DES植入患者的死亡、心肌梗死和再次血运重建的发生率明显低于BMS植入患者

      最近的一项研究显示，现实世界中植入药物洗脱支架（DES）患者的死亡、心肌梗死和再次血运重建的发生率明显低于金属裸支架（BMS）。这项题为“药物洗脱支架和金属裸支架晚期心肌梗死和死亡发生率的比较”的研究结果发表在2007年2月1日出版的美国心脏病杂志（the American Journal of Cardiology）上。

      这项在Winston-Salem, N.C的Wake Forest大学医学院进行的观察性研究比较了2359例接受BMS（n=1,126）或DES（n=1,233）植入的非选择性患者的临床结果。支架植入后9个月，DES组的急性心肌梗死（AMI）和死亡发生率较BMS组分别下降了23%和32%（危险比分别为0.77和0.68）。DES组和BMS组的AMI发生率分别为3.7%和4.7%，死亡发生率分别为4.9%和7.1%（p=0.03）。而DES组的再血管化，即再次血运重建发生率比BMS组发生率的一半还要低（6%比13.3%，p<0.001）。另外，两组的支架血栓发生率虽然都很低，但DES组（0.4%）较BMS组（0.7%）有降低的趋势。

      在各亚组分析中，DES都具有更低的死亡发生率，包括合并糖尿病等其他疾患的患者亚组、复杂病变亚组等。实际上，DES的益处在高危患者中体现得更加明显，譬如罹患近期MI的患者、植入多个支架的患者等。

      “这项研究十分值得关注，因为它显示了药物洗脱支架的死亡、心肌梗死以及再次血运重建发生率都要明显低于金属裸支架”，波士顿科学的首席执行官 Paul LaViolette先生说，“这一发现与TAXUS系列临床研究的结果相一致，进一步提示药物洗脱支架的益处可以扩展至所有现实世界的患者。”

      2006年12月提交给FDA针对DES所举行的听证会的数据显示， 4项随机对照临床研究中2797例患者随访4年，TAXUS支架的死亡和MI发生率与BMS相当或者更低，而再次血运重建发生率则降低了接近50%。而现实世界的ARRIVE登记研究结果显示，7000例病变更为复杂患者的死亡率与病变相对简单的随机对照患者相比仅有微小的增加。如今，Wake Forest的研究结果提示现实世界中的复杂病变植入DES后的死亡和MI发生率都要低于BMS，这进一步验证了ARRIVE研究的结果，也与此前一些将DES与相对简单病变的BMS植入相比较而提示DES死亡率略有增加的非随机历史性对照研究结果形成了对照。

附原文：

STUDY FAVORS DRUG-ELUTING STENTS OVER BARE-METAL STENTS IN KEY PATIENT OUTCOMES

DES patients have significantly lower rates of death, heart attack and re-intervention than BMS patients

A study shows that drug-eluting stents (DES) have substantially lower rates of death, heart attack and re-intervention in real-world patients compared to bare-metal stents (BMS).  The results of the study, "Comparison of Drug-Eluting Versus Bare-Metal Stents on Later Frequency of Acute Myocardial Infarction and Death" were published in the February 1 issue of the American Journal of Cardiology.

The observational study, which was conducted by the cardiology section of the Wake Forest University School of Medicine in Winston-Salem, N.C., compared clinical outcomes among 2,359 unselected patients receiving either BMS (n=1,126) or DES (n=1,233).  At nine months, DES reduced the risk of acute myocardial infarction (AMI) and death by 23 percent and 32 percent, respectively (based on hazard ratios of 0.77 and 0.68).  The rate of AMI, commonly referred to as a heart attack, was 3.7 percent in DES patients versus 4.7 percent in BMS patients, while the rate of death was 4.9 percent versus 7.1 percent, respectively (p=0.03).  Furthermore, the rate of revascularization, or re-intervention, in DES was less than half that in BMS patients after nine months (6 percent versus 13.3 percent, p<0.001).   Finally, there was a trend toward less stent thrombosis (clotting) in DES patients compared to BMS patients, though the rates were low in both groups (0.4 percent and 0.7 percent, respectively).

In an analysis of various patient subgroups, the use of DES was associated with lower risk of death across all populations, including those suffering from additional diseases such as diabetes, and those with complex lesions.  In fact, the benefit of DES was most pronounced in higher-risk patients, such as those who experienced recent MI and those who received multiple stents.
 
"This study is worthy of note because it shows a significant advantage for drug-eluting stents over bare-metal stents with lower rates of death and heart attack as well as lower rates of re-intervention,"said Paul LaViolette, Chief Operating Officer of Boston Scientific.  "These findings are consistent with results shown in the TAXUS clinical program and suggest further that the benefit of drug-eluting stents may be even greater in real-world patients."

Data presented at a special panel on DES convened by the U.S. Food and Drug Administration (FDA) in December 2006 showed equivalent or lower rates of death and MI, and a nearly 50 percent reduction in the need for repeat procedures, for the TAXUS Stent versus BMS in 2,797 patients followed out to four years in four randomized clinical trials.  Data on more than 7,000 patients with more complex lesions from the real-world ARRIVE registries predictably showed a slightly higher rate of death than in the simpler randomized patients.  The Wake Forest results, suggesting lower death and MI with DES versus BMS in real-world complex lesions, further support the ARRIVE registry data and help counterbalance some earlier non-randomized comparisons that suggested slightly higher mortality with DES compared to historical BMS data in somewhat simpler lesions.