SEARCH · PubMed Health

Results for “Randomized trial”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 361 records · Page 20Linked to original sources

PubMed2003

Hilar dissection versus the "glissonean" approach and stapling of the pedicle for major hepatectomies: a prospective, randomized trial.

OBJECTIVE: A randomized study was conducted of hilar dissection and the "glissonean" approach and stapling of the pedicle for major hepatectomies to contrast their feasibility, safety, amount of hemorrhage, postoperative complications, operative times, and costs. SUMMARY BACKGROUND DATA: The "glissonean" approach is reported as requiring a shorter portal triad closure time; furthermore, the procedure seems to expedite the transection of the liver. PATIENTS AND METHODS: Between 1998 and 2001, 80 patients were enrolled in this study. The major liver resections included 15 extended right, 7 extended left, 42 right, and 16 left hepatectomies. The patients were randomly assigned to the hilar dissection group (G1; n = 40) or to the "glissonean" approach and stapling of the portal triad group (G2; n = 40). RESULTS: The groups were equally matched for age, sex, diagnosis, mean resected specimen weight, number of tumoral lesions, type of liver resection performed, and percentage of patients with margin invasion (G1: 4; 10% vs G2: 5; 12.5%). The duration of the 2 procedures was similar (G1: 247 +/- 54 min vs G2: 236 +/- 43 min; P = 0.4). However, the duration of the hilar dissection was shorter for G2 (50 +/- 17 min) versus G1 (70 +/- 26 min; P <0.001). By contrast, the duration of pedicular clamping was shorter for G1 (43 +/- 15 min) versus G2 (51 +/- 15 min; P = 0.015). No differences were observed in the amount of hemorrhage (G1: 887 +/- 510 mL vs G2: 937 +/- 636 mL; P = 0.7), and only 6 patients in G1 and 10 in G2 were transfused (P = 0.26). Morbidity rates were similar for both groups (G1: 23% vs G2: 33%; P = 0.3). Surgical injury of the contralateral biliary duct was not observed. However, 3 patients in G1 and 4 patients in G2 presented a biliary fistula that resolved spontaneously. Postoperative hospital stay was similar (G1: 8 [range, 6-24] vs G2: 9 [range, 5-31] days; P = 0.6). The postoperative levels of alanine transaminase (ALT) during the 2 first postoperative days were lower for G1 than G2. Cost of the surgical material was 1235.80 US dollars for G1 and 1301.10 US dollars for G2. CONCLUSIONS: The 2 techniques are equally effective procedures for treating hilar structures. Although en bloc stapling transection is faster, hilar dissection was associated with a shorter pedicular clamping time, less cytolysis, and the materials required were less expensive.

Adult↗

PubMed1992

Comparison of OK-432 and mitomycin C pleurodesis for malignant pleural effusion caused by lung cancer. A randomized trial.

A prospective randomized study to compare the effectiveness of pleurodesis by two new sclerosing agents: OK-432 and mitomycin C were conducted in 53 patients with malignant pleural effusion caused by lung cancer. None of the patients received concomitant systemic chemotherapy or radiation therapy during the study. After complete drainage of pleural fluid, the patients were allocated randomly to receive 10 Klinische Einheit units of OK-432 or 8 mg of mitomycin C by intrapleural injection at weekly intervals. The treatment was terminated if the pleural effusion disappeared or the patients had received four consecutive procedures. There were 26 patients who received pleurodesis with OK-432 and 27, with mitomycin C. Patient characteristics in the two treatment groups (age, sex, histologic type, performance status, and prior treatment before pleurodesis) were compatible. These results showed that pleurodesis with OK-432 achieved a higher complete response rate (73%) than that of mitomycin C (41%). The rates of objective treatment response (complete response plus partial response) were comparable in both groups (88% for OK-432 and 67% for mitomycin C). The average number of intrapleural injections needed to achieve complete response was fewer in the OK-432 group (1.9 +/- 0.9) than in mitomycin C group (2.8 +/- 0.9). There was no significant difference in the median survival of the patients who received pleurodesis with OK-432 (5.8 months) or mitomycin C (5.1 months). However, the effusion-free period in the OK-432 group was significantly longer than that in the mitomycin C group (7.0 months versus 1.5 months). Patients who underwent OK-432 pleurodesis had a higher complication rate (80%) than did those in the mitomycin C group (30%). Transient febrile reaction was the most common reaction encountered. The immunologic study in OK-432 group showed an increase in peripheral leukocyte count and decrease in the OKT4/OKT8 ratio. The mitomycin C group had a mild reduction in peripheral blood leukocyte count and no significant change in the OKT4/OKT8 ratio. It was concluded that pleurodesis with OK-432 is an effective alternative treatment for malignant effusion in patients with lung cancer.

Adenocarcinoma↗

PubMed1987

Shunt surgery versus endoscopic sclerotherapy for long-term treatment of variceal bleeding. Early results of a randomized trial.

In September 1982, a prospective randomized trial comparing shunt surgery and endoscopic sclerotherapy for the elective management of variceal hemorrhage in patients with cirrhosis was initiated. Twenty-seven patients have received shunts (distal splenorenal = 23, nonselective = 4) and 30 patients have had chronic sclerotherapy. Eighty-six per cent of patients had alcoholic cirrhosis and 33% were Child's class C. After a mean follow-up of 25 months, 19% of shunt and 57% of sclerotherapy patients have had rebleeding (p = 0.003). Kaplan-Meier survival analysis reveals similar 2-year survival rates for shunt (65%) and sclerotherapy (61%) groups. Only two of 10 sclerotherapy failures have been salvaged by surgery. Posttherapy quantitative hepatic function, frequency of encephalopathy, and cumulative medical costs were similar for both groups. Hepatic portal perfusion and portal pressure at 1 year were better maintained by sclerotherapy than by distal splenorenal shunt. In conclusion, endoscopic sclerotherapy and shunt surgery provide similar results with respect to survival, hepatic function, frequency of encephalopathy, and costs. Sclerotherapy is an acceptable, but not superior, alternative to shunt surgery for treatment of variceal hemorrhage.

Clinical Trials as Topic↗

PubMed2006

Implication from randomized trials of rate and rhythm controls on management of patients with persistent atrial fibrillation.

Recently, several randomized trials were published on the issue of rate or rhythm control for patients with atrial fibrillation (AF). Patients were typically minor symptomatic, relatively old, with age above 70, presenting with a recurrence of AF and suffering from only mild to moderate underlying heart disease. The main outcome of these trials is that rate control is not inferior to rhythm control for the management of patients with AF concerning morbidity and mortality. Also patients' quality of life did not differ significantly in follow-up in these trials. However, rhythm control is not redundant in the treatment of AF. Focus is now on subgroups of patients who could still have benefit being in sinus rhythm. For severely symptomatic patients, patients presenting with the first episode of AF and probably those with severe congestive heart failure, to restore and maintain sinus rhythm should still be the goal. With the failure of antiarrhythmic therapy, nonpharmacological approaches such as pulmonary vein isolation can be performed. Another finding of the randomized trials is that being in sinus rhythm does not prevent from the occurrence of thromboembolic complications. This means that for patients with AF, with risk factors for thromboembolic events, adequate anticoagulant therapy is indicated irrespective of the current heart rhythm. As with antiarrhythmic therapy, the search for new and safer anticoagulant therapy is underway. This review will focus on the key aspects we have learned from the randomized trials on rate and rhythm controls for patients with AF.

Anti-Arrhythmia Agents↗

PubMed2003

Medicinal herbs for hepatitis C virus infection: a Cochrane hepatobiliary systematic review of randomized trials.

OBJECTIVE: The aim of this study was to assess beneficial and harmful effects of medicinal herbs for hepatitis C virus (HCV) infection. METHODS: The databases of the Cochrane Collaboration, MEDLINE, EMBASE, and BIOSIS were searched combined with manual searches of five Chinese and one Japanese journals. We included randomized trials comparing medicinal herbs with placebo, no intervention, nonspecific treatment, other herbs, or interferon and/or ribavirin. Trials of herbs with or without other drug(s) were included. Methodological quality of the trials was evaluated by randomization, double blinding, and the Jadad scale. RESULTS: Thirteen randomized trials (n = 818) evaluated 14 medicinal herbs. Four trials had adequate methodology. Compared with placebo, none of the herbs showed effects on HCV RNA or liver enzyme, except for silybin, which showed a significant reduction of serum AST and gamma-glutamyltranspeptidase levels in one trial. Oxymatrine showed effects on clearance of HCV RNA (relative risk = 9.20, 95% CI = 1.26-67.35) compared with vitamins. The herbal mixture Bing Gan Tang plus interferon-alpha showed better effects on clearance of HCV RNA (relative risk = 2.54, 95% CI = 1.43-4.49) and on normalization of serum ALT (relative risk = 2.54, 95% CI = 1.43-4.49) than interferon-alpha alone. The herbal mixture Yi Zhu decoction showed better effects on clearance of HCV RNA and normalization of ALT compared with glycyrrhizin plus ribavirin. Yi Er Gan Tang showed effects on normalizing serum ALT compared with silymarin plus glucurolactone. The herbs were associated with adverse events. CONCLUSIONS: There is no firm evidence supporting medicinal herbs for HCV infection, and further randomized trials are justified.

Hepacivirus↗

PubMed2002

Overview of randomized trials of antiarrhythmic drugs and devices for the prevention of sudden cardiac death.

BACKGROUND: Sudden cardiac death is a prominent feature of the natural history of heart disease. The efficacy of antiarrhythmic drugs and devices in preventing sudden death and reducing total mortality is uncertain. METHODS: We reviewed randomized trials and quantitative overviews of type I and type III antiarrhythmic drugs. We also reviewed the randomized trials of implantable cardioverter defibrillators and combined these outcomes in a quantitative overview. RESULTS: Randomized trials of type I antiarrhythmic agents used as secondary prevention after myocardial infarction show an overall 21% increase in mortality rate. Randomized trials of amiodarone suggest a 13% to 19% decrease in mortality rate, and sotalol has been effective in several small trials. Trials of pure type III agents, however, have shown no mortality benefit. An overview of implantable defibrillator trials shows a 24% reduction in mortality rate (CI 15%-33%) compared with alternative therapy, most often amiodarone. CONCLUSION: Amiodarone is effective in reducing the total mortality rate by 13% to 19%, and the implantable defibrillator reduces the mortality rate by a further 24%.

Aged↗

PubMed2004

Intracluster correlation coefficients in cluster randomized trials: empirical insights into how should they be reported.

BACKGROUND: Increasingly, researchers are recognizing that there are many situations where the use of a cluster randomized trial may be more appropriate than an individually randomized trial. Similarly, the need for appropriate standards of reporting of cluster trials is more widely acknowledged. METHODS: In this paper, we describe the results of a survey to inform the appropriate reporting of the intracluster correlation coefficient (ICC)--the statistical measure of the clustering effect associated with a cluster randomized trial. RESULTS: We identified three dimensions that should be considered when reporting an ICC--a description of the dataset (including characteristics of the outcome and the intervention), information on how the ICC was calculated, and information on the precision of the ICC. CONCLUSIONS: This paper demonstrates the development of a framework for the reporting of ICCs. If adopted into routine practice, it has the potential to facilitate the interpretation of the cluster trial being reported and should help the development of new trials in the area.

Cluster Analysis↗

PubMed1983

An additional basic science for clinical medicine: II. The limitations of randomized trials.

Although highly successful in investigating remedial therapy, randomized clinical trials have sometimes created rather than clarified controversy when the treatments were given for the complex problems involved in studying either the primary prevention of disease or the secondary prevention of adverse progression for an established disease. Another source of difficulty has been the inevitable conflicts created by two legitimate and justifiable but opposing policies regarding the fastidious or pragmatic goals of the trials. These problems limit the scope of clinical questions that can be answered successfully by randomized trials, but other limitations are produced by problems in logistics or ethics. Randomized trials are unfeasible for studying multiple therapeutic candidates, minor changes in therapy, "instabilities" due to rapid technologic improvements in available treatment, long-term adverse effects, studies of etiologic or other suspected "noxious" agents, and the diverse clinical roles of diagnostic technology. Consequently, despite the magnificent scientific achievements of randomized clinical trials, the foundation for a basic science of patient care will also require major attention to the events and observations that occur in the ordinary circumstances of clinical practice.

Clinical Trials as Topic↗

PubMed2002

Effect of patient education on self-management skills and health status in patients with asthma: a randomized trial.

We conducted a randomized clinical trial to assess the effectiveness of a newly established education program for adults with asthma. The program was designed to improve patients' health and functional status. Hospitalized patients with asthma were randomly assigned to immediate education or a 6-month waiting list. The education program consisted of three group sessions, delivered by trained educators, and focused on improving patients' self-management skills. Of 253 eligible patients, 131 agreed to participate (66 assigned to immediate education, 65 controls) and 115 (88%) completed the follow-up assessment at 6 months. At follow-up, most indicators of self-management skills and health and functional status had improved significantly among educated patients, but similar improvements were also seen among controls. The trial arms differed significantly on only four variables: patients in the immediate-education group were more likely to develop confidence in their asthma treatment (odds ratio adjusted for baseline [OR] = 2.9; 95% confidence interval [CI]: 1.0 to 8.1), to improve their knowledge of correct inhalation technique (OR = 2.4; 95% CI: 1.0 to 5.7), and to improve knowledge of the peak flow reading that warrants calling a physician (OR = 3.1; 95% CI: 1.4 to 6.7), but they improved less on the Asthma Quality of Life Questionnaire "activity" score (difference: -0.4 on a 1 to 7 scale; 95% CI: -0.8 to 0.0). Use of health services during follow-up was similar in the two groups. The education program did not enhance patients' health and functional status, despite improving a few self-management skills. These results underscore the need for controlled evaluations of education programs.

Adult↗

PubMed1990

Quality of life during chemotherapy for small cell lung cancer: assessment and use of a daily diary card in a randomized trial.

Fifty-three patients who were taking part in a randomized trial of chemotherapy in small cell lung cancer (SCLC) were entered into a study of quality of life measurement using a daily diary card. Patients received either four or eight cycles of initial chemotherapy and daily records were scored, using a four point scale of nausea, sickness, appetite, sleep, mood, pain, activity and general well being. Two hundred and fifty-six of a possible 379 cards were returned (68% compliance). The first 31 patients took part in an assessment of the diary card where comparison was made with nurse ratings using the card, the EORTC questionnaire and the Spitzer quality of life index. These comparisons showed appropriate convergent and divergent validity and demonstrated the sensitivity of the diary card to short term changes compared with the other measures. In the randomized trial the diary card demonstrated a worsening of sickness and related variables as treatment continued. This spilled over into mood and general well being although physical variables of pain, sleep and activity were largely unaffected. Prophylactic cranial irradiation was associated with a transient increase in sickness and vomiting. The study shows that the diary card is an instrument sensitive to short term changes in quality of life and thus especially useful for comparing effects during the period of treatment.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed1993

Early ambulation following diagnostic 7-French cardiac catheterization: a prospective randomized trial.

There is a paucity of randomized studies concerning transfemoral cardiac catheterization and its complications, in particular that of 7F catheterization. Accordingly, we conducted a prospective, randomized trial comparing early ambulation (group A) 6 hr after diagnostic 7F cardiac catheterization versus late ambulation (group B) the following morning. A total of 273 patients were randomized in the study; 142 in group A and 131 in group B (NS). Except for a difference in the indications for catheterization, the baseline and procedure-related parameters were similar between the 2 groups. Early hematoma (formed within 6 hr) developed in 6 (4%) and 7 (5%) patients in groups A and B, respectively (NS). Similarly, there was no difference in the incidence of late hematoma formation (2% in each group). All hematomas detected were small and required no surgical intervention or extension of hospital stay. Our data showed that early ambulation following 7F left heart catheterization is feasible and safe. The access site complication rate is acceptably low and minor in nature.

Cardiac Catheterization↗

PubMed1991

Allogeneic marrow transplantation in patients with chronic myeloid leukemia in the chronic phase: a randomized trial of two irradiation regimens.

A randomized trial was performed to compare two regimens of total body irradiation in patients with chronic myeloid leukemia treated by allogeneic marrow transplantation while in the chronic phase. All patients received cyclophosphamide 120 mg/kg followed by total body irradiation and marrow from HLA-identical siblings. Cyclosporine and methotrexate were used for prophylaxis against acute graft-versus-host disease. Fifty-seven patients were randomized to receive 2.0 Gy fractions of irradiation daily for 6 days and 59 were randomized to receive 2.25 Gy fractions daily for 7 days. The probabilities of relapse at 4 years were 0.25 for the 12.0 Gy group and 0.00 for the 15.75 Gy group (P = .008). The actuarial probabilities of survival and relapse-free survival at 4 years were 0.60 and 0.58 among the patients who received 12.0 Gy compared with 0.66 and 0.66 for those who received 15.75 Gy. The 4-year probabilities of transplant-related mortality were 0.24 and 0.34 respectively (P = .13) while the probability of moderate to severe acute graft-versus-host disease was 0.33 for the 12.0 Gy group and 0.44 for the 15.75 Gy group (P = .15). The lower relapse probability in the patients receiving the higher dose of total body irradiation did not result in improved survival because mortality from causes other than relapse was increased.

Adult↗

PubMedDate not supplied

Comparison of balloon angioplasty and Simpson atherectomy for lesions in the femoropopliteal artery: angiographic and clinical results of a prospective randomized trial.

PURPOSE: This study involves a prospective randomized trial comparing clinical and angiographic results of balloon angioplasty (BA) and Simpson directional atherectomy (DA) in patients with short lesions in the femoropopliteal artery causing symptoms of intermittent claudication. MATERIALS AND METHODS: Thirty-five patients were treated with BA and 38 with DA. Procedural complications were seen in eight patients. Residual stenoses immediately after the procedure with between 30% and 50% diameter reduction (DR) were observed in three patients after BA and in five patients after DA. In all other patients, residual stenosis was less than 30% DR. Two study end-points during a 2-year follow-up were used: the angiographic occurrence of restenosis with a DR of 50% or greater or the recurrence of symptoms. RESULTS: Clinical success after 2 years, according to the criteria of the Society for Vascular Surgery/International Society for Cardiovascular Surgery, was seen in 79% of the BA patients and 56% of the DA patients (P = .07). The 2-year primary angiographic patency rates were 67% in patients treated with BA and 44% in patients treated with DA (P = .06). The secondary angiographically determined patency rates were 80% and 65%, respectively (P = .15). CONCLUSION: Simpson atherectomy is an interventional technique to treat arterial lesions in the femoropopliteal artery with an acceptably low complication rate. The clinical and angiographic results of DA and BA are comparable. DA should not be used to replace BA for routine treatment of short femoropopliteal lesions.

Angioplasty, Balloon↗

PubMed1991

Cost of schizophrenia in a randomized trial of home-based treatment.

A randomized trial of acute psychiatric care was conducted to compare home-based interventions with standard care. The setting of the study was a comprehensive urban psychiatric service in London. Sixteen of the 172 patients in the study had schizophrenia--11 in standard care (SC) and 5 in community care (CC). Care for patients with schizophrenia was, on average, twice as expensive as care for nonschizophrenic patients. This large and statistically significant difference was mainly the result of increased inpatient care, which averaged 33 days for the schizophrenic group compared to 7.6 days for non-schizophrenic patients. There was a modest increase in general practice and outpatient contacts among the schizophrenic patients compared with nonschizophrenic patients, but surprisingly little use of day hospital facilities. The SC schizophrenic care cost nearly twice as much as CC care, but this was not a statistically significant difference. These results suggest that provision of active community services for schizophrenic patients may lead to overall savings in care costs, mainly by a reduction in inpatient stays.

Ambulatory Care↗

PubMed1999

Levofloxacin in the empirical treatment of patients with suspected bacteraemia/sepsis: comparison with imipenem/cilastatin in an open, randomized trial.

An open, randomized, multinational, multicentre study was conducted to compare the efficacy, safety and tolerability of levofloxacin 500 mg twice daily with imipenem/cilastatin 1 g iv three-times daily in the treatment of hospitalized adult patients with clinically suspected bacteraemia/ sepsis. Levofloxacin patients could change from iv to oral administration after a minimum of 48 h iv treatment if clinical signs and symptoms of sepsis had improved. The primary efficacy analysis was based on the clinical and bacteriological response at clinical endpoint. A total of 503 patients were randomized and 499 included in the intent-to-treat population. The per-protocol population comprised 287 patients with bacteriologically proven infection. Clinical cure rates at clinical endpoint in the intent-to-treat population and per-protocol population were 77% (184/239) and 89% (125/140), respectively, for levofloxacin and 68% (178/260) and 85% (125/147), respectively, for imipenem/cilastatin. At follow-up, the cure rates in the per-protocol population were 84% for levofloxacin and 69% for imipenem/cilastatin. The 95% confidence interval for both populations showed that levofloxacin was as effective as imipenem/cilastatin. A satisfactory bacteriological response was obtained in 87% (96/110) of levofloxacin patients and 84% (97/116) of imipenem/cilastatin patients at clinical endpoint. Adverse events possibly related to the study drug were reported in 74 (31%) levofloxacin patients and 79 (30%) imipenem/cilastatin patients. There were no clinically appreciable differences between the treatment groups. Levofloxacin 500 mg twice daily, either iv or as sequential iv/oral therapy, was as effective and well tolerated as imipenem/cilastatin 1 g iv three-times daily in the treatment of hospitalized patients with suspected bacteraemia/sepsis.

Adolescent↗

PubMed2000

Vitamin supplements and cardiovascular risk: review of the randomized trials of homocysteine-lowering vitamin supplements.

Epidemiological studies have shown that higher blood homocysteine levels appear to be associated with higher risks of coronary, cerebral, and peripheral vascular disease and are inversely related to blood levels of folate and of vitamin B12 and vitamin B6. However, observational studies cannot exclude the possibility that elevated homocysteine levels may be associated with some other factor, rather than being causally related to vascular disease. Large-scale clinical trials of sufficient dose and duration of treatment are required to test this hypothesis, but there was substantial uncertainty about the optimal vitamin regimen to test in such trials. A meta-analysis of 12 randomized trials of vitamin supplements to lower homocysteine levels was carried out to determine the optimal dose of folic acid required to lower homocysteine levels and to assess whether vitamin B12 or vitamin B6 had additive effects. This meta-analysis demonstrated that reductions in blood homocysteine levels were greater at higher pretreatment blood homocysteine levels and at lower pretreatment folate concentrations. After standardization for a pretreatment homocysteine concentration of 12 micromol/L and folate concentration of 12 nmol/L (approximate average concentrations for western populations), dietary folic acid reduced homocysteine levels by 25% (95% confidence interval [CI]: 23 to 28%) with similar effects in a daily dosage range of 0.5 to 5 mg. Vitamin B12 (mean 0.5 mg) produced an additional reduction in blood homocysteine of 7%, whereas vitamin B6 (mean 16.5 mg) did not have any significant effect. Hence, in typical populations, daily supplementation with both 0.5 to 5 mg folic acid and about 0.5 mg vitamin B12 would be expected to reduce homocysteine levels by one quarter to one third (from about 12 micromol/L to about 8 to 9 micromol/L). Large-scale randomized trials of such regimens are now required to determine whether lowering homocysteine levels by folic acid and vitamin B12, with or without added vitamin B6, reduces the risk of vascular disease.

Adult↗

PubMed1997

rhGM-CSF vs placebo following rhGM-CSF-mobilized PBPC transplantation: a phase III double-blind randomized trial.

In this placebo-controlled randomized trial we evaluated the hematological and clinical effects of r-Hu GM-CSF after high-dose chemotherapy (HDC) followed by GM-CSF-mobilized PBPC transplantation. Fifty patients with poor prognosis malignancies were randomized in a double-blind study to receive either GM-CSF or placebo after HDC followed by PBPC rescue. For all patients, PBPCs were recruited using a combination of VP-16 (300 mg/m2 on days 1 and 2), cytoxan (3 g/m2 on days 3 and 4) and GM-CSF (5 micrograms/kg from day 5). No differences were demonstrated between the two groups in median time to neutrophil or platelet recoveries. There was no significant difference between the GM-CSF group and the placebo group in the median duration of post-transplant hospitalization, in the number of days of antibiotic treatment, in the number of infections and in red blood cell or platelet transfusion requirements. There was a significant difference with an advantage for the placebo group in the mean duration of febrile days (P = 0.01). We conclude that the administration of GM-CSF in patients transplanted with GM-CSF-mobilized PBPC is not associated with a clinical benefit in term of tempo of engraftment, numbers of documented infections, transfusion requirements and mucositis grading.

Adult↗

PubMed1991

Percutaneous balloon versus surgical closed commissurotomy for mitral stenosis. A prospective, randomized trial.

BACKGROUND: We performed a prospective, randomized trial comparing percutaneous balloon commissurotomy with surgical closed commissurotomy in 40 patients with severe rheumatic mitral stenosis. METHODS AND RESULTS: Data were analyzed by investigators who were masked to treatment assignment or phase of study. Patients randomized to balloon (n = 20) or surgical (n = 20) commissurotomy had severe mitral stenosis without significant baseline differences (left atrial pressure, 26.1 +/- 4.2 versus 27.6 +/- 6.2 mm Hg; mitral valve gradient, 18.0 +/- 4.2 versus 19.7 +/- 6.3 mm Hg; mitral valve area, 1.0 +/- 0.2 versus 1.0 +/- 0.4 cm2, respectively). At 1-week follow-up after balloon commissurotomy, pulmonary wedge pressure was 14.3 +/- 7.2 mm Hg; mitral valve gradient was 9.6 +/- 5.1 mm Hg; and mitral valve area was 1.6 +/- 0.6 cm2 (all p less than 0.0001). At 1-week follow-up after surgical closed commissurotomy, wedge pressure was 13.7 +/- 5.4 mm Hg; mitral valve gradient was 9.4 +/- 4.2 mm Hg (both p less than 0.0001); and mitral valve area was 1.6 +/- 0.7 cm2 (p less than 0.003). At 8-month follow-up, improvement occurred in both groups: Mitral valve area was 1.6 +/- 0.6 cm2 in the balloon commissurotomy group (p less than 0.002) and was 1.8 +/- 0.6 cm2 in the surgical closed commissurotomy group (p less than 0.0001). There was no difference between the groups at 1-week or 8-month follow-up (all p greater than 0.4). One case of severe mitral regurgitation occurred in each group; complications were otherwise related to transseptal catheterization. There was no death, stroke, or myocardial infarction. Cost analysis revealed that balloon commissurotomy may substantially exceed the cost of surgical commissurotomy in developing countries, whereas it may represent a significant savings in industrialized nations. CONCLUSIONS: We conclude that percutaneous balloon commissurotomy and surgical closed commissurotomy result in comparable hemodynamic improvement that is sustained through 8 months of follow-up.

Adult↗