UNLABELLED: To study the immediate effects of prolonged total balloon inflation during PTCA, 41 patients (44 lesions) with chronic stable angina were randomized for prolonged sequential inflations (three to five inflations of 3 to 5 min each, for a total duration of > or = 12 min, group 1, n = 20 lesions) or 'standard' sequential inflations (three to five inflations of < or = 1 min each, for a total duration of < or = 3 min, group 2, n = 24 lesions). The mean duration of total balloon inflation time was 958 +/- 129 s in group 1 vs 205 +/- 46 s in group 2. Results of angioplasty were assessed on both angiography and percutaneous transluminal coronary angioscopy performed immediately after the procedure. High quality imaging of the coronary lumen and lesion morphology was possible on angioscopy in all patients without any complications. Post-PTCA angiographic percent diameter stenosis was significantly less in group 1 compared to group 2: 26 +/- 10% vs 36 +/- 8% (P < 0.05). On angioscopy, flaps were seen in 16 patients in group 2, but in only six in group 1 (P < 0.02). There was no difference in the incidence of thrombi on angioscopy between the two groups (group 1: nine cases, group 2: 10 cases). Sensitivity of angiographic detection of flaps and thrombi was poor: 10% and 12% respectively. One patient in each group developed a longitudinal dissection, detected on both angiography and angioscopy. CONCLUSIONS: (1) prolonged sequential balloon inflations lead to less residual luminal stenosis after PTCA, with a decreased incidence of intimal flaps in comparison with standard inflations. (2) Post-PTCA transluminal coronary angioscopy is safe and offers better assessment of luminal effects of PTCA than angiography.
RCT Entities:
UNLABELLED: To study the immediate effects of prolonged total balloon inflation during PTCA, 41 patients (44 lesions) with chronic stable angina were randomized for prolonged sequential inflations (three to five inflations of 3 to 5 min each, for a total duration of > or = 12 min, group 1, n = 20 lesions) or 'standard' sequential inflations (three to five inflations of < or = 1 min each, for a total duration of < or = 3 min, group 2, n = 24 lesions). The mean duration of total balloon inflation time was 958 +/- 129 s in group 1 vs 205 +/- 46 s in group 2. Results of angioplasty were assessed on both angiography and percutaneous transluminal coronary angioscopy performed immediately after the procedure. High quality imaging of the coronary lumen and lesion morphology was possible on angioscopy in all patients without any complications. Post-PTCA angiographic percent diameter stenosis was significantly less in group 1 compared to group 2: 26 +/- 10% vs 36 +/- 8% (P < 0.05). On angioscopy, flaps were seen in 16 patients in group 2, but in only six in group 1 (P < 0.02). There was no difference in the incidence of thrombi on angioscopy between the two groups (group 1: nine cases, group 2: 10 cases). Sensitivity of angiographic detection of flaps and thrombi was poor: 10% and 12% respectively. One patient in each group developed a longitudinal dissection, detected on both angiography and angioscopy. CONCLUSIONS: (1) prolonged sequential balloon inflations lead to less residual luminal stenosis after PTCA, with a decreased incidence of intimal flaps in comparison with standard inflations. (2) Post-PTCA transluminal coronary angioscopy is safe and offers better assessment of luminal effects of PTCA than angiography.