Dr. Weeks’ Comment: To Stent or not to Stent…. A patient who claimed excellent fitness and health but had demonstrated coronary artery blockage weighed his options (reviewed the literature below which suggests that stents reduce angina but do not prolong life or reduce risk of sudden death from heart attack or stroke) and requested a referral to a trusted cardiologist who placed the stents and what happened? The patient felt “like a new man” – “I have more energy and stamina!” – proving again that excellent health care is individualized and takes the time to apply science to a personal situation.
Percutaneous coronary intervention vs. medical therapy
Abstracts from the literature
Circ Cardiovasc Interv. 2012 Aug 1;5(4):476-90. doi: 10.1161/CIRCINTERVENTIONS.112.970954. Epub 2012 Aug 7.
Percutaneous coronary intervention versus optimal medical therapy in stable coronary artery disease: a systematic review and meta-analysis of randomized clinical trials.
Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
The role of percutaneous coronary intervention (PCI) (ed. “stenting”) in the management of stable coronary artery disease remains controversial. Given advancements in medical therapies and stent technology over the last decade, we sought to evaluate whether PCI, when added to medical therapy, improves outcomes when compared with medical therapy alone.
METHODS AND RESULTS:
We performed a systematic review and meta-analysis, searching PubMed, EMBASE, and CENTRAL databases, until January 2012, for randomized clinical trials comparing revascularization with PCI to optimal medical therapy (OMT) in patients with stable coronary artery disease. The primary outcome was all-cause mortality, and secondary outcomes included cardiovascular death, nonfatal myocardial infarction, subsequent revascularization, and freedom from angina. Primary analyses were based on longest available follow-up with secondary analyses stratified by trial duration, with short-term (≤1 year), intermediate (1-5 years), and long-term (≥5 years) time points. We identified 12 randomized clinical trials enrolling 7182 participants who fulfilled our inclusion criteria. For the primary analyses, when compared with OMT, PCI was associated with no significant improvement in mortality (risk ratio [RR], 0.85; 95% CI, 0.71-1.01), cardiac death (RR, 0.71; 95% CI, 0.47-1.06), nonfatal myocardial infarction (RR, 0.93; 95% CI, 0.70-1.24), or repeat revascularization (RR, 0.93; 95% CI, 0.76-1.14), with consistent results over all follow-up time points. Sensitivity analysis restricted to studies in which there was >50% stent use showed attenuation in the effect size for all-cause mortality (RR, 0.93; 95% CI, 0.78-1.11) with PCI. However, for freedom from angina, there was a significant improved outcome with PCI, as compared with the OMT group (RR, 1.20; 95% CI, 1.06-1.37), evident at all of the follow-up time points.
In this most rigorous and comprehensive analysis in patients with stable coronary artery disease, PCI, as compared with OMT, did not reduce the risk of mortality, cardiovascular death, nonfatal myocardial infarction, or revascularization. PCI, however, provided a greater angina relief compared with OMT alone, larger studies with sufficient power are required to prove this conclusively.
Curr Atheroscler Rep. 2010 Nov;12(6):423-31. doi: 10.1007/s11883-010-0135-2.
Strategies in stable ischemic heart disease: lessons from the COURAGE and BARI-2D trials.
Division of Cardiovascular Medicine, University at Buffalo and Buffalo General Hospital, University at Buffalo School of Medicine, State University of New York at Buffalo, Buffalo, NY, USA.
There is a continuing debate regarding the most effective strategy for treating stable ischemic heart disease (SIHD). Conflicting data have emerged from several small, randomized controlled trials and meta-analyses regarding the benefits of early revascularization in SIHD. Two recent multicenter, randomized trials, the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial and the Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes (BARI-2D) trial, compared two management strategies in SIHD-an initial conservative approach with optimal medical therapy (OMT) versus a strategy of early revascularization in combination with OMT. COURAGE randomized SIHD patients who were candidates for percutaneous coronary intervention (PCI) to either a strategy of early PCI in combination with OMT or OMT alone, whereas BARI-2D randomized diabetic patients with coronary artery disease to either early revascularization (PCI or coronary artery bypass surgery [CABG]) versus OMT. This review examines the principal findings of these trials, with discussion of their strengths, limitations, and applicability to the general population. The results support the hypothesis that in patients with SIHD, early revascularization with PCI in combination with OMT is not superior to OMT alone in reducing mortality and other major cardiovascular events. Subset analysis from BARI-2D did suggest that early CABG, although it did not reduce mortality, significantly reduced the rate of nonfatal myocardial infarction compared with an initial OMT approach. Based on these data, the majority of patients with SIHD should be managed initially with medical therapy, a strategy that is also the most cost effective. Revascularization can be considered for patients with severe or refractory symptoms despite a trial of medical therapy. For diabetic patients who have extensive coronary artery disease, early revascularization with CABG may be reasonable.
Curr Opin Cardiol. 2009 Nov;24(6):591-5. doi: 10.1097/HCO.0b013e32833155e2.
Evolving concepts in selecting optimal strategies for the management of patients with stable coronary disease: pharmacologic or revascularization therapy.
Division of Cardiovascular Medicine, University at Buffalo Schools of Medicine and Public Health, Buffalo General Hospital, Buffalo, New York, USA.
PURPOSE OF REVIEW:
Initial management of patients with stable ischemic heart disease (SIHD) continues to be vigorously debated amongst cardiologists. Despite the lack of robust data to support percutaneous coronary intervention (PCI) as the initial management of SIHD patients, it remains one of the most commonly performed procedures. Results of the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial reignited the controversy of the benefit of routine initial PCI over optimal medical therapy (OMT).
The trial suggested that, as an initial management strategy in patients with SIHD, PCI did not reduce the risk of death, myocardial infarction, or any other major cardiovascular events, when added to OMT. A meta-analysis from Schomig et al. suggests that a PCI-based invasive strategy may improve long-term survival compared with solely medical treatment in stable coronary artery disease patients.
As the ability to mechanically dilate obstructive coronary arterial stenoses has vastly improved our approach to managing patients with SIHD, the result has been a swing from an initial pharmacologic approach. An improved understanding of the pathophysiology of acute coronary syndrome, increased insight into plaque and patient vulnerability has led to the more aggressive use of appropriately targeted pharmacologic agents and an evolution in what constitutes OMT, based largely on the results of the COURAGE trial. Recent studies support the concept that, in SIHD patients, OMT alone compares favorably with a therapeutic strategy combining OMT with mechanical intervention. Thus, the treatment pendulum may be swinging back to the understanding that ‘best practice’ today requires the judicious use of interventional and medical therapies in the appropriate patient population.
N Engl J Med. 2007 Apr 12;356(15):1503-16. Epub 2007 Mar 26.
Optimal medical therapy with or without PCI for stable coronary disease.
Boden WE, O’Rourke RA, Teo KK, Hartigan PM, Maron DJ, Kostuk WJ, Knudtson M, Dada M, Casperson P, Harris CL, Chaitman BR, Shaw L, Gosselin G, Nawaz S, Title LM, Gau G, Blaustein AS, Booth DC, Bates ER, Spertus JA, Berman DS, Mancini GB, Weintraub WS; COURAGE Trial Research Group.
Western New York Veterans Affairs Healthcare Network and Buffalo General Hospital-SUNY, Buffalo, NY 14203, USA. firstname.lastname@example.org
In patients with stable coronary artery disease, it remains unclear whether an initial management strategy of percutaneous coronary intervention (PCI) with intensive pharmacologic therapy and lifestyle intervention (optimal medical therapy) is superior to optimal medical therapy alone in reducing the risk of cardiovascular events.
We conducted a randomized trial involving 2287 patients who had objective evidence of myocardial ischemia and significant coronary artery disease at 50 U.S. and Canadian centers. Between 1999 and 2004, we assigned 1149 patients to undergo PCI with optimal medical therapy (PCI group) and 1138 to receive optimal medical therapy alone (medical-therapy group). The primary outcome was death from any cause and nonfatal myocardial infarction during a follow-up period of 2.5 to 7.0 years (median, 4.6).
There were 211 primary events in the PCI group and 202 events in the medical-therapy group. The 4.6-year cumulative primary-event rates were 19.0% in the PCI group and 18.5% in the medical-therapy group (hazard ratio for the PCI group, 1.05; 95% confidence interval [CI], 0.87 to 1.27; P=0.62). There were no significant differences between the PCI group and the medical-therapy group in the composite of death, myocardial infarction, and stroke (20.0% vs. 19.5%; hazard ratio, 1.05; 95% CI, 0.87 to 1.27; P=0.62); hospitalization for acute coronary syndrome (12.4% vs. 11.8%; hazard ratio, 1.07; 95% CI, 0.84 to 1.37; P=0.56); or myocardial infarction (13.2% vs. 12.3%; hazard ratio, 1.13; 95% CI, 0.89 to 1.43; P=0.33).
As an initial management strategy in patients with stable coronary artery disease, PCI (“stenting or bypass”) did not reduce the risk of death, myocardial infarction, or other major cardiovascular events when added to optimal medical therapy. (ClinicalTrials.gov number, NCT00007657 [ClinicalTrials.gov].)