Summary Background Clopidogrel and aspirin are the most commonly used antiplatelet therapies for percutaneous coronary intervention (PCI). We assessed the effect of various clopidogrel and aspirin ...regimens in prevention of major cardiovascular events and stent thrombosis in patients undergoing PCI. Methods The CURRENT-OASIS 7 trial was undertaken in 597 centres in 39 countries. 25 086 individuals with acute coronary syndromes and intended early PCI were randomly assigned to double-dose (600 mg on day 1, 150 mg on days 2–7, then 75 mg daily) versus standard-dose (300 mg on day 1 then 75 mg daily) clopidogrel, and high-dose (300–325 mg daily) versus low-dose (75–100 mg daily) aspirin. Randomisation was done with a 24 h computerised central automated voice response system. The clopidogrel dose comparison was double-blind and the aspirin dose comparison was open label with blinded assessment of outcomes. This prespecified analysis is of the 17 263 individuals who underwent PCI. The primary outcome was cardiovascular death, myocardial infarction, or stroke at 30 days. Analyses were by intention to treat, adjusted for propensity to undergo PCI. This trial is registered with ClinicalTrials.gov , number NCT00335452. Findings 8560 patients were assigned to double-dose and 8703 to standard-dose clopidogrel (8558 and 8702 completed 30-day follow-up, respectively), and 8624 to high-dose and 8639 to low-dose aspirin (8622 and 8638 completed 30-day follow-up, respectively). Compared with the standard dose, double-dose clopidogrel reduced the rate of the primary outcome (330 events 3·9% vs 392 events 4·5%; adjusted hazard ratio 0·86, 95% CI 0·74–0·99, p=0·039) and definite stent thrombosis (58 0·7% vs 111 1·3%; 0·54 0·39–0·74, p=0·0001). High-dose and low-dose aspirin did not differ for the primary outcome (356 4·1% vs 366 4·2%; 0·98, 0·84–1·13, p=0·76). Major bleeding was more common with double-dose than with standard-dose clopidogrel (139 1·6% vs 99 1·1%; 1·41, 1·09–1·83, p=0·009) and did not differ between high-dose and low-dose aspirin (128 1·5% vs 110 1·3%; 1·18, 0·92–1·53, p=0·20). Interpretation In patients undergoing PCI for acute coronary syndromes, a 7-day double-dose clopidogrel regimen was associated with a reduction in cardiovascular events and stent thrombosis compared with the standard dose. Efficacy and safety did not differ between high-dose and low-dose aspirin. A double-dose clopidogrel regimen can be considered for all patients with acute coronary syndromes treated with an early invasive strategy and intended early PCI. Funding Sanofi-Aventis and Bristol-Myers Squibb.
The no reflow phenomenon is reported to occur in >2% of all percutaneous coronary interventions (PCIs) and portends a poor prognosis. We analyzed data from 5,286 consecutive patients who underwent ...PCI from the Melbourne Interventional Group (MIG) registry from April 2004 through January 2008 who had 30-day follow-up completed. Patients without no reflow (normal reflow, n = 5,031) were compared to 255 (4.8%) with no reflow (n = 217 for transient no reflow, n = 38 for persistent no reflow). Patients with transient or persistent no reflow were more likely to present with ST-elevation myocardial infarction (MI) or cardiogenic shock (p <0.0001 for the 2 comparisons). They were also more likely to have complex lesions (American College of Cardiology/American Heart Association type B2/C), have lesions within a bypass graft, require an intra-aortic balloon pump, receive glycoprotein IIb/IIIa inhibition, and have a longer mean stent length (p <0.0001 for all comparisons). In-hospital outcomes were significantly worse in those patients with transient or persistent no reflow, with increased death, periprocedural MI, renal impairment, and major adverse cardiac events (p <0.0001 for all comparisons). Similarly, transient and persistent no reflow portended worse 30-day clinical outcomes, with a progressive increase in mortality (normal reflow 1.7% vs transient no reflow 5.5% vs persistent no reflow 13.2%, p <0.0001), MI, target vessel revascularization, and major adverse cardiac events (p <0.0001 for all comparisons) compared to patients with normal flow. In conclusion, transient or persistent no reflow complicates approximately 1 in 20 PCIs and results in stepwise increases in in-hospital and 30-day adverse outcomes.
Since the call for a National Cardiac Procedures Database in 2001, much work has been accomplished in both cardiac surgery and interventional cardiology in an attempt to establish a unified, ...systematic approach to data collection, defining a common minimum dataset pertinent to the Australian context, and instituting quality control measures to ensure integrity and privacy of data. In this paper we outline the aims of the Australasian Society of Cardiac and Thoracic Surgeons (ASCTS) and the Melbourne Interventional Group (MIG) registries, and propose a comprehensive set of standardised data elements and their definitions to facilitate transparency in data collection, consistency between these and other data sets, and encourage ongoing peer-review. The aims are to improve outcomes for patients by determining key performance indicators and standards of performance for hospital units, to allow estimation of procedural risks and likelihood of outcomes for patients, and to report outcomes to relevant stake-holders and the public.
Recent reports suggest that drug-eluting stents (DESs) may increase the risk of stent thrombosis (ST) relative to bare-metal stents (BMSs). Therefore, the aim of this study was to compare DES and BMS ...outcomes with a specific focus on ST. We analyzed 30-day and 1-year outcomes of 2,919 patients who underwent percutaneous coronary intervention with stent implantation from the Melbourne Interventional Group registry. Academic Research Consortium definitions of ST were used: (1) definite ST (confirmed using angiography in patients with an acute coronary syndrome), (2) probable ST (unexplained death <30 days or target-vessel myocardial infarction without angiographic confirmation), and (3) possible ST (unexplained death >30 days). Multivariate analysis was performed to identify predictors of ST. The incidence of ST (early or late) was similar between BMSs and DESs (1.6% vs 1.4%; p = 0.66), and DES use was not predictive of ST. Independent predictors of ST included the absence of clopidogrel therapy at 30 days (odds ratio OR 2.58, 95% confidence interval CI 1.29 to 5.29, p <0.01), renal failure (OR 3.30, 95% CI 1.43 to 7.59, p <0.01), index procedure presentation with an acute coronary syndrome (OR 2.59, 95% CI 1.14 to 5.87, p = 0.02), diabetes mellitus (OR 2.25, 95% CI 1.19 to 4.23, p = 0.01), and total stent length ≥20 mm (OR 1.85, 95% CI 1.00 to 3.42, p = 0.04). In conclusion, DESs were not associated with increased risk of ST compared with BMSs at 12 months in this large Australian registry that selectively used DESs for patients at high risk of restenosis.
Objective To describe and outline audit and quality control activities of the multicentre interventional and cardiac surgery registry in Victoria as a potential model for a national registry. Design, ...setting, and patients The Melbourne Interventional Group (MIG) database is a prospective multicentre registry recording consecutive percutaneous coronary interventional (PCI) procedures across eight Victorian hospitals. Similarly, the Australasian Society of Cardiac and Thoracic Surgeons (ASCTS) database captures cardiac surgical activity across six Victorian hospitals. Auditing of each registry involved systematic selection of baseline, clinical and procedural variables from 5% of procedures to examine for data integrity and mismatches. Main outcome measures Performance trend and data accuracy of each registry was assessed by the number of mismatches detected during the auditing process for different demographic, clinical and procedural variables and across different (de-identified) sites. Results Over two auditing phases from 2004–2006 and 2007, 10 (4.3%) of variables from 3% of all PCI procedures and 15 (6.4%) variables from 5% of PCI procedures were analysed. There was 96.5% agreement during the first auditing phase of the MIG registry with an average of 0.35 mismatches per audit (CI 0.28–0.42), whereas during the second audit phase, agreement was up to 97% with 0.32 mismatches per 10 fields per audit (CI 0.25–0.40). The ASCTS database audit selected 39 (14.8%) variables from 5% of annual surgical cases across six cardiac surgical centres with an overall 96.7% agreement. Conclusion The current auditing process of these two databases is rigorous, robust and reflects a high degree of accuracy of data collected by participating hospitals.
There are few data on the incidence and clinical outcomes of patients with atrial fibrillation (AF) treated in the era of percutaneous coronary intervention (PCI). We analyzed 30-day clinical ...outcomes in 3,307 consecutive patients with and without AF (sinus rhythm) undergoing PCI from January 2007 through December 2008 enrolled in a multicenter Australian registry. Periprocedural AF was present in 162 patients (4.9%). AF was associated with older age (74.1 ± 8.9 vs 63.9 ± 11.9 years, p <0.001), higher baseline serum creatinine (0.13 ± 0.14 vs 0.10 ± 0.13 mmol/L, p = 0.01), and lower left ventricular ejection fraction (49.5 ± 13.2% vs 53.4% ± 11.6%, p <0.001). Significantly more patients with AF had a history of heart failure and cerebrovascular and peripheral arterial diseases (p ≤0.01 for all comparisons). Periprocedural glycoprotein IIb/IIIa inhibitor (31.5% vs 31.4%, p = 0.98) and antithrombin use were not different between groups, but in-hospital bleeding complications were higher in patients with AF (5.0% vs 2.1%, p = 0.015). Fewer patients with AF received drug-eluting stents (p = 0.004). AF was associated with a greater than fourfold increase in 30-day mortality (9.9% vs 2.2%, p <0.0001) and readmission rates at 30 days (p = 0.01). Fewer patients with AF were on dual antiplatelet therapy at 30 days (86.3% vs 94.3%, p <0.0001), although 28.1% of patients with AF were on triple therapy (dual antiplatelet therapy plus oral anticoagulation). In conclusion, patients with periprocedural AF represent a very high-risk group. Excess 30-day morbidity and mortality after PCI may be due to the higher incidence of co-morbidities, bleeding complications, and suboptimal antiplatelet therapy.
Survival of Elderly Patients Undergoing Percutaneous Coronary Intervention for Acute Myocardial Infarction Complicated by Cardiogenic Shock Han S. Lim, Omar Farouque, Nick Andrianopoulos, Bryan P. ...Yan, Chris C. S. Lim, Angela L. Brennan, Chris M. Reid, Melanie Freeman, Kerrie Charter, Alexander Black, Gishel New, Andrew E. Ajani, Stephen J. Duffy, David J. Clark, on behalf of the Melbourne Interventional Group The objective of this study was to assess clinical outcomes of elderly patients (≥75 years old) undergoing percutaneous coronary intervention (PCI) for acute myocardial infarction (MI) complicated by cardiogenic shock (CS) in a contemporary multicenter PCI registry. We analyzed 143 consecutive patients presenting with MI and CS who underwent PCI from the Melbourne Interventional Group registry between 2004 and 2007. A total 45 patients were elderly. In this study, the 1-year survival of elderly patients with acute MI complicated by CS undergoing PCI was comparable to younger patients. This suggests elderly patients presenting with CS may benefit from selective use of early revascularization.
The Mystery of Coronary Artery Spasm Ajani, Andrew E., MD, FRACP, FJFICM, FCSANZ; Yan, Bryan P., FRACP
Heart, lung & circulation,
02/2007, Volume:
16, Issue:
1
Journal Article
Peer reviewed
Coronary artery spasm is an important cause of chest pain and myocardial ischaemia. It can be defined as an exaggerated contractile response of epicardial coronary artery smooth muscle to various ...stimuli but the underlying mechanism is not well understood. Recent studies have shown that the loss of endothelial vasodilatory function in conjunction with an increase in vascular smooth muscle constrictor sensitivity to calcium are the likely predisposing conditions for coronary spasm. This review highlights current understanding of the pathophysiology, predisposing factors, diagnostic and therapeutic approaches for coronary spasm.
Objectives Controversy continues over the optimal revascularisation strategy for patients with multi-vessel coronary artery disease. Clinical characteristics, risk profile, and mortality of patients ...undergoing coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) are thought to differ but there are limited contemporary comparative data. Methods We compared clinical characteristics, in-hospital and 30-day mortality of 3841 consecutive patients undergoing isolated CABG and 4417 undergoing PCI. Independent predictors of 30-day mortality were determined by multiple logistic regression analysis. Results CABG patients were older ( p < 0.01). The CABG group had a higher incidence of diabetes, heart failure, left ventricular ejection fraction <45%, multi-vessel coronary artery, peripheral vascular and cerebro-vascular disease (all p < 0.01). Patients undergoing PCI had a higher incidence of recent myocardial infarction (MI) as the indication for revascularisation ( p < 0.01). In-hospital and 30-day mortality was 1.8% and 1.7% in the CABG group, and 1.4% and 1.8% in the PCI group, respectively. Independent predictors of 30-day mortality after CABG were age (odds ratio 1.1 per year, 95% confidence interval 1.0–1.1), cardiogenic shock (4.10, 1.7–10.5) and previous CABG (6.6, 2.4–17.7). Predictors after PCI were diabetes (2.7, 1.4–5.1), female gender (3.0, 1.6–5.5), renal failure (3.2, 1.2–8.0), MI < 24 h (4.0, 2.2–7.6), left main intervention (5.4, 1.0–27.7), heart failure (6.0, 2.6–14.0) and cardiogenic shock (11.7, 5.4–25.2). Conclusions In contemporary clinical practice, CABG is preferred in patients with multi-vessel coronary and associated non-coronary vascular disease, while PCI is the dominant strategy for acute MI. Despite this, in-hospital and 30-day mortality rates were similar. Predictors of early mortality after CABG differ to those of PCI.
Background The optimal duration of clopidogrel use for prevention of stent thrombosis with drug-eluting stent (DES) use is uncertain. Our objective was to determine whether the planned duration of ...clopidogrel at the time of percutaneous coronary intervention affected patient outcomes. Methods We analyzed data from 2,980 patients who underwent percutaneous coronary intervention in the Melbourne Interventional Group registry who had 12-month follow-up. We compared outcomes at 30 days and 12 months according to planned duration of clopidogrel use. Results Twelve-month mortality was significantly lower in patients with a DES with a longer (≥12 months) planned duration of clopidogrel when compared with a shorter (≤6 months) planned duration (2.8% vs 5.3%, P = .012). However, myocardial infarction, target-vessel revascularization, and overall major adverse cardiac events were similar in the longer- and shorter-duration clopidogrel strategies. In contrast, in patients receiving a bare-metal stent, mortality at 12 months was similar among the clopidogrel-duration strategies. Kaplan-Meier analysis demonstrated improved cumulative survival with planned clopidogrel use of ≥12 months (log rank P = .017), and the propensity score–adjusted odds ratio was 0.59 (95% confidence interval 0.35-0.99, P = .04). Premature cessation of clopidogrel in DES patients was documented in 5.2% of patients alive at 30-day follow-up, and these patients had increased 12-month mortality (10.6% vs 1.4%, P < .0001) and major adverse cardiac events (22.4% vs 12.0%, P = .005). Conclusions These data suggest that in patients treated with DES, longer (≥12 months) planned duration of clopidogrel results in reduced 12-month mortality and that premature cessation of clopidogrel results in significantly higher event rates. Randomized studies are urgently needed to address this issue.
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