Up to 15-Year Survival of Men and Women after Percutaneous Coronary Intervention Paid by the Brazilian Public Healthcare System in the State of Rio de Janeiro, 1999-2010

Abstract Background: Percutaneous coronary intervention (PCI) is the most frequently used invasive therapy for ischemic heart disease (IHD). Studies able to provide information about PCI's effectiveness should be conducted in a population of real-world patients. Objectives: To assess the survival rate of IHD patients treated with PCI in the state of Rio de Janeiro (RJ). Methods: Administrative (1999-2010) and death (1999-2014) databases of dwellers aged ≥ 20 years old in the state of RJ submitted to one single PCI paid by the Brazilian public healthcare system (SUS) between 1999 and 2010 were linked. Patients were grouped as follows: 20-49 years old, 50-69 years old and ≥ 70 years old, and PCI in primary PCI, with stent and without stent placement (bare metal stent). Survival probabilities in 30 days, one year and 15 years were estimated by using the Kaplan-Meier method. Cox hazards regression models were used to compare risks among sex, age groups and types of PCI. Test results with a p-value < 0.05 were deemed statistically significant. Results: Data of 19,263 patients (61 ± 11 years old, 63.6% men) were analyzed. Survival rates of men vs. women in 30 days, one year and 15 years were: 97.3% (97.0-97.6%) vs. 97.1% (96.6-97.4%), 93.6% (93.2-94.1%) vs. 93.4% (92.8-94.0%), and 55.7% (54.0-57.4%) vs. 58.1% (55.8-60.3%), respectively. The oldest age group was associated with lower survival rates in all periods. PCI with stent placement had higher survival rates than those without stent placement during a two-year follow-up. After that, both procedures had similar survival rates (HR 0.91, 95% CI 0.82-1.00). Conclusions: In a population of real-world patients, women had a higher survival rate than men within 15 years after PCI. Moreover, using a bare-metal stent failed to improve survival rates after a two-year follow-up compared to simple balloon angioplasty.

摘要 背景：经皮冠状动脉介入治疗（Percutaneous Coronary Intervention，PCI）是缺血性心脏病（Ischemic Heart Disease，IHD）最常用的侵入性治疗手段。旨在评估经皮冠状动脉介入治疗有效性的研究，需基于真实世界患者人群开展。
研究目的：评估里约热内卢州（RJ）接受经皮冠状动脉介入治疗的缺血性心脏病患者的生存率。
方法：将1999-2010年间接受巴西公共医疗体系（SUS）单次经皮冠状动脉介入治疗的里约热内卢州20岁及以上居民的行政数据库（1999-2010年）与死亡数据库（1999-2014年）进行关联。按年龄将患者分为三组：20~49岁、50~69岁及≥70岁；按治疗类型分为直接经皮冠状动脉介入治疗、置入支架（裸金属支架）与未置入支架组。采用Kaplan-Meier法（Kaplan-Meier method）估算30天、1年及15年的生存概率；采用Cox风险回归模型（Cox hazards regression models）比较不同性别、年龄组及治疗类型间的风险差异。以p值<0.05为差异具有统计学意义。
结果：共纳入19263例患者进行分析，患者平均年龄为（61±11）岁，男性占比63.6%。男性与女性患者在30天、1年及15年的生存率分别为：97.3%（95%置信区间：97.0%~97.6%） vs 97.1%（95%置信区间：96.6%~97.4%）、93.6%（95%置信区间：93.2%~94.1%） vs 93.4%（95%置信区间：92.8%~94.0%）、55.7%（95%置信区间：54.0%~57.4%） vs 58.1%（95%置信区间：55.8%~60.3%）。高龄组患者在各随访时段的生存率均更低。随访2年内，置入支架的经皮冠状动脉介入治疗患者生存率高于未置入支架者；随访2年后，两种治疗方式的生存率无显著差异（风险比HR=0.91，95%置信区间：0.82~1.00）。
结论：在真实世界患者人群中，接受经皮冠状动脉介入治疗的女性患者术后15年内生存率高于男性。此外，相较于单纯球囊成形术，裸金属支架置入在随访2年后并未改善患者生存率。