After rigorous screening by means of registries and controlled trials, various atherectomy devices, excimer laser catheters, and endoluminal stents were approved for general clinical use. Few data are available describing their safety and effectiveness after approval. This analysis was undertaken to assess the impact on patient outcomes of the unrestricted clinical application of new transcatheter devices for coronary angioplasty.
Thirty-six cardiologists performed 3,113 transcatheter procedures during 1995. Each chose the transcatheter modality best suited to the clinical and angiographic features of the patient. Baseline clinical and angiographic data and initial outcome were recorded by cardiac catheterization laboratory personnel. In-hospital events were obtained by independent chart review.
Balloon angioplasty alone was employed in 1,089 (35.0%) patients. A stent was deployed after balloon angioplasty in 1,029 (33.1%) patients. An atherectomy or laser device was used without stent support in 631 (20.3%) patients, and stent support was added in an additional 364 (11.7%) patients. In all three new device categories the angiographic success (final luminal narrowing F50%) rate was better than in balloon angioplasty for type-C lesions and for chronic occlusions. The frequency of adverse events in the aggregate was not increased with device use, but the frequency of coronary rtery bypass surgery was reduced with stent use. The frequency of non-Q-wave myocardial infarction was greater with devices than with balloon angioplasty alone. After adjustment for the differences in baseline clinical and angiographic variables by means of multivariate analysis, each of the three new device categories was independently associated with an increased chance of angiographic and procedural success compared to balloon angioplasty.
The availability of new transcatheter devices for clinical practice enhances patient outcomes during hospitalization for the procedure.