Very long-term efficacy and safety of paclitaxel-eluting balloon after a bare-metal stent for the treatment of ST-elevation myocardial infarction: 8-year results of a randomized clinical trial (PEBSI study).

Background: Drug-eluting stents (DES) are considered the therapy of choice in ST-segment elevation myocardial infarction (STEMI); however, a low persistent rate of revascularizations and stent thrombosis exist over the time. We have previously shown that a paclitaxel (PTX)-drug-coated balloon (DCB) after a bare-metal stent (BMS) implantation (DCB-combined strategy) yields superior angiographic and clinical results compared to BMS in the short term. However, the long-term safety and efficacy of this approach remain uncertain. Methods: An 8-year clinical follow-up was conducted on patients enrolled in the randomized PEBSI-1 trial (NCT01839890). The original trial included patients who suffered a STEMI, patients were randomly assigned to receive a DCB-combined strategy or BMS only and the primary endpoint was in-stent late luminal loss (LLL) at 9-month follow-up. After the completion of this study, death, myocardial re-infarction, ischemia-driven repeated revascularizations included target lesion revascularization (TLR) and target vessel revascularization (TVR), and stent thrombosis, were assessed by yearly contact by a clinical visit, telephone or by electronic records. These outcomes were adhered to ARC-2 criteria. Results: The rate of incomplete follow-up was very low, with only 3 out of 111 patients (2.7%) in the DCB-combined strategy group and 1 out of 112 patients (0.9%) in the BMS group. At 8 years there were a lower rate of TVR [3.7% vs. 14.3%; hazard ratio (HR): 0.243; 95% confidence interval (CI): 0.081-0.727; P=0.006], and a trend towards lower TLR (2.8% vs. 8.9%; HR: 0.300; 95% CI: 0.083-1.090; P=0.052) in the DCB-combined strategy group. No statistical difference between the DCB-combined strategy and BMS groups were found for all causes of death, deaths from cardiovascular disease, reinfarctions or stent thrombosis. Notably in the DCB-combined strategy group, no episode of stent thrombosis occurred after the first year. Similarly, there were no cardiovascular deaths, TVR and TLR in the DCB-combined strategy group after 5 years. In contrast, during the period from year 5 to 8, the BMS group experienced an additional cardiovascular death, as well as one case of TVR, one case of TLR, and one case of stent thrombosis. Conclusions: In STEMI patients, the DCB-combined strategy maintains its safety and clinical efficacy over time. Our rates of TVR, TLR, and very late stent thrombosis (VLST) at very long-term are the lowest ever found in a STEMI trial. Further studies are warranted to assess the potential superiority of this novel strategy as compared with new-generation DES to prevent very late events in these patients. Trial Registration: ClinicalTrials.gov; identifier: NCT01839890.

Three-year outcomes of A Randomized Multicentre Trial Comparing Revascularization and Optimal Medical Therapy for Chronic Total Coronary Occlusions (EuroCTO).

BACKGROUND: Percutaneous coronary intervention (PCI) for chronic total coronary occlusions (CTO) improves clinical symptoms and quality of life. The longer-term safety of PCI compared to optimal medical therapy (OMT) remains uncertain. AIMS: We sought to evaluate the long-term safety of PCI for CTO in a randomised trial as compared to OMT. METHODS: A total of 396 patients with a symptomatic CTO were enrolled into a randomised, multicentre clinical trial comparing PCI and OMT. Half of the patients had a single CTO; the others had multivessel disease. Non-CTO lesions were treated prior to randomisation (2:1 ratio). During follow-up, crossover from OMT to PCI occurred in 7.3% (1 year) and 17.5% (3 years) of patients. RESULTS: At 3 years, the incidence of cardiovascular death or nonfatal myocardial infarction was not significantly different between the groups (OMT 3.7% vs PCI 6.2%; p=0.29). By per-protocol analysis, the difference remained non-significant (OMT 5.7% vs PCI 4.7%; p=0.67). Overall, major adverse cardiovascular events (MACE) were more frequent with OMT (OMT 21.2% vs PCI 11.2%), largely because of ischaemia-driven revascularisation. The rates of stroke or hospitalisation for bleeding were not different between the groups. CONCLUSIONS: At 3 years there was no difference in the rate of cardiovascular death or myocardial infarction between PCI or OMT among patients with a remaining single coronary CTO. The MACE rate was higher in the OMT group due largely to ischaemia-driven revascularisation. CTO PCI appears to be a safe option for patients with a single remaining significant coronary CTO. CinicalTrials.gov: NCT01760083.

Short-term mortality differs between men and women according to the presence of previous cardiovascular disease: Insights from a nationwide STEMI cohort.

BACKGROUND: Sex and prior cardiovascular disease (CVD) are known independent prognostic factors following an ST-elevation myocardial infarction (STEMI). We aimed to examine whether the association between sex and 30-day mortality differ according to the presence of previous CVD in STEMI patients. METHODS: Prospective, observational, multicentre registry of consecutive patients managed in 17 STEMI networks in Spain (83 centres), between April and June 2019. Unadjusted and adjusted logistic regression models assessed the association of 30-day mortality with sex and prior CVD status, as well as their interaction. RESULTS: Among 4366 patients (mean age 63.7 ± 13.0 years; 78% male), there were 337 (8.1%) deaths within the first 30 days. There was an association between crude 30-day mortality and sex (women 10.4% vs. men 7.4%, p = 0.003), and prior CVD (CVD 13.7% vs non-CVD 6.8%, p < 0.001). After adjustment for potential confounding, neither sex nor prior CVD were apparently associated with mortality. Nevertheless, we found a significant sex-CVD interaction (p-interaction = 0.006), since women were at lower risk than men in the subset of patients with prior CVD (OR = 0.30, 95%CI = 0.12-0.80) but not in those without CVD (OR = 1.17, 95%CI = 0.79-1.74). CONCLUSIONS: Women as well as patients with prior CVD have an increased crude risk of 30-day mortality. However, sex-related differences in short term mortality are modulated by the interaction with CVD in STEMI patients. Compared to men, women had a similar prognosis in the subset of patients without CVD, whereas they were associated with a lower risk of mortality among those with prior CVD after adjusting for other prognostic factors.

Analysis of the management of ST-segment elevation myocardial infarction in Spain. Results from the ACI-SEC Infarction Code Registry.

INTRODUCTION AND OBJECTIVES: ST-segment elevation myocardial infarction (STEMI) networks should guarantee STEMI care with good clinical results and within the recommended time parameters. There is no contemporary information on the performance of these networks in Spain. The objective of this study was to analyze the clinical characteristics of patients, times to reperfusion, characteristics of the intervention performed, and 30-day mortality. METHODS: Prospective, observational, multicenter registry of consecutive patients treated in 17 STEMI networks in Spain (83 centers with the Infarction Code), between April 1 and June 30, 2019. RESULTS: A total of 5401 patients were attended (mean age, 64±13 years; 76.9% male), of which 4366 (80.8%) had confirmed STEMI. Of these, 87.5% were treated with primary angioplasty, 4.4% with fibrinolysis, and 8.1% did not receive reperfusion. In patients treated with primary angioplasty, the time between symptom onset and reperfusion was 193 [135-315] minutes and the time between first medical contact and reperfusion was 107 [80-146] minutes. Overall 30-day mortality due to STEMI was 7.9%, while mortality in patients treated with primary angioplasty was 6.8%. CONCLUSIONS: Most patients with STEMI were treated with primary angioplasty. In more than half of the patients, the time from first medical contact to reperfusion was <120 minutes. Mortality at 30 days was relatively low.

Impact of diabetes in patients waiting for invasive cardiac procedures during COVID-19 pandemic.

BACKGROUND: During COVID-19 pandemic, elective invasive cardiac procedures (ICP) have been frequently cancelled or postponed. Consequences may be more evident in patients with diabetes. OBJECTIVES: The objective was to identify the peculiarities of patients with DM among those in whom ICP were cancelled or postponed due to the COVID-19 pandemic, as well as to identify subgroups in which the influence of DM has higher impact on the clinical outcome. METHODS: We included 2,158 patients in whom an elective ICP was cancelled or postponed during COVID-19 pandemic in 37 hospitals in Spain. Among them, 700 (32.4%) were diabetics. Patients with and without diabetes were compared. RESULTS: Patients with diabetes were older and had a higher prevalence of other cardiovascular risk factors, previous cardiovascular history and co-morbidities. Diabetics had a higher mortality (3.0% vs. 1.0%; p = 0.001) and cardiovascular mortality (1.9% vs. 0.4%; p = 0.001). Differences were especially important in patients with valvular heart disease (mortality 6.9% vs 1.7% [p < 0.001] and cardiovascular mortality 4.9% vs 0.9% [p = 0.002] in patients with and without diabetes, respectively). In the multivariable analysis, diabetes remained as an independent risk factor both for overall and cardiovascular mortality. No significant interaction was found with other clinical variables. CONCLUSION: Among patients in whom an elective invasive cardiac procedure is cancelled or postponed during COVID-19 pandemic, mortality and cardiovascular mortality is higher in patients with diabetes, irrespectively on other clinical conditions. These procedures should not be cancelled in patients with diabetes.

Scoring balloon predilation before bioresorbable vascular scaffold implantation in patients with in-stent restenosis: the RIBS VI 'scoring' study.

BACKGROUND: Currently drug-eluting stents (DES) and drug-eluting balloons are recommended in patients with in-stent restenosis (ISR). However, the efficacy of bioresorbable vascular scaffolds (BVS) after scoring balloon (SCB) predilation in these patients is unknown. METHODS: RIBS VI (NCT02672878) and RIBS VI 'Scoring' (NCT03069066) are prospective multicentre studies assessing the value of BVS in patients with ISR. Inclusion and exclusion criteria were identical in both studies. Results of conventional BVS implantation (112 patients) were compared with those obtained with systematic SCB therapy before BVS (108 patients). Angiographic follow-up was scheduled for all patients. RESULTS: On late angiography (93% of eligible patients) the in-segment minimal lumen diameter (primary end-point) (1.88 ± 0.5 vs. 1.90 ± 0.4 mm, P = 0.81), % diameter stenosis (28 ± 17 vs. 29 ± 15%), late lumen loss (0.23 ± 0.4 vs. 0.22 ± 0.4 mm) and binary restenosis rate (8.5 vs. 9.3%) were similar in the conventional BVS and SCB + BVS groups, respectively. At 1-year follow-up (100% of patients) target lesion revascularization (TLR) requirement (9.8 vs. 11.1%) was similar with the two strategies. Freedom from cardiac death, myocardial infarction and TLR was 88% and 87%, respectively. Results remained unchanged after adjusting for potential baseline confounders and were consistent in 10 prespecified subgroups. CONCLUSION: This study suggests that results of conventional BVS implantation in patients with ISR are not improved by systematic predilation with SCB. ClinicalTrials.gov ID: NCT02672878 (RIBS VI) and NCT03069066 (RIBS VI 'Scoring').

Consequences of canceling elective invasive cardiac procedures during Covid-19 outbreak.

BACKGROUND: During COVID-19 pandemic in Spain, elective procedures were canceled or postponed, mainly due to health care systems overwhelming. OBJECTIVE: The objective of this study was to evaluate the consequences of interrupting invasive procedures in patients with chronic cardiac diseases due to the COVID-19 outbreak in Spain. METHODS: The study population is comprised of 2,158 patients that were pending on elective cardiac invasive procedures in 37 hospitals in Spain on the 14th of March 2020, when a state of alarm and subsequent lockdown was declared in Spain due to the COVID-19 pandemic. These patients were followed-up until April 31th. RESULTS: Out of the 2,158 patients, 36 (1.7%) died. Mortality was significantly higher in patients pending on structural procedures (4.5% vs. 0.8%, respectively; p < .001), in those >80 year-old (5.1% vs. 0.7%, p < .001), and in presence of diabetes (2.7% vs. 0.9%, p = .001), hypertension (2.0% vs. 0.6%, p = .014), hypercholesterolemia (2.0% vs. 0.9%, p = .026) [Correction added on December 23, 2020, after first online publication: as per Dr. Moreno's request changes in p-values were made after original publication in Abstract.], chronic renal failure (6.0% vs. 1.2%, p < .001), NYHA > II (3.8% vs. 1.2%, p = .001), and CCS > II (4.2% vs. 1.4%, p = .013), whereas was it was significantly lower in smokers (0.5% vs. 1.9%, p = .013). Multivariable analysis identified age > 80, diabetes, renal failure and CCS > II as independent predictors for mortality. CONCLUSION: Mortality at 45 days during COVID-19 outbreak in patients with chronic cardiovascular diseases included in a waiting list due to cancellation of invasive elective procedures was 1.7%. Some clinical characteristics may be of help in patient selection for being promptly treated when similar situations happen in the future.

In-hospital outcomes of COVID-19 ST-elevation myocardial infarction patients.

AIMS: The aim of this study was to assess clinical and prognosis differences in patients with COVID-19 and STEMI. METHODS AND RESULTS: Using a nationwide registry of consecutive patients managed within 42 specific STEMI care networks, we compared patient and procedure characteristics and in-hospital outcomes in two different cohorts, according to whether or not they had COVID-19. Among 1,010 consecutive STEMI patients, 91 were identified as having COVID-19 (9.0%). With the exception of smoking status (more frequent in non-COVID-19 patients) and previous coronary artery disease (more frequent in COVID-19 patients), clinical characteristics were similar between the groups, but COVID-19 patients had more heart failure on arrival (31.9% vs 18.4%, p=0.002). Mechanical thrombectomy (44% vs 33.5%, p=0.046) and GP IIb/IIIa inhibitor administration (20.9% vs 11.2%, p=0.007) were more frequent in COVID-19 patients, who had an increased in-hospital mortality (23.1% vs 5.7%, p<0.0001), that remained consistent after adjustment for age, sex, Killip class and ischaemic time (OR 4.85, 95% CI: 2.04-11.51; p<0.001). COVID-19 patients had an increase of stent thrombosis (3.3% vs 0.8%, p=0.020) and cardiogenic shock development after PCI (9.9% vs 3.8%, p=0.007). CONCLUSIONS: Our study revealed a significant increase in in-hospital mortality, stent thrombosis and cardiogenic shock development after PCI in patients with STEMI and COVID-19 in comparison with contemporaneous non-COVID-19 STEMI patients.

Impacto de la COVID-19 en el tratamiento del infarto agudo de miocardio con elevación del segmento ST. La experiencia española / Impact of COVID-19 on ST-segment elevation myocardial infarction care. The Spanish experience

INTRODUCCIÓN Y OBJETIVOS: El impacto del brote de COVID-19 en el tratamiento del infarto agudo de miocardio con elevación del segmento ST (IAMCEST) no está claro. El objetivo de este estudio es evaluar los cambios en el tratamiento del IAMCEST durante el brote de COVID-19. MÉTODOS: Se utilizó un registro multicéntrico, nacional, retrospectivo y observacional de pacientes consecutivos atendidos en 75 centros, se compararon las características de los pacientes y de los procedimientos y los resultados hospitalarios en 2 cohortes según se los hubiera tratado antes o durante la COVID-19. RESULTADOS: Los casos con sospecha de IAMCEST disminuyeron el 27,6% y los pacientes con IAMCEST confirmado se redujeron de 1.305 a 1.009 (22,7%). No hubo diferencias en la estrategia de reperfusión (más del 94% tratados con angioplastia primaria). El tiempo de isquemia fue más largo durante la COVID-19 (233 [150-375] frente a 200 [140-332] min; p <0,001), sin diferencias en el tiempo primer contacto médico-reperfusión. La mortalidad hospitalaria fue mayor durante la COVID-19 (el 7,5 frente al 5,1%; OR bruta=1,50; IC95%, 1,07-2,11; p <0,001); esta asociación se mantuvo tras ajustar por factores de confusión (OR ajustada=1,88; IC95%, 1,12-3,14; p = 0,017). La incidencia de infección confirmada por SARS-CoV-2 fue del 6,3%. CONCLUSIONES: El brote de COVID-19ha implicado una disminución en el número de pacientes con IAMCEST, un aumento del tiempo entre el inicio de los síntomas y la reperfusión y un aumento en la mortalidad hospitalaria. No se han detectado cambios en la estrategia de reperfusión. La combinación de infección por SARS-CoV-2 e IAMCEST fue relativamente infrecuente

INTRODUCTION AND OBJECTIVES: The COVID-19 outbreak has had an unclear impact on the treatment and outcomes of patients with ST-segment elevation myocardial infarction (STEMI). The aim of this study was to assess changes in STEMI management during the COVID-19 outbreak. METHODS: Using a multicenter, nationwide, retrospective, observational registry of consecutive patients who were managed in 75 specific STEMI care centers in Spain, we compared patient and procedural characteristics and in-hospital outcomes in 2 different cohorts with 30-day follow-up according to whether the patients had been treated before or after COVID-19. RESULTS: Suspected STEMI patients treated in STEMI networks decreased by 27.6% and patients with confirmed STEMI fell from 1305 to 1009 (22.7%). There were no differences in reperfusion strategy (> 94% treated with primary percutaneous coronary intervention in both cohorts). Patients treated with primary percutaneous coronary intervention during the COVID-19 outbreak had a longer ischemic time (233 [150-375] vs 200 [140-332] minutes, P<.001) but showed no differences in the time from first medical contact to reperfusion. In-hospital mortality was higher during COVID-19 (7.5% vs 5.1%; unadjusted OR, 1.50; 95%CI, 1.07-2.11; P <.001); this association remained after adjustment for confounders (risk-adjusted OR, 1.88; 95%CI, 1.12-3.14; P=.017). In the 2020 cohort, there was a 6.3% incidence of confirmed SARS-CoV-2 infection during hospitalization. CONCLUSIONS: The number of STEMI patients treated during the current COVID-19 outbreak fell vs the previous year and there was an increase in the median time from symptom onset to reperfusion and a significant 2-fold increase in the rate of in-hospital mortality. No changes in reperfusion strategy were detected, with primary percutaneous coronary intervention performed for the vast majority of patients. The co-existence of STEMI and SARS-CoV-2 infection was relatively infrequent

[Impact of COVID-19 on ST-segment elevation myocardial infarction care. The Spanish experience]. / Impacto de la COVID-19 en el tratamiento del infarto agudo de miocardio con elevación del segmento ST. La experiencia española.

INTRODUCTION AND OBJECTIVES: The COVID-19 outbreak has had an unclear impact on the treatment and outcomes of patients with ST-segment elevation myocardial infarction (STEMI). The aim of this study was to assess changes in STEMI management during the COVID-19 outbreak. METHODS: Using a multicenter, nationwide, retrospective, observational registry of consecutive patients who were managed in 75 specific STEMI care centers in Spain, we compared patient and procedural characteristics and in-hospital outcomes in 2 different cohorts with 30-day follow-up according to whether the patients had been treated before or after COVID-19. RESULTS: Suspected STEMI patients treated in STEMI networks decreased by 27.6% and patients with confirmed STEMI fell from 1305 to 1009 (22.7%). There were no differences in reperfusion strategy (> 94% treated with primary percutaneous coronary intervention in both cohorts). Patients treated with primary percutaneous coronary intervention during the COVID-19 outbreak had a longer ischemic time (233 [150-375] vs 200 [140-332] minutes, P < .001) but showed no differences in the time from first medical contact to reperfusion. In-hospital mortality was higher during COVID-19 (7.5% vs 5.1%; unadjusted OR, 1.50; 95%CI, 1.07-2.11; P < .001); this association remained after adjustment for confounders (risk-adjusted OR, 1.88; 95%CI, 1.12-3.14; P = .017). In the 2020 cohort, there was a 6.3% incidence of confirmed SARS-CoV-2 infection during hospitalization. CONCLUSIONS: The number of STEMI patients treated during the current COVID-19 outbreak fell vs the previous year and there was an increase in the median time from symptom onset to reperfusion and a significant 2-fold increase in the rate of in-hospital mortality. No changes in reperfusion strategy were detected, with primary percutaneous coronary intervention performed for the vast majority of patients. The co-existence of STEMI and SARS-CoV-2 infection was relatively infrequent.

Impact of COVID-19 on ST-segment elevation myocardial infarction care. The Spanish experience.

INTRODUCTION AND OBJECTIVES: The COVID-19 outbreak has had an unclear impact on the treatment and outcomes of patients with ST-segment elevation myocardial infarction (STEMI). The aim of this study was to assess changes in STEMI management during the COVID-19 outbreak. METHODS: Using a multicenter, nationwide, retrospective, observational registry of consecutive patients who were managed in 75 specific STEMI care centers in Spain, we compared patient and procedural characteristics and in-hospital outcomes in 2 different cohorts with 30-day follow-up according to whether the patients had been treated before or after COVID-19. RESULTS: Suspected STEMI patients treated in STEMI networks decreased by 27.6% and patients with confirmed STEMI fell from 1305 to 1009 (22.7%). There were no differences in reperfusion strategy (> 94% treated with primary percutaneous coronary intervention in both cohorts). Patients treated with primary percutaneous coronary intervention during the COVID-19 outbreak had a longer ischemic time (233 [150-375] vs 200 [140-332] minutes, P<.001) but showed no differences in the time from first medical contact to reperfusion. In-hospital mortality was higher during COVID-19 (7.5% vs 5.1%; unadjusted OR, 1.50; 95%CI, 1.07-2.11; P <.001); this association remained after adjustment for confounders (risk-adjusted OR, 1.88; 95%CI, 1.12-3.14; P=.017). In the 2020 cohort, there was a 6.3% incidence of confirmed SARS-CoV-2 infection during hospitalization. CONCLUSIONS: The number of STEMI patients treated during the current COVID-19 outbreak fell vs the previous year and there was an increase in the median time from symptom onset to reperfusion and a significant 2-fold increase in the rate of in-hospital mortality. No changes in reperfusion strategy were detected, with primary percutaneous coronary intervention performed for the vast majority of patients. The co-existence of STEMI and SARS-CoV-2 infection was relatively infrequent.

Evidencia científica y opinión de expertos. ¿Por qué el TAVI es diferente? / Scientific evidence and expert opinion. Why is TAVI different?

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Renal Sympathetic Denervation in Patients with Resistant Hypertension: A Feasibility Study.

BACKGROUND/AIMS: We assessed the feasibility of renal sympathetic denervation (RDN) treatment in patients with resistant hypertension using the Iberis® RDN system. This study was a prospective, multicenter, single-arm feasibility registry. METHODS: We collected data from patients who underwent RDN treatment using the Iberis system. From November 2014 to February 2016, 16 patients from 6 centers in Europe were enrolled in this registry. RESULTS: Consistent reductions in the 24-h systolic blood pressure (SBP) and diastolic blood pressure were obtained. At any follow-up point, more than 70% of the patients were responders. The change in the 24-h SBP at 1 month was strongly correlated with that at 12 months. CONCLUSION: The Iberis system is safe and effective in patients for the treatment of resistant hypertension. Furthermore, our results suggest that we can estimate the effect of RDN in the long term at the 1-month follow-up point using the 24-h SBP.

Magnesium 2000 postmarket evaluation: Guideline adherence and intraprocedural performance of a sirolimus-eluting resorbable magnesium scaffold.

BACKGROUND: The Magmaris bioresorbable magnesium scaffold was successfully tested in in-vitro and in clinical premarket studies. Subsequently the Magmaris postmarket program aimed to review intraprocedural data of at least 2000 patients to assess user preferences, guideline adherence and intraprocedural performance in clinical routine. METHODS: This international multicentre survey encompasses data from 356 hospitals across 45 countries. As part of the certification for Magmaris implantation, each hospital had to complete consecutive post-market evaluation forms of their first 10 commercial Magmaris patients. RESULTS: From June 2016 to May 2018, data on 2018 implantations were collected. Main reasons for selecting Magmaris was patients' life expectancy (67%, n = 1359) and low or not calcified lesions, (67%, n = 1357). Magmaris was successfully deployed in 99% of cases (n = 1995), predilatation was performed in 95% (n = 1922) and post-dilatation in 87% (n = 1756). Physicians rated the overall performance and the pushability as good or very good in 96% of cases (n = 1799). Guide wire friction, trackability, and conformability were rated as good or very good in 94% of cases, and crossability in 93%. The majority of patients were scheduled to receive dual antiplatelet therapy for up to 12 months. CONCLUSION: Generally, implantation guidelines were adhered to and theoretical advantages of the metal scaffold observed in in-vitro tests have translated into practice with good intraprocedural performance outcomes, confirming the controlled roll-out of this novel technology into clinical practice. SUMMARY FOR ANNOTATED TABLE OF CONTENT: The Magmaris 2000 program includes the first commercial cases at each hospital. Overall, data on 2018 implantations were collected. The high rate of pre- and post-dilatation as well as other parameters confirm that generally the implantation guidelines are adhered to and the good intraprocedural performance (rated as good or very good in 96%) confirm the theoretical advantages of a metallic scaffold in practice.

Coronary Artery Tenting After Bypass Grafting: A Key Issue During Percutaneous Coronary Intervention of a Chronic Total Occlusion.

This image series shows how bypass grafts may tent the vessel to which they are anastomosed, potentially changing the expected course of the native coronary vessel. This fact must be taken into account during CTO-PCI, and this case emphasizes the importance of careful analysis of coronary anatomy with several angiographic projections.

A randomized multicentre trial to compare revascularization with optimal medical therapy for the treatment of chronic total coronary occlusions.

Aims: The clinical value of percutaneous coronary intervention (PCI) for chronic coronary total occlusions (CTOs) is not established by randomized trials. This study should compare the benefit of PCI vs. optimal medical therapy (OMT) on the health status in patients with at least one CTO. Method and results: Three hundred and ninety-six patients were enrolled in a prospective randomized, multicentre, open-label, and controlled clinical trial to compare the treatment by PCI with OMT with a 2:1 randomization ratio. The primary endpoint was the change in health status assessed by the Seattle angina questionnaire (SAQ) between baseline and 12 months follow-up. Fifty-two percent of patients have multi-vessel disease in whom all significant non-occlusive lesions were treated before randomization. An intention-to-treat analysis was performed including 13.4% failed procedures in the PCI group and 7.3% cross-overs in the OMT group. At 12 months, a greater improvement of SAQ subscales was observed with PCI as compared with OMT for angina frequency [5.23, 95% confidence interval (CI) 1.75; 8.71; P = 0.003], and quality of life (6.62, 95% CI 1.78-11.46; P = 0.007), reaching the prespecified significance level of 0.01 for the primary endpoint. Physical limitation (P = 0.02) was also improved in the PCI group. Complete freedom from angina was more frequent with PCI 71.6% than OMT 57.8% (P = 0.008). There was no periprocedural death or myocardial infarction. At 12 months, major adverse cardiac events were comparable between the two groups. Conclusion: Percutaneous coronary intervention leads to a significant improvement of the health status in patients with stable angina and a CTO as compared with OMT alone. Trial registration: NCT01760083.

Bioresorbable Vascular Scaffolds for Patients With In-Stent Restenosis: The RIBS VI Study.

OBJECTIVES: This study sought to assess the value of bioresorbable vascular scaffolds (BVS) in patients with in-stent restenosis (ISR). BACKGROUND: Currently both drug-eluting stents (DES) and drug-eluting balloons (DEB) are recommended in patients with ISR. However, the value of BVS in this setting remains unclear. METHODS: RIBS VI (Restenosis Intra-stent: drug-eluting Balloon vs everolimus-eluting Stent) was a prospective multicenter study (19 Spanish sites) that included 141 patients treated with BVS for either bare-metal stent (BMS) ISR or DES-ISR. Late angiography was scheduled at 6 to 9 months. Inclusion/exclusion criteria were similar to those used in the RIBS IV (patients with DES-ISR) and RIBS V (patients with BMS-ISR) trials, where DEB (n = 249) was compared with everolimus (EES)-DES (n = 249). Results of BVS in RIBS VI were compared with those obtained with DEB and EES in the RIBS IV and V trials. RESULTS: On late angiography (n = 134; 95% of eligible) the in-segment minimal lumen diameter (primary endpoint) was 1.87 ± 0.5 mm, late lumen loss was 0.23 ± 0.4 mm, and restenosis rate was 11%. At 1-year follow-up (100% of patients) no patient died, 4 (2.8%) experienced a myocardial infarction, and 16 (11.3%) required target lesion revascularization. One patient (0.7%) who discontinued antiplatelet therapy experienced definitive BVS thrombosis. Freedom from cardiac death, myocardial infarction, and target lesion revascularization was 86%. The minimal lumen diameter at follow-up after BVS was similar to that obtained with DEB (1.88 ± 0.6 mm; p = NS) but smaller than that achieved after EES (2.16 ± 0.7 mm; p < 0.001). Likewise, target lesion revascularization rates after BVS were similar to those seen with DEB (10.4%) but higher than with EES (3.2%; p < 0.001). Results remained unchanged after adjusting for potential confounders in baseline characteristics. CONCLUSIONS: This study suggests the safety and efficacy of BVS in patients with ISR. In this challenging anatomic scenario BVS obtained late angiographic and clinical results similar to DEB but inferior to EES. (Restenosis Intrastent: Bioresorbable Vascular Scaffolds Treatment [RIBS VI]; NCT02672878).