Elective Intra-aortic Balloon Counterpulsation During High-Risk Percutaneous Coronary Intervention<subtitle>A Randomized Controlled Trial</subtitle>

Abstract

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 Յ30%) and extensive coronary disease (Jeopardy Score Ն8/12); 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%, PϽ.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.

Efficacy and timing of intra-aortic counterpulsation in patients with ST-elevation myocardial infarction complicated by cardiogenic shock

“…Of note, a recent large randomised trial (BCIS-1) of IABPassisted PCI versus no IABP in the setting of elective PCI did Comparison of effect of IABP therapy pre-PCI vs. post-PCI in CS on 30-day mortality across strata (quintiles) of propensity score IABP intra-aortic balloon pump; OR odds ratio; CI confidence interval; n number of patients who died; N total number of patients in group a Manthel-Haenzel pooled estimate (p00.176) ABP intra-aortic balloon pump; OR odds ratio; CI: confidence interval; IRA infarct-related artery; LAD left descending artery MBP mean blood pressure; HR heart rate not prove to reduce major adverse cardiac and cerebral events [23]. In addition in the setting of STEMI without haemodynamic derangement, the CRISP-AMI (Counterpulsation to Reduce Infarct Size Pre-PCI-Acute Myocardial Infarction) trial [24], again randomising between IABP-assisted PCI vs. PCI without IABP support, also did not show improved outcomes, i.e.…”

In-Hospital and Long Term Results of Percutaneous Coronary Intervention With Biventricular Support and Extracorporeal Membrane Oxygenation

“…Например, случаи с продолжающейся ишемией, незащищенным стволом левой коронарной артерии, многососудистым сложным коронарным пораже-нием, с вмешательством на единственной оставшейся коронарной артерии, со сниженной функцией левого желудочка [7,8]. Более агрессивные чрескожные про-цедуры у пациентов высокого риска, не подходящих для хирургического вмешательства, требуют приме-нения устройств левожелудочковой поддержки.…”

“…Исследование BCIS-1(The Balloon Pump Assisted Coronary Intervention Study) -единственное про-спективное рандомизированное исследование, кото-рое подтверждает гипотезу о том, что подключение ВАБК перед ЧКВ высокого риска уменьшает вероят-ность развития неблагоприятных кардиальных и цереброваскулярных исходов [8,18]. Авторами не было выявлено различий в комбинированной конечной точке, которая включала смерть, острый ИМ, цереброваскулярные осложнения и повторную реваскуляризацию в госпитальный период [8].…”

2015 SCAI/ACC/HFSA/STS clinical expert consensus statement on the use of percutaneous mechanical circulatory support devices in cardiovascular care (Endorsed by the American heart assocation, the cardiological society of India, and sociedad latino Americana de cardiologia intervencion; Affirmation of value by the canadian association of interventional cardiology–association canadienne de cardiologie d'intervention)

“…Finally, a prospective randomized clinical trial, BCIS-1, enrolled 301 patients across 17 centers in the UK and failed to show a mortality benefit of routine IABP over provisional IABP use among those referred for HR-PCI [87]. On the other hand, routine IABP use significantly reduced major procedural complications (1.3% vs. 10.7%, P < 0.001), particularly procedural hypotension.…”