Bern-Rotterdam队列研究显示,随访5年,确诊的支架内血栓形成带来的总体死亡率方面的影响即药物支架相对于裸支架在5年时相对危险度高2%。
在Bern-Rotterdam研究之后,另一项临床研究BASKET LATE研究显示,3年随访后发现直径<3mm的药物支架比直径>3mm的药物支架表现更好。
Bern-Rotterdam队列研究显示,随访5年,确诊的支架内血栓形成带来的总体死亡率方面的影响即药物支架相对于裸支架在5年时相对危险度高2%。
在Bern-Rotterdam研究之后,另一项临床研究BASKET LATE研究显示,3年随访后发现直径<3mm的药物支架比直径>3mm的药物支架表现更好。
Bern-Rotterdam研究
瑞士的Peter Juni博士称紫杉醇药物洗脱支架和雷帕霉素洗脱支架相比,出现明确的支架内血栓的比例稍高(P=0.21)。
晚期和极晚期明确支架内血栓形成的危险性始终存在(年均为0.4%至0.6%),8146例患者中,702例死亡。共有192例为明确诊断的支架内血栓形成,27例因明确的支架内血栓形成死亡。
Juni根据一项已经发表的荟萃分析(Stettler et al, The Lancet, 2007)获得关于裸支架的相关数据用来评估明确的支架内血栓形成对于总体死亡率的影响到底有多大。这项荟萃分析显示共有687例患者死亡,共有87例为明确的支架内血栓形成,其中15例死亡。
Juni认为药物支架比裸支架在总体死亡率方面的相对危险度高2%主要是因为支架内血栓形成,但是明确的支架内血栓形成对于总体死亡率的影响很低,总体累积发生率为14.2%。
这个研究是在Bern和鹿特丹进行的。由于资源受限等原因,Juni仅报道了Bern中心的5年研究结果,在这个队列研究中,3823例患者接受西罗莫司药物洗脱支架植入,4323例患者接受了紫杉醇药物支架置入。
BASKET LATE
Matthias Pfisterer, MD, of the University Hospital Basel, Switzerland, said that in BASKET LATE at three-year follow-up, cardiac death/MI occurred two to three times more frequently with DES vs. bare-metal stents. These findings back up the 18-month follow-up data, Pfisterer said.
After adjusting for patients who withdrew before follow-up, the patient cohort consisted of 532 DES patients and 275 bare-metal stent patients. At three years, there were significantly more instances of late cardiac death/MI (after six months) with DES compared with bare-metal stents (3.5% vs. 1.5%, P=.009).
A subgroup analysis between patients with large (n=558) and small (n=558) stents (>3 mm vs. <3 mm) showed that, in patients with small stents, there was no difference in survival, but there was a difference in survival free of MI, MACE-free survival, and TVR (see Figure).
Pfisterer reported a persistent benefit with small DES over large DES and with DES over either size of bare-metal stent in high-risk patients in terms of increased rate of late cardiac death/MI (P=.008).
To study cardiac death and MI in patients with large stents (>3 mm), researchers have initiated the BASKET PROVE trial. Enrollment was completed in May.