Prevalence, Management and Outcomes of Percutaneous Coronary Intervention for Coronary In-Stent Restenosis: Insights From the France PCI Registry.

BACKGROUND: Despite the evolution of stent technology, there is a non-negligible risk of in-stent restenosis (ISR) after Percutaneous coronary intervention (PCI). Large-scale registry data on the prevalence and clinical management of ISR is lacking. METHODS: The aim was to describe the epidemiology and management of patients with ≥1 ISR lesions treated with PCI (ISR PCI). Data on characteristics, management and clinical outcomes were analyzed for patients undergoing ISR PCI in the France-PCI all-comers registry. RESULTS: Between January 2014 and December 2018, 31,892 lesions were treated in 22,592 patients, 7.3 % of whom underwent ISR PCI. Patients undergoing ISR PCI were older (68.5 vs 67.8; p < 0.001), and more likely to have diabetes (32.7 % vs 25.4 %, p < 0.001), chronic coronary syndrome or multivessel disease. ISR PCI concerned drug eluting stents (DES) ISR in 48.8 % of cases. Patients with ISR lesions were more frequently treated with DES than drug eluting balloon or balloon angioplasty (74.2 %, 11.6 % and 12.9 %, respectively). Intravascular imaging was rarely used. At 1 year, patients with ISR had higher target lesion revascularization rates (4.3 % vs. 1.6 %; HR 2.24 [1.64-3.06]; p < 0.001). CONCLUSIONS: In a large all-comers registry, ISR PCI was not infrequent and associated with worse prognosis than non-ISR PCI. Further studies and technical improvements are warranted to improve the outcomes of ISR PCI.

Early survival after acute myocardial infarction with ST-segment elevation: What could be improved? Insights from France PCI French registry.

Early mortality post-ST-segment elevation myocardial infarction (STEMI) in France remains high. The multicentre France Percutaneous Coronary Intervention Registry includes every patient undergoing coronary angiography in France. We analyzed the prevalence and impact of unmodifiable and modifiable risk factors on 30-day survival in patients experiencing STEMI. Patients admitted for STEMI between 01/2014 and 12/2016 were included in the analysis. Patients with nonobstructive coronary artery disease, with cardiogenic shock or cardiac arrest without STEMI, were excluded. Prehospital, clinical and procedural data were collected prospectively by the cardiologist in the cath lab using medical reporting software. Information on outcomes, including mortality, was obtained by a dedicated research technician by phone calls or from medical records. Marginal Cox proportional hazards regression was used to test the predictive value for survival at 30 days in a multivariable analysis. Included were 2590 patients (74% men) aged 63 ± 14 years. During the first month, 174 patients (6.7%) died. After adjustment, unmodifiable variables significantly associated with reduced 30-day survival were: age > 80 years (prevalence 15%; hazard ratio [HR] 2.7; 95% confidence interval [CI] 1.5-4.7), chronic kidney disease (2%; HR 5.3; 95% CI 2.6-11.1), diabetes mellitus (14%; HR 1.6; 95% CI 1.0-2.5), anterior or circumferential electrical localization (39%; HR 2.0; 95% CI 1.4-2.9), and Killip class 2, 3, or 4 (7%; HR 3.4; 95% CI 1.9-5.9; 2%; HR 10.1; 95% CI 5.3-19.4; 4%; HR 18; 95% CI 10.8-29.8, respectively). Among modifiable variables, total ischemic time > 3 hours (68%; HR 1.8; 95% CI 1.1-3.0), lack of appropriate premedication (18%; HR 2.2; 95% CI 1.5-3.3), and post-PCI TIMI < 3 (6%; HR 4.9; 95% CI 3.2-7.6) were significantly associated with reduced 30-day survival. Most predictors of 30-day survival post-STEMI are unmodifiable, but outcomes might be improved by optimizing modifiable factors, most importantly ischemic time and appropriate premedication.

Clinical impact of FFR-guided PCI compared to angio-guided PCI from the France PCI registry.

OBJECTIVES: We sought to compare, in a national French registry (FrancePCI), the clinical impact of fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) compared with angio-guided PCI at 1 year. BACKGROUND: FFR has become the invasive gold standard to quantify myocardial ischemia generated by a coronary stenosis in patients with chronic coronary syndrome, but in clinical practice it is still underutilised to guide PCI compared to angiography (angio). METHODS: We extracted from the FrancePCI database all chronic coronary syndrome patients treated with PCI for coronary stenosis <90% between 2014 and 2019. Our composite clinical endpoint was the rate of major adverse clinical events (MACE). RESULTS: Fourteen thousand three hundred eighty-four patients with 1-year clinical follow-up were included. Among them, 13,125 had angio-guided PCI (91%) and 1259 (9%) had FFR-guided PCI. We observed a significantly higher rate of MACE in the angio-guided group versus the FFR-guided group: 1478 (11.3%) versus 100 (7.9%) (p < 0.0001), respectively, with hazard ratio (HR) of 1.440, 95% confidence interval (CI) [1.211-1.713] (p = 0.0004). This result was driven by the higher occurrence of death in the angio-guided group versus the FFR-guided-group: 506 (3.9%) versus 17 (1.4%) (p < 0.0001), respectively, with HR of 2.845, 95% CI [2.099-3.856] (p < 0.0001). After adjustment for potential confounding factors, HRs were 1.287, 95% CI [1.028-1.613] (p = 0.028) for MACE and 2.527, 95% CI [1.452-4.399] (p = 0.001) for death. No significant differences between angio-guided PCI and FFR-guided PCI were observed for other clinical endpoints. CONCLUSIONS: FFR-guided PCI improves outcome at 1 year compared to angio-guided PCI with a reduction of 64% of death.

Indirect Transfer to Catheterization Laboratory for ST Elevation Myocardial Infarction Is Associated With Mortality Independent of System Delays: Insights From the France-PCI Registry.

Background: First medical contact (FMC)-to-balloon time is associated with outcome of ST-elevation myocardial infarction (STEMI). We assessed the impact on mortality and the determinants of indirect vs. direct transfer to the cardiac catheterization laboratory (CCL). Methods: We analyzed data from 2,206 STEMI patients consecutively included in a prospective multiregional percutaneous coronary intervention (PCI) registry. The primary endpoint was 1-year mortality. The impact of indirect admission to CCL on mortality was assessed using Cox models adjusted on FMC-to-balloon time and covariables unequally distributed between groups. A multivariable logistic regression model assessed determinants of indirect transfer. Results: A total of 359 (16.3%) and 1847 (83.7%) were indirectly and directly admitted for PCI. Indirect admission was associated with higher risk features, different FMCs and suboptimal pre-PCI antithrombotic therapy.At 1-year follow-up, 51 (14.6%) and 137 (7.7%) were dead in the indirect and direct admission groups, respectively (adjusted-HR 1.73; 95% CI 1.22-2.45). The association of indirect admission with mortality was independent of pre-FMC and FMC characteristics. Older age, paramedics- and private physician-FMCs were independent determinants of indirect admission (adjusted-HRs 1.02 per year, 95% CI 1.003-1.03; 5.94, 95% CI 5.94 3.89-9.01; 3.41; 95% CI 1.86-6.2, respectively). Conclusions: Our study showed that, indirect admission to PCI for STEMI is associated with 1-year mortality independent of FMC to balloon time and should be considered as an indicator of quality of care. Indirect admission is associated with higher-risk features and suboptimal antithrombotic therapy. Older age, paramedics-FMC and self-presentation to a private physician were independently associated with indirect admission. Our study, supports population education especially targeting elderly, more adequately dispatched FMC and improved pre-CCL management.

INCREASED EXPOSURE TO X-RAYS DURING CORONARY ANGIOGRAPHY AND PERCUTANEOUS CORONARY INTERVENTIONS ASSOCIATED WITH FRACTIONAL FLOW RESERVE MEASUREMENT AND ENDOCORONARY IMAGING TECHNIQUES.

Growing use of fractional flow reserve (FFR) and intracoronary imaging techniques by optical coherence tomography or intravascular ultrasound has raised concerns about additional exposure during coronary angiography and percutaneous coronary interventions (PCIs). Using data from the prospective CRAC-France PCI Prospective Multicentre registry, we sought to evaluate the effect of these new techniques on the radiation dose to patients undergoing coronary procedures. Data on Kerma Area Product (PKA), total air kerma (KAr) and fluoroscopy time from 42 182 coronary procedures were retrospectively compared, using multivariable linear regression, according to whether they included FFR and intracoronary imaging. In coronary angiography, FFR was associated with longer fluoroscopy time and higher PKA (21.0 vs. 18.9 Gy.cm2) and KAr (372 vs. 299 mGy) (all p < 0.001). Intracoronary imaging was associated with longer fluoroscopy time, higher contrast volume (both p < 0.001), lower PKA (18.3 vs. 19.0 Gy.cm2, p = 0.02) and similar KAr. In PCI, FFR was associated with a moderate increase in KAr (682 vs. 626 mGy, p < 0.01) but not PKA (35.9 vs. 33.7 Gy.cm2, p = 0.34). For intracoronary imaging, there were no differences between groups, except for contrast volume. Increased patient exposure associated with FFR and intracoronary imaging is moderate in diagnostic coronary angiography and minimal or none in PCI, provided optimization techniques are used. It should not be a limitation on the use of these techniques given the important additional information they provide.

Is coronary multivessel disease in acute myocardial infarction patients still associated with worse clinical outcomes at 1-year?

BACKGROUND: ST-elevation myocardial infarction (STEMI) patients with multivessel disease (MVD) are associated with a worse prognosis. However, few comparisons are available according to coronary status in the era of modern reperfusion and optimized secondary prevention. HYPOTHESIS: We hypothesized that the difference in prognosis according to number of vessel disease in STEMI patients has reduced. METHODS: All consecutive STEMI patients undergoing primary percutaneous coronary intervention (PCI) within 24 h of symptoms onset between January 1, 2014 and June 30, 2016 enrolled in the CRAC (Club Régional des Angioplasticiens de la région Centre) France PCI registry were analyzed. Baseline characteristics, management, and outcomes at 1-year were analyzed according to coronary status (one-, two-, and three-VD). RESULTS: A total of 1886 patients (mean age 62.2 ± 14.0 year; 74% of male) were included. Patients with MVD (two or three-VD) represented 53.7%. They were older with higher cardiovascular risk factor profile. At 1 year, the rate of major adverse cardiovascular events (MACE, defined as all-cause death, stroke or re-MI) was 10%, 12%, and 12% in one-, two, and three-VD respectively (p = .28). In multivariable adjusted Cox proportional hazard regression model, two- and three-VD were not associated with higher rate of MACE compared to patients with single VD (HR, 1.09; 95%CI 0.76-1.56 for two-VD; HR, 0.74; 95%CI 0.48-1.14 for three-VD). CONCLUSIONS: MVD still represents an important proportion of STEMI patients but their prognoses were not associated with worse clinical outcomes at 1-year compared with one-VD patients in a modern reperfusion area and secondary medication prevention.

Incidence, delays, and outcomes of STEMI during COVID-19 outbreak: Analysis from the France PCI registry.

Objectives: The aim of this study was to assess the impact of the coronavirus disease 2019 (COVID-19) outbreak on incidence, delays, and outcomes of ST-elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PPCI) in France. Methods: We analyzed all patients undergoing PPCI <24 hours STEMI included in the prospective France PCI registry. The 2 groups were compared on mean monthly number of patients, delays in the pathway care, and in-hospital major adverse cardiac events (MACE: death, stent thrombosis, myocardial infarction, unplanned coronary revascularization, stroke, and major bleeding). Results: From January 15, 2019 to April 14, 2020, 2064 STEMI patients undergoing PPCI were included: 1942 in the prelockdown group and 122 in the lockdown group. Only 2 cases in the lockdown group were positive for COVID-19. A significant drop (12%) in mean number of STEMI/month was observed in the lockdown group compared with prelockdown (139 vs 122, P < 0.04). A significant increase in "symptom onset to first medical contact" delay was found for patients who presented directly to the emergency department (ED) (238 minutes vs 450 minutes; P = 0.04). There were higher rates of in-hospital MACE (7.7% vs 12.3%; P = 0.06) and mortality (4.9% vs 8.2%; P = 0.11) in the lockdown group but the differences were not significant. Conclusion: According to the multicenter France PCI registry, the COVID-19 outbreak in France was associated with a significant decline in STEMI undergoing PPCI and longer transfer time for patients who presented directly to the ED. Mortality rates doubled, but the difference was not statistically significant.

Does helicopter transport delay prehospital transfer for STEMI patients in rural areas? Findings from the CRAC France PCI registry.

AIMS: The aim of this study was to analyse delays in emergency medical system transfer of ST-segment elevation myocardial infarction (STEMI) patients to percutaneous coronary intervention (PCI) centres according to transport modality in a rural French region. METHODS AND RESULTS: Data from the prospective multicentre CRAC / France PCI registry were analysed for 1911 STEMI patients: 410 transferred by helicopter and 1501 by ground transport. The primary endpoint was the percentage of transfers with first medical contact to primary percutaneous coronary intervention within the 90 minutes recommended in guidelines. The secondary endpoint was time of first medical contact to primary percutaneous coronary intervention. With helicopter transport, time of first medical contact to primary percutaneous coronary intervention in under 90 minutes was less frequently achieved than with ground transport (9.8% vs. 37.2%; odds ratio 5.49; 95% confidence interval 3.90; 7.73; P<0.0001). Differences were greatest for transfers under 50 km (13.7% vs. 44.7%; P<0.0001) and for primary transfers (22.4% vs. 49.6%; P<0.0001). The median time from first medical contact to primary percutaneous coronary intervention and from symptom onset to primary percutaneous coronary intervention (total ischaemic time) were significantly higher in the helicopter transport group than in the ground transport group (respectively, 137 vs. 103 minutes; P<0.0001 and 261 vs. 195 minutes; P<0.0001). There was no significant difference in inhospital mortality between the helicopter and ground transport groups (6.9% vs. 6.6%; P=0.88). CONCLUSIONS: Helicopter transport of STEMI patients was five times less effective than ground transport in maintaining the 90-minute first medical contact to primary percutaneous coronary intervention time recommended in guidelines, particularly for transfer distances less than 50 km.

Factors associated with delay in transfer of patients with ST-segment elevation myocardial infarction from first medical contact to catheterization laboratory: Lessons from CRAC, a French prospective multicentre registry.

BACKGROUND: It is critical to minimize the time between the first medical contact and primary percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction. AIMS: To identify factors associated with a delay of>120min between first medical contact and primary percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction. METHODS: Data were analysed from a regional French registry of patients undergoing coronary angioplasty for ST-segment elevation myocardial infarction<24h after symptom onset. Patients (n=2081) were grouped according to transfer times from first medical contact to primary percutaneous coronary intervention:>120min; or≤120min. Independent predictors of delay were identified by univariate and multivariable analyses. RESULTS: The median transfer time from first medical contact to primary percutaneous coronary intervention was 112min; 892 patients (42.9%) had a transfer time>120min. A delay of>120min was significantly associated with:≥75km distance from interventional cardiology centre at symptom onset (odds ratio 7.9); more than one medical practitioner involved before interventional cardiology centre (odds ratio 4.5); first admission to a hospital without an interventional cardiology centre (odds ratio 2.9); absence of emergency call (odds ratio 1.6); ≥90min between symptom onset and first medical contact (odds ratio 1.3); Killip class at admission>1 (odds ratio 1.8); lateral ischaemia (odds ratio 1.8); diabetes mellitus (odds ratio 1.6); and hypertension (odds ratio 1.3). CONCLUSIONS: In ST-segment elevation myocardial infarction, a transfer time from first medical contact to primary percutaneous coronary intervention of>120min was associated with geographic, systemic and comorbid factors, several of which appear reasonably actionable.