Kuck Karl-Heinz, Tilz Roland Richard, Deneke Thomas, Hoffmann Boris A, Ventura Rodolfo, Hansen Peter Steen, Zarse Markus, Hohnloser Stefan H, Kautzner Josef, Willems Stephan
From the Department of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany (K.-H.K., R.R.T.); University Heart Center, University Hospital Bergmannsheil, Bochum, Germany (T.D.); University Heart Center, Department of Cardiology - Electrophysiology, Hamburg, Germany (B.A.H., R.V., S.W.); Department of Cardiology, Aarhus University Hospital, Denmark (P.S.H.); University of Witten-Herdecke, Germany (M.Z.); University Hospital Frankfurt, Germany (S.H.H.); and Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.).
Circ Arrhythm Electrophysiol. 2017 Mar;10(3). doi: 10.1161/CIRCEP.116.004422.
The implantable cardioverter-defibrillator (ICD) is the standard therapy to prevent sudden cardiac death in patients with coronary artery disease and unstable ventricular tachyarrhythmias. The prospective multinational SMS (Substrate Modification Study) was designed to assess whether prophylactic ablation of the arrhythmogenic substrate reduces or prevents the recurrence of ventricular tachycardia/ventricular fibrillation in such patients.
Of 111 patients included in an intention-to-treat analysis, 54 were randomly assigned catheter ablation plus ICD implantation (ablation group: 68±8 years; 47 men), whereas 57 were assigned ICD implantation without catheter ablation (ICD-only group: 66±8 years; 46 men). Primary study end point was the time to first recurrence of ventricular tachycardia/ventricular fibrillation. ICD episodes were assessed and verified by an independent board. Patients were followed up for 2.3±1.1 years. The primary end point was reached by 25 ablation patients and 26 ICD-only patients. Two-year event-free survival was estimated at 49.0% (95% confidence interval, 33.3%-62.9%) in the former and 52.4% (36.7%-65.9%) in the latter groups. Comparison of episode incidence revealed no significant difference in the primary end point (=0.84). In an Andersen-Gill regression model with multiple end point recurrences, the difference between the study arms significantly favored catheter ablation for both the primary end point and all but one of the predefined subgroups of detected arrhythmia events.
SMS failed to meet the primary end point of time to first ventricular tachycardia/ventricular fibrillation recurrence. However, catheter ablation did reduce the total number of ICD interventions during the duration of follow-up.
https://clinicaltrials.gov. Unique identifier: NCT00170287.
植入式心脏复律除颤器（ICD）是预防冠心病合并不稳定室性心律失常患者心源性猝死的标准治疗方法。前瞻性跨国SMS（基质改良研究）旨在评估对致心律失常基质进行预防性消融是否能减少或预防此类患者室性心动过速/心室颤动的复发。
在意向性分析纳入的111例患者中，54例被随机分配接受导管消融加ICD植入（消融组：68±8岁；47例男性），而57例被分配接受ICD植入但不进行导管消融（单纯ICD组：66±8岁；46例男性）。主要研究终点是首次出现室性心动过速/心室颤动的时间。ICD事件由独立委员会进行评估和核实。患者随访2.3±1.1年。25例消融患者和26例单纯ICD患者达到主要终点。前一组的两年无事件生存率估计为49.0%（95%置信区间，33.3%-62.9%），后一组为52.4%（36.7%-65.9%）。发作发生率比较显示主要终点无显著差异（P=0.84）。在具有多个终点复发的Andersen-Gill回归模型中，对于主要终点以及除一个预定义的已检测心律失常事件亚组外的所有亚组，研究组之间的差异显著有利于导管消融。
SMS未达到首次室性心动过速/心室颤动复发时间的主要终点。然而，导管消融确实减少了随访期间ICD干预的总数。
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