Key result
Gradual coronary angioplasty balloon inflation reduced the dissection rate compared to rapid inflation (36% vs. 59%, p<0.01) and lowered the collective complication rate (6% vs. 19%, p<0.03).
Why the study?
Does a gradual balloon inflation protocol reduce dissection and complication rates compared to rapid inflation in patients undergoing coronary angioplasty?
RCT (n=103)
Does a gradual balloon inflation protocol reduce dissection and complication rates compared to rapid inflation in patients undergoing coronary angioplasty?
Absolute Event Rate: 36% vs 59%
p-value: p=<0.01
Gradual balloon inflation during coronary angioplasty reduces the frequency of dissection and procedure-related complications compared to rapid inflation.
Gradual balloon inflation may be adopted in coronary angioplasty to lower procedural risks; confirms benefit in this RCT.
Although a variety of coronary angioplasty balloon inflation protocols are employed, prior studies have not evaluated the relation of rate of inflation to the type and extent of arterial damage produced by angioplasty. We randomized 103 patients to either a gradual (gradual, incremental increase to peak inflation pressure) or rapid inflation protocol (rapid increase to peak inflation pressure). Fifty-one patients with 72 lesions underwent gradual and 52 patients with 73 lesions received rapid inflation protocols. There were no significant group differences with regard to age, sex, artery dilated, number of diseased vessels, presence of unstable angina and lesion morphological characteristics except for more lesions located on a bend in the gradual inflation group (p < 0.02). Although there was a tendency towards a higher success rate in patients with gradual inflation, the complete success rates were high in both groups (100% vs. 93%, p < 0.08). The dissection rate was higher in patients with rapid inflation (43/73 [59%] vs. 26/72 [36%], p < 0.01). The collective complication rate was higher in patients with rapid inflation (19% vs. 6%, p < 0.03). No deaths occurred in either group. Thus a gradual compared to rapid coronary angioplasty balloon inflation protocol reduces the frequency of dissection despite similar inflation pressure and balloon/vessel diameter ratio. Gradual inflations may reduce the frequency of procedure-related complications.
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Ilia et al. (1993) conducted an RCT in Coronary artery disease requiring angioplasty (n=103). Gradual balloon inflation protocol vs. Rapid balloon inflation protocol was evaluated on Dissection rate (p=<0.01). Gradual coronary angioplasty balloon inflation reduced the dissection rate compared to rapid inflation (36% vs. 59%, p<0.01) and lowered the collective complication rate (6% vs. 19%, p<0.03).
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