Controlled balloon inflation reduces long-term restenosis after percutaneous transluminal coronary angioplasty.

PURPOSE: The trauma induced by balloon angioplasty has an impact on the outcome of coronary interventions, such as stent procedures. However, balloon inflation for PTCA is not yet standardized even though procedural and long-term outcomes might be affected. METHODS: During routine PTCA, a total of 454 patients [mean age, 60.9 +/- 9.0 years; 162 (35.7%) with 1-vessel disease; 159 (35%) with 2-vessel disease; 133 (29.3%) with 3-vessel disease] were allotted to computer-assisted dilatation (CAPS) with a pressure slope of 0.2 bar/s (CAPS 0.2; n = 149 patients), 1.0 bar/s (CAPS 1.0; n = 154 patients) or to standard inflation with a hand-driven pump (n = 151 patients). Angiographic follow-up rates after 4.1 +/- 3.2 months were 88.1% for the hand-driven pump, 94% for CAPS 0.2 and 87.7% for CAPS 1.0. RESULTS: Flow reducing (1.3-2.0%) and non-flow reducing (12.6-14.9%) dissections were equally distributed among all groups as were major adverse cardiac events (2.6-4.0%). The stent rate was 1.3% with the hand-driven pump, 0.7% with CAPS 0.2 and 1.3% with CAPS 1.0. Angiographic restenosis rate was 48.9% with the hand-driven pump, 44.3% with CAPS 0.2 and 32.6% with CAPS 1.0. (hand-driven pump versus CAPS 1.0, p < 0.007; CAPS 0.2 versus CAPS 1.0, p < 0.049). CONCLUSIONS: The pressure slope during balloon inflation in PTCA has a significant impact on restenosis. The impact on stent procedures has yet to be determined.