Effectiveness and safety of Xuefu Zhuyu decoction for treating coronary heart disease angina: A systematic review and meta-analysis.

BACKGROUND: Coronary heart disease angina is a very common cardiovascular disease, which not only causes personal health problems, but also a serious burden on the social economy. Xuefu Zhuyu Decoction (XFZYD) has been widely adapted to clinical practice for people with coronary heart disease angina. At present, it is necessary to update the existing research, re-evaluate the effectiveness and safety of XFZYD, and provide the latest evidence for coronary heart disease angina. METHODS AND ANALYSIS: The purpose of this study was to search the electronic database for XFZYD in the treatment of coronary heart disease angina. The database includes PubMed, EMBASE, Cochrane Library, Chinese National Knowledge Infrastructure database (CNKI), Wanfang database, Chinese Biomedical Literature database (CBM), Chinese Scientific Journal database (VIP). In addition, ongoing trials will be retrieved from the WHO ICTRP Search Portal, the Chinese Clinical Trial Register and The Clinical Trials Register. We will assess all the documents from the database establishment to January 31, 2019. The RevMan V.5.3 software will be used to calculate the data synthesis and perform a meta-analysis when the literature is appropriate. RESULTS: The study will provide a high-quality synthesis of current evidence of XFZYD for coronary heart disease angina from the various comprehensive assessment, including Significantly effective, Effective, Invalid, Aggravation, which based on the "Guidelines for Clinical Research of New Chinese Medicine". Adverse events are also included. CONCLUSION: The systematic review will provide evidence for assessing the effectiveness and safety of XFZYD in the treatment of coronary heart disease angina. PROSPERO REGISTRATION NUMBER: PROSPERO CRD42019122003.

[Spinal cord stimulation for refractory chronic angina pectoris: 100 patients treated in our 12-year experience]. / La stimolazione spinale nell'angina pectoris cronica refrattaria: 100 soggetti trattati in 12 anni di esperienza.

BACKGROUND: The aim of this study was to evaluate the quality of life (QoL) benefit of patients with chronic refractory angina treated with spinal cord stimulation (SCS) in our experience. METHODS: Between February 1998 and August 2010, 100 patients with chronic refractory angina who could not benefit from myocardial revascularization underwent SCS at the San Raffaele Scientific Institute of Milan (Italy). All patients were prospectively followed up at our outpatient clinic. The Spitzer index was used to evaluate QoL of patients before the procedure and at follow-up. RESULTS: Mean age was 66 ± 8 years (range 46-79). Ninety-four patients (94%) were in CCS class III-IV (mean CCS class 3.5 ± 0.1) and 62 patients (62%) were in NYHA class III-IV (mean NYHA class 2.6 ± 0.1). The preoperative Spitzer index was 4.4 ± 1.4. Mean angina episodes per week were 12.6 ± 9.3 and mean consumption of sublingual nitrates was 11.0 ± 9.4. At follow-up, overall mortality was 11% (n = 11), and cardiovascular death was 3%. A reduction in angina episodes per week >50% was observed in 88% of patients (from 12.6 ± 9.3 to 2.7 ± 1.13; p<0.0001). Mean consumption of sublingual nitrates decreased from 11.0 ± 9.4 to 2.3 ± 0.1 (p<0.0001). The Spitzer index significantly improved (from 4.4 ± 0.1 to 2.3 ± 0.1; p<0.0001). NYHA class and CCS class decreased from 2.6 ± 0.1 to 2.0 ± 0.1 and from 3.5 ± 0.1 to 1.7 ± 0.1, respectively (both p<0.0001). CONCLUSIONS: SCS is an effective and safe therapeutic option for patients with chronic refractory angina and it is associated with improved functional status and QoL at follow-up.

Long-term effects of spinal cord stimulation on angina symptoms and quality of life in patients with refractory angina pectoris--results from the European Angina Registry Link Study (EARL).

OBJECTIVE: To assess the long-term effect of spinal cord stimulation (SCS) on angina symptoms and quality of life in patients with refractory angina pectoris defined as severe angina due to coronary artery disease resistant to conventional pharmacological therapy and/or revascularisation. METHODS: During 2003-2005, all patients with refractory angina referred for SCS treatment at 10 European centres were consecutively included in the European registry for refractory angina (European Angina Registry Link, EARL), a prospective, 3-year follow-up study. In the present study, the SCS-treated patients were followed-up regarding angina symptoms and quality of life assessed was with a generic (Short Form 36, SF-36) and a disease-specific (Seattle Angina Questionnaire, SAQ) quality of life questionnaire. RESULTS: In total, 235 patients were included in the study. After screening, 121 patients were implanted and followed up 12.1 months after implantation. The implanted patients reported fewer angina attacks (p<0.0001), reduced short-acting nitrate consumption (p<0.0001) and improved Canadian Cardiovascular Society class (p<0.0001). Furthermore, quality of life was significantly improved in all dimensions of the SF-36 and the SAQ. Seven (5.8%) of the implanted patients died within 1 year of follow up. CONCLUSIONS: SCS treatment is associated with symptom relief and improved quality of life in patients with refractory angina pectoris suffering from severe coronary artery disease.

Serum selenium and prognosis in cardiovascular disease: results from the AtheroGene study.

OBJECTIVE: Experimental data suggest a protective role of the essential trace element selenium against cardiovascular disease (CVD), whereas epidemiological data remains controversial. We aimed to investigate the impact of serum selenium concentration in patients presenting with stable angina pectoris (SAP) or acute coronary syndrome (ACS) on long term prognosis. METHODS: Baseline selenium concentration was measured in 1731 individuals (852 with SAP, and 879 with ACS). During a median follow-up of 6.1 years, 190 individuals died from cardiovascular causes. RESULTS: In those ACS patients who subsequently died of cardiac causes, selenium levels were lower compared to survivors (61.0microg/L versus 71.5microg/L; P<0.0001). In a fully adjusted model, patients in the highest tertile of selenium concentration had a hazard ratio of 0.38 (95% CI: 0.16-0.91; P=0.03) as compared with those in the lowest. No association between selenium levels and cardiovascular outcome was observed in SAP. CONCLUSIONS: Low selenium concentration was associated with future cardiovascular death in patients with ACS.

Myocardial perfusion after one year of spinal cord stimulation in patients with refractory angina.

AIM: Spinal cord stimulation (SCS) is recommended for patients with coronary artery disease (CAD) and refractory angina. We used positron emission tomography (PET) to investigate the long-term effect of SCS on regional myocardial perfusion in patients suffering from angina pectoris refractory to medical treatment and without option for coronary intervention. PATIENTS, METHODS: We analyzed data of 44 patients with stable CAD (91% three vessel disease). At baseline, we determined coronary flow reserve (CFR) using 13N-ammonia-PET and myocardial viability with 18F-FDG. SCS was performed for one year (Medtronic Itrell III or Synergy, Düsseldorf, Germany). During follow-up, no cardiac interventions were necessary and no myocardial infarctions occurred. At one year follow-up, CFR was measured again. RESULTS: In the majority of patients (77%), SCS led to an improvement of clinical symptoms. CFR did not change significantly during follow-up. Subjective improvement did not correlate with an increase of CFR. CONCLUSIONS: Despite its clinical effect, SCS does not have a direct impact on CFR in patients with stable CAD. According to our results, the pain relief is not due to an improvement of the myocardial blood supply.

Resource utilization implications of treatment were able to be assessed from appropriately reported clinical trial data.

BACKGROUND AND OBJECTIVE: Published clinical trial data rarely allow assessment of the health care resource utilization implications of treatment. We give an example of how these can be assessed given appropriate tabulation of data. METHODS: Data from a trial comparing long-acting nifedipine gastrointestinal therapeutic system to placebo in 7,665 patients with stable angina pectoris was analyzed. RESULTS: Relative to placebo, nifedipine significantly increased mean cardiovascular (CV) event-free survival by 41 days but had no effect on mean survival. Per 100 years of follow-up, 78.1 patient-years of double-blind nifedipine administration reduced use of another calcium antagonist, an angiotensin converting enzyme inhibitor, an angiotensin receptor blocker, a diuretic and a cardiac glycoside by 1.54, 3.73, 2.63, 2.23, and 0.64 years, respectively, whereas 0.21 less hospitalization for overt heart failure, 0.47 less hospitalization for any stroke or transient ischemic attack, 0.8 less coronary angiogram, 0.38 less coronary bypass procedure, and 0.13 additional orthopedic procedure was required. Combining resource utilization with cost data for one particular hospital showed that one additional year of CV event-free survival costs an average additional euro 3,036 in the setting considered. CONCLUSION: Appropriately tabulated clinical trial data allows clinicians to judge the resource utilization implications and economic effect of treatment decisions.

Secondary prevention of CHD in UK men: the Diet and Reinfarction Trial and its sequel.

The Diet and Reinfarction Trial (DART) involved 2033 men (mean age 56.5 years) recovering from myocardial infarction. They were randomly allocated to receive advice or to receive no advice on each of three dietary factors: an increase in fatty fish intake; a reduction in fat intake with an increase in polyunsaturated fat:saturated fat; an increased intake of cereal fibre. Compliance was satisfactory with the fish and fibre advice, but less so with the fat advice. The men given fish advice had 29% lower 2-year all-cause mortality; the other forms of advice did not have any significant effects. The Diet and Angina Randomized Trial (DART-2) involved 3114 men (mean age 61.1 years) with stable angina, who were followed up for 3-9 years. Advice to eat oily fish or take fish oil did not affect all-cause mortality, but it was associated with a significant increase in sudden cardiac death (P=0.018), and this effect was largely confined to the subgroup given fish oil capsules. Advice to eat more fruit and vegetables had no effect, probably because of poor compliance. The outcome of DART-2 appears to conflict with that of DART and some other studies; various possible explanations are considered. Nutritional interventions are not equally acceptable and should be tailored to the individuals for whom they are intended. Various distinct groups have a raised risk of CHD, and it cannot be assumed that the same nutritional interventions are appropriate to them all. Nutritional supplements do not necessarily have the same effects as the foods from which they are derived.

Long-term results following percutaneous myocardial laser therapy.

OBJECTIVES: The usefulness and safety of percutaneous myocardial laser therapy in selected patients have been identified in previous 1-year randomized trial reports, including that from a double-blind, sham-controlled trial we independently conducted. We aimed to determine whether the 1-year effects are maintained through a long-term, longitudinal follow-up. METHODS: Patients (n=77) with chronic, stable, medically refractory angina (class III or IV) not amenable to conventional revascularization and with evidence of reversible ischemia, ejection fraction > or =25%, and myocardial wall thickness > or =8 mm were treated with percutaneous myocardial laser. After the 1-year follow-up and disclosure of all randomized assignments as prespecified in the respective study protocol, patients were followed up longitudinally for a mean of 3 years for angina class, left ventricular ejection fraction, medication usage, and adverse events. RESULTS: No procedural mortality, myocardial infarction, or cerebral embolism occurred. Pericardiocentesis was required in two patients (2.6%). Cardiac event-free survival was 88% at 1 year and 66% at late follow-up. Mean Canadian Cardiovascular Society angina class was significantly improved from baseline (3.2+/-0.4) at 1 year (2.2+/-1.1, P<0.001) and at a mean of 3 years (1.9+/-1.2, P<0.001). Nitrate usage was significantly reduced at late follow-up; however, ejection fraction did not change over time. In a multivariate analysis, angina improvement at 1 year was found to be a significant independent predictor of both survival and angina improvement at late follow-up. CONCLUSION: We conclude that percutaneous myocardial laser therapy in selected patients with severe, medically refractory angina not treatable with conventional revascularization induces significant and sustained symptomatic benefit.

Is fish oil good or bad for heart disease? Two trials with apparently conflicting results.

Two successive randomized trials examined the effect of an increased intake of fatty fish, or the use of fish oil supplements, in reducing mortality in men with heart disease. The Diet and Reinfarction Trial (DART) was conducted in 2033 men who were recovering from acute myocardial infarction (MI). Those who were advised to eat fatty fish (or who opted to take fish oil capsules instead) had a 29% reduction in all-cause mortality over the following two years compared with those not so advised. The effect appeared in the first few months of the trial. The Diet and Angina Randomized Trial (DART 2) involved 3114 men with stable angina. Advice to eat fatty fish did not reduce mortality, and taking fish oil capsules was associated with a higher risk of cardiac and sudden death. The adverse effects of fish or fish oil were restricted to men not taking beta-blockers or dihydropyridine calcium-channel blockers, and were greater in those taking digoxin. Evidence from other sources strongly suggests an anti-arrhythmic action of fish oil, particularly after MI or in the presence of acute ischemia. The apparently conflicting results of the two trials may reflect different actions of n-3 fatty acids in acute and chronic conditions, together with different effects of eating fish and taking fish oil capsules. A mechanism is proposed that could account for these findings.

[Importance of spinal cord stimulation in the treatment of refractory angina]. / Il ruolo della stimolazione spinale nel trattamento dell'angina refrattaria.

A small non-quantified number of patients is reported to be affected by forms of angina pectoris already treated by traditional therapy but no longer able to achieve better results by drugs or surgery: this is called "refractory angina". Treatments like external counterpulsation, transmyocardial laser revascularization, stem cell transplantation or spinal cord stimulation may be suitable for these patients. The analysis of major studies on spinal cord stimulation based on exercise ECG, Holter monitoring and positron emission tomography, has shown a reduction in anginal attacks and in nitroglycerin pills. Though in small figures, an improved perfusion of the ischemic areas, an increase in the time of ischemia and cardiac mortality comparable to bypass surgery as well as a better quality of life and lower costs with respect to traditional treatment are also evident. Patients who are at high risk of mortality for bypass surgery, and who cannot receive significant benefits from revascularization or improved pharmacological therapy are candidate to spinal cord stimulation. Spinal cord stimulation is safe and effective in about 70% of patients. Some issues have not been investigated yet: the clinical characteristics of "non-responders" and the possibility of avoiding sudden cardiac death in stimulated patients.

Long-term effects of integrated rehabilitation in patients with advanced angina pectoris: a nonrandomized comparative study.

OBJECTIVES: An evaluation of Integrative Rehabilitation (IR) of patients with angina pectoris with respect to death rate, the need for invasive treatment, and cost effectiveness. DESIGN: A report from a clinical database. Death rates were compared to those of the general Danish population matched for age, gender, and observation period, as well as with data from the literature concerning medical and invasive treatments. SETTING: The treatment was carried out as an ambulatory treatment in a private clinic. SUBJECTS: One hundred and sixty-eight (168) patients with angina pectoris, of whom 103 were candidates for invasive treatment and 65 for whom this had been rejected. INTERVENTIONS: Integrated rehabilitation consists of acupuncture, a self-care program including acupressure, Chinese health philosophy, stress management techniques, and lifestyle adjustments. OUTCOME MEASURES: Death rate from any cause, the need for invasive treatment, and health care expenses. RESULTS: The 3-year accumulated risk of death was 2.0% (95% confidence limits: 0.0%-4.7%) for the 103 candidates for invasive treatment, 6.4% for the general Danish population, 5.4% (4.7%-6.1%), and 8.4% (7.7%-9.1%) for patients who underwent percutaneous transluminal balloon angioplasty and coronary artery bypass grafting, respectively, in New York. For the 65 inoperable patients the risk of death due to heart disease was 7.7% (3.9%-11.5%), compared to 16% (10%-34%) and 25% (18%-36%) for American patients, who were treated with laser revascularization or medication, respectively. Of the 103 candidates for invasive treatment, only 19 (18%) still required surgery. Cost savings over 3 years were US 36,000 dollars and US 22,000 dollars for surgical and nonsurgical patients, respectively. These were mainly achieved by the reduction in the use of invasive treatment and a 95% reduction in in-hospital days. CONCLUSIONS: Integrated rehabilitation was found to be cost effective, and added years to the lives of patients with severe angina pectoris. The results invite further testing in a randomized trial.

Immediate and long-term clinical outcome after spinal cord stimulation for refractory stable angina pectoris.

The treatment of patients with angina pectoris refractory to medical therapy and unsuitable for revascularization procedures has yet not been well standardized. Previous retrospective studies and small prospective studies have suggested beneficial effects of spinal cord stimulation (SCS) in these patients. We created a Prospective Italian Registry of SCS to evaluate the short- and long-term clinical outcome of patients who underwent SCS device implantation because of severe refractory angina pectoris. Overall, 104 patients were enrolled in the registry (70 men, aged 68 +/- 17 years), most of whom (83%) had severe coronary artery disease. Average follow-up was 13.2 +/- 8 months. Overall, 17 patients (16%) died, 8 (8%) due to cardiac death. Among clinical variables, only age was found to be significantly associated both with total mortality (p = 0.04) and cardiac mortality (p = 0.02) on Cox regression analysis. A significant improvement of anginal symptoms (> or =50% reduction of weekly anginal episodes, compared with baseline) occurred in 73% of patients, and Canadian Cardiovascular Society angina class improved by > or =1 class in 80% and by > or =2 classes in 42% of patients, with a relevant reduction in the rate of hospital admission and days spent in the hospital because of angina (p <0.0001 for both). No life-threatening or clinically serious complications were observed. The most frequent side effect consisted of superficial infections, either at the site of puncture of electrode insertion or of the abdominal pocket, which occurred in 6 patients. In conclusion, our prospective data point out that SCS can be performed safely and is associated with a sustained improvement of anginal symptoms in a relevant number of patients with refractory stable angina pectoris.

[Epidural spinal stimulation in the treatment of refractory angina pectoris. Its clinical efficacy, complications and long-term mortality. An Italian multicenter retrospective study]. / La stimolazione spinale epidurale nel trattamento dell'angina pectoris refrattaria. Efficacia clinica, complicanze e mortalità a lungo termine. Studio retrospettivo multicentrico Italiano.

BACKGROUND: Spinal cord stimulation has been used for many years in the treatment of refractory angina pectoris. Its anti-anginal and anti-ischemic effect has been well documented in several studies, but the long-term efficacy, safety and survival rate are not well known. The aim of this study was to carry out a retrospective analysis of a series of patients from the Italian Multicenter Registry, the data of which were collected in five centers, by means of a questionnaire. METHODS: One hundred and thirty patients (83 males, 47 females, mean age 74.8 +/- 9.8 years) were submitted to spinal cord stimulator implantation for refractory angina pectoris in the period 1988-1995 and controlled during a mean follow-up of 31.4 +/- 25.9 months. A previous myocardial infarction had already occurred in 69.3% of patients, whereas in 67.6% multivessel coronary artery disease was documented. A left ventricular dysfunction (ejection fraction < 0.40) was present in 34% of patients; bypass surgery and coronary angioplasty were performed in 49.6% and in 27% of patients respectively. In 96.3% of cases revascularization procedures were not advisable. RESULTS: A complete follow-up of 116 patients (89.2%) was available. The spinal cord stimulator induced a significant reduction in NYHA functional class from 2.5 +/- 1.2 to 1.5 +/- 0.9 (p < 0.01). During the follow-up 41 patients (35.3%) died, and in 14.2% a new acute myocardial infarction developed. The total percentage of minor spinal cord stimulation-related complications was 6.8%. No major complications occurred. The annual total mortality rate was 6.5%, whereas the cardiac mortality rate was 5%. Compared to the survivors, patients who died showed a higher incidence of left ventricular dysfunction, previous myocardial infarction and bypass surgery at implantation. CONCLUSIONS: In our experience, spinal cord stimulation is an effective therapy in patients affected by refractory angina pectoris and who cannot undergo revascularization procedure. The complication rate is low, with the total and cardiac mortality showing a trend as that reported for patients with similar coronary disease.

Prognostic implications of ambulatory myocardial ischemia and arrhythmias and relations to ischemia on exercise in chronic stable angina pectoris (the Angina Prognosis Study in Stockholm [APSIS]).

The prognostic significance of ambulatory ischemia, alone and in relation to ischemia during exercise was assessed in 686 patients (475 men) with chronic stable angina pectoris taking part in the Angina Prognosis Study In Stockholm (APSIS), who had 24-hour ambulatory electrocardiographic registrations and exercise tests at baseline (n = 678) and after 1 month (n = 607) of double-blind treatment with metoprolol or verapamil. Ambulatory electrocardiograms were analyzed for ventricular premature complexes and ST-segment depression. During a median follow-up of 40 months, 29 patients died of cardiovascular (CV) causes, 27 had a nonfatal myocardial infarction, and 89 underwent revascularization. Patients with CV death had more episodes (median 5 vs. 1; p<0.01) and longer median duration (24 vs. 3 minutes; p<0.01) of ST-segment depression than patients without events. For those who had undergone revascularization, the duration was also longer (12 vs. 3 minutes; p<0.05). In a multivariate Cox model including sex, history of previous myocardial infarction, hypertension, and diabetes, the duration of ST-segment depression independently predicted CV death. When exercise testing was included, ambulatory ischemia carried additional prognostic information only among patients with ST-segment depression > or =2 mm during exercise. When the treatment given and treatment effects on ambulatory ischemia were added to the Cox model, no significant impact on prognosis was found. Ventricular premature complexes carried no prognostic information. Thus, in patients with stable angina pectoris, ischemia during ambulatory monitoring showed independent prognostic importance regarding CV death. Ambulatory electrocardiographic monitoring and exercise testing provide complementary information, but only among patients with marked ischemia during exercise. Treatment reduced ambulatory ischemia, but the short-term treatment effects did not significantly influence prognosis.

Clinical outcome of patients treated with spinal cord stimulation for therapeutically refractory angina pectoris. The Working Group on Neurocardiology.

OBJECTIVE: To determine morbidity and mortality characteristics in patients treated with electrical neuromodulation for refractory angina pectoris. DESIGN: A retrospective multicentre study of patients treated with spinal cord stimulation between 1987 and 1997; 21 centres were contacted and 14 responded. SETTING: Specialist centres worldwide. PATIENTS: Questionnaires were returned on 517 patients, of whom 71% were male. One was lost to follow up. Mean (SD) age was 63.9 (10.1) years. Duration of angina pectoris was 8.1 (6.3) years. RESULTS: Before spinal cord stimulation, 66% of the patients had experienced myocardial infarction, 68% had three vessel disease, and in 24% the left ventricular ejection fraction (LVEF) was /= 71 years were independent predictors of mortality. During spinal cord stimulation, New York Heart Association functional class improved from 3.5 to 2.1 (p < 0.01); 25 of the deceased patients (24%) and 32 survivors (8%) experienced myocardial infarction; hospital admissions were significantly (p < 0.001) more common in the deceased group (66% v 37%). CONCLUSIONS: The clinical outcome of patients with intractable angina is not adversely affected by the chronic use of neurostimulation.

Safety of nifedipine in angina pectoris: a meta-analysis.

-Our objective was to compare cardiovascular event rates in patients with stable angina receiving nifedipine as monotherapy or combination therapy and in active drug controls. A MEDLARS search of published articles from 1966 to 1995 in English, French, German, Italian, or Spanish, supplemented by a manual search of bibliographies, identified 60 randomized controlled trials that met protocol criteria. Blinded articles were extracted by 2 physicians. The pooled risks of death, withdrawal, and cardiovascular event were computed and expressed as odds ratios (ORs) for all nifedipine formulations and relative to same study control drug regimens. Thirty cardiovascular events were reported in 2635 nifedipine exposures (1.14%) and 19 events in 2655 other active drug exposures (0.72%). Unadjusted ORs for nifedipine versus controls were 1.40 (95% CI, 0.56 to 3.49) for major events (death, nonfatal myocardial infarction, stroke, revascularization procedure), 1.75 (95% CI, 0.83 to 3.67) for increased angina, and 1.61 (95% CI, 0.91 to 2.87) for all events (major events plus increased angina). Episodes of increased angina were more frequent on immediate-release nifedipine (OR, 4.19 [95% CI, 1.41 to 12.49]) and on nifedipine monotherapy (OR, 2.61 [95% CI, 1.30 to 5.26]). The OR for immediate-release nifedipine was significantly higher than that for sustained-release/extended-release nifedipine (P=0.001), and the OR for nifedipine monotherapy was higher than that for nifedipine combination therapy (P=0.03). Increased risks of cardiovascular events in patients with stable angina on nifedipine were due primarily to more episodes of increased angina, confined to the immediate-release formulation and to nifedipine monotherapy.

Electrical stimulation versus coronary artery bypass surgery in severe angina pectoris: the ESBY study.

BACKGROUND: Spinal cord stimulation (SCS) has been shown to have antianginal and anti-ischemic effects in severe angina pectoris. The present study was performed to investigate whether SCS can be used as an alternative to coronary artery bypass grafting (CABG) in selected patient groups, ie, patients with no proven prognostic benefit from CABG and with an increased surgical risk. METHODS AND RESULTS: One hundred four patients were randomized (SCS, 53; CABG, 51). The patients were assessed with respect to symptoms, exercise capacity, ischemic ECG changes during exercise, rate-pressure product, mortality, and cardiovascular morbidity before and 6 months after the operation. Both groups had adequate symptom relief (P<.0001), and there was no difference between SCS and CABG. The CABG group had an increase in exercise capacity (P=.02), less ST-segment depression on maximum (P=.005) and comparable (P=.0009) workloads, and an increase in the rate-pressure product both at maximum (P=.0003) and comparable (P=.03) workloads compared with the SCS group. Eight deaths occurred during the follow-up period, 7 in the CABG group and 1 in the SCS group. On an intention-to-treat basis, the mortality rate was lower in the SCS group (P=.02). Cerebrovascular morbidity was also lower in the SCS group (P=.03). CONCLUSIONS: CABG and SCS appear to be equivalent methods in terms of symptom relief in this group of patients. Effects on ischemia, morbidity, and mortality should be considered in the choice of treatment method. Taking all factors into account, it seems reasonable to conclude that SCS may be a therapeutic alternative for patients with an increased risk of surgical complications.

Stable angina: drugs, angioplasty or surgery?

Stable angina is a common condition with a good overall prognosis and annual mortality is 2-4%, whatever treatment is employed. Medical therapy with nitrates, beta-blockers, calcium antagonists and lipid-lowering agents is appropriate as first-line therapy in those patients not specifically identified as being at risk by exercise testing and/or angiography. Dosage should be optimized. Coronary artery bypass grafting appears to improve prognosis in those at risk when compared with medical therapy but the trials are old and do not take into account major advances in medical therapy nor the use of arterial conduits in coronary artery bypass grafting (CABG). Percutaneous transluminal coronary angioplasty (PTCA) relieves symptoms when medical therapy is ineffective but its role as an initial therapy has not been established, nor does it compare favourably with CABG with regard to the degree of revascularization and subsequent re-intervention or need for additional anti-anginal drugs. There are little substantial data on prognostic effects. PTCA is, however, less traumatic, less expensive and associated with a quicker recovery than CABG, providing a viable alternative for symptomatic (not prognostic) benefit in appropriately selected and informed patients. Medical therapy, PTCA and CABG should not be seen as competitive but complementary strategies. Optimal utilization of all three treatment modalities, either alone or in combination, can provide substantial symptomatic relief for the angina patient.

Sequelae of spinal cord stimulation for refractory angina pectoris. Reliability and safety profile of long-term clinical application.

BACKGROUND: Spinal cord stimulation (SCS) is effective in the treatment of severe coronary artery disease (CAD) unresponsive to anti-anginal medication or revascularization procedures. However, there is still concern about its safety. OBJECTIVE: To investigate the reliability, morbidity, and mortality aspects of SCS in patients with refractory angina pectoris by studying the predictors of outcome, defined by efficacy, adverse events and mortality, in patients with CAD and SCS. METHODS: Fifty-seven patients (18 women) treated with SCS, aged 59.8 +/- 7.6 years (mean +/- SD) were studied retrospectively. They had suffered from manifest CAD for 9.4 +/- 4.9 years; 46 of them had experienced a myocardial infarction prior to the implantation; 28 had had a previous percutaneous transluminal coronary angioplasty; and 52 had undergone coronary artery bypass surgery. The mean left ventricular ejection fraction was 51.8 +/- 13.8%. All of the patients were being treated with two or three anti-anginal drugs. RESULTS: During 2042 patient-months follow-up, nine of the 57 patients died (annual mortality rate 6.5%). The percentage of adverse events requiring reprogramming or surgical reintervention was reduced from 83% for 18 patients with the Medtronic ITREL lead to 33% for 39 patients with the ITREL II system. The clinical outcome was correlated positively with a left ventricular ejection fraction > 40% (P = 0.0005), and negatively with a high cholesterol level (P = 0.0042), more prior revascularizations (P = 0.028), and a higher New York Heart Association classification (P = 0.04). CONCLUSIONS: Improvement of the SCS system reduced the equipment-related complication rate. The predictors of outcome are related to the traditional risk factors for CAD. The mortality rate of patients with refractory angina treated with SCS is similar to that of patients with CAD and stable angina pectoris.