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Triple Vessel Stenting for Triple Vessel Coronary Disease
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Any views and opinions expressed are those of the author(s) and/or participants and do not necessarily reflect the views, policy, or position of the Journal of Invasive Cardiology or HMP Global, their employees, and affiliates.
J INVASIVE CARDIOL 2002 Jan;14(1):1-5.
Introduction
When percutaneous coronary intervention (PCI) was introduced, it was limited to patients suffering from refractory angina pectoris due to isolated lesions of a single major epicardial coronary artery.1 Over the last 2 decades, however, the treatment of multivessel coronary disease has expanded from surgical bypass to include PCI with and without implantation of stents.2 Coronary artery bypass graft surgery (CABG) has been shown to prolong survival of patients with left main or triple vessel coronary disease, significant ischemia, or left ventricular dysfunction.3 On the other hand, controlled and uncontrolled studies have confirmed the feasibility of multivessel coronary stenting and, in selected patients, it has been associated with a comparable short-term survival to CABG.2,4-10 However, studies published thus far have not focused on patients with triple vessel coronary disease, and have generally included a majority of patients with single or double vessel disease. Since the publication of the most recent studies, percutaneous revascularization techniques have evolved significantly, and stenting, which is now attempted nearly systematically, has increased the safety of the procedures and reduced the risk of restenosis. Thus, in a carefully selected patient population with multivessel coronary disease, stenting may be a desirable alternative to CABG. However, in actual clinical practice, most patients with triple vessel coronary disease are regularly managed surgically on the basis of recommended guidelines, presence of one or more occluded vessels judged unsuitable for PCI, and high expected restenosis rate of a triple vessel procedure. This study was performed to measure the percentage of candidates for multiple stenting of triple vessel coronary artery disease among a large population of consecutive patients undergoing elective PCI, and to examine their short- and intermediate-term outcomes.
Methods
Study population. The overall study population consisted of 6810 consecutive patients who underwent PCI and were prospectively entered into a registry kept at 2 medical centers, by 7 experienced interventional cardiologists, between January 1996 and January 1999. During that period, angioplasty with stenting was systematically offered to the patients as an alternative to surgery whenever complete revascularization with a finite number of stents was judged feasible. This report focuses on the clinical characteristics and outcomes of a subgroup of 115 patients who underwent successful implantation of stents after PCI performed for miscellaneous immediate indications, in the context of multiple vessel disease, usually in a single procedure. Patients were considered for this therapeutic strategy if they had type A, B1 or B2 lesions of all 3 major epicardial coronary arteries, judged manageable with PCI and stenting. They were excluded if they had type C coronary lesions, contraindications to antiplatelet therapy or anticoagulation, left main coronary artery disease, coronary luminal diameter 1 complex lesion or the need for a stent length greater than 80 mm were not recommended to have percutaneous PCI and were advised to undergo CABG. PCI was performed by standard techniques via femoral or radial approaches, as described previously.11,12 In each procedure, attempts were made to achieve complete revascularization by dilating all coronary stenoses greater than 60%, in a single session whenever possible. A standard 12-lead electrocardiogram (ECG) was recorded before and immediately after each procedure, as well as 24 hours later, in search of signs of myocardial ischemia, new abnormal Q-waves, or both. CK enzymes were systematically measured on the day after each procedure and CK-MB enzyme fraction was also measured if total CK was greater than twice the upper limit of normal values in our laboratory.
Drug treatment protocol. Intravenous heparin was administered during each procedure as an initial 7500 to 10 000 U bolus, followed by additional intermittent doses to maintain an activated clotting time of at least 300 seconds. All patients who were not pretreated with oral aspirin received 250 mg of intravenous aspirin before each procedure followed by aspirin 100 mg daily indefinitely thereafter. Oral ticlopidine 250 to 500 mg daily was begun immediately after the procedure and continued for 4 weeks. Treatment with abciximab was administered to Stent implantation and angiographic analysis. All lesions were predilated and stents were implanted with a pressure dilatation of 10 to 20 atmospheres, as required to achieve patient follow-up. Patients were prospectively followed by telephone interviews and outpatient department visits scheduled at 3, 6, 12, 24, and 36 months after each procedure. All data collected were stored in a regularly updated computer database.
Definitions. Multivessel disease was defined as at least 60% stenosis of 3 major epicardial coronary arteries or branches. Dilatations of tandem lesions within the same vessel were treated as dilatations of a single vessel. Procedural success was defined as success of all attempts to dilate lesions in the 3 coronary arteries, with = 2 grades according to the Minnesota code,13 or new left bundle branch on 12-lead ECG, and/or a rise in total CK enzyme above twice the upper limit of normal values and an abnormal MB isoenzyme fraction. Diabetes was defined as a history of diabetes and use of insulin or oral hypoglycemic agents on entry into the study.
Statistical analysis. Statistical analyses were performed with SAS 6.08 software. Data were summarized using means and standard deviation (SD) for continuous variables and frequency for categorical variables. Univariate analysis was performed by student's t-test or Chi-square test, as appropriate. Survival and event-free survival, ie, freedom from death, myocardial infarction or further revascularization procedures, were analyzed by the Kaplan-Meier method. All values are expressed as means ± SD. All P-values were 2-tailed and considered significant if less than or equal to 0.05.
Results
The baseline characteristics and clinical presentation of the 115 patients analyzed in this report are presented in Table 1. Stable or unstable angina pectoris was the indication for the procedure in nearly 3 out of 4 patients. A total of 483 lesions were stented, representing a mean of 4.2 ± 1.4 stents per patient. The types of stents implanted and rates of their use are shown in Table 2. Table 3 lists the vessels in which stents were implanted in order of frequency. The left anterior descending and the right coronary arteries were the site of implantation in more than 80% of instances, and the left marginal and circumflex arteries each received stents approximately 50% of the time. The mean luminal diameter of the treated vessels was 2.9 ± 0.3 mm and the mean total length of stents implanted was 66.9 ± 24.9 mm.
In-hospital outcomes. Stenting of all vessels was accomplished in a single session in 89 patients (78%), and in interventions staged within 1 week in 26 patients (22%). Angiographically successful revascularization was achieved in 113 patients (98.7%). Major in-hospital adverse events included death in 2 patients (1.7%), Q-wave myocardial infarction in 1 patient (0.8%), non-Q wave myocardial infarction in 4 patients (3.6%), and emergent and non-emergent CABG in 1 patient (0.8%) each. The mean duration of hospitalization of surviving patients was 2.7 ± 2.2 days.
Long-term follow-up. Over an average follow-up period of 16 ± 14 months (range, 1-36 months) on all but a single patient (99.1%), four patients (3.4%) died, five patients (4.3%) underwent CABG, and 23 patients (20%) underwent further PCI (Table 4). The overall cumulative survival and the survival-free of major adverse events up to 36 months are presented in Figure 1. Univariate analysis of all clinical, angiographic and procedural variables tested showed that younger age and stented coronary segments > 80 mm were the only predictors of need for additional target vessel revascularization (Table 5).
Discussion
The clinical results of several prospective randomized studies comparing conventional multivessel PCI with CABG have consistently shown comparable 1 to 5 year rates of major adverse cardiac events and death, although higher rates of further revascularization procedures, ranging between 30% and 50%, among patients initially randomized to PCI.14-18 These studies share the characteristics of including a minority of patients with symptomatic triple vessel coronary disease, few patients with depressed left ventricular function, and the absence of stent use. Two recent randomized studies of CABG versus PCI plus stents have reported conflicting results from the standpoint of long-term patient survival and major cardiac ischemic events, although percutaneous interventions, which were found to be more cost effective in one study, were followed by a more frequent need for further revascularization procedures in both trials.19,20 In the ERACI trial, it is noteworthy that approximately 55% of 450 patients randomized by 7 participating centers over a 2-year period had triple vessel coronary disease, representing an average of 18 patients per center per year.19 Similarly, in the ARTS trial, which was conducted in 67 centers, fewer than one third of 1205 patients had triple vessel coronary disease, representing approximately 5 patients per center per year during an enrollment period of 14 months.20 The introduction of stents in coronary interventional procedures represented an important therapeutic advance. Compared with balloon PCI, stenting is associated with better immediate angiographic results and lower rates of acute vessel closure and restenosis.21, 22 Besides expanding the use of percutaneous procedures to highly complex lesions, including chronic complete occlusions23 and ostial,24 calcified or bifurcation lesions,25, 26 these observations have raised hopes of lower long-term restenosis rates and reduced need for additional revascularization procedures. In addition, recent studies have reported the feasibility of implanting multiple stents with low rates of procedural complications, although restenosis rates have remained relatively high.27-29 The safety, duration and immediate outcome of coronary interventional procedures are a function of vessel size, as well as length, location and overall complexity of the lesion. In this study, the mean luminal diameter of the treated vessels was 2.7 ± 0.3 mm and the average length of stents was 66.9 ± 24.9 mm. Our angiographic success rate of 98.7% and in-hospital adverse events rates, including 1.7% mortality, are comparable with those measured in other studies of multivessel coronary stenting.7,11 Furthermore, our long-term results, including overall survival and survival free of major adverse cardiac events or need for further revascularization, are consistent with those reported by others.29,30
Conclusions
In this systematic, prospective study of a large population of patients undergoing PCI, the proportion of patients in whom multiple stenting of all 3 coronary vessels was deemed technically feasible and safe was low. When performed, PCI was associated with low rates of early complications and alternate revascularization procedures. The long-term outcomes seemed comparable with those observed after CABG in terms of mortality and acute myocardial infarction. However, a higher rate of reintervention was reported due to the continuing challenge represented by in-stent restenosis. The need for additional target vessel revascularization was higher in younger patients and in patients who underwent stenting of coronary segments of more than 80 mm in the index procedure. These observations will soon need to be revisited in the context of emerging strategies aimed at preventing in-stent restenosis (particularly drug-eluting stents).
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