Small-Bore Percutaneous Ventricular Assist Device (pVAD) Shows Similar 30-Day Outcomes to Intra-Aortic Balloon Pump (IABP) in High-Risk PCI: TCT 2025

Use of the NyokAssist small-bore percutaneous ventricular assist device (pVAD) resulted in comparable 30-day safety outcomes to intra-aortic balloon pump (IABP) support in patients undergoing elective high-risk percutaneous coronary intervention, according to results of the trial presented by Dr. Rui Wang on behalf of principal investigator Dr. Junbo Ge at TCT 2025.

The trial was a prospective, randomized, controlled study conducted across 11 centers, designed to evaluate whether the NyokAssist pVAD was non-inferior to IABP support in non-emergent, hemodynamically stable patients undergoing high-risk PCI. A total of 236 patients were randomized equally to pVAD or IABP. Eligible patients had left ventricular ejection fraction of 40 percent or less or were scheduled to undergo rotational atherectomy, and met at least one high-risk angiographic feature including unprotected left main PCI, PCI to the last remaining vessel, or three-vessel coronary disease.

The NyokAssist device has a 9 Fr insertion profile and expands to 24 Fr during use, providing mean flows of 3.5 L/min and peak flows of 5 L/min. It features an external motor intended to reduce hemolysis and currently holds FDA Breakthrough Device designation.

Baseline characteristics were well balanced between groups, with mean age 62 years and left ventricular ejection fraction around 34 to 35 percent. Prior myocardial infarction was present in 68 percent of the pVAD arm and 63 percent of the IABP arm, while diabetes was recorded in 62 percent and 53 percent, respectively.

The primary endpoint, 30-day major adverse cardiovascular and cerebrovascular events, occurred in 4.4 percent of patients treated with pVAD and 2.6 percent of those treated with IABP. Mortality was 0.9 percent in the pVAD group and 1.7 percent in the IABP group. Stroke occurred in 0.9 percent of patients in both groups, and myocardial infarction occurred in 1.8 percent of the pVAD arm and in none of the IABP arm. No repeat revascularization was recorded in either group.

Secondary outcomes at 30 days, including acute renal failure, ventricular arrhythmia requiring cardioversion, and cardiac pulmonary resuscitation, were also similar. No major bleeding, hemolysis, or major vascular complications were observed in either group.

Echocardiography showed improvement in left ventricular ejection fraction at 30 days in both groups, though no between-group comparison was presented. Vascular closure strategies differed, with ProGlide used more frequently in the pVAD arm, while manual compression was more common with IABP access. No access-related complications were reported.

Follow-up to 90 days is ongoing, and final adjudication of major events remains pending.