Several studies from the pre-stent era compared PCI with lone medical therapy in patients with single- or double-vessel disease without a prognostic indication for CABG.
The Veterans Affairs ACME trial was the first randomized trial to compare plain balloon angioplasty with medical therapy.91 In this study, 212 patients with single-vessel disease, stable angina pectoris, and positive results on stress testing or MI within the preceding 3 months were randomized to an initial strategy of plain balloon angioplasty or medical therapy. The primary end points were change in exercise tolerance and change in symptoms at 6 months. Compared with lone medical therapy, balloon angioplasty significantly improved treadmill exercise performance, with an increase in duration of 2.1 ± 3.1 minutes after angioplasty versus 0.5 ± 2.2 minutes without PCI. Moreover, 64% of the patients primarily treated with balloon angioplasty were free of angina pectoris at 6 months, compared with 45% of those in the medical therapy group. Balloon angio-plasty was also associated with greater improvement in quality-of-life variables. No significant difference was seen in the frequency of death and MI between the two groups. For the entire cohort, the study demonstrated significant improvement of symptoms with early angioplasty. On the other hand, among patients who become symptom-free on medical therapy, there was no advantage of PCI, because the conservative approach was not associated with any excess MIs or deaths.
Subsequently, the study was extended by including 201 patients with double-vessel coronary disease (ACME-2).92 At 6 months, patients treated with plain balloon angioplasty and those treated with plain medical therapy had similar degrees of improvement in exercise duration, freedom from angina, and overall quality-of-life score. There was no appreciable increased hazard observed with the conservative approach. This part of the ACME trial suggested that patients with double-vessel disease achieved less benefit from an interventional approach than did patients with single-vessel disease. This may be attributed in part to the limitations that were prevalent in the era of plain balloon angioplasty, which included a relatively high risk of restenosis and inability to achieve full revascularization in a large proportion of patients.
The largest trial comparing balloon angioplasty with medical therapy was RITA-2, which included 1018 patients with single-vessel or multivessel disease.93 Most of the patients had stable angina and preserved left ventricular function, although unstable angina and left ventricular dysfunction did not constitute an exclusion criterion. Of the patients included, 60% had single-vessel disease, 33% double-vessel disease, and 7% had triple-vessel disease. The primary end point of the trial was the composite of all-cause death and nonfatal MI during a median follow-up of 2.7 years. The incidence of the primary end point was significantly higher in the PTCA arm compared with the conservative arm (6.3% vs. 3.3%; P = .02). This difference was largely due to one periprocedural death and seven periprocedural MIs. As in the ACME trial, balloon angioplasty was more efficient in reducing symptoms than the primary medical approach. At 3 months, medical therapy was associated with a 60.5% higher prevalence of grade 2 or worse angina compared with balloon angioplasty (P < .01), a difference that attenuated to 7.6% during follow-up. There also was a larger improvement in total exercise time in the balloon angioplasty group compared with the medically treated group. Subgroup analysis revealed that patients with more severe symptoms at study entry obtained a larger symptomatic benefit from balloon angioplasty than did patients with minor symptoms.
A recent study, AVERT, included 341 patients with single- or double-vessel disease who were randomly assigned to either medical treatment including vigorous risk factor modification with state-of-the-art statin therapy or PCI and usual care.94 The primary study end point was the composite of a variety of
(0.50 to 0.98)
Fatal and nonfatal
(0.90 to 2.25)
(0.65 to 2.70)
(0.71 to 3.36)
(1.09 to 2.32)
Figure 6-11. Pooled risk ratios for various end points from six randomized controlled trials comparing percutaneous transluminal coronary angioplasty (PCTA) with medical treatment in patients with nonacute coronary heart disease. CABG, coronary artery bypass grafting; CI, confidence interval; MI, myocardial infarction. (From Bucher HC, Hengstler P, Schindler C, Guyatt GH: Percutaneous transluminal coronary angioplasty versus medical treatment for non-acute coronary heart disease: Meta-analysis of randomised controlled trials. BMJ 2000;321:73-77.)
events including cardiac death, nonfatal MIs, stroke, CABG, PCI, or hospitalization for unstable angina. One ore more ischemic events occurred in 13% of the medically treated patients and in 21% of the PCI-treated patients during the follow-up period of 18 months. When adjusted for interim analyses that were performed, this difference did not reach statistical significance, although the unadjusted level of significance was P = .048. The study did not assess relief of angina. AVERT is difficult to interpret, because state-of-the-art risk factor modification was not instituted in the PCI arm. It is known that patients undergoing PCI obtain particular benefit from high-dose statin treatment. Therefore, the patients who were randomly assigned to balloon angioplasty were penalized by not receiving established treatments for secondary prevention in coronary artery disease. Hence, AVERT cannot answer the key question of whether best-possible medical therapy combined with best-possible PCI will provide superior freedom from death and nonfatal MI as well as better relief of angina, compared with best-possible medical therapy alone. This issue has been addressed in the randomized COURAGE trial.29 COURAGE included 2287 patients with stable angina who received optimized state-of-the-art medical therapy. Patients were randomly assigned to revascularization by PCI or conservative management alone. Confirming earlier studies, COURAGE did not find a benefit of PCI with respect to death and myocardial infarction during a median follow-up of 4.6 years (19.0% in the PCI group versus 18.5% in the medical-therapy group; HR = 1.05; 95% CI: 0.87 to 1.27; P = .62). There was, however, a significant difference in the rates of freedom from angina throughout most of the follow-up period, favoring PCI. When interpreting the results of COURAGE two aspects need to be considered. First, severe angina (CCS IV) or a markedly positive stress test precluded participation in the study, thus limiting the potential benefit from revas-cularization. Second, COURAGE pursued the strategy of culprit-lesion treatment. Although seventy percent of the patients had multivessel disease, most of the patients received only one stent. Hence, the revascu-larization strategy in COURAGE might have fallen short of the full potential of PCI.
A meta-analysis that included ACME (1 and 2), RITA-2, and AVERT as well as MASS and one smaller German trial, demonstrated a significant 30% reduction in angina but a significant increase in the need for CABG with PCI, compared with medical treatment, as well as trends toward increased risk of death, MI, and nonscheduled PCI (Fig. 6-11).95 This meta-analysis supported the concept that PCI, compared with lone medical therapy in patients with stable angina, reduces symptoms but may be associated with a higher incidence of serious complications such as death and MI. However, none of the studies included in this meta-analysis used contemporary interventional techniques such as the systematic use of stents, vigorous peri-interventional and postinter-ventional antiplatelet treatment, and strict risk factor modification, in particular with statins, in patients treated with PCI. Modern peri-interventional and postinterventional drug therapy would have reduced the risk of death and MI, and each of the three elements of modern interventional treatment—stents, statins and antiplatelet drugs—would have reduced the need for subsequent unplanned revascularization procedures. Hence, it may be anticipated that with modern interventional approaches the complications of catheter intervention may be substantially lower without corrupting the beneficial effect of this treatment on angina, compared with lone medical therapy.
Although the benefit/risk ratio of PCI versus medical treatment in patients without an established indication for CABG will be superior with modern interventional techniques, there is currently no evidence from randomized studies that in this setting PCI compared with medical therapy reduces the risk of death or nonfatal MI. Therefore, in patients who are free of symptoms under an antianginal medication that is well tolerated, there is no established benefit of PCI. Accordingly, current guidelines suggest that, for patients with stable angina, PCI should be reserved for those who are not free of symptoms with lone medical therapy or who have substantial side effects. This recommendation was challenged recently by a large meta-analysis from the Duke University Medical Center registry that included 18,481 patients (see Fig. 6-8).50 As detailed earlier, this study demonstrated that, even in patients with low-severity coronary artery disease (one or two vessels = 75%, none = 95%), the initial revascularization by PCI conferred a significant survival benefit (8 months in 7 years, adjusted for pertinent covariables).
When coronary revascularization is considered, prognostic and symptomatic indications need to be distinguished. With prognostic indications, PCI offers an alternative to CABG; with symptomatic indications, PCI competes with medical treatment.
In general, PCI for single-vessel disease is justified only if improvement of symptoms can be anticipated.
In patients with multivessel disease without relevant left main coronary artery involvement and without diabetes mellitus, survival after PCI is at least not substantially inferior to that after CABG, provided that complete revascularization can be achieved. Patients must be informed that the higher need for repeat procedures after PCI has to be weighed against the discomfort of surgery.
In patients with diabetes mellitus, it is unclear whether multivessel PCI can achieve a prognostic benefit similar to that of CABG. Nevertheless, stents, vigorous antiplatelet treatment, and tight metabolic control have been shown to improve the outcome of PCI in diabetic patients substantially. Depending on the chances for success and the risk for surgery, mul-tivessel PCI may offer a reasonable option even in diabetic patients.
Currently available evidence does not allow proposing PCI for distal left main coronary artery disease in patients who are good candidates for surgery. Promising results from recent registries indicate that PCI is an acceptable alternative to CABG in poor surgical candidates.
In many instances, individualized decisions must be taken that consider the likelihood of complete revascularization and the risk associated with either approach, the patient's life expectancy based on age and comorbidities, and the patient's preference after thorough counseling. Such decisions are best reached jointly by the cardiac surgeon and the interventional cardiologist.
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Diabetes is a disease that affects the way your body uses food. Normally, your body converts sugars, starches and other foods into a form of sugar called glucose. Your body uses glucose for fuel. The cells receive the glucose through the bloodstream. They then use insulin a hormone made by the pancreas to absorb the glucose, convert it into energy, and either use it or store it for later use. Learn more...