Swedish Registry: No Increased Mortality With Drug-eluting Stents

　　瑞典SCAAR研究对34,530例PCI患者随访1至4年，结果显示：与置入金属裸支架（BMS）组相比，置入药物洗脱支架（DES）组心肌梗死发生率和死亡率均无显著差异。瑞典Stefan James教授指出，无论置入BMS还是DES，非适应证PCI组不良事件发生率较适应证范围内行PCI组显著增高。

　　对于BMS和Cypher支架，长度<33mm、直径2.5～3.5mm的原位血管病变属适应证。对于Taxus支架，长度<32mm、直径2.5～3.75mm病变属适应证范围。

　　结果显示：置入支架6个月内，无论适应证还是非适应证，置入DES组心肌梗死发生率较BMS组显著降低。置入支架6个月后，DES组与BMS组心肌梗死发生率无显著差异。

　　适应证范围内置入支架，与BMS组相比，DES组再狭窄率相对减少60%，绝对减少4%；非适应证范围内，与BMS组相比，DES组再狭窄率相对减少40%，绝对减少2.5%。

　　Stefan James教授指出，对于ST段抬高型心肌梗死患者，置入支架6个月内，DES组心血管不良事件较BMS组明显降低；但6个月后，DES组死亡和心梗发生率增加，优势丧失。

　　（哈尔滨医科大学附属第一医院　李悦　耿建强　编译　李为民　审校）

Swedish Registry: No Increased Mortality With Drug-eluting Stents

Reductions in restenosis rates with DES were better than expected in the SCAAR Registry.

Updated data from the Swedish Coronary Angiography and Angioplasty Registry, with 1- to 4-year follow-up on 34,530 patients, indicate no significant difference in death or MI between DES and bare-metal stents.

In addition, the adverse-event rate with either DES or bare-metal stents was higher for off-label use
compared with on-label use, said Stefan James, MD, of the Uppsala Clinical Research Center in Sweden
(Figure).

Reduced MI risk

In the first 6 months after stent implantation, there was a reduced relative risk of MI associated with
both off-label use of DES compared with bare-metal stents (RR = 0.72; 0.57-0.92) and with on-label use of DES (RR = 0.75; 0.57-0.98). There was no significant difference in adjusted rates of MI between the 2 types of stents after 6 months.

On-label use of DES was associated with a 60% relative reduction and a 4% absolute reduction in the risk of restenosis compared with bare-metal stent use; for off-label use of DES, these reductions in risk were 40% and 2.5%, respectively.

On-label use was defined as use within de novo lesions , 33 mm in length and between 2.5 mm and 3.5
mm in diameter for bare-metal stents and for the Cypher stent (Cordis, Johnson & Johnson); for the Taxus stent (Boston Scientific), on-label use was within a lesion , 32 mm in length and between 2.5 mm and 3.75 mm in diameter.

For this analysis, no more than 2 stents could be used in the same vessel. Patients had to be non-STEMI
and without a chronic total occlusion, graft lesions, or cardiogenic shock.

When death or MI rates were broken down by stable and unstable CAD vs. STEMI, there were no significant differences between on- or off-label use of DES vs. bare-metal stents.

“With STEMI there was a significant reduction in events with DES vs. BMS for the initial six months, which was compensated by a significantly increased risk of death and MI in the period of time after 6 months with DES,” James said.

No increased risk

Overall, the registry data indicate that off-label use of DES vs. baremetal stents is not associated with an
increased risk of adverse events, James said. Use of DES resulted in a lower reduction of clinically meaningful restenosis than had been expected.

Off-label use of DES compared with bare-metal stents still needs further evaluation in prospective randomized trials for various indications, James said.

The SCAAR Registry has records of all procedures performed in Sweden from 1989 through the present day. The registry lists over 13,000 patients who have undergone implantation with at least 1 DES, and over 20,000 patients with 1 or more bare-metal stents implanted between 2003 and 2005. During the study period, there have been 3,850 MIs and 2,631 deaths.