Miketic S, Carlsson J, Tebbe U
Department of Internal Medicine II (Cardiology), Klinikum Lippe-Detmold, Detmold, Germany.
Am Heart J. 1998 Apr;135(4):709-13. doi: 10.1016/s0002-8703(98)70290-x.
Balloon inflation during coronary angioplasty results in shear stress-induced vessel wall injury with development of restenosis. This randomized trial compared the impact of two different balloon inflation strategies (slow versus fast) on restenosis after coronary angioplasty.
Two hundred seven patients were randomized to undergo either fast or gradually increased slow inflation after successful placement of the balloon catheter inside the target lesion. One hundred six underwent fast, and 101 underwent gradually increased slow balloon inflation. Coronary angiograms were quantitatively analyzed before angioplasty, after angioplasty, and at follow-up 5.9+/-1.6 months after the initial procedure.
Both groups had an identical primary success rate (98.1% vs 98%; p = 0.96) and a similar minimal luminal diameter before (0.49+/-0.26 mm vs 0.48+/-0.22 mm; p = 0.8) and after (2.22+/-0.97 mm vs 2.26+/-0.66 mm; p = 0.7) angioplasty. Slow balloon inflation did not reduce late luminal loss (0.58+/-0.77 mm vs 0.74+/-0.87 mm; p = 0.2), net gain (1.33+/-0.84 mm vs 1.19+/-0.81 mm; p = 0.3), or minimal luminal diameter at follow-up (1.80+/-0.97 mm vs 1.72+/-1.0 mm; p = 0.6) significantly. Restenosis, defined as >50% diameter stenosis at follow-up, occurred in 24% in the slow inflation group versus 36% in the fast inflation group (p = 0.09). Clinical events during 6-month follow-up were similar in both groups (repeat angioplasty, fast 5.6%, slow 4.8%, p = 0.8; nonfatal myocardial infarction, fast 2.2%, slow 1.2%, p = 0.6; death, fast 1.1%, slow 0%, p = 0.3).
The present randomized trial of two different balloon inflation strategies shows no statistically significant difference in net gain, minimal luminal diameter, or restenosis after coronary angioplasty. The difference in net gain, minimal luminal diameter, and restenosis rate were not statistically significant, but may represent a trend toward a reduction of smooth muscle cell proliferation and intimal hyperplasia induced by careful dilation of the stenotic lesion with gradually increased slow balloon inflation and reduction of shear stress-related vessel wall injury.
冠状动脉血管成形术中球囊扩张会导致剪切应力引起血管壁损伤，并引发再狭窄。这项随机试验比较了两种不同的球囊扩张策略（快速与缓慢）对冠状动脉血管成形术后再狭窄的影响。
207例患者在球囊导管成功置入靶病变后，随机分为快速扩张组或缓慢递增扩张组。106例接受快速扩张，101例接受缓慢递增的球囊扩张。在血管成形术前、术后以及初次手术后5.9±1.6个月的随访时，对冠状动脉造影进行定量分析。
两组的主要成功率相同（98.1%对98%；p = 0.96），血管成形术前（0.49±0.26 mm对0.48±0.22 mm；p = 0.8）和术后（2.22±0.97 mm对2.26±0.66 mm；p = 0.7）的最小管腔直径相似。缓慢球囊扩张并未显著降低晚期管腔丢失（0.58±0.77 mm对0.74±0.87 mm；p = 0.2）、净增管腔直径（1.33±0.84 mm对1.19±0.81 mm；p = 0.3）或随访时的最小管腔直径（1.80±0.97 mm对1.72±1.0 mm；p = 0.6）。随访时定义为直径狭窄>50%的再狭窄，在缓慢扩张组为24%，快速扩张组为36%（p = 0.09）。两组在6个月随访期间的临床事件相似（再次血管成形术，快速组5.6%，缓慢组4.8%，p = 0.8；非致命性心肌梗死，快速组2.2%，缓慢组1.2%，p = 0.6；死亡，快速组1.1%，缓慢组0%，p = 0.3）。
目前关于两种不同球囊扩张策略的随机试验表明，冠状动脉血管成形术后的净增管腔直径、最小管腔直径或再狭窄方面无统计学显著差异。净增管腔直径、最小管腔直径和再狭窄率的差异无统计学意义，但可能代表一种趋势，即通过缓慢递增的球囊扩张仔细扩张狭窄病变，减少剪切应力相关的血管壁损伤，从而减少平滑肌细胞增殖和内膜增生。
