Long-term analysis of conventional coronary balloon angioplasty and an initial 'stent-like' result: The NHLBI PTCA registry

Objectives. We examined the influence of an initial 'stent-like' result on long-term outcome in patients in the 1985-86 NHLBI PTCA Registry. Background. Stent use in selected patients is associated with improved angiographic and short-term clinical outcome; however, due to potential for in-stent restenosis and high costs of stents, there is interest in a strategy of more optimal dilatation to achieve a 'stent-like' result without a stent. The long-term outcome of patients with a 'stent-like' percutaneous transluminal coronary angioplasty (PTCA) remains unknown. Methods. Ten-year outcome was compared between 225 successfully treated patients with and 1,764 successfully treated patients without an initial 'stent-like' result (≤1 lesion dilated to ≤10% stenosis). The sample had 75% and 80% power, respectively, to detect an absolute difference of 8% in the 10-year rate of death and myocardial infarction (MI) between the two groups. Results. Ten- year rates of death and MI were similar between the stent-like and non- stent-like groups (22.3% vs. 22.2%, 17.6% vs. 17.9%), however, there was less target lesion revascularization in the stent-like group (30.2% vs. 36.8%). In subgroup analysis of patients with multivessel disease, those with a stent- like result had less follow-up bypass surgery (25.2% vs. 32.7%), yet more repeat PTCA (53.8% vs. 42.7%). These findings were unaffected by adjustment for differences in baseline characteristics between the two patient groups. Conclusions. Achievement of an initial stent-like result via balloon angioplasty alone may not appreciably reduce the longterm risk of death or MI, nor confer equivalent clinical benefit as achieving a stent-like result with a stent.