Development and evaluation of the accuracy of an indicator of the appropriateness of interventional cardiology generated from a French registry.

BACKGROUND: Development of appropriateness indicators of medical interventions has become a major quality-of-care issue, especially in the domain of interventional cardiology (IC). The objective of this study was to develop and evaluate the accuracy of an indicator of the appropriateness of interventional cardiology acts (invasive coronary angiographies (ICA) and percutaneous coronary interventions (PCI)) in patients with coronary stable disease and silent ischemia, automated from a French registry. METHODS: All ICA and PCI recorded in a Regional IC Registry (ACIRA) and operated for a stable coronary artery disease or silent ischemia from January 1st to December 31th 2013 in eight IC hospitals of Aquitaine, southwestern France, were included. The indicator was developed to reflect European guidelines. Classification of appropriateness by the indicator, measured on the registry database, was compared to the classification of a reference standard (expert judgment applied through complete record review) on a random sample of 300 interventions. Accuracy parameters were estimated. A second version of the indicator was defined, based on the analysis of false negative and positive results, and its accuracy estimated. RESULTS: The second indicator accuracy was: sensitivity 63.5% (95% confidence interval CI [51.7-75.3]), specificity 76.0% (95%CI [70.4-81.6]), PPV 43.0% (95% CI [33.0-53.0]) and NPV 88.0% (95% CI [83.4-92.6]). When stratified on the type of act, parameters were better for ICA alone than for PCI. CONCLUSIONS: Accuracy of the indicator should raise with improvement of database quality. Despite its average accuracy, it is already used as a benchmark indicator for cardiologists. It is sent annually to each IC center with value of the indicator at the region level to allow a comparison.

The ACIRA Registry: A Regional Tool to Improve the Healthcare Pathway for Patients Undergoing Percutaneous Coronary Interventions and Coronary Angiographies in the French Aquitaine Region: Study Design and First Results.

BACKGROUND: In France, there is a lack of information about practices and pathways of coronary angiographies and percutaneous coronary interventions (PCI). We present the design and the first results of the ACIRA registry, the goal of which is to answer questions about quality, security, appropriateness, efficiency of, and access to interventional cardiology (IC) healthcare pathway in the French Aquitaine region. METHODS: The ACIRA registry is an on-going, multicenter, prospective, exhaustive, scalable, and nominative cohort study of patients who undergo coronary angiographies or percutaneous coronary intervention in any of the catheterization laboratories. The data related to hospitalizations and procedures are directly extracted from hospital information systems. In-hospital mortality, readmissions, and cardiovascular morbidity are collected from the French hospital medical information system database. An identity management system has been implemented to create the patient health care pathway. RESULTS: From January 1, 2012, to June 30, 2018, 147,136 procedures performed on 106,005 patients have been included in the ACIRA registry. CONCLUSIONS: ACIRA has shown its ability to study the patient IC healthcare pathway, up to 1 year after the procedure. Nominative data enable the linkage between clinical and medico-administrative databases and possible supplementary data collection. The use of existing databases allowed us to limit patients lost to follow-up, prevent the double entry of data, improve data quality, and reduce the operating costs. The prospect of linkage with the French National Health Data System may offer promising opportunities for future medical research projects and for developing collaboration and benchmarking with other IC registries abroad.

Technical aspects of the provisional side branch stenting strategy.

Provisional side branch (SB) stenting is the recommended treatment strategy in the vast majority of bifurcation lesions. Over the past 10 years, advances in fundamental knowledge have led to a better understanding and to improvements of this technical approach. This strategy has reached maturity, and long-term clinical results are now comparable to those of non-bifurcation lesions. This paper describes in detail simple rules and tips and tricks which may help physicians in daily practice to use provisional side branch (SB) stenting as the gold standard treatment for the majority of bifurcation lesions.

Two-year outcomes of everolimus vs. paclitaxel-eluting stent for the treatment of unprotected left main lesions: a propensity score matching comparison of patients included in the French Left Main Taxus (FLM Taxus) and the LEft MAin Xience (LEMAX) registries.

AIMS: With newer drug-eluting stents (DES), PCI has appeared as an acceptable alternative to cardiac surgery in the treatment of unprotected left main (ULM) lesions. Using data from the French Left Main Taxus and the LEft MAin Xience registries, we compared two-year outcomes in consecutive patients from 2003-2008 using everolimus-eluting stents (EES) vs. paclitaxel-eluting stents (PES). METHODS AND RESULTS: We performed a matched comparison according to SYNTAX score, distal LM stenosis, provisional side-branch T-stenting and single stent use, focusing on the primary endpoints of target vessel MI (TVMI) and target vessel failure (TVF). After propensity score matching, there were 172 patients in each group. There was no difference in gender (76.5% male), age (69.5 ± 11.3 years), diabetes (26.2% vs. 24.4%, p=0.71), NSTEMI (40.7% vs. 40.7%, p=1), or LVEF <40% (11.0% vs. 6.7%, p=0.22). Patients with distal LM lesions (75.9%) were treated using provisional T-stenting in 91.1%. The side branch was stented in 22% of all patients (p=0.51). Cumulative two-year events showed significant differences in TVMI (9.9% vs. 4.1%, p=0.04) and TVF (16.3% vs. 7.6%, p=0.01) for PES and EES, respectively. CONCLUSIONS: ULM stenting with EES is safer and more effective than PES with a reduction in TLF by 53% at two years.

Unprotected left main stenting in the real world: five-year outcomes of the French Left Main Taxus registry.

AIMS: Limited long-term data are available to support drug-eluting stent (DES) unprotected left main (LM) intervention. We sought to evaluate long-term outcomes of LM intervention with paclitaxel-eluting stents. METHODS AND RESULTS: In this prospective multicentre registry, 291 patients with unprotected LM stenosis underwent percutaneous revascularisation with the TAXUS® Express® stent, using a consistent technical approach for both ostial/shaft and bifurcation lesions (provisional side branch stenting). At five years (n=263), the cumulative incidence of major adverse cardiac events (MACE) and cardiac death were 23.6% and 12.5%, respectively. Myocardial infarction (MI) occurred in 16 patients (6.1%), definite stent thrombosis in 0.4%, and target lesion revascularisation (TLR) was required in 10.3%. Patients with distal LM lesions requiring two-stent procedures had increased MACE compared with those with single-stent interventions (34.1% vs. 17.8%, p=0.009). This was primarily driven by an increased incidence of cardiac death (18.2% vs. 8.5%, p=0.05). Diabetes was associated with increased TLR and was an independent predictor of MACE at five years (odds ratio [OR] 2.10, 95% confidence interval [CI] 1.10-3.99, p=0.02). CONCLUSIONS: This study confirms the long-term safety and efficacy of the TAXUS® DES in unprotected LM stenting. Diabetes and the need for a second stent in distal LM interventions were associated with an increased risk of adverse outcomes.

Unprotected left main stenting with a second-generation drug-eluting stent: one-year outcomes of the LEMAX Pilot study.

AIMS: We sought to assess the efficacy and safety of everolimus-eluting stents for unprotected left main disease. METHODS AND RESULTS: A total of 173 consecutive patients with de novo significant unprotected left main stenosis received an everolimus-eluting stent in four French centres. Among them, 140 (81 %) had involvement of the distal portion of left main, and 129/140 (92%) were treated with provisional side branch T-stenting, with a side branch stenting rate of 20%. Angiographic success was achieved in all cases. At 12 months, the cumulative rate of major adverse cardiac or cerebrovascular events (MACCE) was 26/173 (15%) including death from any cause (N=5, 2.9%), stroke (N=4, 2.3%), Q-wave myocardial infarction (MI) (N=2, 1.2%), non-Q-wave MI (N=6, 3.5%) and any repeat revascularisation (N=16, 9.3%). At one year, the rate of target-lesion revascularisation (TLR) was 5/173 (2.9%), target-vessel revascularisation was 12/173 (7 %) and the rate of definite or probable left main stent thrombosis 1/173 (0.6 %). CONCLUSIONS: Unprotected left main stenting using everolimus-eluting stents and a strategy of provisional side branch T-stenting for distal lesions, is safe and effective in the midterm, with a relatively low rate of events and reintervention at one year.

Unprotected left main stenting in the real world: two-year outcomes of the French left main taxus registry.

BACKGROUND: Cardiac surgery is the reference treatment for patients with left main (LM) disease, although percutaneous coronary intervention with drug-eluting stents is emerging as a possible alternative. The objective of this registry was to evaluate the 2-year outcome of elective percutaneous coronary intervention for unprotected LM disease with paclitaxel-eluting stents. METHODS AND RESULTS: A total of 291 patients were prospectively included from 4 centers. Acute myocardial infarction and cardiogenic shock were the only exclusion criteria. Patients were 69+/-11 years old, 29% were diabetic, and 25% had 3-vessel disease. For distal LM lesions (78%), the provisional side-branch T-stenting approach was used in 92% of cases and final kissing balloon inflation in 97%. Angiographic success was obtained in 99.7% of cases. At 2-year follow-up, the total cardiac death rate was 5.4% (1 EuroSCORE point was associated with a 15% [95% confidence interval 2.9% to 28.2%, P=0.013] higher risk of cardiac death), target-lesion revascularization was 8.7%, and incidence of Q-wave or non-Q-wave myocardial infarction was 0.9% and 3.1%, respectively. The combined end point occurred in 15.8% of cases and stroke in 0.7%. The incidence of definite and probable LM stent thrombosis was 0.7%, whereas the incidence of any stent thrombosis was 3.8%, with a higher risk in patients with side-branch stenting in the presence of LM bifurcation lesions (hazard ratio 9.6, 95% confidence interval 1.2 to 77.7, P=0.035). CONCLUSIONS: Unprotected LM stenting with paclitaxel-eluting stents, with a strategy of provisional side-branch T-stenting for distal lesions, provides excellent acute angiographic results and good mid-term clinical outcomes, with a 15.8% rate of major adverse cardiac events at 2-year follow-up.