BACKGROUND: The increase in the use of stents has seen the increasing emergence of in-stent restenosis (ISR). Reports suggest that the Cutting Balloon (Interventional Technologies, San Diego, California) may be a useful treatment modality for this new clinical entity. METHODS: In this study, we compared the efficacy of Cutting Balloon angioplasty (CBA) with conventional balloon angioplasty (PTCA) for ISR in 47 patients (47 lesions). Results were evaluated with intravascular ultrasound (IVUS). The CBAgroup included 25 patients (mean age, 65 +/- 78 years; 7 females) and the PTCAgroup included 22 patients (mean age, 69 +/- 51 years; 6 females). RESULTS: The procedural success rate was 100% in both groups. IVUS showed that luminal area acute gain was larger in the CBA group (2.5 +/- 0.8 mm2) compared to the PTCA group (1.8 +/- 1.0 mm2), while late loss was smaller in the CBA group (0.5 +/- 0.4 mm2) compared to the PTCA group (1.3 +/- 0.5 mm2). The change in total area was similar in both groups. The increase in area at the stented portion was 0.4 +/- 0.8 mm2 in the CBA group and 1.2 +/- 0.5 mm2 in the PTCA group. The restenosis rate at follow-up (mean follow-up, 5.4 months) was higher in PTCA patients (59%) than in the CBA patients (24%). CONCLUSION:CBA may result in no increase in total vessel area, a constant stent area, a decrease in plaque area, and an increase in lumen area (induced by the decrease in plaque area). Our IVUS findings suggest that compared to PTCA, the dilatation mechanism of CBA may be associated with reduced dilatation of both the total vessel area and the stent area for ISR. The mechanism of this modality may minimize injury to the intimal membrane and may potentially be a primary device for in-stent restenosis in the future.
RCT Entities:
BACKGROUND: The increase in the use of stents has seen the increasing emergence of in-stent restenosis (ISR). Reports suggest that the Cutting Balloon (Interventional Technologies, San Diego, California) may be a useful treatment modality for this new clinical entity. METHODS: In this study, we compared the efficacy of Cutting Balloon angioplasty (CBA) with conventional balloon angioplasty (PTCA) for ISR in 47 patients (47 lesions). Results were evaluated with intravascular ultrasound (IVUS). The CBA group included 25 patients (mean age, 65 +/- 78 years; 7 females) and the PTCA group included 22 patients (mean age, 69 +/- 51 years; 6 females). RESULTS: The procedural success rate was 100% in both groups. IVUS showed that luminal area acute gain was larger in the CBA group (2.5 +/- 0.8 mm2) compared to the PTCA group (1.8 +/- 1.0 mm2), while late loss was smaller in the CBA group (0.5 +/- 0.4 mm2) compared to the PTCA group (1.3 +/- 0.5 mm2). The change in total area was similar in both groups. The increase in area at the stented portion was 0.4 +/- 0.8 mm2 in the CBA group and 1.2 +/- 0.5 mm2 in the PTCA group. The restenosis rate at follow-up (mean follow-up, 5.4 months) was higher in PTCA patients (59%) than in the CBApatients (24%). CONCLUSION:CBA may result in no increase in total vessel area, a constant stent area, a decrease in plaque area, and an increase in lumen area (induced by the decrease in plaque area). Our IVUS findings suggest that compared to PTCA, the dilatation mechanism of CBA may be associated with reduced dilatation of both the total vessel area and the stent area for ISR. The mechanism of this modality may minimize injury to the intimal membrane and may potentially be a primary device for in-stent restenosis in the future.
Authors: Gregory G Westin; Ehrin J Armstrong; Usman Javed; Christopher R Balwanz; Haseeb Saeed; William C Pevec; John R Laird; David L Dawson Journal: Ann Vasc Surg Date: 2014-08-06 Impact factor: 1.466