Ticagrelor alone versus ticagrelor plus aspirin from month 1 to month 12 after percutaneous coronary intervention in patients with acute coronary syndromes (ULTIMATE-DAPT): a randomised, placebo-controlled, double-blind clinical trial.

BACKGROUND: Following percutaneous coronary intervention with stent placement to treat acute coronary syndromes, international clinical guidelines generally recommend dual antiplatelet therapy with aspirin plus a P2Y12 receptor inhibitor for 12 months to prevent myocardial infarction and stent thrombosis. However, data on single antiplatelet therapy with a potent P2Y12 inhibitor earlier than 12 months after percutaneous coronary intervention for patients with an acute coronary syndrome are scarce. The aim of this trial was to assess whether the use of ticagrelor alone, compared with ticagrelor plus aspirin, could reduce the incidence of clinically relevant bleeding events without an accompanying increase in major adverse cardiovascular or cerebrovascular events (MACCE). METHODS: In this randomised, placebo-controlled, double-blind clinical trial, patients aged 18 years or older with an acute coronary syndrome who completed the IVUS-ACS study and who had no major ischaemic or bleeding events after 1-month treatment with dual antiplatelet therapy were randomly assigned to receive oral ticagrelor (90 mg twice daily) plus oral aspirin (100 mg once daily) or oral ticagrelor (90 mg twice daily) plus a matching oral placebo, beginning 1 month and ending at 12 months after percutaneous coronary intervention (11 months in total). Recruitment took place at 58 centres in China, Italy, Pakistan, and the UK. Patients were required to remain event-free for 1 month on dual antiplatelet therapy following percutaneous coronary intervention with contemporary drug-eluting stents. Randomisation was done using a web-based system, stratified by acute coronary syndrome type, diabetes, IVUS-ACS randomisation, and site, using dynamic minimisation. The primary superiority endpoint was clinically relevant bleeding (Bleeding Academic Research Consortium [known as BARC] types 2, 3, or 5). The primary non-inferiority endpoint was MACCE (defined as the composite of cardiac death, myocardial infarction, ischaemic stroke, definite stent thrombosis, or clinically driven target vessel revascularisation), with an expected event rate of 6·2% in the ticagrelor plus aspirin group and an absolute non-inferiority margin of 2·5 percentage points between 1 month and 12 months after percutaneous coronary intervention. The two co-primary endpoints were tested sequentially; the primary superiority endpoint had to be met for hypothesis testing of the MACCE outcome to proceed. All principal analyses were assessed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT03971500, and is completed. FINDINGS: Between Sept 21, 2019, and Oct 27, 2022, 3400 (97·0%) of the 3505 participants in the IVUS-ACS study were randomly assigned (1700 patients to ticagrelor plus aspirin and 1700 patients to ticagrelor plus placebo). 12-month follow-up was completed by 3399 (>99·9%) patients. Between month 1 and month 12 after percutaneous coronary intervention, clinically relevant bleeding occurred in 35 patients (2·1%) in the ticagrelor plus placebo group and in 78 patients (4·6%) in the ticagrelor plus aspirin group (hazard ratio [HR] 0·45 [95% CI 0·30 to 0·66]; p<0·0001). MACCE occurred in 61 patients (3·6%) in the ticagrelor plus placebo group and in 63 patients (3·7%) in the ticagrelor plus aspirin group (absolute difference -0·1% [95% CI -1·4% to 1·2%]; HR 0·98 [95% CI 0·69 to 1·39]; pnon-inferiority<0·0001, psuperiority=0·89). INTERPRETATION: In patients with an acute coronary syndrome who had percutaneous coronary intervention with contemporary drug-eluting stents and remained event-free for 1 month on dual antiplatelet therapy, treatment with ticagrelor alone between month 1 and month 12 after the intervention resulted in a lower rate of clinically relevant bleeding and a similar rate of MACCE compared with ticagrelor plus aspirin. Along with the results from previous studies, these findings show that most patients in this population can benefit from superior clinical outcomes with aspirin discontinuation and maintenance on ticagrelor monotherapy after 1 month of dual antiplatelet therapy. FUNDING: The Chinese Society of Cardiology, the National Natural Scientific Foundation of China, and the Jiangsu Provincial & Nanjing Municipal Clinical Trial Project. TRANSLATION: For the Mandarin translation of the abstract see Supplementary Materials section.

Outcome of double vs. single valve replacement for rheumatic heart disease.

OBJECTIVE: To compare the follow-up results of double valve replacement (DVR) i.e. mitral valve replacement (MVR) and aortic valve replacement (AVR) vs. isolated MVR or AVR for rheumatic heart disease. STUDY DESIGN: An interventional qausi-experimental study. PLACE AND DURATION OF STUDY: Department of Cardiac Surgery, Punjab Institute of Cardiology, Lahore, from September 1994 till December 2007. METHODOLOGY: Prospective follow-up of 493 patients with mechanical heart valves was carried out using clinical assessment, international normalized ratio and echocardiography. Patients were divided into three groups: group I having MVR, group II having AVR and group III having DVR. Survival, time and causes of mortality, and frequency of valve thrombosis, haemorrhage and cerebrovascular haemorrhage was noted in the three groups and described as proportions. Actuarial survival was analyzed by Kaplan-Meier method. RESULTS: There were 493 with 287 (58.3%) in group I, 87 (17.6%) in group II and 119 (24.1%) in group III. Total follow-up was 2429.2 patient (pt)-years. Of 77 (15.6%) deaths, 19 (3.8%) were in-hospital and 58 (11.8%) were late. In-hospital mortality was highest 4 (4.6%) in group II followed by 5 (4.2%) group III and 10 (3.5%) group I. Late deaths were 39 (13.4%) in group I, 9 (10.2%) in group II and 10 (8.3%) in group III. The total actuarial survival was 84.4% with survival of 83%, 85.1%, 87.4% in groups I, II and III respectively. On follow-up valve thrombosis occurred in 12 (0.49%/pt-years) patients; 9 (0.67%/pt-years) group I, 1 (0.22%/pt-years) in group II and 2 (0.31%/pt-years) in group III. Severe haemorrhage occurred in 19 (0.78%/pt-years); 14 in (1.04%/pt-years) in group I, 3 (0.66%/pt-years) group II and 2 (0.31%/pt-years) in group III. Cerebrovascular accidents occurred in 34 (1.3%/pt-years); 26 (1.95%/pt-years) in group I and 4 in groups II (0.89%/pt-years) and III (0.62%/pt-years) each. CONCLUSION: In patients with rheumatic heart disease having combined mitral and aortic valve disease DVR should be performed whenever indicated as it has similar in-hospital mortality and better late survival as compared to isolated aortic or mitral valve replacement.

Role of 64-slice multi detector computed tomography for non-invasive visualisation of coronary artery bypass grafts for follow up in post CABG patients.

BACKGROUND: Coronary artery bypass graft surgery is a commonly performed revascularization procedure in ischemic heart disease patients. Conventional coronary angiography is an invasive method for evaluation of grafts in such patients. Non-invasive evaluation of grafts in post CABG patient has been made possible with the advent of 64-Slice Multi Detector Computed Tomography (MDCT) The Objective of the study was to non-invasively assess the graft patency with MDCT. METHODS: Sixty post CABG patients (52 male, 8 female) with atypical chest pain or stable angina were evaluated with MDCT for graft patency. The grafts were considered as patent if there was continuous lumen visualisation at origin, in the body and at its insertion with native recipient vessels. Grafts were defined as blocked when only stumps were seen. They were classified as stenotic if there was > or = 50% diameter narrowing. RESULTS: The mean age of the patients was 60.1 +/- 9.7 years, mean duration since CABG was 8.01 +/- 6 years. Total number of grafts assessed was 175 including 124 (71%) venous grafts and 51 (28.9%) arterial grafts. A total of 82/124 (66.1%) venous grafts and 47/51 (92%) arterial grafts were patent. Forty-two (34%) venous grafts were blocked whereas 4 arterial grafts were not developed. Arterial grafts patency was 92% and venous grafts patency was 67.7% after a mean follow up of 8.01 +/- 6 years. CONCLUSION: The study shows that 64 slice MDCT can be used for the evaluation of patency and occlusion of venous and arterial grafts in post CABG patients for follow up.