意大利米兰San Raffaele医院的Alaide Chieffo在TCT上发表的新研究结果指出无保护左主干病变中长期预后支持DES的PCI优于CABG。
该研究入选了米兰单中心的249例患者,随访至少4年,结果显示住院期间严重心脑血管事件DES组低于CABG组,TCT上公布了4年随访结果。
包括4年再血管化的MACCE 结果最初支持CABG,DES组有更高再血管化的趋势,36%vs28%(adjusted OR=1.44; 95% CI 0.75-2.77),但是差异并无显著性。尽管4年MACCE结果并无统计学显著性差异,但两组脑血管事件、死亡和心肌梗死的联合终点有显著差异,DES 明显优于CABG,14% vs 22% (adjusted OR=0.43; 0.17-0.97).
在该单中心经验中左主干病变DES和CABG组的MACCE并无显著差异,但死亡、心肌梗死和脑血管事件联合终点明显支持DES。
在另外一个独立报告中波兰Upper Silesian医疗中心的Pawel E. Buszman发布了LEMANS注册的结果,这是一个无保护左主干干预注册系统。目前的指南仍强烈支持外科手术,因为多个研究证实左主干支架置入围手术期风险较高。但最近支架工艺和置入技术的进展使得左主干支架置入广泛开展。
LEMANS 注册研究结果显示介入治疗 30天死亡率是1.6%,MACCE 是4.8%,平均四年最长11年随访中死亡率13.9%、MACCE 25.4%,另外17例(6.7%)造影证实再狭窄,肯定支架血栓和可能支架血栓各一例。
DES和裸支架对比的亚组分析支持DES,裸支架MACCE是1934%,DES 5.9%,裸支架死亡率是10.3%,DES是3.6%。
By TCT Daily Staff
Long-term data appear to support the use of PCI instead of CABG in unprotected left main coronary artery lesions.
According to a study presented by Alaide Chieffo, MD, of San Raffaele Hospital, Milan, Italy, follow-up of at least four years in 249 patients at a single center in Milan demonstrated lower rates of in-hospital and major cardiac and cerebrovascular events (see Figure) in patients treated with DES compared with surgical intervention. The study adds updated, four-year data to previously reported results.
Results for MACCE, including repeat revascularization, appeared at first to favor CABG at four years, Chieffo said. There was a trend towards more frequent revascularization among patients treated with DES: 36% of DES patients compared with 28% in the CABG group (adjusted OR=1.44; 95% CI 0.75-2.77). However, the difference was not statistically significant (P=.30).
Although four-year differences results in MACCE were not statistically significant, a clear difference could be seen in the two intervention strategies in terms of combined cerebrovascular events, death, and MI, with results favoring the use of DES and PCI. According to Chieffo, 14% of patients in the PCI group had one of these events compared with 22% in the CABG group (adjusted OR=0.43; 0.17-0.97).
"There was a significant reduction of combined endpoints of MI, death and cerebrovascular events that was in favor of PCI as compared to CABG at four years," Chieffo said.
"At four-year clinical follow-up in this single-center experience, there was still no difference in the occurrence of MACCE between elective PCI with DES implantation and CABG in LMCA lesions," Chieffo said. "There was a significant reduction of combined endpoints of MI, death and cerebrovascular events that was in favor of PCI as compared to CABG at four years."
In a separate presentation, Pawel E. Buszman, MD, of Upper Silesian Medical Center, Poland, presented data from the LEMANS registry, a tracking system for interventions in unprotected left main coronary artery stenosis. Current guidelines strongly recommend surgical revascularization because several studies have associated stent implantation in the left main coronary artery with periprocedural risk, Buszman said.
However, recent advances in both stent technology and implantation techniques have made stenting a more popular choice among interventionalists.
Overall, the LEMANS registry showed a mortality rate of 1.6% at 30 days and a MACCE rate of 4.8%. In long-term follow-up – average four years but as long as 11 years – mortality was 13.9% and MACCE was 25.4%. In addition, there were 17 (6.7%) cases of angiographically confirmed restenosis and one definite and one probable case of "in-stent thrombosis."
Subgroup analysis comparing results of DES vs. bare-metal stents favored DES, Bauszman said. The rate of MACCE with bare-metal stents was 19.4% compared with 5.9% in DES. The rate of death with bare-metal stents was 10.3% compared with 3.6% with DES.
Disclosures
• Dr. Chieffo reports no relevant conflicts of interest.
• Dr. Buszman is chairman of the Executive Board and co-owner of American Heart of Poland, Inc. He owns shares in NAFIS Inc. and Intercard Inc, and is the chairman of the scientific committee and advisory board of Balton Ltd.