Long-Term Mortality Data From the Balloon Pump–Assisted Coronary Intervention Study (BCIS-1)

Abstract

I ntra-aortic balloon counterpulsation ameliorates ischemia by simultaneously augmenting coronary blood flow and reducing myocardial oxygen demand, making it a potentially valuable therapy for providing circulatory support in cardiogenic shock or preventing the occurrence of major complications during high-risk percutaneous coronary intervention (PCI). Singlecenter observational data had suggested a reduction in mortality and major complications with the use of an elective intra-aortic balloon pump (IABP) during high-risk PCI, 1,2 but the Balloon Pump-Assisted Coronary Intervention Study (BCIS-1) was the first randomized controlled evaluation of the safety and efficacy of counterpulsation during high-risk PCI.3 Compared with patients who had PCI without planned IABP support, those who received elective IABP insertion were found to have a similar incidence of major adverse cardiac and cerebrovascular events (MACCE) at hospital discharge, which is the primary outcome of the study. However, differences were observed in the major secondary outcomes of BCIS-1: the occurrence of procedural complications and all-cause mortality at 6 months. Procedural complications occurred much less frequently in patients who received elective IABP support, and fewer early deaths were noted in this group, although relatively few deaths had occurred at 6 months, and the difference in mortality was not statistically significant at that stage. Elective IABP use during high-risk PCI has a class IIb recommendation (level of evidence C) in the current American College of Cardiology Foundation/American Background-There is conflicting evidence on the utility of elective intra-aortic balloon pump (IABP) use during high-risk percutaneous coronary intervention (PCI). Observational series have indicated a reduction in major in-hospital adverse events, although randomized trial evidence does not support this. A recent study has suggested a mortality benefit trend early after PCI, but there are currently no long-term outcome data from randomized trials in this setting. Methods and Results-Three hundred one patients with left ventricular impairment (ejection fraction <30%) and severe coronary disease (BCIS-1 jeopardy score ≥8; maximum possible score=12) were randomized to receive PCI with elective IABP support (n=151) or without planned IABP support (n=150). Long-term all-cause mortality was assessed by tracking the databases held at the Office of National Statistics (in England and Wales) and the General Register Office (in Scotland). The groups were balanced in terms of baseline characteristics (left ventricular ejection fraction, 23.6%; BCIS-1 jeopardy score, 10.4) and the amount and type of revascularization performed. Mortality data were available for the entire cohort at a median of 51 months (interquartile range, 41-58) from randomization. All-cause mortality at follow-up was 33% in the overall cohort, with significantly fewer deaths occurring in the elective IABP group (n=42) than in the group that underwent PCI without planned IABP support ...

Complete percutaneous revascularisation feasibility in ischaemic heart failure is related to improved outcomes: insights from the COMMIT-HF registry

“…In fact, the age and profile of comorbidities in the COMMIT-HF registry are more similar to those observed in studies strictly concerning high-risk PCI and haemodynamic support [13,14]. Nonetheless, we consider the COMMIT-HF population to be representative of a real-life, contemporary ischaemic HF patient.…”

Unprotected Left Main Percutaneous Coronary Intervention in Acute Coronary Syndromes with Extracorporeal Life Support Backup

“…Registry data, however, suggest significant early adverse event rates after LMCA PCI (19.2% mortality, 7.5% AMI, and 1.7% stroke) [7]. Routinely implanted IABP or the left ventricular assist devices like Impella or TandemHeart for high-risk PCI showed heterogeneous results [8–14]. Therefore the optimal backup system for left main PTCA in patients with high risk of hemodynamic instability during PCI is still to be determined.…”

Intra-Aortic Balloon Pump for High-Risk Percutaneous Coronary Intervention

“…19 It is thought that prior hemodynamic stabilization can be protective by maintaining perfusion pressure throughout the procedure, thus reducing intraprocedural risk. 45 The first reported use of elective IABP support in patients undergoing high-risk PCI in 1990 was in 28 patients with severe LV dysfunction and either multivessel coronary disease or left main coronary artery disease. IABP-support was found to be safe and feasible, with no observed intraprocedural complications of hypotension, death, or MI within 72 hours.…”

“…15 Interestingly, long-term all-cause mortality at a median follow-up of 51 months was significantly less in the elective IABP (42 patients) group compared with no IABP (58 patient; hazard ratio, 0.66; 95% confidence interval, 0.44-0.98; P=0.039); a 34% relative reduction in long-term allcause mortality compared with unsupported PCI (Figure 5). 45 The evidence would suggest that routine IABP use does not provide clinical benefit in patients undergoing high-risk procedures or those with AMI in the absence of CS. The current American Heart Association guidance considers it reasonable to consider elective IABP in high-risk PCI in a carefully selected subgroup (Class IIB) but not in patients with AMI in the absence of CS.…”