[AF-FORUM] 71E 倍他阻滞剂诱发心动过缓. Dr. Perez Riera,

星期六四月 21 09:06:04 ART 2007

来自古巴的 Perdomo 提问:carvedilol(卡维地洛)疗效?

Dr. Perez Riera 解答:关于冠脉血管再造术后的房颤 ACC/ 
AHA 指南推荐使用β阻断剂. Carvedilol 是非选择性的肾 
上腺素受体阻断剂,具有抗氧化,抗炎,多种阳离子通道 
阻断特性. COMPACT 试验(Carvedilol or Metoprolol Post- 
Revascularization Atrial Fibrillation Controlled Trial) 是第一个 
多中心 , 随机 , 对照试验 , 比较了carvedilol(卡维地洛) 
和 Metoprolol(美托洛尔)这两种不同的β阻断剂在冠脉血 
管再造术后房颤的病人的疗效.临床研究提示对于有 
房颤的心衰病人, carvedilol 有更大的益处相对于选择性 
β1 阻断剂 Metoprolol. Carvedilol 的抗炎抗氧化特性有利 
于防止术后房颤.

研究类型:干预研究

研究设计:预防,随机化,开放性, 阳性对照,平行对照, 
疗效,受试对象(650)

主要结局指标:终点是术后第一个七天期间新的房颤 
发作;AF 是发作性心房颤动或房扑持续

大于 30 秒.

次要指标:术后出院前新发AF的发病率、持续时间和复 
发率；术后出院前心外或心内电复律次数；出院时的 
AF节律；　提前中止给定药物治疗；术后院内死亡 
率，术后院内患病率；术后出院前资源消耗。

总期望例数:参加随机分组的受试对象总例数至少650 
例。初始口服剂量：carvedilol 5mg Bid, 或20mg; metoprolol  
T.i.d. 每种beta阻滞剂的剂量将增至最大耐受量。

入选标准：成年男女患者，符合下列条件：

1、年龄20-89岁

2、做过非体外循环冠状动脉旁路移植术

3、签署书面知情同意书

排除标准：凡有下列情形则予以排除。

1、术前术中使用机械循环支持(主动脉气囊泵除外)

2、合并其它手术，如动脉瘤切除术、颈动脉内膜切 
除术

3、除正中胸骨切除以外的手术

4、参加试验前3天内急性心梗

5、有使用beta阻滞剂的禁忌征

6、术前有慢性房颤或房扑

7、有阵发性房颤病史

8、正在使用除beta阻滞剂、钙通道拮抗剂、洋地黄以 
外的其它抗心律失常药物

9、在未用减慢窦性心律治疗的情况下静息心律<50次/分

10、内分泌疾病：如嗜铬细胞瘤、活动期甲亢，未治 
疗的甲低

11、孕妇或未充分避孕的育龄妇女

12.外科手术前需要安装临时或永久起搏器

13.ECG 不能判断的 P 波

14.正在治疗的哮喘或其它慢性阻塞性肺部疾病

15.二度或三度房室阻滞

16.病态窦房结综合征

17.未受控制的心衰

18.未稳定的胰岛素依赖型糖尿病

19.需要类固醇治疗

20. 自身免疫性疾病病史

21.活动性感染性疾病病,包括:心肌炎和心包炎

22.任何其它严重的疾病,存在潜在的复杂的治疗和跟进

我们正在等待结果.或许能给我们新的信息和权威认 
可的主要研究者是来自日本的Dr.Masataka Kamei, Email:  
mkamei在hsp.ncvc.go.jp

参考文献:

1) Kamei M, Morita S, Hayashi Y et al., Carvedilol versus Metoprolol  
for the prevention of atrial fibrillation after off-pump coronary  
bypass surgery: rationale and design of the Carvedilol or Metoprolol  
Post-Revascularization Atrial Fibrillation Controlled Trial  
(COMPACT). Cardiovasc Drugs Ther. 2006; 20: 219-227.

祝好

Andrés Ricardo Pérez Riera MD

Chief of Electro-Vectocardiology Sector of the Discipline of Cardiology,

ABC Faculty of Medicine (FMABC), Foundation of ABC (FUABC) - Santo

André São Paulo - Brazil.

riera在uol.com.br

翻译：庄宁宁

----------------------------------------------------------------------
Re: [AF-FORUM] 71E Beta-blocking induced bradycardia. Dr. Perez Riera

Dear Perdomo from Cuba. Here Andrés Ricardo Pérez Riera from São
Paulo Brazil.

Your question: What about carvedilol?

Answer: The ACC/AHA guidelines for surgical coronary
revascularization recommend beta-blockers for the prevention of AF.
Carvedilol is a non-selective adrenergic blocker with anti-
inflammatory, antioxidant, and multiple cationic channel blocking
properties. The Carvedilol or Metoprolol Post-Revascularization
Atrial Fibrillation Controlled Trial (COMPACT) was the first multi-
center, randomized, controlled trial to compare two different beta-
blockers (carvedilol versus metoprolol) in patients following
surgical coronary revascularization. Clinical studies indicate that,
unlike the beta1-selective agent metoprolol, carvedilol has
incremental benefits for AF management in HF patients. The anti-
inflammatory and antioxidant properties of carvedilol have generated
interest in its use as a prophylaxis for postoperative AF.

Study Type:  Interventional

Study Design:  Prevention, Randomized, Open Label, Active Control,
Parallel Assignment, Efficacy Study  Expected Total Enrollment:  650

Primary Outcomes: The primary endpoint is the incidence of new-onset
AF during the first seven days after surgery; AF is defined as an
episode of AK or flutter lasting for >30 seconds as detected on the
continuous cardiac monitor.

Secondary Outcomes: the incidence, duration, and recurrence of new-
onset AF after surgery and before hospital discharge; the frequency
of external or internal electrical cardioversion after surgery and
before hospital discharge; the incidence of AF rhythm at hospital
discharge; premature discontinuation of assigned drug administration;
in-hospital mortality for any cause after surgery; in-hospital
morbidity after surgery; resource use after surgery until hospital
discharge.

Expected Total Enrollment:  A total of at least 650 patients will be
randomized to receive an initial oral dose of either 5 mg of
carvedilol twice per day or 20 mg of metoprolol tartrate three times
per day following surgery. The dose of each beta-blocker will be
increased to the maximum tolerated dose.

Inclusion criteria: Adult male or female patients are required to
meet the following criteria:

   1.. Aged 20 to 89 years
   2.. Underwent isolated off-pump coronary artery bypass graft surgery
   3.. Written informed consent
Exclusion criteria: Patients with the following conditions will be
excluded from the study:

   1.. Pre- and intraoperative use of mechanical circulatory support
devices, except an intra-aortic balloon pump
   2.. Concomitant operations, such as aneurysmectomy or carotid
endarterectomy
   3.. Surgical approaches other than a median full sternotomy
   4.. Acute myocardial infarction ?3 days before enrollment in the  
trial
   5.. Contraindication against treatment with ? blockers
   6.. Presence of preoperative chronic AF or flutter
   7.. History of paroxysmal AF
   8.. Presence of antidysrhythmic medication other than ? blockers,
calcium channel blockers, or digitalis
   9.. A resting heart rate of less than 50 beats/min in the absence
of medical therapy known to slow the sinus rate
   10.. Endocrine disorders, such as pheochromocytoma, active
hyperthyroidism, and untreated hypothyroidism
   11.. Pregnant women and females with childbearing potential unless
utilizing adequate contraception
   12.. Preoperative need for a temporary or permanent pacemaker
   13.. Non-interpretable electrocardiogram for P wave assessment
   14.. Undergoing treatment for asthma or other chronic obstructive
pulmonary disease
   15.. Second- or third-degree atrioventricular block
   16.. Sick sinus syndrome
   17.. Uncontrolled heart failure
   18.. Unstable insulin-dependent diabetes mellitus
   19.. Steroid therapy requirement
   20.. History of autoimmune diseases
   21.. Active infectious diseases, including myocarditis or  
pericarditis
   22.. Any other serious disease that could potentially complicate
the management and follow-up protocols.
We are waiting the results. Someone who can give us some new
information about this trial? or someone who is authorized.  Perhaps
the main research Dr  Masataka Kamei from Japan.

Email: mkamei在hsp.ncvc.go.jp

Reference

1)        Kamei M, Morita S, Hayashi Y et al., Carvedilol versus
Metoprolol for the prevention of atrial fibrillation after off-pump
coronary bypass surgery: rationale and design of the Carvedilol or
Metoprolol Post-Revascularization Atrial Fibrillation Controlled
Trial (COMPACT). Cardiovasc Drugs Ther. 2006; 20: 219-227.
All the best for all
Andrés Ricardo Pérez Riera MD
Chief of Electro-Vectocardiology Sector of the Discipline of Cardiology,
ABC Faculty of Medicine (FMABC), Foundation of ABC (FUABC) - Santo
André São Paulo - Brazil.
riera在uol.com.br

--
Dr. Sergio Dubner
President of Scientific Committee

Dr. Edgardo Schapachnik
President of Steering Committee