High-risk percutaneous coronary intervention (PCI) without elective mechanical circulatory support (MCS) is a safe treatment option for acute coronary syndrome (ACS) patients, according to new data published in the American Journal of Cardiology.
“Widespread utilization of MCS for high-risk PCI remains controversial, with a lack of randomized supporting evidence and associated risk of device-related complications,” wrote lead author Nauman Khalid, MD, of MedStar Washington Hospital Center in Washington, D.C., and colleagues. “We investigated whether high-risk PCI of native coronary arteries without elective MCS in patients with ACS is safe and feasible.”
Khalid et al. tracked data from 499 patients presenting with unstable angina pectoris (UAP), 1,218 patients with non-STEMI and another 868 patients with STEMI. Any patients with cardiogenic shock were excluded from the analysis. All patients underwent high-risk PCI from 2003 to 2018 at a single facility.
Procedural success was seen in 97.2% of UAP patients, 98.3% of non-STEMI patients and 96.6% of STEMI patients. The study’s primary endpoint, in-hospital mortality and 30-day all-cause mortality, was seen in 2% of UAP patients, 2.1% of non-STEMI patients and 4.7% of STEMI patients. Common complication for each patient group included target lesion revascularization (2.3%, 1.4% and 1.5%, respectively), stroke or transient ischemic attack (0.8%, 0.6% and 1.3%, respectively), acute renal failure (8.2%, 7.2% and 10.2%, respectively) and major bleeding (1.6%, 3.1% and 8.5%, respectively.
The option of “bailout” MCS with an intra-aortic balloon pump (IABP) or Abiomed’s Impella device was available to all operators. Bailout MCS was utilized at each operator’s discretion.
These bailout scenarios were seen in 1.6% of UAP patients, 3.1% of non-STEMI patients and 10.3% of STEMI patients. All cases of bailout MCS, the authors noted, were bailout IABP. There were no instances of bailout Impella use.
Because the number of bailout cases was relatively small, Khalid and colleagues did not include these cases in their final analysis.
“Our findings challenge the widespread utilization of MCS in ACS patients undergoing high-risk PCI,” the authors wrote. “Although there is a perception that elective MCS may allow operators to treat more vessels in a ‘protected’ environment, there are no prospective data to support such an assertion. A randomized clinical trial comparing MCS support versus conventional therapy assisted by adjunctive vasopressors when required remains an unmet clinical need.”
Click here to read the full analysis in the American Journal of Cardiology.