Commentary

Stenting in Patients with Multivessel Disease: The New Eon?

Luis Gruberg, MD, Eugenia Nikolsky, MD, Rafael Beyar, MD, DSc
Luis Gruberg, MD, Eugenia Nikolsky, MD, Rafael Beyar, MD, DSc
Since 1977, when Gruentzig introduced balloon angioplasty as a less invasive alternative to coronary artery bypass graft surgery, the results have steadily improved. The proportion of complex patients who undergo this procedure has substantially increased, fueled by an unprecedented evolutionary change that has included the discovery of stents and the introduction of potent adjuvant pharmacological agents. Approximately 60% of all patients who undergo coronary artery revascularization via coronary artery bypass graft surgery or percutaneous intervention have multivessel disease that is amenable to treatment by either one of these procedures. Still, the most appropriate type of treatment for these patients is a matter of heated debate. In skilled hands, both techniques are relatively safe and highly effective in reducing angina, and have similar mortality and myocardial infarction rates, albeit fewer additional revascularization procedures in patients who undergo bypass surgery.1 In the last decade, several randomized trials have compared percutaneous balloon angioplasty to coronary artery bypass surgery; these studies have shown that bypass surgery may prolong survival in a certain subset of patients. Initial trials showed that although both procedures established equivalent safety results, patients with chronic coronary occlusion, left main coronary stenosis, severely impaired left ventricular function or the need for valve surgery had a better outcome with bypass surgery.2 Recently published follow-up data (up to 8 years) of patients who were enrolled in the Bypass Angioplasty Revascularization Investigation (BARI)3 and Emory Angioplasty vs. Surgery Trial (EAST),4 which compared bypass surgery with balloon angioplasty in patients with multivessel disease, have shown that survival was virtually identical for non-diabetic patients (Figure 1). A survival benefit was evident only in diabetic patients who underwent surgical revascularization with internal mammary artery graft (Figure 2). Subgroup analysis of diabetic patients treated with saphenous vein grafts, including diabetics who were not on oral hypoglycemic or insulin treatment and non-diabetic patients, showed no difference in mortality. Furthermore, there was no significant difference among other high-risk subgroups, such as patients with reduced left ventricular function, triple-vessel disease, left anterior descending coronary artery disease or the those with the presence of type C lesions. Neither stents nor newer anti-platelet agents were used in these trials. The introduction of stents, which have shown to reduce the incidence of acute events, restenosis and urgent revascularization procedures and the use of newer surgical techniques have mandated a re-evaluation of these surgical and percutaneous techniques. Two recently published studies have compared multivessel stented angioplasty and coronary bypass surgery. The Arterial Revascularization Therapies Study (ARTS) was a randomized, multicenter trial designed to compare the clinical outcomes between 1) coronary artery bypass surgery and 2) percutaneous coronary angioplasty and stenting in 1,205 patients.5 The primary endpoint was freedom from major adverse cardiac and cerebrovascular events (death, stroke, transient ischemic attacks, non-fatal myocardial infarction and revascularization procedures) for 12 months after randomization. The analysis incorporated data on the efficacy of the procedure, cost and cost-effectiveness, and quality of life at 30 days and at 1, 3 and 5 years. At 1-year follow-up, there were no significant differences between the two groups, in terms of mortality rates, stroke or myocardial infarction. Among those patients who did not experience myocardial infarction or stroke, a total of 16.8% in the stenting group and 3.5% in the surgical group underwent revascularization. Multivariate analysis showed that the presence of diabetes mellitus (19% of stented patients) was a key predictor of outcome, corroborating the BARI trial results. Conversely, coronary bypass graft surgery was significantly more expensive than stenting, by approximately $3,000 per patient. The ERACI II study was a multicenter, randomized trial that compared stent-enhanced percutaneous coronary angioplasty with coronary artery bypass graft surgery.6 A total of 405 patients with multivessel disease underwent randomization to either percutaneous revascularization with stents versus conventional coronary artery bypass graft surgery. The composite primary endpoint was the occurrence of a major adverse cardiac event, defined as death, Q-wave myocardial infarction or stroke at 30 days. Follow-up was obtained at 1, 3 and 5 years. At long-term follow-up (18.5 ± 6.4 months), survival was 96.9% for patients randomized to the stented arm versus 92.5% for patients randomized to the surgical arm (p = 60% stenosis of 3 major epicardial arteries) who were considered good candidates for either coronary artery surgery See Villegas et al. on pages 1–5 or multivessel stenting, underwent coronary artery stenting as an alternative to bypass surgery. Patients with complex lesions (Type C), small vessel disease (minimal lumen diameter
References
1. Pocock SJ, Henderson RA, Rickards AF, et al. Meta-analysis of randomized trials comparing coronary angioplasty with bypass surgery. Lancet 1995;346:1184–1189. 2. Yusuf S, Zucker D, Peduzzi P, et al. Effect of coronary artery bypass graft surgery on survival: Overview of 10-year result from randomized trials by the Coronary Artery Bypass Graft Surgery Trialist Collaboration. Lancet 1994;344:563–570. 3. The BARI Investigators. Seven-year outcome in the Bypass Angioplasty Revascularization Investigation (BARI) by treatment and diabetic status. J Am Coll Cardiol 2000;35:1122–1129. 4. King SB III, Kosinnski AS, Guyton RA, et al., for the Emory Angioplasty versus Surgery Trial (EAST) Investigators. Eight-year mortality in the Emory Angioplasty versus Surgery Trial (EAST). J Am Coll Cardiol 2000;35:1116–1121. 5. Serruys PW, Unger F, Sousa E, et al., for the Arterial Revascularization Therapies Study Group. Comparison of coronary artery bypass surgery and stenting for the treatment of multivessel disease. N Engl J Med 2001;344:1117–1124. 6. Rodriguez A, Bernardi V, Navia J, et al., for the ERACI II Investigators. Argentine Randomized Study: Coronary angioplasty with stenting versus coronary bypass surgery in patients with multiple vessel disease (ERACI II): 30-day and one-year follow-up results. J Am Coll Cardiol 2001;37:51–58. 7. Villegas B, Morice MC, Hernandez S, et al. Triple vessel stenting for triple vessel coronary disease. J Invas Cardiol 2002;14:1–5. 8. Nikolsky E, Halabi M, Roguin A, et al. Staged versus one-step approach for multivessel percutaneous coronary interventions. Am Heart J (in press).