OBJECTIVES: The present study assesses clinical outcomes in patients from the Potential Angina Class Improvement From Intramyocardial Channels (PACIFIC) trial of percutaneous transmyocardial revascularization (PTMR) who had previously been considered “no-option,” but who subsequently underwent percutaneous coronary intervention (PCI) for continuing symptoms. BACKGROUND: Patients with advanced symptomatic coronary artery disease who are not candidates for coronary artery bypass grafting (CABG) or PCI comprise an important group, for which no established treatment is currently available. These patients have been described as having “no option,” and are currently targeted for various experimental therapies. One such proposed therapy, PTMR, was recently examined in the PACIFIC trial. A subgroup of patients in this trial subsequently underwent PCI, although to initially qualify for the study they had previously been considered as unsuitable for PCI and as having “no option.” The therapeutic benefit of PCI for patients of this type is unknown. METHODS: A retrospective analysis was performed on data obtained from all subjects of the PACIFIC study who underwent PCI within the 12-month follow-up period. RESULTS: Ten subjects originally randomized to PTMR and 11 subjects from the medical treatment group underwent PCI. Most had undergone at least one prior PCI and at least one CABG, and there was a high prevalence of cardiovascular risk factors. Despite excellent immediate procedural success, PCI resulted in only modest, statistically nonsignificant increases in mean exercise duration, small improvements in angina status, and no significant improvements in quality of life. CONCLUSIONS: These data suggest that PCI provides only marginal-if any-symptomatic benefit in these patients.
Tags: Angioplasty, Arteries, CABG, clinical, Coronary Artery Bypass, Coronary Disease, exercise, female, human, male, Massachusetts, methods, Middle Aged, NO, patients, Percutaneous Coronary, Prevalence, Quality of Life, Randomized Controlled Trials, Retrospective Studies, Risk, Risk Factors, therapy, Transluminal, Treatment Outcome