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{{CMG}}; '''Associate Editor(s)-In-Chief:''' {{CZ}}; [[John Fani Srour, M.D.]]; [[WikiDoc Scholars#WikiDoc Scholars with Distinction|Jinhui Wu, M.D.]]  
{{CMG}}; '''Associate Editor(s)-In-Chief:''' [[Lakshmi Gopalakrishnan, M.B.B.S.]]  


==Overview==
==Overview==
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*The patient population evaluated in older trials was confined to patients with preserved [[EF|left ventricular function]] and [[CAD|focal coronary artery disease]] and hence, its difficult to conclude the same results in patients with [[CAD|diffuse coronary artery disease]] and/or patients with [[left ventricular dysfunction]].
*The patient population evaluated in older trials was confined to patients with preserved [[EF|left ventricular function]] and [[CAD|focal coronary artery disease]] and hence, its difficult to conclude the same results in patients with [[CAD|diffuse coronary artery disease]] and/or patients with [[left ventricular dysfunction]].


*Majority of the patients evaluated in earlier trials underwent coronary angioplasty alone without stenting and even in a few trials that compared the benefit of PCI with concurrent [[BMS|bare-metal stent]]; involved patients who did not receive the current anti-thrombotic regimen.
*Majority of the patients evaluated in earlier trials underwent coronary angioplasty alone without stenting and even in a few trials that compared the benefit of PCI with concurrent [[BMS|bare-metal stenting]]; '''involved patients who did not receive the current anti-thrombotic regimen and lifestyle intervention.'''


==Clinical trials comparing PCI versus Medical therapy==
==Clinical trials comparing PCI versus Medical therapy in the Management of Stable Angina==
*In the '''ACME trial''' (1992), approximately 213 patients with [[CAD|stable single-vessel CAD]] were assessed to compare the effects of [[Chronic stable angina revascularization percutaneous coronary intervention(PCI)|PCI]] with [[Chronic stable angina pharmacotherapy overview|medical therapy]] on [[Chronic stable angina definition|angina]] and [[Chronic stable angina risk assessment in patients with an intermediate or high probability of coronary artery disease|exercise tolerance]]. 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)''. 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.<ref name="pmid1345754">Parisi AF, Folland ED, Hartigan P (1992) [http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&retmode=ref&cmd=prlinks&id=1345754 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. [http://dx.doi.org/10.1056/NEJM199201023260102 DOI:10.1056/NEJM199201023260102] PMID: [http://pubmed.gov/1345754 1345754]</ref>
*In the '''ACME trial''' (1992), approximately 213 patients with [[CAD|stable single-vessel CAD]] were assessed to compare the effects of [[Chronic stable angina revascularization percutaneous coronary intervention(PCI)|PCI]] with [[Chronic stable angina pharmacotherapy overview|medical therapy]] on [[Chronic stable angina definition|angina]] and [[Chronic stable angina risk assessment in patients with an intermediate or high probability of coronary artery disease|exercise tolerance]]. 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)''. 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.<ref name="pmid1345754">Parisi AF, Folland ED, Hartigan P (1992) [http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&retmode=ref&cmd=prlinks&id=1345754 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. [http://dx.doi.org/10.1056/NEJM199201023260102 DOI:10.1056/NEJM199201023260102] PMID: [http://pubmed.gov/1345754 1345754]</ref>


*Other older trials compared PTCA to both limited (AVERT trial) and optimal medical interventions (RITA-2 and MASS II). The findings of these trials were that patients undergoing PTCA had similar rates of death and myocardial infarction as those on medical therapy and were less likely to have angina during the first few years.
:*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.<ref name="pmid9874045">Hartigan PM, Giacomini JC, Folland ED, Parisi AF (1998) [http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&retmode=ref&cmd=prlinks&id=9874045 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: [http://pubmed.gov/9874045 9874045]</ref>


*More recent literature provides comparison between the use of stents and medical management, however, there is few data examining the extensive use of drug eluting stents and current extensive antithrombotic regimens (clopidogrel and GP IIb/IIIa inhibitors). In the most recent trial, COURAGE<ref>Optimal medical therapy with or without PCI for stable coronary disease.
:*PCI was shown to offer similar benefits at 6-month and late follow-up, in patients with double vessel disease in comparison to medical therapy.<ref name="pmid9180111">Folland ED, Hartigan PM, Parisi AF (1997) [http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&retmode=ref&cmd=prlinks&id=9180111 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: [http://pubmed.gov/9180111 9180111]</ref>


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.
*The '''AVERT trial''' (1999), demonstrated that in patients with [[Chronic stable angina assessing the pretest probability of coronary artery disease|low-risk]] for [[coronary artery disease]], an initial [[Chronic stable angina treatment anti-lipid agents|aggressive lipid-lowering therapy]] aimed at reversing plaque growth and promoting plaque stabilization, had significantly prolonged the time to first ischemic event ''(p=0.03)'' when compared to [[Chronic stable angina revascularization|PCI]] and [[Chronic stable angina pharmacotherapy overview|standard medical therapy]]. Hence, in low-risk patients with stable [[CAD]], it is beneficial to start with medical therapy and reserve revascularization strategies for non-responders.<ref name="pmid10395630">Pitt B, Waters D, Brown WV, van Boven AJ, Schwartz L, Title LM et al. (1999) [http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&retmode=ref&cmd=prlinks&id=10395630 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. [http://dx.doi.org/10.1056/NEJM199907083410202 DOI:10.1056/NEJM199907083410202] PMID: [http://pubmed.gov/10395630 10395630]</ref><ref name="pmid11174355">Amoroso G, Van Boven AJ, Crijns HJ (2001) [http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&retmode=ref&cmd=prlinks&id=11174355 Drug therapy or coronary angioplasty for the treatment of coronary artery disease: new insights.] ''Am Heart J'' 141 (2 Suppl):S22-5. PMID: [http://pubmed.gov/11174355 11174355]</ref>


N Engl J Med. 2007 Apr 12;356(15):1503-16. Epub 2007 Mar 26.
:*Another randomized study (2004) that assessed PCI versus exercise training in patients with [[chronic stable angina definition|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 [[Canadian cardiovascular society classification of angina pectoris|CCS class]], 6956 dollars was spent in the PCI group versus 3429 dollars in the training group; p= less than 0.001)''.<ref name="pmid15007010">Hambrecht R, Walther C, Möbius-Winkler S, Gielen S, Linke A, Conradi K et al. (2004) [http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&retmode=ref&cmd=prlinks&id=15007010 Percutaneous coronary angioplasty compared with exercise training in patients with stable coronary artery disease: a randomized trial.] ''Circulation'' 109 (11):1371-8. [http://dx.doi.org/10.1161/01.CIR.0000121360.31954.1F DOI:10.1161/01.CIR.0000121360.31954.1F] PMID: [http://pubmed.gov/15007010 15007010]</ref>


PMID: 17387127</ref>, drug-eluting stents were used in only 15 percent of patients. However, the COURAGE trial has the data most applicable to current practice. In this study 2287 patients were randomized to either aggressive medical therapy alone or aggressive medical therapy plus [[PCI]] with bare metal stenting. Patients were required to have both objective evidence of ischemia and significant CHD in a least one vessel; 87 percent were symptomatic and 58 percent had Canadian Cardiovascular Society [[CCS]] class II or III angina. Patients were excluded if they had [[CCS]] class IV angina, ≥50 percent left main disease, a markedly positive treadmill test (significant ST segment depressions and/or a hypotensive response during stage I of the Bruce protocol), an LVEF less than 30 percent, or coronary lesions deemed unsuitable for PCI. All patients received optimal medical therapy with beta blockers, calcium channel blockers, nitrates, antiplatelet therapy (either aspirin or clopidogrel), and aggressive lipid-lowering therapy with statin (attained median LDL-cholesterol was 72 mg/dL at five years). Exercise was recommended to achieve further improvements in the lipid profile when necessary.  The results were published at a median follow-up of 4.6 years. There was no significant difference between the two treatment strategies for the primary end point of death from any cause and non-fatal MI. There was no significant difference in the rates of hospitalization for ACS. Patients in the PCI group underwent significantly fewer subsequent revascularization procedures (21 versus 33 percent, HR 0.60, 95% CI 0.51-71).  
*Major trials such as the RITA-2 and MASS-II, 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 [[Chronic stable angina pharmacotherapy overview|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)''.<ref name="pmid9274581"> (1997) [http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&retmode=ref&cmd=prlinks&id=9274581 Coronary 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: [http://pubmed.gov/9274581 9274581]</ref>


*The issue of whether patients who receive [[PCI]] plus optimal medical therapy have a better quality of life and less angina than those who receive optimal medical therapy was addressed in COURAGE as well: At baseline, 22 percent of patients were free of angina. At three months, significantly more patients who received PCI were angina free (53 versus 42 percent), but at 36 months there was no significant difference (59 versus 56 percent). Patients in both groups showed significant improvements from baseline values in various measures of quality of life. The percent of patients with clinically significant improvement in parameters such as physical limitation, angina stability, angina frequency, and overall quality of life was significantly higher in the PCI group by the sixth months. However, there was no significant difference in these rates at 36 months. The results of COURAGE demonstrate that PCI with bare metal stents plus optimal medical therapy and initial, optimal medical therapy with revascularization as necessary are comparable strategies.
::*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.<ref name="pmid10732887">Pocock SJ, Henderson RA, Clayton T, Lyman GH, Chamberlain DA (2000) [http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&retmode=ref&cmd=prlinks&id=10732887 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: [http://pubmed.gov/10732887 10732887]</ref>
 
::*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.<ref name="pmid14522473">Henderson RA, Pocock SJ, Clayton TC, Knight R, Fox KA, Julian DG et al. (2003) [http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&retmode=ref&cmd=prlinks&id=14522473 Seven-year outcome in the RITA-2 trial: coronary angioplasty versus medical therapy.] ''J Am Coll Cardiol'' 42 (7):1161-70. PMID: [http://pubmed.gov/14522473 14522473]</ref>
 
:*A '''2000 meta-analysis''' of six randomized controlled trials that assessed the benefit of PCI versus [[Chronic stable angina pharmacotherapy overview|medical treatment]] for patients with [[CAD|non-acute coronary heart disease]], reported that PCI may lead to a greater reduction in angina in patients with CAD in comparison to [[Chronic stable angina pharmacotherapy overview|medical therapy]]; however, sufficient patients were not included to assess the effect of PCI on [[MI]], death, or subsequent [[Chronic stable angina revascularization|revascularization]].<ref name="pmid10884254">Bucher HC, Hengstler P, Schindler C, Guyatt GH (2000) [http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&retmode=ref&cmd=prlinks&id=10884254 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: [http://pubmed.gov/10884254 10884254]</ref>
 
:*A '''2005 meta-analysis''' of 11 randomized studies involving 2950 patients with [[chronic stable angina definition|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.<ref name="pmid15927966">Katritsis DG, Ioannidis JP (2005) [http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&retmode=ref&cmd=prlinks&id=15927966 Percutaneous coronary intervention versus conservative therapy in nonacute coronary artery disease: a meta-analysis.] ''Circulation'' 111 (22):2906-12. [http://dx.doi.org/10.1161/CIRCULATIONAHA.104.521864 DOI:10.1161/CIRCULATIONAHA.104.521864] PMID: [http://pubmed.gov/15927966 15927966]</ref>
 
*More recent literature provides comparison between the use of stents and [[Chronic stable angina pharmacotherapy overview|medical management]]; however, there are a few data examining the extensive use of [[Chronic stable angina revascularization drug eluting stents|drug eluting stents]] and current extensive anti-thrombotic regimens ([[Chronic stable angina revascularization adjunctive pharmacotherapy for percutaneous coronary intervention|clopidogrel and GP IIb/IIIa inhibitors]]). In the most recent COURAGE trial,<ref name="pmid17387127">Boden WE, O'Rourke RA, Teo KK, Hartigan PM, Maron DJ, Kostuk WJ et al. (2007) [http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&retmode=ref&cmd=prlinks&id=17387127 Optimal medical therapy with or without PCI for stable coronary disease.] ''N Engl J Med'' 356 (15):1503-16. [http://dx.doi.org/10.1056/NEJMoa070829 DOI:10.1056/NEJMoa070829] PMID: [http://pubmed.gov/17387127 17387127]</ref> 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 '''[[Clinical Outcomes Utilizing Revascularization And Aggressive Drug Evaluation|here]]'''.
 
*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 [[Chronic stable angina pharmacotherapy overview|medical therapy]] in the management of patients with [[chronic stable angina|non-acute CAD]]. In all direct or indirect comparisons, succeeding advancements in [[Chronic stable angina revascularization percutaneous coronary intervention(PCI)|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.<ref name="pmid19286090">Trikalinos TA, Alsheikh-Ali AA, Tatsioni A, Nallamothu BK, Kent DM (2009) [http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&retmode=ref&cmd=prlinks&id=19286090 Percutaneous coronary interventions for non-acute coronary artery disease: a quantitative 20-year synopsis and a network meta-analysis.] ''Lancet'' 373 (9667):911-8. [http://dx.doi.org/10.1016/S0140-6736(09)60319-6 DOI:10.1016/S0140-6736(09)60319-6] PMID: [http://pubmed.gov/19286090 19286090]</ref>
 
:*A '''2010 meta-analysis''' of 14 randomized trials evaluated the evidence of angina-relief from [[Chronic stable angina revascularization percutaneous coronary intervention(PCI)|PCI]] compared to [[Chronic stable angina pharmacotherapy overview|medical therapy]] in patients with [[chronic stable angina definition|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)''.<ref name="pmid20231568">Wijeysundera HC, Nallamothu BK, Krumholz HM, Tu JV, Ko DT (2010) [http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&retmode=ref&cmd=prlinks&id=20231568 Meta-analysis: effects of percutaneous coronary intervention versus medical therapy on angina relief.] ''Ann Intern Med'' 152 (6):370-9. [http://dx.doi.org/10.1059/0003-4819-152-6-201003160-00007 DOI:10.1059/0003-4819-152-6-201003160-00007] PMID: [http://pubmed.gov/20231568 20231568]</ref>


==References==
==References==
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{{Reflist|2}}


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Revision as of 16:18, 15 September 2011

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; 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 is achieved either by medical therapy or by revascularization procedures such as 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.

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.

  • Majority of the patients evaluated in earlier trials underwent coronary angioplasty alone without stenting and even in a few trials that compared the benefit of PCI with concurrent bare-metal stenting; involved patients who did not receive the current anti-thrombotic regimen and lifestyle intervention.

Clinical trials comparing PCI versus Medical therapy in the Management of Stable Angina

  • In the ACME trial (1992), approximately 213 patients with stable single-vessel CAD were assessed to compare the effects of PCI with medical therapy on angina and exercise tolerance. 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). 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.[2]
  • 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.[3]
  • PCI was shown to offer similar benefits at 6-month and late follow-up, in patients with double vessel disease in comparison to medical therapy.[4]
  • 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).[7]
  • Major trials such as the RITA-2 and MASS-II, 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).[8]
  • 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.[9]
  • 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.[10]
  • 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.[12]
  • 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,[13] 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.
  • 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.[14]
  • 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).[15]

References

  1. ↑ Moliterno DJ, Elliott JM (1995) Randomized trials of myocardial revascularization. Curr Probl Cardiol 20 (3):125-90. PMID: 7600846
  2. ↑ 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
  3. ↑ 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
  4. ↑ 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. ↑ 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. DOI:10.1056/NEJM199907083410202 PMID: 10395630
  6. ↑ 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
  7. ↑ 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
  8. ↑ (1997) Coronary 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
  9. ↑ 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
  10. ↑ 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
  11. ↑ 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
  12. ↑ 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
  13. ↑ 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
  14. ↑ 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
  15. ↑ 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


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