[TCT2008]左主干病变中PCI vs. CABG 的注册研究

发布于:2008-10-16 19:17

韩玮，医学博士，心内科主治医师，发表论文10余篇，主要从事心血管疾病介入治疗

Hanwei, attending physician in Cardiology department of the General Hospital of Chinese Armed Police Forces, doctor degree in PLA General Hospital. Be proficiency in transradial coronary artery disease interventional therapy, IVUS and Multi-slice computed tomography coronary artery imagination, published 14 articles and 3 books recent years.

左主干病变中PCI vs. CABG 的注册研究

Registries Examine PCI vs. CABG in Left Main Disease Treatment

（北京武警总医院韩玮翻译）

TCT 公布的一个注册研究为真实世界中PCI 和CABG 治疗左主干的对比提供了新资料。

DELFT ：DES成功的预测因素

意大利Ferrara 大学的Marco Valgimigli发布了DELFT 注册研究结果，该研究2002年4月至2004年4 月间入选358例无保护左主干患者，使用雷帕霉素或紫杉醇药物洗脱支架治疗。

结果显示EuroSCORE >6和小于6组相比的死亡率显著增加(HR=1.25; 95% CI, 1.16-34; P<.0001)，主要心脏不良事件也显著增加(MACE; HR=1.12; 95% CI, 1.06-19; P<.0001)，分叉支架和单支架相比的MACE 和TVR 都显著增加。Valgimigli说“外科危险、复杂的LM远端病变、需要或不需分叉支架技术以及胰岛素依赖的糖尿病是长期预后的主要危险因素，这将有助于在临床实践或未来临床研究中的选择最佳的再血管化策略。”

另一外的注册研究

意大利米兰Raffaele 研究所的Alaide Chieffo教授发布了左主干开口注册研究结果，该注册研究证实224例无保护、非分叉的开口和或干部的左主干病变6个月再狭窄率是3%。

该注册证实“该手术是安全有效的”，平均873±279的随访中死亡率是4.4%，MACE 发生率11.6%。

波兰Upper Silesian心脏中心的Pawel E. Buszman教授发布了LE MANS ACS 注册研究结果，该研究入选138例无保护左主干和非ST 段抬高急性冠脉综合征患者，分为PCI (n=63) 或CABG (n=75)组，30天时PCI 组死亡率显著低于CABG (1.6% vs. 12%; P=.043)，但一年时仅有降低死亡率的趋势(6.3% vs. 16%; P=NS)。同样PCI 组30天心脑血管不良事件（MACCE）发生率显著低于CABG (3.2% vs. 14.7%; P=.04)，但一年的MACCE 发生率相似(9.5% vs. 9.3%; P=NS)。

未来研究展望

Buszman也发布了POLEMICA 的初步结果，这是波兰43个中心超过1600例患者左主干治疗的注册研究，计划到2009年12月入选3000例患者。韩国汉城Asan医疗中心的Myeong Ki Hong教授发布了PRE-COMBAT研究，该研究比较无保护左主干中雷帕霉素药物洗脱支架和CABG ，该研究已经入选1189例患者，包括注册研究和随机研究两部分，最终结果将在TCT 2010上公布。

（来源：www.tctmd.com）

Registries Examine PCI vs. CABG in Left Main Disease Treatment

Key Points:

Data from DELFT, Ostial LM Multicenter, LE MANS ACS, POLEMICA, PRE-COMBAT registries presented.

By TCT Daily Staff

Data presented on Monday from several registries provided more details about real-world experience with PCI and CABG for left main disease.

DELFT: Predictors of DES success

Marco Valgimigli, MD, PhD, of the University of Ferrara, Italy, presented results from the DELFT registry on 358 patients with unprotected left main (LM) disease who were treated with either sirolimus-eluting or paclitaxel-eluting stents (SES and PES) between April 2002 and April 2004.

The DELFT data indicated that a EuroSCORE >6 vs. <6 significantly increased mortality (HR=1.25; 95% CI, 1.16-34; P<.0001) and major adverse cardiac events (MACE; HR=1.12; 95% CI, 1.06-19; P<.0001). Bifurcation vs. single stenting, meanwhile, significantly increased MACE (see Figure 1) and TVR (see Figure 2).

"Surgical risk status, complexity of distal LM lesion, requiring or not requiring bifurcation stenting, and insulin-dependent diabetes mellitus are major risk factors for long-term outcomes," Valgimigli said. "This may help tailor the best revascularization option both in our practice and in future clinical studies."

Additional LM registries

Alaide Chieffo, MD, of San Raffaele Scientific Institute, Milan, Italy, presented data from the Ostial Left Main Multicenter registry. That registry identified a six-month restenosis rate of 3% in 224 patients treated with DES for unprotected, non-bifurcation LM disease in the ostium and/or midshaft.

The registry confirmed that the procedure is "safe and effective," with a death rate of 4.4% and MACE rate of 11.6% at 873±279 days of follow-up, Chieffo said.

Pawel E. Buszman, MD, of Upper Silesian Heart Center, Katowice, Poland, presented data from the LE MANS ACS registry. The registry included 138 patients with unprotected LM disease and non-ST segment elevation (NSTE) acute coronary syndrome who received either PCI (n=63) or CABG (n=75). At 30 days, PCI offered a significant mortality advantage over CABG (1.6% vs. 12%; P=.043), but by one year only a trend was apparent (6.3% vs. 16%; P=NS).

Similarly, 30-day major adverse cardiac and cerebrovascular event (MACCE) rates were significantly lower with PCI vs. CABG (3.2% vs. 14.7%; P=.04) but one-year MACCE rates were equivalent (9.5% vs. 9.3%; P=NS).

Preview of future findings

Buszman also presented preliminary results from POLEMICA, a Polish registry of LM prevalence and treatment patterns with over 1,600 patients treated at 43 centers. The registry aims to include an additional 3,000 patients by December 2009.

Myeong-Ki Hong, MD, PhD, of Asan Medical Center, Seoul, South Korea, gave an update on PRE-COMBAT, a prospective trial comparing sirolimus-eluting stent implantation with CABG in patients with unprotected LM disease. The study, which has enrolled 1,189 patients, includes both randomized and registry cohorts. Hong predicted that the final report on PRE-COMBAT will be announced at TCT 2010.

Disclosures:

Dr. Buszman reports being co-owner of the American Heart of Poland Inc., is chairman of its executive board, a shareholder of NAFIS Inc. and Intercard Inc, and chairman of the scientific committee and advisory board for Balton Ltd.
Drs. Valgimigli, Chieffo, and Hong report no relevant conflicts of interest.

（source：www.tctmd.com）

来源：医心网

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