Background: We conducted a randomized, controlled trial of circumferential pulmonary-vein ablation for the treatment of chronic atrial fibrillation. Methods: A total of 146 patients with a mean(± SD) age of 57± 9 years who had chronic atrial fibrillation were randomly assigned to receive amiodarone and undergo two cardioversions during the first three months alone(the control group) or in combination with circumferential pulmonary-vein ablation. Cardiac rhythm was assessed with daily telephonic transmissions for one year. The left atrial diameter and the severity of symptoms were assessed at 12 months. Results: Among the 77 patients assigned to undergo circumferential pulmonary-vein ablation, ablation was repeated because of recurrent atrial fibrillation in 26 percent of patients and atypical atrial flutter in 6 percent. An intention-to-treat analysis showed that 74 percent of patients in the ablation group and 58 percent of those in the control group were free of recurrent atrial fibrillation or flutter without antiarrhythmic-drug therapy at one year(P=0.05). Among the 69 patients in the control group, 53(77 percent) crossed over to undergo circumferential pulmonary-vein ablation for recurrent atrial fibrillation by one year and only 3(4 percent) were in sinus rhythm without antiarrhythmic-drug therapy or ablation. There were significant decreases in the left atrial diameter(12± 11 percent, P< 0.001) and the symptom severity score(59± 21 percent, P< 0.001) among patients who remained in sinus rhythm after circumferential pulmonary-vein ablation. Except for atypical atrial flutter, there were no complications attributable to circumferential pulmonary-vein ablation. Conclusions: Sinus rhythm can be maintained long term in the majority of patients with chronic atrial fibrillation by means of circumferential pulmonary-vein ablation independently of the effects of antiarrhythmic-drug therapy, cardioversion, or both. The maintenance of sinus rhythm is associated with a significant decrease in both the severity of
Background: The treatment of rest pain, ulceration, and gangrene of the leg(severe limb ischaemia) remains controversial. We instigated the BASIL trial to compare the outcome of bypass surgery and balloon angioplasty in such patients. Methods: We randomly assigned 452 patients, who presented to 27 UK hospitals with severe limb ischaemia due to infra-inguinal disease, to receive a surgery-first(n=228) or an angioplasty-first(n=224)strategy. The primary endpoint was amputation(of trial leg) free survival. Analysis was by intention to treat. The BASIL trial is registered with the National Research Register(NRR) and as an International Standard Randomised Controlled Trial, number ISRCTN45398889. Findings: The trial ran for 5.5 years, and follow-up finished when patients reached an endpoint(amputation of trial leg above the ankle or death). Seven individuals were lost to follow-up after randomisation(three assigned angioplasty, four surgery); of these, three were lost(one angioplasty, two surgery) during the first year of follow-up. 195(86% ) of 228 patients assigned to bypass surgery and 216(96% ) of 224 to balloon angioplasty underwent an attempt at their allocated intervention at a median(IQR) of 6(3- 16) and 6(2- 20) days after randomisation, respectively. At the end of follow-up, 248(55% ) patients were alive without amputation(of trial leg), 38(8% ) alive with amputation, 36(8% ) dead after amputation, and 130(29% ) dead without amputation. After 6 months, the two strategies did not differ significantly in amputation-free survival(48 vs 60 patients; unadjusted hazard ratio 1.07, 95% CI 0.72- 1.6; adjusted hazard ratio 0.73, 0.49- 1.07). We saw no difference in health- related quality of life between the two strategies, but for the first year the hospital costs associated with a surgery-first strategy were about one third higher than those with an angioplasty-first strategy. Interpretation: In patients presenting with severe limb ischaemia due to infra-inguinal disease and who are suitable for surgery and angiopl
Background &Aims: In patients with stones in their bile ducts and gallbladders, cholecystectomy is generally recommended after endoscopic sphincterotomy and clearance of bile duct stones. However, only approximately 10%of patients with gallbladders left in situ will return with further biliary complications. Expectant management is alternately advocated. In this study, we compared the treatment strategies of laparoscopic cholecystectomy and gallbladders left in situ. Methods: We randomized patients (>60 years of age) after endoscopic sphincterotomy and clearance of their bile duct stones to receive early laparoscopic cholecystectomy or expectant management. The primary outcome was further biliary complications. Other outcome measures included adverse events after cholecystectomy and late deaths from all causes. Results: One hundred seventy-eight patients entered into the trial (89 in each group); 82 of 89 patients who were randomized to receive laparoscopic cholecystectomy underwent the procedure. Conversion to open surgery was needed in 16 of 82 patients (20%). Postoperative complications occurred in 8 patients (9%). Analysis was by intention to treat. With a median follow-up of approximately 5 years, 6 patients (7%) in the cholecystectomy group returned with further biliary events (cholangitis, n = 5; biliary pain, n = 1). Among those with gallbladders in situ, 21 (24%) returned with further biliary events (cholangitis, n = 13; acute cholecystitis, n = 5; biliary pain, n = 2; and jaundice, n = 1; log rank, P = .001). Late deaths were similar between groups (cholecystectomy, n = 19; gallbladder in situ, n = 11; P = .12). Conclusions: In the Chinese, cholecystectomy after endoscopic treatment of bile duct stones reduces recurrent biliary events and should be recommended.
Objective: To determine if the macrolide clarithromycin affects mortality and cardiovascular morbidity in patients with stable coronary heart disease. Design: Centrally randomised multicentre trial. All parties at all stages were blinded. Analyses were by intention to treat. Setting: Five Copenhagen University cardiology departments and a coordinating centre. Participants: 13 702 patients aged 18 to 85 years who had a discharge diagnosis of myocardial infarction or angina pectoris in 1993- 9 and alive in August 1999 were invited by letter; 4373 were randomised. Interventions: Two weeks’ treatment with clarithromycin 500 mg/day or matching placebo. Main outcome measures: Primary outcome: composite of all cause mortality, myocardial infarction, or unstable angina pectoris during three years’ follow-up. Secondary outcome: composite of cardiovascular mortality, myocardial infarction, or unstable angina pectoris. The outcomes were obtained from Danish registers and were blindly assessed by the event committee. Results: 2172 participants were randomised to clarithromycin and 2201 to placebo. We found no significant effects of clarithromycin on the primary outcome(hazard ratio 1.15, 95% confidence interval 0.99 to 1.34) or secondary outcome(1.17, 0.98 to 1.40). Mortality was significantly higher in the clarithromycin arm(1.27, 1.03 to 1.54; P=0.03) as a result of significantly higher cardiovascular mortality(1.45, 1.09 to 1.92; P=0.01). Conclusions: Short term clarithromycin in patients with stable coronary heart disease may cause significantly higher cardiovascular mortality. The long term safety of clarithromycin in patients with stable ischaemic heart disease should be examined.
