Rationale:
Centers for Medicare and Medicaid Services (CMS) announced (March 2006) the PCI patient's eligibility for PhII. Most programs in the US had either eliminated or never enrolled these patients. Questions regarding this patient population, including the amount of ECG monitoring and the reliability of risk stratification in predicting complications addressed in PhII, are now being raised. Our program, among others in Iowa and other states, had never eliminated these patients as recommended by CMS.
Objective:
To describe PCI patients' events during PhII that result in revision in medical management (RMM) and to determine if risk stratification (AACVPR) predicts events.
Methods:
From January 2000 to February 2006 data were collected on all patients (n = 714) enrolled in PhII. All were risk-stratified on admission. Patients without coronary artery disease (n = 74) and with abnormal QRS complexes making ST segment analysis unreliable (n = 96) were omitted from analysis, leaving 544 patients. Events were defined as electrocardiographic (ECG) evidence of ischemia, supraventricular and ventricular arrhythmias, and exercise induced hypotension; RMM were collected for all patients. Pearson's chi-squared test for independence was used to compare the PCI-only with other patients' ischemic events as well as to determine if ischemic events vary by risk stratum.
Results:
Of the 544 patients, 51.1% (n = 278) had PCI; 24.3% (n = 132) had PCI only. In the PCI-only group, 33.3% showed ischemia, 18.2% arrhythmia, 16.7% exercise-induced hypotension. Compared with other patients, the PCI-only group had more ischemic events, 33.3% vs. 16.5%. Risk stratification revealed that the PCI-only group consisted of 66.7% low-, 27.3% moderate-, and 6.1% high-risk. Of the low, moderate, and high risk patients, 33%, 30.6%, and 50% showed ischemia respectively.
Conclusion:
The PCI-only patient is more likely than other patients in PhII to exhibit ECG signs indicative of myocardial ischemia ([chi] = 17.3, 1 df; P < 0.0001). The clinical significance of ischemia is supported by a 54% rate of RMM. There is no statistically significant evidence to indicate that the percentage of PCI-only patients experiencing an ischemic event varies by risk stratum ([chi]2 = 1.13, 2 df; P = 0.5682).