Ventricular Tachycardia Ablation versus Escalation of Antiarrhythmic Drugs

P

Patients were eligible for inclusion if they had had
a myocardial infarction, had undergone placement
of an ICD, and had had an episode of ventricular
tachycardia during treatment with amiodarone or
another class I or class III AAD within the previous
6 months.

心筋梗塞後にICD植え込みをされ、VTの既往があり、抗不整脈薬を使用している。

I　アブレーションを行う郡

C　内服治療を強化する郡

O

The primary outcome was a composite of death
occurring at any time after randomization or ventricular
tachycardia storm (three or more documented
episodes of ventricular tachycardia within
24 hours) or appropriate ICD shock after a 30-day
treatment period.

プライマリーアウトカムは上記の複合エンドポイント

We conducted a multicenter, randomized, controlled trial involving patients with ischemic
cardiomyopathy and an ICD who had ventricular tachycardia despite the use of
antiarrhythmic drugs.

マルチセンターのRCTで内的妥当性あり

A blockrandomization design was used with randomly

permuted block sizes of 2 and 4 on the basis of

a computerized random-number generator with
sequentially numbered opaque, sealed envelopes
for each stratum.

ランダム化は行われている。

ブロック法でランダム化

施設ごとに層別化

両群のバックグラウンドは同等

アスピリンやACE-Iなどの薬も両郡で同等

ブラインドは出来ないが解析者は割り付けが分からない。

calculated that enrolling 260 patients would provide
a power of 80% to determine that the absolute
risk of the primary outcome would be 12.25
percentage points lower in the ablation group
than in the escalated-therapy group (reduction in
relative risk, 35%),1,17-19 allowing for a 2% loss to
follow-up and a 2% rate of crossover at a significance
level of 0.05 (two-sided).

260人必要　数は足りている

プライマリーアウトカムはアブレーション郡で少ない傾向

NNT：10

副作用

In the escalatedtherapy
group, treatment-related adverse events
were more frequent (51 vs. 22, P = 0.002) 

副作用は抗不整脈薬強化郡で多い傾向。

手技に伴う副作用はアブレーション郡で当然多いが、薬剤副作用は抗不整脈薬強化郡で多い。

感想

比較的信頼性のあるスタディ

アブレーションでVFが起こらなくなるのなら良さそうに思う。

抗不整脈薬の副作用もバカには出来ないし。