Beyond restenosis - Five-year clinical outcomes from second-generation coronary stent trials
Beyond restenosis - Five-year clinical outcomes from second-generation coronary stent trials
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DOI：
10.1161/01.cir.0000140721.27004.4b
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发表时间：
2004-09-01
期刊：
影响因子：
37.8
通讯作者：
Ho, KKL
中科院分区：
文献类型：
--
作者：
Cutlip, DE;Chhabra, AG;Ho, KKL
背景 - 在冠状动脉支架植入后的第一年，临床失败主要由手术并发症和再狭窄引起，但随后再狭窄和疾病进展对晚期失败的相对影响尚不明确。 方法和结果 - 作为关键的第二代冠状动脉支架试验的一部分，我们对支架植入后的 1228 名患者进行了为期 5 年的观察。死亡、心肌梗死、重复血运重建以及因急性冠脉综合征或充血性心力衰竭重复住院等临床事件归因于支架置入（目标）病变或其他不同部位（目标或其他冠状血管），并进一步分类为手术性、再狭窄或非再狭窄。第一年，目标病变事件的危险率为 18.3%，与目标病变无关的事件的危险率为 12.4%。第一年后，目标病变事件的平均年危险率为 1.7%，非目标病变事件的年平均危险率为 6.3%。到第五年，20.3% 的患者发生再狭窄事件，37.9% 的患者发生 30 天手术并发症或后来的非再狭窄事件，其中 11.4% 的患者也经历过再狭窄事件，合计累积事件率为 46.4%。糖尿病和多支血管疾病与再狭窄和非再狭窄事件的风险增加独立相关。结论——在低风险临床试验人群中，支架置入后 1 年以上的临床结果是由与支架病变以外的其他节段疾病进展相关的高事件率决定的，而支架病变本身保持相对稳定。
Background-In the first year after coronary stent implantation, clinical failures are driven mainly by procedural complications and restenosis, but the subsequent relative contributions of restenosis and disease progression to late failures are less clear.Methods and Results-We observed 1228 patients for 5 years after the implantation of stents as part of pivotal second-generation coronary stent trials. Clinical events of death, myocardial infarction, repeat revascularization, and repeat hospitalization for acute coronary syndrome or congestive heart failure were attributed to the index stented ( target) lesion or other distinct sites ( either in the target or other coronary vessels) and further classified as procedural, restenosis, or nonrestenosis. During the first year the hazard rate was 18.3% for target-lesion events and 12.4% for events unrelated to the target lesion. After the first year the average annual hazard rate was 1.7% for target-lesion events and 6.3% for nontarget-lesion events. By the fifth year, restenosis events occurred in 20.3% of patients, whereas 30-day procedural complications or later nonrestenosis events occurred in 37.9%, including 11.4% who also experienced a restenosis event, for a combined cumulative event rate of 46.4%. Diabetes mellitus and multivessel disease were independently associated with increased risk for both restenosis and nonrestenosis events.Conclusion-In a low-risk clinical trial population, the clinical outcome beyond 1 year after stenting is determined by a high rate of events related to disease progression in segments other than the stented lesion, which itself remains relatively stable.