[TCT2008]SYNTAX 研究结果

发布于:2008-10-17 10:21

SYNTAX研究结果带给临床医生的启示……

荷兰Serruys 博士说，SYNTAX研究最大的贡献是总结出SYNTAX评分标准，该评分标准将糖尿病对临床结果的影响包含在内。所以，参照这个标准，我们就能分辨出哪类患者适合外科手术，哪类患者适合PCI。

Serruys博士和Mohr博士（SYNTAX试验的主要研究者）共同发表了MACCE SYNTAX评分，分高、中、低3个等级（见图）。

SYNTAX评分低（0~22）者，行PCI还是CABG并无差异，随访12个月时，MACCE率在CABG组（n=274例）是14.4%，而Taxus支架组为13.5%,P=0.71。“对于这类人群，选择哪种治疗方式，取决于患者的临床表现、患者的选择和医生的决策” Serruys说。

评分中等（23~32）者，12个月时MACCE率在CABG组(n=300)为11.7%，Taxus组为16.6%(n=310; P=.10)。“这类患者不良事件率低，即使行PCI，该比例也不会有明显增加。但是对于中等SYNTAX分值者PCI仍然是有效的选择，采用何种治疗方式取决于患者临床特点和是否有其他合并症” Serruys说。

不适合行PCI的人群
SYNTAX评分高（≥33）时，随访12个月，MACCE率在PCI组明显上升。CABG组（n＝316）和PCI组(n=290)分别为10.7% vs. 23.3%, P<0.001。“这类患者血管解剖结构复杂，CABG应该是首选，PCI只能作为补充手段。” Serruys说。

将安全性指标12个月时死亡、心梗、CVA进行综合分析发现，CABG组(n=897)MACCE率为7.7%，Taxus组(n=903)为7.6%，P=0.99，所以，对于左主干病变和多支血管病变的患者CABG仍然是标准治疗方法。

综合行CABG的注册研究和随机组研究，两者在危险因素和合并症方面无明显差异，唯一的差异在于冠脉病变的复杂程度不同，这一点，在SYNTAX评分中早已经体现出来。

Mohr说：“总之，患者死亡和心梗发生率都比较低，2.2%的中风比例仍然需要进一步研究来证实，也许这些可以通过调整手术方式或者是良好的药物治疗来避免。从外科角度来看，这样的结果是非常好的。SYNTAX试验结果告诉我们，仍有55%的患者应首选CABG，余下的45%，应该选择PCI。”

(医心评论：马秀芹译朱婧校）

SYNTAX Trial: What the Results Mean to Clinicians

Key Points:

PCI is still a valid option in patients with intermediate SYNTAX scores, but not patients with high scores.

By TCT Daily Staff

The most important contribution of the SYNTAX trial may be SYNTAX scores, according to Patrick W. Serruys, MD, PhD, head of interventional cardiology at Erasmus Medical Center, Rotterdam, The Netherlands.

"The SYNTAX score has to be combined in an interactive way with diabetes, and then we should be able to see who has to go to surgery and who has to be naturally treated with PCI," he said.

Serruys and Friedrich W. Mohr, MD, PhD, surgical primary investigator of the SYNTAX trial, presented their perspective on the MACCE SYNTAX results for low, intermediate, and high score tertiles (see Figure).

MACCE rate at one year

Findings from the SYNTAX low score tertile (0 to 22) showed that patients had comparable outcomes after revascularization with PCI or CABG. The cumulative MACCE rate by 12 months was 14.4% (n=274) in the CABG group and 13.5% in the Taxus group (n=299; P=.71).

"Treatment will depend on individual patient characteristics, patient preference and physician choice," Serruys said.

MACCE rate by 12 months in the intermediate score tertile (23 to 32) was 11.7% in the CABG group (n=300) and 16.6% in the Taxus group (n=310; P=.10). These adverse events were slightly but not significantly increased in PCI patients, according to Serruys.

"This suggests that PCI still is a valid option in patients with intermediate SYNTAX scores," he said, "and treatment will depend on the patients’ characteristics and comorbidity."

Not suitable for PCI

High SYNTAX scores (≥33) translated to significantly higher MACCE rates at 12 months in the PCI group: 10.7% in the CABG group (n=316) and 23.3% in the Taxus group (n=290; P<.001).

"These patients have very complex anatomy," Serruys said. "This suggests that PCI is most likely not a viable option and these patients should remain surgical candidates."

Combined safety data for death, CVA and MI at 12 months showed an overall MACCE rate of 7.7% in the CABG cohort (n=897) compared with 7.6% in the Taxus cohort (n=903; P=.99). CABG remains the standard of care for left main and triple-vessel disease, according to Serruys.

No major difference in comorbidities and no difference in risk scores were identified in a comparison of CABG results among registry patients vs. randomized cohorts. There were differences in complex coronary disease, which was expressed in the SYNTAX score.

Overall, mortality and MI rates were low. The 2.2% stroke rate requires further investigation and may be addressed by adjustments in surgical technique and better medical therapy, according to Mohr, of Herzzentrum Leipzig in Germany.

"From the surgical standpoint, patients in the randomized and CABG registry represent today’s excellent standard of surgical treatment," he said. "Results of the SYNTAX trial suggest that 55% of all patients are still best treated with CABG; however, for the remaining patients PCI is an excellent alternative to surgery," Serruys said.

Disclosures:

l Dr. Serruys reports no relevant conflicts of interest.

l Dr. Mohr reports no relevant conflicts of interest.

（source：www.tctmd.com）

来源：医心网

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