CARDIOLOGY
Symptoms
Restenosis 14/35 22140 6/25 15/21
L/o&me
$0
79;1
and
2.50% (40%) (55 %) (24%) (71%)
Restenosis 5135 14/40 3/25 13121
270% (14%) (35%) (12%) (62%)
stable angina, dilating only this stenosis produced results equal to complete revascularization.13 In patients with multivessel disease, unstable angina and postinfarction angina, De Feyter et a114-16usually relieved angina completely by dilating only the “ischemia-related” vessel. In patients with multivessel disease in whom dilatation was successful in the National Heart, Lung, and Blood Institute PTCA registry, relief of angina in completely and incompletely revascularized lesions was similar, with more second angioplasty procedures in the former and more bypass surgery in the latter.17
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12. Wohlgelernter D, Cleman M, Highman HA, Zaret BL. Percutaneous transfuminal coronary angioplasty of the “culprit lesion” for management of unstable angina pectoris in patients with multivessel coronary artery disease. Am 1 Cardiol 1986;58:460-464. 13. Wohlgelernter D, Yeatman LA, Cabin HS, Cleman M. Functionally directed revascularization using coronary angioplasty: an aiternative approach in the management of multivessel disease (abstr). IACC 1387;3:15A\. 14. De Feyter PJ. Serruys PW, Van den Brand M, Balakumaran K, Mochtar B, Soward AL, Arnold AER, Hugenholtz PG. Emergency coronary angioplasty in refractory unstable angina. N Engl f Med 1385;313:342-346. 15. De Feyter PJ, Serruys PW, Arnold A, Simoons ML, Wijns W, Geuskens R, Soward A, Van den Brand M, Hugenholtz PG. Coronary angioplasty of the unstable aneina related vessel in oatients with multivessel disease. Eur Heart J 1986;7:46&467. 16. De Feyter PJ, Serruys PW, Soward A, Van den Brand M, Bos E. Hugenholtz PG. Coronary angioplasty for early postinfarction unstabie angina. Circulation 1986;74:1365-1370. 17. Reeder GS, Holmes DR, Detre K, Costigan T, Kelsey S. Complete versus incomplete revascularization in multivessel disease: a report from the NHLBI PTCA registry [obstr). [ACC 1987;9:15A.