Figulla H R, Mudra H, Reifart N, Werner G S
Department of Cardiology, Center for Internal Medicine, Georg-August-University, Goettingen, Germany.
Cathet Cardiovasc Diagn. 1998 Mar;43(3):245-52; discussion 253. doi: 10.1002/(sici)1097-0304(199803)43:3<245::aid-ccd1>3.0.co;2-9.
Coronary stenting is the primary therapeutic option for many coronary lesions, after the risk of subacute stent thrombosis and bleeding complications has been reduced by antithrombotic regimens and improved stent expansion. It would be desirable to shorten the procedure and the duration of ischemia, and to reduce the risk of ischemic complications during balloon inflation by implanting the stent without previous dilatation of the lesion. This is not possible with the presently available stent delivery systems. This new therapeutic concept was tested with a specially designed balloon catheter, on which slotted-tube stents can be fixed between two conical radiopaque markers. Sixty-one patients eligible for angioplasty underwent direct stent implantation without predilatation. Four procedures were performed for acute myocardial infarction, and two as high-risk PTCA. Single slotted-tube stents (Palmaz-Schatz, NIR, or JOStent) of 14-16-mm length were mounted between the conical radiopaque markers of a special balloon which provided a fixation for the crimped stent. The direct implantation was successful in 80% of all patients, while in 10% the stent could be deployed after predilatation of the lesion. In 10% of lesions a stent could not be implanted with this and any other delivery system. When patients with successful direct stenting were compared with those with indirect (after predilatation) or unsuccessful stent deployment, the presence of angiographically visible calcification was higher in the unsuccessful cases (75% vs. 19%; P < 0.01), and the patients were older (72+/-8 vs. 61+/-12 years; P < 0.01). Radiation exposure time was only 8.7+/-5.1 min as compared with 12.6+/-7.6 min in conventional stent procedures with predilatation (P < 0.05). The number of balloons used per lesion was also lower than with conventional stenting. Stent dislocation was observed in 5%, and no embolization occurred. The new therapeutic approach of direct stenting without predilatation proved to be a safe and successful procedure in this initial series of coronary angioplasties. When calcified coronary lesions are avoided, it provides a way to rationalize stent implantation with shorter radiation exposure times, fewer balloons, and the potential advantage of fewer ischemic complications as no balloon predilatation is required.
在通过抗血栓治疗方案降低亚急性支架血栓形成和出血并发症风险以及改善支架扩张后，冠状动脉支架置入术是许多冠状动脉病变的主要治疗选择。通过在不预先扩张病变的情况下植入支架来缩短手术过程和缺血持续时间，并降低球囊扩张期间缺血并发症的风险，将是理想的。但使用目前可用的支架输送系统无法做到这一点。使用一种专门设计的球囊导管对这一新的治疗概念进行了测试，在该球囊导管上，开槽管支架可固定在两个锥形不透射线标记之间。61例适合血管成形术的患者接受了无预扩张的直接支架植入术。其中4例用于急性心肌梗死，2例用于高危经皮冠状动脉腔内血管成形术（PTCA）。将长度为14 - 16毫米的单开槽管支架（Palmaz-Schatz、NIR或JOStent）安装在特殊球囊的锥形不透射线标记之间，该球囊为压缩后的支架提供固定。直接植入在所有患者中的成功率为80%，10%的患者在病变预扩张后成功置入支架。10%的病变无法使用该输送系统及任何其他输送系统植入支架。将直接支架置入成功的患者与间接（预扩张后）或支架置入失败的患者进行比较，造影可见钙化在失败病例中的发生率更高（75%对19%；P < 0.01），且患者年龄更大（72±8岁对61±12岁；P < 0.01）。与有预扩张的传统支架手术的12.6±7.6分钟相比，辐射暴露时间仅为8.7±5.1分钟（P < 0.05）。每个病变使用的球囊数量也低于传统支架置入术。观察到5%的支架移位，未发生栓塞。在这一系列初步的冠状动脉血管成形术中，无预扩张的直接支架置入这一新的治疗方法被证明是一种安全且成功的手术。当避免钙化冠状动脉病变时，它提供了一种使支架植入合理化的方法，具有更短的辐射暴露时间、更少的球囊，以及因无需球囊预扩张而潜在减少缺血并发症的优势。
