Serruys P W, de Bruyne B, Carlier S, Sousa J E, Piek J, Muramatsu T, Vrints C, Probst P, Seabra-Gomes R, Simpson I, Voudris V, Gurné O, Pijls N, Belardi J, van Es G A, Boersma E, Morel M A, van Hout B
Thoraxcenter, Rotterdam, the Netherlands.
Circulation. 2000 Dec 12;102(24):2930-7. doi: 10.1161/01.cir.102.24.2930.
Coronary stenting improves outcomes compared with balloon angioplasty, but it is costly and may have other disadvantages. Limiting stent use to patients with a suboptimal result after angioplasty (provisional angioplasty) may be as effective and less expensive.
To analyze the cost-effectiveness of provisional angioplasty, patients scheduled for single-vessel angioplasty were first randomized to receive primary stenting (97 patients) or balloon angioplasty guided by Doppler flow velocity and angiography (523 patients). Patients in the latter group were further randomized after optimization to either additional stenting or termination of the procedure to further investigate what is "optimal." An optimal result was defined as a flow reserve >2.5 and a diameter stenosis <36%. Bailout stenting was needed in 129 patients (25%) who were randomized to balloon angioplasty, and an optimal result was obtained in 184 of the 523 patients (35%). There was no significant difference in event-free survival at 1 year between primary stenting (86.6%) and provisional angioplasty (85.6%). Costs after 1 year were significantly higher for provisional angioplasty (EUR 6573 versus EUR 5885; P:=0.014). Results after the second randomization showed that stenting was also more effective after optimal balloon angioplasty (1-year event free survival, 93.5% versus 84.1%; P:=0. 066).
After 1 year of follow-up, provisional angioplasty was more expensive and without clinical benefit. The beneficial value of stenting is not limited to patients with a suboptimal result after balloon angioplasty.
与球囊血管成形术相比，冠状动脉支架置入术可改善治疗效果，但费用高昂且可能存在其他缺点。将支架使用限于血管成形术效果欠佳的患者（临时血管成形术）可能同样有效且成本更低。
为分析临时血管成形术的成本效益，计划接受单支血管血管成形术的患者首先被随机分为接受直接支架置入术组（97例患者）或接受由多普勒流速和血管造影引导的球囊血管成形术组（523例患者）。后一组患者在优化治疗后进一步随机分为接受额外支架置入术或终止手术组，以进一步研究何为“最佳”治疗效果。最佳治疗效果定义为血流储备>2.5且直径狭窄<36%。随机分配至球囊血管成形术组的129例患者（25%）需要补救性支架置入术，523例患者中有184例（35%）获得了最佳治疗效果。直接支架置入术组（86.6%）和临时血管成形术组（85.6%）1年时的无事件生存率无显著差异。临时血管成形术1年后的费用显著更高（6573欧元对5885欧元；P:=0.014）。第二次随机分组后的结果显示，最佳球囊血管成形术后支架置入术也更有效（1年无事件生存率，93.5%对84.1%；P:=0.066）。
经过1年随访，临时血管成形术费用更高且无临床益处。支架置入术的有益价值并不限于球囊血管成形术效果欠佳的患者。
