Ameet Bakhai

Coronary artery bypass surgery versus percutaneous coronary intervention with stent implantation in patients with multivessel coronary artery disease (the Stent or Surgery trial): a randomised controlled trial

BACKGROUND: Results of trials, comparing percutaneous transluminal coronary angioplasty (PTCA) with coronary artery bypass grafting (CABG), indicate that rates of death or myocardial infarction are similar with either treatment strategy. Management with PTCA is, however, associated with an increased requirement for subsequent, additional revascularisation. Coronary stents, used as an adjunct to PTCA, reduce restenosis and the need for repeat revascularisation. The aim of the Stent or Surgery (SoS) trial was to assess the effect of stent-assisted percutaneous coronary intervention (PCI) versus CABG in the management of patients with multivessel disease. METHODS: In 53 centres in Europe and Canada, symptomatic patients with multivessel coronary artery disease were randomised to CABG (n=500) or stent-assisted PCI (n=488). The primary outcome measure was a comparison of the rates of repeat revascularisation. Secondary outcomes included death or Q-wave myocardial infarction and all-cause mortality. Analysis was by intention to treat. FINDINGS: All patients were followed-up for a minimum of 1 year and the results are expressed for the median follow-up of 2 years. 21% (n=101) of patients in the PCI group required additional revascularisation procedures compared with 6% (n=30) in the CABG group (hazard ratio 3.85, 95% CI 2.56-5.79, p<0.0001). The incidence of death or Q-wave myocardial infarction was similar in both groups (PCI 9% [n=46], CABG 10% [n=49]; hazard ratio 0.95, 95% CI 0.63-1.42, p=0.80). There were fewer deaths in the CABG group than in the PCI group (PCI 5% [n=22], CABG 2% [n=8]; hazard ratio 2.91, 95% CI 1.29-6.53, p=0.01). INTERPRETATION: The use of coronary stents has reduced the need for repeat revascularisation when compared with previous studies that used balloon angioplasty, though the rate remains significantly higher than in patients managed with CABG. The apparent reduction in mortality with CABG requires further investigation.BACKGROUND Results of trials, comparing percutaneous transluminal coronary angioplasty (PTCA) with coronary artery bypass grafting (CABG), indicate that rates of death or myocardial infarction are similar with either treatment strategy. Management with PTCA is, however, associated with an increased requirement for subsequent, additional revascularisation. Coronary stents, used as an adjunct to PTCA, reduce restenosis and the need for repeat revascularisation. The aim of the Stent or Surgery (SoS) trial was to assess the effect of stent-assisted percutaneous coronary intervention (PCI) versus CABG in the management of patients with multivessel disease. METHODS In 53 centres in Europe and Canada, symptomatic patients with multivessel coronary artery disease were randomised to CABG (n=500) or stent-assisted PCI (n=488). The primary outcome measure was a comparison of the rates of repeat revascularisation. Secondary outcomes included death or Q-wave myocardial infarction and all-cause mortality. Analysis was by intention to treat. FINDINGS All patients were followed-up for a minimum of 1 year and the results are expressed for the median follow-up of 2 years. 21% (n=101) of patients in the PCI group required additional revascularisation procedures compared with 6% (n=30) in the CABG group (hazard ratio 3.85, 95% CI 2.56-5.79, p<0.0001). The incidence of death or Q-wave myocardial infarction was similar in both groups (PCI 9% [n=46], CABG 10% [n=49]; hazard ratio 0.95, 95% CI 0.63-1.42, p=0.80). There were fewer deaths in the CABG group than in the PCI group (PCI 5% [n=22], CABG 2% [n=8]; hazard ratio 2.91, 95% CI 1.29-6.53, p=0.01). INTERPRETATION The use of coronary stents has reduced the need for repeat revascularisation when compared with previous studies that used balloon angioplasty, though the rate remains significantly higher than in patients managed with CABG. The apparent reduction in mortality with CABG requires further investigation.

Beyond Restenosis Five-Year Clinical Outcomes From Second-Generation Coronary Stent Trials

Background—In the first year after coronary stent implantation, clinical failures are driven mainly by procedural complications and restenosis, but the subsequent relative contributions of restenosis and disease progression to late failures are less clear. Methods and Results—We observed 1228 patients for 5 years after the implantation of stents as part of pivotal second-generation coronary stent trials. Clinical events of death, myocardial infarction, repeat revascularization, and repeat hospitalization for acute coronary syndrome or congestive heart failure were attributed to the index stented (target) lesion or other distinct sites (either in the target or other coronary vessels) and further classified as procedural, restenosis, or nonrestenosis. During the first year the hazard rate was 18.3% for target-lesion events and 12.4% for events unrelated to the target lesion. After the first year the average annual hazard rate was 1.7% for target-lesion events and 6.3% for nontarget-lesion events. By the fifth year, restenosis events occurred in 20.3% of patients, whereas 30-day procedural complications or later nonrestenosis events occurred in 37.9%, including 11.4% who also experienced a restenosis event, for a combined cumulative event rate of 46.4%. Diabetes mellitus and multivessel disease were independently associated with increased risk for both restenosis and nonrestenosis events. Conclusion—In a low-risk clinical trial population, the clinical outcome beyond 1 year after stenting is determined by a high rate of events related to disease progression in segments other than the stented lesion, which itself remains relatively stable.

Cost-Effectiveness of Sirolimus-Eluting Stents for Treatment of Complex Coronary Stenoses Results From the Sirolimus-Eluting Balloon Expandable Stent in the Treatment of Patients With De Novo Native Coronary Artery Lesions (SIRIUS) Trial

Background—Recently, sirolimus-eluting stents (SESs) have been shown to dramatically reduce the risk of angiographic and clinical restenosis compared with bare metal stent (BMS) implantation. However, the overall cost-effectiveness of this strategy is unknown. Methods and Results—Between February and August 2001, 1058 patients with complex coronary stenoses were enrolled in the SIRIUS trial and randomized to percutaneous coronary revascularization with either a SES or BMS. Clinical outcomes, resource use, and costs were assessed prospectively for all patients over a 1-year follow-up period. Initial hospital costs were increased by

Remote monitoring after recent hospital discharge in patients with heart failure: a systematic review and network meta-analysis

2881 per patient with SESs. Over the 1-year follow-up period, use of SESs led to substantial reductions in the need for repeat revascularization, including repeat percutaneous coronary intervention and bypass surgery. Although follow-up costs were reduced by

Fondaparinux versus Enoxaparin in non-ST-elevation acute coronary syndromes:short-term cost and long-term cost-effectiveness using data from the Fifth Organization to Assess Strategies in Acute Ischemic Syndromes Investigators (OASIS-5) trial

2571 per patient with SESs, aggregate 1-year costs remained

Postoperative B-type Natriuretic Peptide for Prediction of Major Cardiac Events in Patients Undergoing Noncardiac Surgery: Systematic Review and Individual Patient Meta-analysis.

309 per patient higher. The incremental cost-effectiveness ratio for SES was

The burden of coronary, cerebrovascular and peripheral arterial disease

1650 per repeat revascularization event avoided or

The cost-effectiveness of the use of clopidogrel in acute coronary syndromes in five countries based upon the CURE study

27 540 per quality-adjusted year of life gained, values that compare reasonably with other accepted medical interventions. Under updated treatment assumptions regarding available stent lengths and duration of antiplatelet therapy, use of SESs was projected to reduce total 1-year costs compared with BMSs. Conclusions—Although use of SESs was not cost-saving compared with BMS implantation, for patients undergoing percutaneous coronary intervention of complex coronary stenoses, their use appears to be reasonably cost-effective within the context of the US healthcare system.

Clinical and Economic Outcomes of Percutaneous Coronary Interventions in the Elderly An Analysis of Medicare Claims Data

Context Readmission to hospital for heart failure is common after recent discharge. Remote monitoring (RM) strategies have the potential to deliver specialised care and management and may be one way to meet the growing needs of the heart failure population. Objective To determine whether RM strategies improve outcomes for adults who have been recently discharged (<28 days) following an unplanned admission due to heart failure. Study design Systematic review and network meta-analysis. Data sources Fourteen electronic databases (including MEDLINE, EMBASE and PsycINFO) were searched to January 2012, and supplemented by hand-searching relevant articles. Study selection All randomised-controlled trials (RCTs) or observational cohort studies with a contemporaneous control group were included. RM interventions included home telemonitoring (TM) (including implanted monitoring devices) with medical support provided during office hours or 24/7 and structured telephone support (STS) programmes delivered via human-to-human contact (HH) or human-to-machine interface (HM). Data Extraction Data were extracted and validity was assessed independently by two reviewers. Results Twenty-one RCTs that enrolled 6317 patients were identified (11 studies evaluated STS (10 of which were HH, while 1 was HM), 9 studies assessed TM, and 1 study assessed both STS and TM). No trial of implanted monitoring devices met the inclusion criteria. Compared with usual care, although not reaching statitistical significance, RM trended to reduce all-cause mortality for STS HH (HR: 0.77, 95% credible interval (CrI): 0.55, 1.08), TM during office hours (HR: 0.76, 95% CrI: 0.49, 1.18) and TM24/7 (HR: 0.49, 95% CrI: 0.20, 1.18). Exclusion of one trial that provided better-than-usual support to the control group rendered each of the above comparisons statistically significant. No beneficial effect on mortality was observed with STS HM. Reductions were also observed in all-cause hospitalisations for TM interventions but not for STS interventions. Care packages generally improved health-related quality-of-life and were acceptable to patients. Conclusions STS HH and TM with medical support provided during office hours showed beneficial trends, particularly in reducing all-cause mortality for recently discharged patients with heart failure. Where ‘usual’ care is less good, the impact of RM is likely to be greater.

Cost-Effectiveness of Coronary Stenting and Abciximab for Patients With Acute Myocardial Infarction Results From the CADILLAC (Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications) Trial

BACKGROUND The study aimed to compare the short-term costs and long-term cost-effectiveness of 2 antithrombotics, fondaparinux and enoxaparin, for non-ST-elevation acute coronary syndrome in the United States. METHODS It was based on a large randomized trial of 20,078 patients Fifth Organization to Assess Strategies in Acute Ischemic Syndromes Investigators [OASIS-5] comparing the therapies in these patients. In OASIS-5, fondaparinux patients had about half the rate of major bleeding 9 days after randomization and at least as good clinical outcomes (death, myocardial infarction, major bleeding and stroke) after 6 months of follow-up. Health care resource use and clinical efficacy data from the trial were incorporated into a cost-effectiveness model as applied to a general US health care system both for the time horizon of the study (6 months) and over the longer term. RESULTS The 180-day cost analysis indicates that fondaparinux would generate a cost saving of