Characteristics and Outcomes of Older Patients Undergoing Protected Percutaneous Coronary Intervention With Impella

In patients undergoing high-risk percutaneous coronary intervention, Impella has become an important adjunctive tool to support revascularization. The impact of age on the outcomes of patients undergoing high-risk percutaneous coronary intervention is limited. The aim of this study is to describe the characteristics and outcomes of patients ≥75 years of age undergoing Impella-supported high-risk percutaneous coronary intervention.

Baseline characteristics and outcomes of patients ≥75 years of age versus those of patients <75 years of age in patients enrolled in the cVAD PROTECT III (Catheter-Based Ventricular Assist Device Prospective, Multi-Center, Randomized Controlled Trial of the IMPELLA RECOVER LP 2.5 System Versus Intra Aortic Balloon Pump in Patients Undergoing Non Emergent High Risk Percutaneous Coronary Intervention) study (NCT04136392). Major adverse cardiovascular and cerebral events (composite of all-cause death, nonfatal myocardial infarction, stroke/transient ischemic attack, and repeat revascularization) were assessed at 30 and 90 days and all-cause death at 1 year. Out of 1237 patients, 493 (39.9%) patients were ≥75 years of age. Patients ≥75 years of age had less diabetes and prior myocardial infarction, more hypertension and dyslipidemia, worse renal function, more severe valvular heart disease, but higher left ventricular ejection fraction (P<0.05 for all comparisons). Baseline Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery scores were similar between groups. Older patients underwent more left main percutaneous coronary intervention (58% versus 39%; P<0.0001), atherectomy (32% versus 22%; P<0.0001), and femoral access (87% versus 79%, P=0.0003) as compared with younger patients. In-hospital vascular complications did not differ, but rates of respiratory failure, pericardial tamponade, and cardiogenic shock were higher in older patients. Rates of all-cause death and major adverse cardiovascular and cerebral events did not differ between groups at 30 and 90 days. Rates of all-cause death at 1 year were higher in patients ≥75 years (adjusted hazard ratio, 1.99 [95% CI, 1.24-3.18], P=0.004).

Impella-supported high-risk percutaneous coronary intervention in older patients is feasible with an acceptable safety profile. However, age ≥75 years remained a statistically significant predictor for all-cause death at 1 year.

URL: https://clinicaltrials.gov; Unique Identifier: NCT04136392.