Chronic stable angina revascularization percutaneous coronary intervention indications

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Chronic stable angina revascularization percutaneous coronary intervention indications On the Web

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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.

Indications

  • In patients with objective large ischemia associated with severe angina, PCI has shown to significantly reduce mortality and provide greater symptomatic improvement. However, on the contrary, patients with mild symptoms do not benefit from PCI.[4][5][6]

Supportive Trial Data

  • The ACIP study', a randomized study of 558 patients with increased cardiac events, compared the 12-week efficacy of three treatment strategies such as medical therapy, medical therapy plus ambulatory ECG monitoring or revascularization to suppress cardiac ischemia. The goal of the study was to assess the feasibility of a prognosis trial in patients with asymptomatic cardiac ischemia, demonstrated both stress-inducible ischemia and two or more ischemic episodes on holter monitoring.[10] Two years after randomization (1997), the total mortality was significantly reduced from 6.6% in the angina-guided strategy to 4.4% in the ischemia-guided strategy and 1.1% in the revascularization strategy (p=less than 0.02). The rate of composite primary end-points was also significantly reduced from 41.8% in the angina-guided strategy to 38.5% in the ischemia-guided strategy and 23.1% in the revascularization strategy (p=less than 0.001). Researchers concluded that a strategy of initial revascularization appeared to improve the prognosis but longer-term study was needed to further establish this relationship. [11][11]
  • In the TIME study (2004), that assessed the long-term survival and quality of life in elderly patients with CCS class II or greater angina receiving atleast two anti-anginal medication at baseline, demonstrated similar long-term survival benefits observed in both the groups; however, freedom from major cardiovascular events remained higher in invasive therapy group versus the medical therapy group (39% versus 20%, p=less than 0.0001). Irrespective of whether patients were catheterized initially or only after failure to respond to medical therapy, their survival rates were better if they were revascularized within the first year.[12]
  • The GISSOC trial (2003), studied the benefit of stent implantation over balloon PTCA for the treatment of chronic total coronary occlusions. The study demonstrated a significant reduction in the major adverse cardiovascular events observed in the stent group during a 6-year follow-up (76.1% in the stent group versus 60.4% in the PTCA group; p=0.055) and attributed this reduction secondary to the target lesion revascularization free-survival rate (85.1% in the stent group versus 65.5% in the PTCA group; p=0.0165). However, in most cases, restenosis of the study occlusion was evident at nine-month angiography. Thus, the study concluded stent implantation was superior to balloon PTCA in chronic total occlusions that can be recanalized percutaneously and is a valuable long-term therapeutic option; however, at nine-month follow-up both the stent and PTCA results appear to remain stable.[13]
  • Similar benefits with stent implantation for chronic total occlusion were reported in few other studies such as:
  • The SICCO trial (1996), reported a significant reduction in the target lesion revascularization (22% in the stent group versus 42% in the PTCA group; p=0.025) and restenosis (32% patients with stent and 74% patients with PTCA only; p=0.025) noted in the stent implantation group.[14]
  • The TOSCA study (1999), demonstrated stent implantation significantly improved late patency and reduced the rates of restenosis (70% in the PTCA group versus 55% in the stent group; p=less than 0.01) and target-vessel revascularization (15.4% in the PTCA group versus 8.4% in the stent group; p=0.03). Hence, the study concluded stent implantation being superior to PTCA for non-acute coronary occlusions.[15]
  • The SARECCO trial (1999), demonstrated a significant event free survival in the stent group observed during a 2-year follow-up (26% in the group that received angioplasty alone versus 52% in the stent group; p=less than 0.05).[16]
  • The SPACTO trial (1999), demonstrated significant reduction in the rates of restenosis (29% in the stent group versus 72% in the PTCA group; p=less than 0.01) and reocclusion (3% in the stent group versus 24% in the PTCA group) observed in the stent group. At follow-up,there was also a significant reduction in cardiac events (p=less than 0.03) and marked improvement in the anginal class (p=less than 0.01) reported in the stent group.[17]
  • The STOP study (2000), demonstrated significant reduction in the rate of restenosis (42.1% in the stent group versus 70.9% in the PTCA group; p=0.034) and reocclusion (7.9% in the stent group versus 16.1% in the PTCA group) observed with the stent implantation. However, stent group was associated with more a diffuse in-stent restenosis in comparison to a focal re-stenosis in the PTCA group that occurred at the point of total obstruction (within 5mm).[18]
  • The PRISON study (2004), that demonstrated a statistically significant reduction in the need for target lesion revascularization (29% in the PTCA group versus 13% in the stent group; p=less than 0.0001) and a non-significant rate of restenosis was observed (33% in the PTCA group versus 22% in the stent group; p=0.137).[19]
  • In the PACTO study (2004), 48 consecutive patients received paclitaxel-eluting stent implantation after successful recanalization of a chronic total occlusion, to assess the efficacy of drug-eluting stent in comparison to bare metal stent for the treatment of chronic total coronary occlusions. At 1-year follow-up, the incidence of major adverse cardiovascular events was significantly reduced in the paclitaxel group (12.5% in the Taxus group and 47.9% in the BMS group; p=less than 0.001) which was secondary to reduced need for repeat revascularization. The secondary end-points included the rate of restenosis (8.3% in the Taxus group and 51.1% in the BMS group; p=less than 0.001) and reocclusion (2.1% in the Taxus group and 23.4% in the BMS group; p=less than 0.005) which was also significantly reduced in the paclitaxel group. Thus, the study concluded, paclitaxel-eluting stent drastically reduced the incidence of major cardiovascular events and restenosis, and almost eliminated reocclusion which is frequently observed with bare metal stents when used for chronic total occlusion.[20]
  • The AWESOME trial and registry (2004), demonstrated the benefit of PCI over CABG in patients with refractory ischemia and who are at increased risk of adverse events, which may also be applicable to patients with left ventricular dysfunction.[21][22]
  • In a sub-study (2002) of patients with prior CABG, the three-year survival rate between CABG and PCI groups did not differ significantly: 73% in the CABG group and 76% in the PCI group (p=NS). However, the patient choice registry, reported that the patients with prior-CABG preferred PCI over repeat CABG.[23]

References

  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
  2. ↑ 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
  3. ↑ 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
  4. ↑ (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
  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. ↑ 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
  7. ↑ Kelley MP, Klugherz BD, Hashemi SM, Meneveau NF, Johnston JM, Matthai WH et al. (2003) One-year clinical outcomes of protected and unprotected left main coronary artery stenting. Eur Heart J 24 (17):1554-9. PMID: 12927190
  8. ↑ Arampatzis CA, Lemos PA, Tanabe K, Hoye A, Degertekin M, Saia F et al. (2003) Effectiveness of sirolimus-eluting stent for treatment of left main coronary artery disease. Am J Cardiol 92 (3):327-9. PMID: 12888147
  9. ↑ de Lezo JS, Medina A, Pan M, Delgado A, Segura J, Pavlovic D et al. (2004) Rapamycin-eluting stents for the treatment of unprotected left main coronary disease. Am Heart J 148 (3):481-5. DOI:10.1016/j.ahj.2004.03.011 PMID: 15389236
  10. ↑ Pepine CJ, Geller NL, Knatterud GL, Bourassa MG, Chaitman BR, Davies RF et al. (1994) The Asymptomatic Cardiac Ischemia Pilot (ACIP) study: design of a randomized clinical trial, baseline data and implications for a long-term outcome trial. J Am Coll Cardiol 24 (1):1-10. PMID: 8006249
  11. ↑ 11.0 11.1 Davies RF, Goldberg AD, Forman S, Pepine CJ, Knatterud GL, Geller N et al. (1997) Asymptomatic Cardiac Ischemia Pilot (ACIP) study two-year follow-up: outcomes of patients randomized to initial strategies of medical therapy versus revascularization. Circulation 95 (8):2037-43. PMID: 9133513
  12. ↑ Pfisterer M, Trial of Invasive versus Medical therapy in Elderly patients Investigators (2004) Long-term outcome in elderly patients with chronic angina managed invasively versus by optimized medical therapy: four-year follow-up of the randomized Trial of Invasive versus Medical therapy in Elderly patients (TIME). Circulation 110 (10):1213-8. DOI:10.1161/01.CIR.0000140983.69571.BA PMID: 15337691
  13. ↑ Rubartelli P, Verna E, Niccoli L, Giachero C, Zimarino M, Bernardi G et al. (2003) Coronary stent implantation is superior to balloon angioplasty for chronic coronary occlusions: six-year clinical follow-up of the GISSOC trial. J Am Coll Cardiol 41 (9):1488-92. PMID: 12742287
  14. ↑ Sirnes PA, Golf S, Myreng Y, Mølstad P, Emanuelsson H, Albertsson P et al. (1996) Stenting in Chronic Coronary Occlusion (SICCO): a randomized, controlled trial of adding stent implantation after successful angioplasty. J Am Coll Cardiol 28 (6):1444-51. PMID: 8917256
  15. ↑ Buller CE, Dzavik V, Carere RG, Mancini GB, Barbeau G, Lazzam C et al. (1999) Primary stenting versus balloon angioplasty in occluded coronary arteries: the Total Occlusion Study of Canada (TOSCA). Circulation 100 (3):236-42. PMID: 10411846
  16. ↑ Sievert H, Rohde S, Utech A, Schulze R, Scherer D, Merle H et al. (1999) Stent or angioplasty after recanalization of chronic coronary occlusions? (The SARECCO Trial). Am J Cardiol 84 (4):386-90. PMID: 10468073
  17. ↑ Höher M, Wöhrle J, Grebe OC, Kochs M, Osterhues HH, Hombach V et al. (1999) A randomized trial of elective stenting after balloon recanalization of chronic total occlusions. J Am Coll Cardiol 34 (3):722-9. PMID: 10483953
  18. ↑ Lotan C, Rozenman Y, Hendler A, Turgeman Y, Ayzenberg O, Beyar R et al. (2000) Stents in total occlusion for restenosis prevention. The multicentre randomized STOP study. The Israeli Working Group for Interventional Cardiology. Eur Heart J 21 (23):1960-6. DOI:10.1053/euhj.2000.2295 PMID: 11071802
  19. ↑ Rahel BM, Suttorp MJ, Laarman GJ, Kiemeneij F, Bal ET, Rensing BJ et al. (2004) Primary stenting of occluded native coronary arteries: final results of the Primary Stenting of Occluded Native Coronary Arteries (PRISON) study. Am Heart J 147 (5):e22. DOI:10.1016/j.ahj.2003.11.023 PMID: 15131557
  20. ↑ Werner GS, Krack A, Schwarz G, Prochnau D, Betge S, Figulla HR (2004) Prevention of lesion recurrence in chronic total coronary occlusions by paclitaxel-eluting stents. J Am Coll Cardiol 44 (12):2301-6. DOI:10.1016/j.jacc.2004.09.040 PMID: 15607390
  21. ↑ Morrison DA, Sethi G, Sacks J, Grover F, Sedlis S, Esposito R et al. (1999) A multicenter, randomized trial of percutaneous coronary intervention versus bypass surgery in high-risk unstable angina patients. The AWESOME (Veterans Affairs Cooperative Study #385, angina with extremely serious operative mortality evaluation) investigators from the Cooperative Studies Program of the Department of Veterans Affairs. Control Clin Trials 20 (6):601-19. PMID: 10588300
  22. ↑ Sedlis SP, Ramanathan KB, Morrison DA, Sethi G, Sacks J, Henderson W et al. (2004) Outcome of percutaneous coronary intervention versus coronary bypass grafting for patients with low left ventricular ejection fractions, unstable angina pectoris, and risk factors for adverse outcomes with bypass (the AWESOME Randomized Trial and Registry). Am J Cardiol 94 (1):118-20. DOI:10.1016/j.amjcard.2004.03.041 PMID: 15219521
  23. ↑ Morrison DA, Sethi G, Sacks J, Henderson WG, Grover F, Sedlis S et al. (2002) Percutaneous coronary intervention versus repeat bypass surgery for patients with medically refractory myocardial ischemia: AWESOME randomized trial and registry experience with post-CABG patients. J Am Coll Cardiol 40 (11):1951-4. PMID: 12475454


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