[TCT2008]SYNTAX研究：左主干病变合并多支血管病变PCI与CABG对比

发布于:2008-10-21 16:16

SYNTAX研究亚组分析显示：在治疗无保护左主干病变时，PCI与CABG的安全性和有效性相似，但若患者同时合并三支血管病变，CABG要更胜一筹。

SYNTAX最初结果是在今年ESC2008会议上公布的，其主要研究终点即2个月MACE率显示：在治疗复杂病变时，PCI并不劣于CABG。根据SYNTAX评分，研究者对该试验做了进一步研究。由Patrick W. Serruys向人们详细阐述了亚组即左主干病变情况，患者或只是左主干存在病变或者合并单支、两支或者三支病变，随机分配至SYNTAX试验，CABG组（患者总数的33.7%）897例，分至PCI组(34.6%)903例。

12个月时，两组患者MACCE（含死亡、中风、MI和再次血运重建）率在CABG组和PCI组相似，15.8% vs. 13.7%, P=0.44。单纯孤立性左主干病变以及左主干病变合并单支血管病变、双支病变和三支病变时，CABG与PCI组MACCE率也没有明显差别，分别为8.5% vs. 7.1%; P=1.0，13.2% vs. 7.5%; P=0.27，14.4% vs. 19.8%; P=0.29，15.4% vs. 19.3%; P=0.42。但是，中风的比例在CABG组更高，2.7% vs. 0.3%; P=0.009，且再次血运重建率在PCI组更高，12.0% vs. 6.7%; P=0.02。

根据最新的SYNTAX评分，低分和中分组患者组12个月时MACCE率在PCI组和CABG组相似，高危组患者中，PCI组该比率却明显升高。“正因如此，我们总结出，对左主干病变患者，PCI与CABG在安全性和有效性方面相当，” Serruys总结说，“在SYNTAX评分属低分和高分组中，选择PCI作为血运重建策略也合乎情理。”

在合并3支血管病变时，CABG更优.

来自德国的Friedrich W. Mohr博士汇报了合并三支病变的亚组人群的情况，该类人群在CABG组占66.3%，PCI占65.4%。结果显示，12个月MACCE率PCI组远高于CABG组，19.1% vs. 11.2%; P=0.001，PCI组MI和再次血运重建率也明显高于CABG组，5.2% vs. 2.6%; P=0.04，14.7% vs. 5.4%; P<0.001。

根据SYNTAX评分：处于2个最高三分位点MACCE率在PCI组明显高于CABG组，低分组患者为18.6% vs. 10.05%; P=0.02，高分组患者为21.5% vs. 8.8%; P=0.002。

“对于SYNTAX高分患者而言，采用PCI的结果是导致患者MACCE率大幅度上升，相反，外科手术却表现出色。” Mohr总结说。

（医心评论：马秀芹译　呼唤校）

SYNTAX: Stenting vs. Surgery in Left Main and Triple Vessel Disease

New subgroup analyses from the SYNTAX trial show equivalent safety and efficacy endpoints between PCI with Taxus paclitaxel-eluting stents and CABG for patients with unprotected left main disease, while CABG still shows improved efficacy outcomes in triple-vessel disease.

Initial results from SYNTAX, announced at the European Society of Cardiology Congress 2008, showed that PCI was not noninferior to CABG for the treatment of complex disease, based on the primary endpoint of 2-month major adverse cardiac and cerebrovascular events (MACCE).

Investigators Tuesday released expanded results stratifying patients by the SYNTAX score (see Figure 1), an amalgamation of angiographic and lesion characteristics that allows adjustment for the complexity of potential PCI procedures, incuding such factors as presence or absence of CTO lesions and lesion location in the arterial tree.
Patrick W. Serruys, MD, PhD, of Thoraxcenter, Rotterdam, Netherlands, presented details on the subset of patients with left main disease, either isolated or with single , double , or triple-vessel disease, in the randomized segment of SYNTAX. These patients accounted for 33.7% of the 897 patients assigned to CABG and 34.6% of the 903 assigned to PCI.

At 12 months, overall MACCE rates (composite of death, stroke, MI, and repeat revascularization) were similar for CABG and PCI (15.8% and 13.7%, P=.44). Equivalent MACCE rates also were shown with CABG and PCI in patients with isolated left main disease (8.5% vs. 7.1%; P=1.0) as well as patients with left main disease plus single-vessel disease (13.2% vs. 7.5%; P=.27), double-vessel disease (14.4% vs. 19.8%; P=.29), and triple-vessel disease (15.4% vs. 19.3%; P=.42).

Stroke rates were significantly higher in CABG patients (2.7% vs. 0.3%; P=.009) and, conversely, repeat revascularization was more prevalent in PCI patients (12.0% vs. 6.7%; P=.02).

Using the newly-developed SYNTAX score, patients in the lowest and intermediate tertiles of coronary lesion complexity had equivalent rates of MACCE at 12 months between PCI and CABG (see Figure 2; see Figure 3). Patients in the highest tertile had significantly higher 12-month MACCE rates with PCI (see Figure 4).

"For patients with left main disease, revascularization with PCI has comparable safety and efficacy outcomes to CABG," Serruys concluded. "[PCI] is therefore a reasonable treatment alternative in this patient population, in particular when the SYNTAX score is low or intermediate."

CABG better for complex triple vessel disease
Friedrich W. Mohr, MD, of Herzzentrum Leipzig, Germany, presented data on the subgroup of randomized patients with triple-vessel disease, which accounted for the remaining 66.3% of patients assigned to CABG and 65.4% of those assigned to PCI.

For triple-vessel disease, 12-month MACCE rates were significantly higher in the PCI group than in the CABG group (19.1% vs. 11.2%; P,.001). The PCI group also had higher rates of MI (5.2% vs. 2.6%; P=.04) and repeat revascularization (14.7% vs. 5.4%; P<.001) compared to CABG.

Based on SYNTAX score, the two highest tertiles had significantly increased MACCE after PCI compared with CABG (18.6% vs. 10.05%; P=.02 for intermediate and 21.5% vs. 8.8%; P=.002 for high).

"In patients with higher SYNTAX scores, PCI results in very high MACCE rates," Mohr noted. "However, surgical results are excellent and unaffected."

来源：医心网

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