Chronic stable angina percutaneous coronary intervention versus medical therapy

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [2]; Associate Editor(s)-In-Chief: Lakshmi Gopalakrishnan, M.B.B.S.

Overview

An increased risk of mortality and morbidity is associated with untreated coronary artery disease.[1] The main aim of therapy in patients with chronic stable angina is to alleviate symptoms, delay the progression of atherosclerosis, reduce the incidence of adverse coronary events and improve prognosis. This may be achieved with either initial medical therapy or with initial revascularization that includes percutaneous coronary intervention or coronary artery bypass grafting. Medical therapy alleviates symptom and improves prognosis; however, on the contrary, revascularization procedures provide symptomatic relief but generally does not improve mortality.

PCI vs Medical Therapy

Limitations of Older Trials

There are some reservations to the application of results from older trials to the current clinical practice. Listed below are a few of the important limitations.

Clinical Trial Data: PCI vs Medical Therapy

Based on the six-major randomized clinical trials such as ACME trial (1992 & 1997),[3][4] RITA-2 trial (1997),[5] AVERT trial (1999),[6] and MASS-II trial (2004)[7] the success rates for PCI varied between 80% and 100% and the associated complication rates varied between 0.01% and 2.8% for MI and between 1.5% and 2.8% for the need of immediate CABG.

The patient population evaluated in these trials had a preserved left ventricular function with an EF range that varied between 65% and 76%. The medical therapy in all trials included the administration of anti-platelet agents, beta-blockers, nitrates, calcium channel blockers and only the AVERT trial[6] used an initial aggressive lipid-lowering therapy.

PCI has not been found to reduce the risk of death, myocardial infarction or other major cardiovascular events when used along with medical therapy as part of initial management in patients with stable coronary artery disease.[8]

More recent literature provides comparison between the use of stents and medical management; however, there are a few data examining the extensive use of drug eluting stents and current extensive anti-thrombotic regimens (clopidogrel and GP IIb/IIIa inhibitors). In the most recent COURAGE trial,[8] drug-eluting stents were used in only 15 percent of patients. However, the COURAGE trial has the data most applicable to the current practice. You can read more detail about the COURAGE trial, here.

Randomized Controlled Trials

  • In the ACME trial (1992), approximately 107 patients with stable single-vessel CAD with mean ejection fraction of 65%, non-Q wave MI within 3-months, ischemia evidenced by ST segment depression greater than 3mm on exercise stress test and no history of previous PCI, were assessed to compare the effects of PCI with medical therapy on angina and exercise tolerance in patients with single-vessel CAD. Successful dilatation was achieved in 82%. The study demonstrated that PCI significantly reduced the incidence of anginal symptoms compared to medical therapy (50% angina free in PCI group versus 24% in medically treated group) at one month and a sustained significant benefit was observed at 6 month follow-up (64% angina free in PCI group versus 46% in medically treated group; p=less than 0.01). Patients treated with PCI were associated with better exercise duration of 2.1 minutes which was significantly greater than the 0.5 minute experienced in the medically treated group (p=less than 0.0001). However, complications related to PCI was the incidence of MI (1.0%), non-Q wave MI (3.0%) and need for CABG (2.0%). Thus, the study concluded that PCI offered earlier and more complete relief of angina than medical therapy and was associated with a better exercise tolerance.[3]
  • In a sub-study (1998) that assessed the long-term effectiveness of PCI for single-vessel CAD, during a mean follow-up of 2.4 year for interview and 3.0 year for exercise testing after randomization, reported a significant angina-free period observed with the PCI group in comparison to the medically treated group (62% versus 47%; p=less than 0.05). Furthermore, exercise duration as measured by treadmill testing was prolonged by 1.33 minutes over baseline in the PCI group, whereas it decreased by 0.28 minutes in the medical group (p=less than 0.04). Thus, the study demonstrated sustained benefits with PCI similar to the ACME trial; hence, making it an attractive therapeutic option.[9]
  • Another randomized study (2004) that assessed PCI versus exercise training in patients with stable CAD, demonstrated a 12-month program of regular physical exercise resulted in a significant benefit in the event-free survival (88% versus 70% in the PCI group; p=0.023) and the improvement in exercise capacity was achieved at a much lower cost (to gain 1 CCS class, 6956 dollars was spent in the PCI group versus 3429 dollars in the training group; p= less than 0.001).[11]
  • Major trials such as the RITA-2[5] and MASS-II[7], which used PCI as a method of revascularization reported similar rates of mortality and MI incidence observed in both the PCI and medically treated groups. However, the incidence of angina during the initial few years were significantly reduced in the PCI groups.
  • The RITA-2 trial (1997) compared the long-term effects of PCI and conventional medical therapy in patients with CAD, demonstrated an early intervention with PCI was associated with greater symptomatic improvement, particularly observed in patients with more severe angina. However, on the contrary, the primary composite end-points during a median 2.7 year follow-up was significantly higher in patients treated with PCI than in patients treated with medical therapy (6.3% in the PCI group versus 3.3% in the medically treated group; p=0.02).[5]
  • The quality of life did not improve significantly in the PCI group in comparison to the continued medical therapy group at 3-year follow-up. However, the substantial improvement in the physical functioning, vitality and general health observed with the PCI group at both 3-month and one-year follow-up was attributed to the alleviation of symptoms.[12]
  • At 7-year follow-up, similar rates of mortality and MI were observed in both the groups (14.5% in the PCI group versus 12.3% in the medically treated group; 95% CI -2.0% to +6.4%; p=0.21). However, there was sustained improvement in angina and exercise tolerance noted in the PCI group.[13]

Meta-analysis

  • A 2005 meta-analysis of 11 randomized studies involving 2950 patients with stable CAD reported no significant difference between the PCI and medical therapy strategies with regard to mortality, incidence of MI or subsequent revascularization. However, a possible survival benefit was seen with PCI only in trials that involved patients with recent myocardial infarction (RR 0.40; 95% CI 0.17 to 0.95). Except for PCI during follow-up, there was no significant between-study heterogeneity for any outcome.[15]
  • The results of the COURAGE trial were reflected in meta-analysis listed below.
  • A 2009 meta-analysis, assessed 61 PCI randomized trials involving 25,338 patients to compare the effect of PCI/PTCA (with BMS or DES) versus medical therapy in the management of patients with non-acute CAD. In all direct or indirect comparisons, succeeding advancements in percutaneous coronary intervention did not produce detectable improvements in the rate of mortality or myocardial infarction incidence. The risk ratio for indirect comparisons between DES and medical therapy was 0.96 (95% CI 0.60-1.52) for death and 1.15 (0.73-1.82) for myocardial infarction. Thereby, the results from this meta-analysis strengthened the strategy of initial management with optimal medical therapy before resorting to revascularization with PCI.[16]
  • A 2010 meta-analysis of 14 randomized trials evaluated the evidence of angina-relief from PCI compared to medical therapy in patients with stable CAD. The study reported that more patients were angina free after PCI than compared to medical therapy alone (OR 1.69; 95% CI, 1.24 to 2.30). The incremental benefit of PCI observed in recent trials (OR 1.13; CI, 0.76 to 1.68 ) was substantially reduced in comparison to older trials performed before the year 2000 (OR 3.38; CI, 1.89 to 6.04).[17]
  • A 2012 meta-analysis of 8 randomized trials established no evidence of benefit of use of initial stent implantation for stable coronary artery disease compared with initial medical therapy for prevention of death, non fatal MI, unplanned revascularization, or angina. The respective event rates for death with stent implantation and medical therapy were 8.9% and 9.1% (OR, 0.98; 95% CI, 0.84-1.16); for nonfatal MI, 8.9% and 8.1% (OR, 1.12; 95% CI, 0.93-1.34); for unplanned revascularization, 21.4% and 30.7% (OR, 0.78; 95% CI, 0.57-1.06); and for persistent angina, 29% and 33% (OR, 0.80; 95% CI, 0.60-1.05).[18]

References

  1. Moliterno DJ, Elliott JM (1995) Randomized trials of myocardial revascularization. Curr Probl Cardiol 20 (3):125-90. PMID: 7600846
  2. Burek KA, Sutton-Tyrrell K, Brooks MM, Naydeck B, Keller N, Sellers MA et al. (1999) Prognostic importance of lower extremity arterial disease in patients undergoing coronary revascularization in the Bypass Angioplasty Revascularization Investigation (BARI). J Am Coll Cardiol 34 (3):716-21. PMID: 10483952
  3. 3.0 3.1 Parisi AF, Folland ED, Hartigan P (1992) A comparison of angioplasty with medical therapy in the treatment of single-vessel coronary artery disease. Veterans Affairs ACME Investigators. N Engl J Med 326 (1):10-6. DOI:10.1056/NEJM199201023260102 PMID: 1345754
  4. 4.0 4.1 Folland ED, Hartigan PM, Parisi AF (1997) Percutaneous transluminal coronary angioplasty versus medical therapy for stable angina pectoris: outcomes for patients with double-vessel versus single-vessel coronary artery disease in a Veterans Affairs Cooperative randomized trial. Veterans Affairs ACME InvestigatorS. J Am Coll Cardiol 29 (7):1505-11. PMID: 9180111
  5. 5.0 5.1 5.2 (1997)angioplasty versus medical therapy for angina: the second Randomised Intervention Treatment of Angina (RITA-2) trial. RITA-2 trial participants. Lancet 350 (9076):461-8. PMID:9274581
  6. 6.0 6.1 6.2 Pitt B, Waters D, Brown WV, van Boven AJ, Schwartz L, Title LM et al. (1999)Aggressive lipid-lowering therapy compared with angioplasty in stable coronary artery disease. Atorvastatin versus Revascularization Treatment Investigators. N Engl J Med 341 (2):70-6. [1] PMID: 10395630
  7. 7.0 7.1 Hueb W, Soares PR, Gersh BJ, César LA, Luz PL, Puig LB et al. (2004) The medicine, angioplasty, or surgery study (MASS-II): a randomized, controlled clinical trial of three therapeutic strategies for multivessel coronary artery disease: one-year results. J Am Coll Cardiol 43 (10):1743-51. DOI:10.1016/j.jacc.2003.08.065 PMID: 15145093
  8. 8.0 8.1 Boden WE, O'Rourke RA, Teo KK, Hartigan PM, Maron DJ, Kostuk WJ et al. (2007) Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med 356 (15):1503-16. DOI:10.1056/NEJMoa070829 PMID: 17387127
  9. Hartigan PM, Giacomini JC, Folland ED, Parisi AF (1998) Two- to three-year follow-up of patients with single-vessel coronary artery disease randomized to PTCA or medical therapy (results of a VA cooperative study). Veterans Affairs Cooperative Studies Program ACME Investigators. Angioplasty Compared to Medicine. Am J Cardiol 82 (12):1445-50. PMID: 9874045
  10. Amoroso G, Van Boven AJ, Crijns HJ (2001) Drug therapy or coronary angioplasty for the treatment of coronary artery disease: new insights. Am Heart J 141 (2 Suppl):S22-5. PMID: 11174355
  11. Hambrecht R, Walther C, Möbius-Winkler S, Gielen S, Linke A, Conradi K et al. (2004) Percutaneous coronary angioplasty compared with exercise training in patients with stable coronary artery disease: a randomized trial. Circulation 109 (11):1371-8. DOI:10.1161/01.CIR.0000121360.31954.1F PMID: 15007010
  12. Pocock SJ, Henderson RA, Clayton T, Lyman GH, Chamberlain DA (2000) Quality of life after coronary angioplasty or continued medical treatment for angina: three-year follow-up in the RITA-2 trial. Randomized Intervention Treatment of Angina. J Am Coll Cardiol 35 (4):907-14. PMID: 10732887
  13. Henderson RA, Pocock SJ, Clayton TC, Knight R, Fox KA, Julian DG et al. (2003) Seven-year outcome in the RITA-2 trial: coronary angioplasty versus medical therapy. J Am Coll Cardiol 42 (7):1161-70. PMID: 14522473
  14. Bucher HC, Hengstler P, Schindler C, Guyatt GH (2000) Percutaneous transluminal coronary angioplasty versus medical treatment for non-acute coronary heart disease: meta-analysis of randomised controlled trials. BMJ 321 (7253):73-7. PMID: 10884254
  15. Katritsis DG, Ioannidis JP (2005) Percutaneous coronary intervention versus conservative therapy in nonacute coronary artery disease: a meta-analysis. Circulation 111 (22):2906-12. DOI:10.1161/CIRCULATIONAHA.104.521864 PMID: 15927966
  16. Trikalinos TA, Alsheikh-Ali AA, Tatsioni A, Nallamothu BK, Kent DM (2009) Percutaneous coronary interventions for non-acute coronary artery disease: a quantitative 20-year synopsis and a network meta-analysis. Lancet 373 (9667):911-8. DOI:10.1016/S0140-6736(09)60319-6 PMID: 19286090
  17. Wijeysundera HC, Nallamothu BK, Krumholz HM, Tu JV, Ko DT (2010) Meta-analysis: effects of percutaneous coronary intervention versus medical therapy on angina relief. Ann Intern Med 152 (6):370-9. DOI:10.1059/0003-4819-152-6-201003160-00007 PMID: 20231568
  18. Stergiopoulos K, Brown DL (2012). "Initial coronary stent implantation with medical therapy vs medical therapy alone for stable coronary artery disease: meta-analysis of randomized controlled trials". Arch Intern Med. 172 (4): 312–9. doi:10.1001/archinternmed.2011.1484. PMID 22371919.

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