We analyzed the safety and the efficacy of the treatment with elective percutaneous coronary intervention (PCI) in patients with coronary heart disease complicated with cardiac insufficiency. We enrolled 217 patients diagnosed with chronic ischemic heart disease complicated with cardiac failure. According to the type of treatment they received, patients were divided into 3 groups: i) The conservative treatment group with 60 patients (they received standard medication); ii) the early PCI group with 82 cases (their condition was stabilized, surgical risk was assessed and PCI was taken as early as possible); and iii) the advanced PCI group with 75 cases (ischemic myocardium was corrected and then elective PCI was applied and for aggravated myocardial ischemia cases, PCI was applied after assessing the risk of surgery). Follow-up visits were set for approximately 3 years and clinical outcomes were compared. Our results showed that the survival time in the early PCI group was significantly prolonged and the survival rate was considerably increased during 3 years. Left ventricular ejection fraction in the early PCI group markedly increased and left ventricular end-diastolic diameter and pro-BNP level decreased significantly. The occurrence rates of perioperative complications in the early PCI group and major adverse cardiac events (MACE) during the follow-up period were significantly reduced. Quality of life scores in the early PCI group markedly improved. We concluded that in patients with coronary heart disease complicated with cardiac insufficiency, early PCI treatment was safe and effective.
Chronic ischemic coronary heart disease is the most common underlying cause of acute and chronic cardiac failure (
Further studies are crucial to have a better understanding on whether to emphasize the maximization of drug treatment primarily or employ PCI treatment as early as possible. This, of course, should be under the premise of fully assessing all involved risks. This study summarized the outcome of controlled clinical trials designed by the Second Affiliated Hospital of Xinjiang Medical University in order to provide more rational treatment strategies for patients suffering from coronary heart disease complicated with cardiac insufficiency.
From January 2012 to January 2013, we enrolled 217 patients diagnosed with chronic ischemic coronary heart disease complicated with cardiac insufficiency. According to the type of treatment they received, patients were divided into 3 groups: i) The conservative treatment group with 60 patients (they received ordinary medication); ii) the early PCI group with 82 cases (their condition was stabilized, surgical risk was assessed and PCI was taken as early as possible); and iii) the advanced PCI group with 75 cases (ischemic myocardium was corrected and then elective PCI was applied and for aggravated myocardial ischemia cases, PCI was operated after assessing the risk of surgery). We obtained permission from the Ethics Committee of the Second Affiliated Hospital of Xinjiang Medical University hospital and informed consent of patients or their families.
Exclusion criteria were: i) Patients with heart failure caused by valvular heart diseases; ii) those with primary cardiomyopathy and congenital heart disease; iii) patients with acute coronary syndrome complicated with heart failure; iv) cases with clear right heart failure; v) those with severe hypertension and diabetes with out-of-control standards; vi) those with complicated cerebral vascular diseases; vii) patients with severe liver and kidney dysfunction; viii) patients with coagulation disorders and severe angina diagnosed by emergency treatment of PCI or CABG; ix) patients with severe heart failure with poor prognosis; x) cases with allergic to contrast medium; xi) those who cannot be prescribed medication; and xii) patients with poor compliance and those with inadequate follow-up data. Comparison of baseline data among the three groups revealed no statistically significant differences (P>0.05) (
All the patients were given intensive drug treatment including anti-myocardial ischemia, antiplatelet, anticoagulant, lipid-lowering therapy, anti-inflammatory, antihypertensive treatment, blood glucose control medication, anti-ventricular remodeling, positive inotropic drugs and vasoactive drugs. We also used diet management (controlling sodium and water intake) and reasonable exercise. Additionally, cardiac assistance devices such as intra-aortic balloon counterpulsation for patients with unstable condition were employed. Use of assisted ventilation was considered for patients with respiratory difficulties, and bedside hemofiltration surgery was considered to treat patients with acute renal failure. Patients in the conservative treatment group were intensively monitored for changes in condition and this was done only under the basis of strict medical treatment. Emergency PCI or CABG surgery was implemented in the context of a full assessment for intervention and risks of surgical operation.
Patients in the early PCI group were assessed by PCI, using the GRACE scoring system (
Patients participated in follow-up examinations for 3 years on average. We compared the survival rate, left ventricular ejection fraction (LVEF), left ventricular end-diastolic diameter (LVEDD) and pro-BNP level. We also compared perioperative complications and the occurrence rate of major adverse cardiac events (MACE) during the follow-up period. Differences in life quality score were also compared. Pro-BNP was tested using ELISA [kits were provided by Shanghai Hufeng Biotechnology Co., Ltd. (Shanghai, China)]. Seattle Angina Questionnaire (SAQ) was used as a reference to test the life quality score which included five major items and 19 entries, the higher the score, the better the quality of life.
SPSS 20.0 (IBM SPSS, Armonk, NY, USA) was used for data analysis. Quantitative data were reported as mean ± standard deviation and comparisons among many groups were made using single-factor ANOVA. Comparisons between groups were conducted using the independent sample t-test and qualitative data were expressed as number of cases or a percentage. Comparisons among groups were made using χ2 test and the survival period was calculated using the Kaplan-Meier (KM) method (log-rank test). P<0.05 was considered to indicate a statistically significant difference.
The median survival time in the early PCI group, the advanced PCI group and the conservative treatment group was 38, 36 and 33 months, respectively. Median survival time was significantly longer in the early PCI group (χ2=171.610, P<0.001) (
LVEF in patients in all three groups was improved after treatment, while LVEDD and pro-BNP levels both decreased. The early PCI group had improved more significantly and all differences were statistically significant (P<0.05) (
There were 15 cases of emergency PCI and 7 cases of CABG in the conservative treatment group. In the advanced PCI group, we had 56 cases of normal elective PCI, 13 cases of emergency treatment in PCI and 6 cases of CABG. In the conservative treatment group we had several perioperative complications with the occurrence rate of 22. Perioperative complications and MACE occurrence rate during the follow-up period were significantly reduced in the conservative treatment group and the difference had statistical significance (P<0.05) (
The average life quality score for the conservative treatment group, the early PCI group and the advanced PCI group was 68.7±9.2, 82.5±10.3 and 75.4±13.6, respectively. Life quality score in the early PCI group improved significantly and the difference had statistical significance (F=10.325, P=0.007).
It has been shown that revascularization may bring benefit to cardiac patients (
In summary, results have shown that the early PCI group survival time was prolonged significantly and the 3-year survival rate was increased as well. Mortality rate increased in the conservative group. During the treatment and follow-up period, the rate of emergency intervention or operative treatment reached 36.7%, which probably was the main reason for the perioperative complication rate increase. Perioperative complications and the follow-up MACE rate in the early PCI group were reduced significantly. Worsening heart condition, heart failure and operation failure were the main perioperative complications observed during the study. This finding suggested the probability of an increased risk in patients who had emergency intervention or operation for their cardiac insufficiency. LVEF of the early PCI group increased significantly, while the LVEDD and pro-BNP level clearly decreased. This result suggested that PCI should conduct reversible ventricular remodeling and improve heart function as early as possible. Moreover, the life quality score in the early PCI group was improved significantly, which greatly improved the long-term life quality of heart failure patients. We concluded that the early PCI treatment in coronary artery disease patients with heart dysfunction is safe and effective.
Kaplan-Meier analysis of survival time.
Comparison of baseline data among 3 groups.
Groups | Case no. | Male/female | Average age (years) | Duration of ischemia (years) | Acute heart failure, case (%) | Classification (Killip) | Chronic heart failure, case (%) | Classification (NYHA) |
---|---|---|---|---|---|---|---|---|
Conservative treatment | 60 | 36/24 | 65.4±12.6 | 4.2±1.3 | 12 (20.0) | 1.6±0.5 | 48 (80.0) | 2.2±0.6 |
Early PCI | 82 | 46/36 | 64.8±13.5 | 4.4±1.5 | 18 (22.0) | 1.7±0.6 | 64 (78.0) | 2.3±0.8 |
Advanced PCI | 75 | 39/36 | 65.3±14.2 | 4.3±1.6 | 15 (20.0) | 1.6±0.4 | 60 (80.0) | 2.2±0.7 |
F-value (χ2) | 0.871 | 0.632 | 0.329 | 0.118 | 0.847 | 0.118 | 0.947 | |
P-value | 0.647 | 0.525 | 0.217 | 0.943 | 0.636 | 0.943 | 0.828 |
PCI, percutaneous coronary intervention; NYHA, The New York Heart Association.
Comparison among LVEF, LVEDD and pro-BNP levels.
Groups | LVEF (%) | LVEDD (mm) | pro-BNP (pg/ml) | |||
---|---|---|---|---|---|---|
Before treatment | After treatment | Before treatment | After treatment | Before treatment | After treatment | |
Conservative treatment | 38.6±5.2 | 43.4±3.4 | 58.2±2.4 | 56.7±2.4 | 1256.4±42.6 | 864.5±32.9 |
Early PCI | 37.7±5.5 | 55.2±3.3 | 58.6±2.5 | 53.2±2.5 | 1320.6±46.5 | 524.6±34.2 |
Advanced PCI | 38.2±5.3 | 48.5±3.5 | 58.5±2.3 | 55.8±2.6 | 1274.5±48.2 | 720.3±35.7 |
F-value | 0.626 | 7.624 | 0.963 | 6.549 | 0.526 | 6.754 |
P-value | 0.532 | <0.001 | 0.754 | <0.001 | 0.423 | <0.001 |
LVEF, left ventricular ejection fraction; LVEDD, left ventricular end-diastolic diameter; PCI, percutaneous coronary intervention.
Comparison of occurrence rate of perioperative complications and MACE, proportion (%).
Groups | Exacerbation of heart failure | Acute renal failure and respiratory failure | Death | Severe hemorrhage | Surgical failure | Perioperative complications | Exacerbation of heart failure | Recurrence of angina pectoris | Target vessel revascularization | MACE occurrence rate |
---|---|---|---|---|---|---|---|---|---|---|
Conservative treatment | 5 | 2 | 3 | 2 | 6 | 18 (81.8) | 10 | 13 | 10 | 33 (55.0) |
Early PCI | 4 | 2 | 2 | 2 | 2 | 12 (14.6) | 8 | 5 | 6 | 19 (23.2) |
Advanced | 9 | 4 | 3 | 3 | 4 | 23 (30.7) | 10 | 10 | 10 | 30 (40.0) |
PCI | ||||||||||
χ2 | 37.635 | 15.170 | ||||||||
P-value | <0.001 | 0.001 |
MACE, major adverse cardiac events; PCI, percutaneous coronary intervention.