Elective Intra-aortic Balloon Counterpulsation During High-Risk Percutaneous Coronary Intervention: A Randomized Controlled Trial | Cardiology | JAMA | JAMA Network
[Skip to Navigation]
Access to paid content on this site is currently suspended due to excessive activity being detected from your IP address Please contact the publisher to request reinstatement.
Keelan PC, Johnston JM, Koru-Sengul T,  et al; Dynamic Registry Investigators.  Comparison of in-hospital and one-year outcomes in patients with left ventricular ejection fractions <or=40%, 41% to 49%, and >or=50% having percutaneous coronary revascularization.  Am J Cardiol. 2003;91(10):1168-117212745097PubMedGoogle ScholarCrossref
Wallace TW, Berger JS, Wang A, Velazquez EJ, Brown DL. Impact of left ventricular dysfunction on hospital mortality among patients undergoing elective percutaneous coronary intervention.  Am J Cardiol. 2009;103(3):355-36019166689PubMedGoogle ScholarCrossref
Williams DO, Korr KS, Gewirtz H, Most AS. The effect of intraaortic balloon counterpulsation on regional myocardial blood flow and oxygen consumption in the presence of coronary artery stenosis in patients with unstable angina.  Circulation. 1982;66(3):593-5977094269PubMedGoogle ScholarCrossref
Kern MJ, Aguirre F, Bach R, Donohue T, Siegel R, Segal J. Augmentation of coronary blood flow by intra-aortic balloon pumping in patients after coronary angioplasty.  Circulation. 1993;87(2):500-5118425297PubMedGoogle ScholarCrossref
Sjauw KD, Engström AE, Vis MM,  et al.  A systematic review and meta-analysis of intra-aortic balloon pump therapy in ST-elevation myocardial infarction: should we change the guidelines?  Eur Heart J. 2009;30(4):459-46819168529PubMedGoogle ScholarCrossref
Cohen M, Urban P, Christenson JT,  et al; Benchmark Registry Collaborators.  Intra-aortic balloon counterpulsation in US and non-US centres: results of the Benchmark Registry.  Eur Heart J. 2003;24(19):1763-177014522572PubMedGoogle ScholarCrossref
Brodie BR, Stuckey TD, Hansen C, Muncy D. Intra-aortic balloon counterpulsation before primary percutaneous transluminal coronary angioplasty reduces catheterization laboratory events in high-risk patients with acute myocardial infarction.  Am J Cardiol. 1999;84(1):18-2310404845PubMedGoogle ScholarCrossref
Briguori C, Sarais C, Pagnotta P,  et al.  Elective versus provisional intra-aortic balloon pumping in high-risk percutaneous transluminal coronary angioplasty.  Am Heart J. 2003;145(4):700-70712679768PubMedGoogle ScholarCrossref
Mishra S, Chu WW, Torguson R,  et al.  Role of prophylactic intra-aortic balloon pump in high-risk patients undergoing percutaneous coronary intervention.  Am J Cardiol. 2006;98(5):608-61216923445PubMedGoogle ScholarCrossref
Smith SC Jr, Feldman TE, Hirshfeld JW Jr,  et al; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention.  ACC/AHA/SCAI 2005 guideline update for percutaneous coronary intervention: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention).  J Am Coll Cardiol. 2006;47(1):e1-e12116386656PubMedGoogle ScholarCrossref
Perera D, Stables R, Booth J, Thomas M, Redwood S.BCIS-1 Investigators.  The balloon pump-assisted coronary intervention study (BCIS-1): rationale and design.  Am Heart J. 2009;158(6):910-91619958856PubMedGoogle ScholarCrossref
Califf RM, Phillips HR III, Hindman MC,  et al.  Prognostic value of a coronary artery jeopardy score.  J Am Coll Cardiol. 1985;5(5):1055-10633989116PubMedGoogle ScholarCrossref
Thygesen K, Alpert JS, White HD,  et al; Joint ESC/ACCF/AHA/WHF Task Force for the Redefinition of Myocardial Infarction.  Universal definition of myocardial infarction.  Circulation. 2007;116(22):2634-265317951284PubMedGoogle ScholarCrossref
Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine.  Nephron. 1976;16(1):31-411244564PubMedGoogle ScholarCrossref
Singh M, Rihal CS, Lennon RJ, Spertus J, Rumsfeld JS, Holmes DR Jr. Bedside estimation of risk from percutaneous coronary intervention: the new Mayo Clinic risk scores.  Mayo Clin Proc. 2007;82(6):701-70817550750PubMedGoogle Scholar
Chowdhary S, Ivanov J, Mackie K, Seidelin PH, Dzavík V. The Toronto score for in-hospital mortality after percutaneous coronary interventions.  Am Heart J. 2009;157(1):156-16319081413PubMedGoogle ScholarCrossref
Hannan EL, Wu C, Walford G,  et al.  Volume-outcome relationships for percutaneous coronary interventions in the stent era.  Circulation. 2005;112(8):1171-117916103238PubMedGoogle ScholarCrossref
Zahn R, Gottwik M, Hochadel M,  et al; Registry of Percutaneous Coronary Interventions of the Arbeitsgemeinschaft Leitende Kardiologische Krankenhausarzte (ALKK).  Volume-outcome relation for contemporary percutaneous coronary interventions (PCI) in daily clinical practice: is it limited to high-risk patients? results from the Registry of Percutaneous Coronary Interventions of the Arbeitsgemeinschaft Leitende Kardiologische Krankenhausarzte (ALKK).  Heart. 2008;94(3):329-33517664190PubMedGoogle ScholarCrossref
Ludman P. British Cardiovascular Intervention Society Annual Audits 2006-8. British Cardiovascular Intervention Society Web site. http://www.bcis.org.uk/pages/default.asp. Accessed July 19, 2010
Ståhle E, Bergström R, Edlund B,  et al.  Influence of left ventricular function on survival after coronary artery bypass grafting.  Ann Thorac Surg. 1997;64(2):437-4449262590PubMedGoogle ScholarCrossref
Sedlis SP, Ramanathan KB, Morrison DA, Sethi G, Sacks J, Henderson W.Department of Veterans Affairs Cooperative Study #385, Angina With Extremely Serious Operative Mortality Evaluation (AWESOME) Investigators.  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. 2004;94(1):118-12015219521PubMedGoogle ScholarCrossref
Holper EM, Blair J, Selzer F,  et al; Percutaneous Transluminal Coronary Angioplasty Registry and Dynamic Registry Investigators.  The impact of ejection fraction on outcomes after percutaneous coronary intervention in patients with congestive heart failure: an analysis of the National Heart, Lung, and Blood Institute Percutaneous Transluminal Coronary Angioplasty Registry and Dynamic Registry.  Am Heart J. 2006;151(1):69-7516368294PubMedGoogle ScholarCrossref
Gioia G, Matthai W, Benassi A, Rana H, Levite HA, Ewing LG. Improved survival with drug-eluting stent implantation in comparison with bare metal stent in patients with severe left ventricular dysfunction.  Catheter Cardiovasc Interv. 2006;68(3):392-39816892436PubMedGoogle ScholarCrossref
Jones RH, Velazquez EJ, Michler RE,  et al; STICH Hypothesis 2 Investigators.  Coronary bypass surgery with or without surgical ventricular reconstruction.  N Engl J Med. 2009;360(17):1705-171719329820PubMedGoogle ScholarCrossref
Sianos G, Morel MA, Kappetein AP,  et al.  The SYNTAX Score: an angiographic tool grading the complexity of coronary artery disease.  EuroIntervention. 2005;1(2):219-22719758907PubMedGoogle Scholar
Allman KC, Shaw LJ, Hachamovitch R, Udelson JE. Myocardial viability testing and impact of revascularization on prognosis in patients with coronary artery disease and left ventricular dysfunction: a meta-analysis.  J Am Coll Cardiol. 2002;39(7):1151-115811923039PubMedGoogle ScholarCrossref
Original Contribution
August 25, 2010

Elective Intra-aortic Balloon Counterpulsation During High-Risk Percutaneous Coronary Intervention: A Randomized Controlled Trial

Author Affiliations

Author Affiliations: Cardiovascular Division, King’s College London, London (Drs Perera, Thomas, and Redwood); Liverpool Heart and Chest Hospital, Liverpool (Dr Stables); Clinical Trials and Evaluation Unit, Royal Brompton Hospital, London (Ms Booth); Birmingham Heartlands Hospital, Birmingham (Dr Pitt); Leeds Teaching Hospitals, Leeds (Dr Blackman); and Brighton and Sussex University Hospital, Brighton (Dr de Belder), United Kingdom.

JAMA. 2010;304(8):867-874. doi:10.1001/jama.2010.1190

Context Observational studies have previously reported that elective intra-aortic balloon pump (IABP) insertion may improve outcomes following high-risk percutaneous coronary intervention (PCI). To date, this assertion has not been tested in a randomized trial.

Objective To determine whether routine intra-aortic balloon counterpulsation before PCI reduces major adverse cardiac and cardiovascular events (MACCE) in patients with severe left ventricular dysfunction and extensive coronary disease.

Design, Setting, and Patients The Balloon Pump–Assisted Coronary Intervention Study, a prospective, open, multicenter, randomized controlled trial conducted in 17 tertiary referral cardiac centers in the United Kingdom between December 2005 and January 2009. Patients (n = 301) had severe left ventricular dysfunction (ejection fraction ≤30%) and extensive coronary disease (Jeopardy Score ≥8/12); those with contraindications to or class I indications for IABP therapy were excluded.

Intervention Elective insertion of IABP before PCI.

Main Outcome Measures Primary end point was MACCE, defined as death, acute myocardial infarction, cerebrovascular event, or further revascularization at hospital discharge (capped at 28 days). Secondary end points included all-cause mortality at 6 months, major procedural complications, bleeding, and access-site complications.

Results MACCE at hospital discharge occurred in 15.2% (23/151) of the elective IABP and 16.0% (24/150) of the no planned IABP groups (P = .85; odds ratio [OR], 0.94 [95% confidence interval {CI}, 0.51-1.76]). All-cause mortality at 6 months was 4.6% and 7.4% in the respective groups (P = .32; OR, 0.61 [95% CI, 0.24-1.62]). Fewer major procedural complications occurred with elective IABP insertion compared with no planned IABP use (1.3% vs 10.7%, P < .001; OR, 0.11 [95% CI, 0.01-0.49]). Major or minor bleeding occurred in 19.2% and 11.3% (P = .06; OR, 1.86 [95% CI, 0.93-3.79]) and access-site complications in 3.3% and 0% (P = .06) of the elective and no planned IABP groups, respectively.

Conclusions Elective IABP insertion did not reduce the incidence of MACCE following PCI. These results do not support a strategy of routine IABP placement before PCI in all patients with severe left ventricular dysfunction and extensive coronary disease.

Trial Registration isrctn.org Identifier: ISRCTN40553718; clinicaltrials.gov Identifier: NCT00910481