Long term clinical outcome of sirolimus drug coated balloons in large coronary vessels.

BACKGROUND: Studies evaluating the safety and efficacy of drug coating balloons (DCB) for the treatment of lesions in large coronary vessel are limited. AIMS: Our study aimed to evaluate the performance of a sirolimus DCB in large coronary arteries. METHODS: We analyzed all the procedures included in the EASTBOURNE Registry (NCT03085823) enrolling patients with a clinical indication to percutaneous coronary intervention performed by a sirolimus DCB according to investigator judgment. In the present analysis, a cut-off of 2.75 mm was used to define large coronary arteries. Primary endpoint of the study was clinically driven target lesion revascularization (TLR) at 24 months whereas secondary endpoint included procedural success, myocardial infarction (MI), cardiac death and total mortality. RESULTS: Among the 2123 patients and 2440 lesions enrolled in the EASTBOURNE study between 2016 and 2020, 757 patients/810 lesions fulfilled the criteria for the present analysis. Mean reference vessel diameter was 3.2 ± 0.3 mm with mean lesion length of 22 ± 7 mm. Procedural success was high (96%) and at 2-year follow up the device showed a good efficacy with a TLR rate of 9%. There were 34 deaths (4.5%), 30 MIs (4%) and 8 BARC type 3-5 bleedings (1.1%). In-stent restenosis (629 lesions) and de novo lesions (181) were associated with 11% and 4% rates of TLR at 2 years, respectively (p = 0.003). CONCLUSIONS: Clinical performance of a sirolimus DCB in large coronary artery vessels shows promising signals at 2-year follow up, both in de novo and in-stent restenosis lesions.

Sirolimus-Coated Balloon in an All-Comer Population of Coronary Artery Disease Patients: The EASTBOURNE Prospective Registry.

BACKGROUND: Drug-coated balloons (DCB) represent 1 of the most promising innovations in interventional cardiology and may represent a valid alternative to drug-eluting stents. Currently, some sirolimus-coated balloons (SCB) are being investigated for several coronary artery disease applications. OBJECTIVES: This study sought to understand the role of a novel SCB for the treatment of coronary artery disease. METHODS: EASTBOURNE (All-Comers Sirolimus-Coated Balloon European Registry) is a prospective, multicenter, investigator-driven clinical study that enrolled real-world patients treated with SCB. Primary endpoint was target lesion revascularization (TLR) at 12 months. Secondary endpoints were procedural success, myocardial infarction (MI), all-cause death, and major adverse clinical events (a composite of death, MI, and TLR). All adverse events were censored and adjudicated by an independent clinical events committee. RESULTS: A total population of 2,123 patients (2,440 lesions) was enrolled at 38 study centers in Europe and Asia. The average age was 66.6 ± 11.3 years, and diabetic patients were 41.5%. De novo lesions (small vessels) were 56%, in-stent restenosis (ISR) 44%, and bailout stenting occurred in 7.7% of the patients. After 12 months, TLR occurred in 5.9% of the lesions, major adverse clinical events in 9.9%, and spontaneous MI in 2.4% of the patients. The rates of cardiac/all-cause death were 1.5% and 2.5%, respectively. The primary outcome occurred more frequently in the ISR cohort (10.5% vs 2.0%; risk ratio: 1.90; 95% CI: 1.13-3.19). After multivariate Cox regression model, the main determinant for occurrence of the primary endpoint was ISR (OR: 5.5; 95% CI: 3.382-8.881). CONCLUSIONS: EASTBOURNE, the largest DCB study in the coronary field, shows the safety and efficacy of a novel SCB in a broad population of coronary artery disease including small vessels and ISR patients at mid-term follow-up. (The All-Comers Sirolimus-Coated Balloon European Registry [EASTBOURNE]; NCT03085823).

Clinical performance of a novel sirolimus-coated balloon in coronary artery disease: EASTBOURNE registry.

AIMS: The purpose of the EASTBOURNE registry is to evaluate the immediate and long-term clinical performance of a novel sirolimus-coated balloon (SCB) in a real-world population of patients with coronary artery disease. We here present the prespecified interim analysis after the enrollment of the first 642 patients who obtained 1-year clinical follow-up. METHODS: EASTBOURNE is a prospective, international, multicenter, all-comer investigator-driven clinical registry, which is enrolling consecutive patients treated with SCB at 42 European and Asiatic centers. Primary study endpoint is target-lesion revascularization (TLR) at 12 months. Secondary endpoints are procedural success and major adverse cardiac events through 36 months. RESULTS: Diabetes mellitus was present in 41% of patients. Acute coronary syndrome was present in 45% of patients and de novo lesions were 55%; 83% of the in-stent restenosis (ISR) patients had drug-eluting stents restenosis. Lesion predilatation was performed in 95% of the cases and bailout stenting occurred in 7.5%. So far, 642 patients have a complete 12-month follow-up. TLR occurred in 2.5%, myocardial infarction in 2.3%, total death in 1% and major adverse cardiac events in 5.8% of patients. A prespecified analysis of comparison between ISR and de-novo lesions showed a significantly higher occurrence of TLR in the ISR population (5.4 vs. 0.2%, P = 0.0008). CONCLUSION: The current interim analysis of 12-month follow-up of the EASTBOURNE registry shows good immediate performance and an adequate and encouraging safety profile through 12 months for this novel SCB.

Recanalization of Chronic Total Occlusions in Patients With vs Without Chronic Kidney Disease: The Impact of Contrast-Induced Acute Kidney Injury.

BACKGROUND: Chronic total occlusion (CTO) percutaneous coronary intervention (PCI) is associated with high contrast volumes, which can be particularly deleterious in patients with chronic kidney disease (CKD). We aimed to study the outcomes of CTO PCI in subjects with vs without CKD, and the impact of contrast-induced acute kidney injury (CI-AKI). METHODS: This multicentre registry included patients who underwent CTO PCI at 5 centres. CI-AKI was defined as an increase in serum creatinine ≥0.3 mg/dL or ≥50% from baseline within 72 hours. Study endpoints were CI-AKI, and all-cause death and target-lesion failure (TLF: cardiac death, target-vessel myocardial infarction, or target-lesion revascularization) on follow-up. RESULTS: Study population included 1092 patients (CKD n = 214, no CKD n = 878). Patients with CKD had more comorbidities and adverse angiographic features, compared with subjects without CKD. Patients with CKD experienced lower technical (79% vs 87%, P = 0.001) and procedural (79% vs 86%, P = 0.008) success rates. CI-AKI developed in 9.1% (CKD 15.0% vs no CKD 7.8%, P = 0.001). Rates of in-hospital need for dialysis were 0.5% vs 0%, respectively (P = 0.03). Patients with CKD had higher 24-month rates of all-cause death (11.2% vs 2.7%, P < 0.001) and new need for dialysis (1.1% vs 0.1%, P = 0.03), but similar TLF rates (12.4% vs 10.5%, P = 0.47). CI-AKI was not an independent predictor of all-cause death or TLF. CONCLUSIONS: CTO PCI in patients with CKD is associated with lower success rates and higher incidence of CI-AKI. The need for dialysis both in-hospital and on follow-up is infrequent. Although patients with CKD suffer higher rates of all-cause death, TLF rates are similar regardless of CKD status.

Uno frente a 2 stents para el tratamiento de lesiones en bifurcación en el contexto de una oclusión coronaria crónica total. Registro multicéntrico / One versus 2-stent strategy for the treatment of bifurcation lesions in the context of a coronary chronic total occlusion. A multicenter registry

Introducción y objetivos: Hay escasa evidencia sobre el tratamiento de lesiones en bifurcación en relación con una oclusión coronaria crónica total (OCT). Este estudio analiza los resultados inmediatos y a medio plazo de pacientes con lesiones en bifurcación en OCT tratados con 1 stent provisional frente a 2 stents en un registro multicéntrico. Métodos: Entre enero de 2012 y junio de 2016, se recanalizaron 922 OCT en los 4 centros participantes. De ellas, 238 (25,8%) con lesión en bifurcación se trataron mediante estrategia simple (n = 201) o compleja (n = 37). Se calculó la puntuación de propensión emparejada para detectar sesgos entre ambos grupos. Los eventos adversos cardiovasculares mayores (MACE) se definieron como muerte cardiaca, infarto y revascularización de la lesión diana. Resultados: Los éxitos angiográfico y del procedimiento fueron similares con la técnica simple (el 94,5 frente al 97,3%; p = 0,48) y con la compleja (el 85,6 frente al 81,1%; p = 0,49), aunque la cantidad de contraste, la dosis de radiación y el tiempo de fluoroscopia fueron menores con la técnica simple. Al seguimiento (25 meses), la tasa de MACE fue del 8% de los pacientes con la técnica simple y el 10,8% de los tratados con 2 stents (p = 0,58). En este grupo hubo tendencia a una menor supervivencia libre de MACE (el 80,1 frente al 69,8%; p = 0,08). Después del análisis de propensión, no se observaron diferencias entre los grupos en los resultados inmediatos ni al seguimiento. Conclusiones: Las LB en OCT pueden tratarse de modo similar que las demás bifurcaciones, para las que el stent provisional es la técnica de elección. Después de la puntuación de propensión emparejada, no hubo diferencias en los resultados inmediatos y a medio plazo entre ambos grupos

Introduction and objectives: There is little evidence on the optimal strategy for bifurcation lesions in the context of a coronary chronic total occlusion (CTO). This study compared the procedural and mid-term outcomes of patients with bifurcation lesions in CTO treated with provisional stenting vs 2-stent techniques in a multicenter registry. Methods: Between January 2012 and June 2016, 922 CTO were recanalized at the 4 participating centers. Of these, 238 (25.8%) with a bifurcation lesion (side branch ≥ 2 mm located proximally, distally, or within the occluded segment) were treated by a simple approach (n = 201) or complex strategy (n = 37). Propensity score matching was performed to account for selection bias between the 2 groups. Major adverse cardiac events (MACE) consisted of a composite of cardiac death, myocardial infarction, and clinically-driven target lesion revascularization. Results: Angiographic and procedural success were similar in the simple and complex groups (94.5% vs 97.3%; P = .48 and 85.6% vs 81.1%; P = .49). However, contrast volume, radiation dose, and fluoroscopy time were lower with the simple approach. At follow-up (25 months), the MACE rate was 8% in the simple and 10.8% in the complex group (P = .58). There was a trend toward a lower MACE-free survival in the complex group (80.1% vs 69.8%; P = .08). After propensity analysis, there were no differences between the groups regarding immediate and follow-up results. Conclusions: Bifurcation lesions in CTO can be approached similarly to regular bifurcation lesions, for which provisional stenting is considered the technique of choice. After propensity score matching, there were no differences in procedural or mid-term clinical outcomes between the simple and complex strategies

Noise reduction technology reduces radiation dose in chronic total occlusions percutaneous coronary intervention: a propensity score-matched analysis.

Chronic total occlusions (CTO) percutaneous coronary intervention (PCI) is associated with high radiation dose. Our study aim was to evaluate the impact of the implementation of a noise reduction technology (NRT) on patient radiation dose during CTO PCI. A total of 187 CTO PCIs performed between February 2016 and May 2017 were analyzed according to the angiographic systems utilized: Standard (n = 60) versus NRT (n = 127). Propensity score matching (PSM) was performed to control for differences in baseline characteristics. Primary endpoints were Cumulative Air Kerma at Interventional Reference Point (AK at IRP), which correlates with patient's tissue reactions; and Kerma Area Product (KAP), a surrogate measure of patient's risk of stochastic radiation effects. An Efficiency Index (defined as fluoroscopy time/AK at IRP) was calculated for each procedure. Image quality was evaluated using a 5-grade Likert-like scale. After PSM, n = 55 pairs were identified. Baseline and angiographic characteristics were well matched between groups. Compared to the Standard system, NRT was associated with lower AK at IRP [2.38 (1.80-3.66) vs. 3.24 (2.04-5.09) Gy, p = 0.035], a trend towards reduction for KAP [161 (93-244) vs. 203 (136-363) Gycm2, p = 0.069], and a better Efficiency Index [16.75 (12.73-26.27) vs. 13.58 (9.92-17.63) min/Gy, p = 0.003]. Image quality was similar between the two groups (4.39 ± 0.53 Standard vs. 4.34 ± 0.47 NRT, p = 0.571). In conclusion, compared with a Standard system, the use of NRT in CTO PCI is associated with lower patient radiation dose and similar image quality.

Impact of Incomplete Revascularization on Long-Term Outcomes Following Chronic Total Occlusion Percutaneous Coronary Intervention.

We aimed to evaluate the impact of incomplete revascularization (ICR) on long-term outcomes of patients undergoing chronic total occlusion (CTO) percutaneous coronary intervention (PCI). Consecutive patients undergoing CTO PCI at 4 centers were included. Baseline SYNTAX score (bSS: low [≤ 22], intermediate [>22 and <33], high [≥33]), residual SYNTAX score (rSS: 0, >0 and ≤8, >8), and SYNTAX revascularization index (SRI: 100 × (bSS-rSS)/bSS: 100%, 50% to 99%, <50%) were calculated. The primary end point was major adverse cardiac events (MACEs; cardiac death, any myocardial infarction, any revascularization) on follow-up. Multivariable Cox regression analysis was conducted to identify predictors of MACEs. Overall, 686 patients were included (low bSS: n = 437; intermediate bSS: n = 187; high bSS: n = 62). Occlusion complexity, crossing strategies, and procedural success rates were similar across groups. The degree of ICR increased with higher bSS categories (rSS was 2.5 ± 4.7 in low vs 6.2 ± 9.3 in intermediate vs 9.1 ± 12.2 in high bSS, p <0.001). The SRI followed a similar pattern. Median follow-up was 781 (369 to 1,217) days. Three-year MACE rates increased with higher bSS and rSS, and decreasing SRI categories (bSS: low 19.4% vs intermediate 25.9% vs high 33.3%, p = 0.02), which was driven by a higher incidence of repeat revascularization. Compared with an rSS = 0, both an rSS >0 and ≤8 (hazard ratio 2.06, p = 0.004) and an rSS >8 (hazard ratio 3.19, p <0.001) were independent predictors of MACEs. Similar findings were observed when the SRI was entered in a separate model. In conclusion, even a mild degree of ICR is associated with a higher incidence of MACEs on long-term follow-up after CTO PCI.

Outcomes of a novel thin-strut bioresorbable-polymer sirolimus-eluting stent in patients with chronic total occlusions: A multicenter registry.

BACKGROUND: We aimed to evaluate the mid-term outcomes of a novel thin-strut bioresorbable-polymer sirolimus-eluting stent (BP-SES) in chronic total occlusion (CTO) percutaneous coronary intervention (PCI), as compared with durable-polymer everolimus-eluting stents (EES). METHODS: We compiled a multicenter registry of patients undergoing CTO recanalization followed by BP-SES or EES implantation. The primary endpoint was the incidence of target-lesion failure (TLF, a composite of cardiac death, target-vessel myocardial infarction, and target-lesion revascularization) at one year. Propensity score matching (PSM) was used to adjust for case mix. RESULTS: Overall, 413 patients were included (BP-SES n = 242, EES n = 171). PSM resulted in 131 matched pairs, which represented the subject of the main analysis. Antegrade wire escalation was the most successful crossing technique (66% vs. 63%, p = 0.98) in both the BP-SES and EES groups, respectively. Procedural success rates were similar between groups (BP-SES 96% vs. EES 93%, p = 0.24). At one-year follow-up, there were no differences in the primary endpoint of TLF (5.7% vs. 8.3%, p = 0.44), and in cardiac death (0.9% vs. 2.8%, p = 0.32), target-vessel myocardial infarction (0.9% vs 1.9%, p = 0.57), target-lesion revascularization (3.7% vs 3.7%, p = 0.99), or stent thrombosis (0.9% vs. 1.9%, p = 0.57), in BP-SES vs. EES, respectively. CONCLUSIONS: Patients undergoing CTO PCI with BP-SES suffer a low rate of TLF at one-year follow-up, which is similar to that of subjects treated with durable-polymer EES.

Long-Term Outcomes of Percutaneous Coronary Intervention for Chronic Total Occlusion in Patients Who Have Undergone Coronary Artery Bypass Grafting vs Those Who Have Not.

BACKGROUND: We aimed to investigate the procedural and long-term outcomes of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) in patients who had undergone previous coronary artery bypass grafting (CABG) vs those who had not, and to evaluate the role of the Registry of CrossBoss and Hybrid procedures in France, the Netherlands, Belgium, and United Kingdom (RECHARGE) score in predicting acute and long-term outcomes. METHODS: We compiled a multicentre registry of consecutive patients undergoing CTO PCI at 7 centres between January 2009 and April 2017. The primary end point was target-vessel failure (TVF), a composite of cardiac death, target-vessel myocardial infarction, and target-vessel revascularization on follow-up. RESULTS: Overall, 2058 patients were included (patients who underwent CABG, n = 401; CABG-naïve patients, n = 1657). Patients who had undergone CABG were older and had a higher prevalence of comorbidities and higher occlusion complexity (RECHARGE score, 3.6 ± 1.3 vs 1.8 ± 1.2; P < 0.001). Antegrade dissection/re-entry techniques and the retrograde approach were used more frequently in patients who had undergone CABG. Procedural metrics were worse, and technical (82% vs 88%; P = 0.001) and procedural (81% vs 87%; P = 0.001) success was lower in patients who had undergone CABG. They also experienced a higher rate of major complications (3.7% vs 1.5%; P = 0.004). The RECHARGE score was inversely associated with technical success (P < 0.001). Median follow-up was 377 days (interquartile range, 277-766 days). The 24-month TVF rate was higher in patients who had undergone CABG than in CABG-naïve patients (16.1% vs 9.0%; P < 0.001). On multivariable analysis, the RECHARGE score (hazard ratio, 1.61; P < 0.001) remained an independent predictor of TVF, together with longer total stent length and not using a drug-eluting stent. CONCLUSIONS: Compared with CABG-naïve patients, CTO PCI in patients who had undergone CABG shows higher procedural complexity, worse success rates, and higher adjusted risk of TVF on follow-up.

Subadventitial stenting around occluded stents: A bailout technique to recanalize in-stent chronic total occlusions.

OBJECTIVES: To evaluate the outcomes of subadventitial stenting (SS) around occluded stents for recanalizing in-stent chronic total occlusions (IS-CTOs). BACKGROUND: There is little evidence on the outcomes of SS for IS-CTO. METHODS: We examined the outcomes of SS for IS-CTO PCI at 14 centers between July 2011 and June 2017, and compared them to historical controls recanalized using within-stent stenting (WSS). Target-vessel failure (TVF) on follow-up was the endpoint of this study, and was defined as a composite of cardiac death, target-vessel myocardial infarction, and target-vessel revascularization. RESULTS: During study period, 422 IS-CTO PCIs were performed, of which 32 (7.6%) were recanalized with SS, usually when conventional approaches failed. The most frequent CTO vessel was the right coronary artery (72%). Mean J-CTO score was 3.1 ± 0.9. SS was antegrade in 53%, and retrograde in 47%. Part of the occluded stent was crushed in 37%, while the whole stent was crushed in 63%. Intravascular imaging was used in 59%. One patient (3.1%) suffered tamponade. Angiographic follow-up was performed in 10/32 patients: stents were patent in six cases, one had mild neointimal hyperplasia, and three had severe restenosis at the SS site. Clinical follow-up was available for 29/32 patients for a mean of 388 ± 303 days. The 24-month incidence of TVF was 13.8%, which was similar to historical controls treated with WSS (19.5%, P = 0.49). CONCLUSIONS: SS is rarely performed, usually as last resort, to recanalize complex IS-CTOs. It is associated with favorable acute and mid-term outcomes, but given the small sample size of our study additional research is warranted.

One Versus 2-stent Strategy for the Treatment of Bifurcation Lesions in the Context of a Coronary Chronic Total Occlusion. A Multicenter Registry.

INTRODUCTION AND OBJECTIVES: There is little evidence on the optimal strategy for bifurcation lesions in the context of a coronary chronic total occlusion (CTO). This study compared the procedural and mid-term outcomes of patients with bifurcation lesions in CTO treated with provisional stenting vs 2-stent techniques in a multicenter registry. METHODS: Between January 2012 and June 2016, 922 CTO were recanalized at the 4 participating centers. Of these, 238 (25.8%) with a bifurcation lesion (side branch ≥ 2mm located proximally, distally, or within the occluded segment) were treated by a simple approach (n=201) or complex strategy (n=37). Propensity score matching was performed to account for selection bias between the 2 groups. Major adverse cardiac events (MACE) consisted of a composite of cardiac death, myocardial infarction, and clinically-driven target lesion revascularization. RESULTS: Angiographic and procedural success were similar in the simple and complex groups (94.5% vs 97.3%; P=.48 and 85.6% vs 81.1%; P=.49). However, contrast volume, radiation dose, and fluoroscopy time were lower with the simple approach. At follow-up (25 months), the MACE rate was 8% in the simple and 10.8% in the complex group (P=.58). There was a trend toward a lower MACE-free survival in the complex group (80.1% vs 69.8%; P=.08). After propensity analysis, there were no differences between the groups regarding immediate and follow-up results. CONCLUSIONS: Bifurcation lesions in CTO can be approached similarly to regular bifurcation lesions, for which provisional stenting is considered the technique of choice. After propensity score matching, there were no differences in procedural or mid-term clinical outcomes between the simple and complex strategies.

Retrograde Chronic Total Occlusion Percutaneous Coronary Intervention Through Ipsilateral Collateral Channels: A Multicenter Registry.

OBJECTIVES: The aim of this study was to describe the procedural aspects and outcomes of retrograde chronic total occlusion (CTO) percutaneous coronary intervention (PCI) through ipsilateral collateral channels (ILCs). BACKGROUND: Retrograde CTO PCI via ILCs is rarely performed, usually when no other retrograde options exist, and available evidence derives mostly from case reports. METHODS: A large retrospective multinational registry was compiled, including all consecutive patients undergoing retrograde CTO PCI through ILCs at 6 centers between September 2011 and October 2016. Success rates, as well as procedural complications and in-hospital outcomes, were studied. RESULTS: A total of 126 patients (17% of all retrograde CTO PCIs) were included. The mean age was 65.7 ± 11.2 years, and the mean J-CTO (Multicenter CTO Registry in Japan) score was 2.36 ± 1.13. The target vessel was the circumflex coronary artery in 42%, the left anterior descending coronary artery in 39%, and the right coronary artery in 19%. The ILCs used were epicardial in 76% and septal in 24%. ILC anatomy was very heterogeneous. One guiding catheter was used in 80%, whereas the ping-pong technique was used in 20%. A retrograde wire could be advanced to the distal cap in 81%. Technical and procedural success rates were 87% and 82%, respectively. ILC perforation with need for intervention was observed in 5.6% and tamponade due to ILC perforation in 2.4%. One patient (0.8%) died. CONCLUSIONS: Retrograde CTO PCI through ILCs is a challenging intervention that can be performed in difficult occlusions with high success rates and reasonable rates of complications by experienced operators.

Transcathether aortic valve implantation with the new repositionable self-expandable Evolut R versus CoreValve system: A case-matched comparison.

BACKGROUND: Despite promising results following transcatheter aortic valve implantation (TAVI), several relevant challenges still remain. To overcome these issues, new generation devices have been developed. The purpose of the present study was to determine whether TAVI with the new self-expanding repositionable Evolut R offers potential benefits compared to the preceding CoreValve, using propensity matching. METHODS: Between June 2007 and November 2015, 2148 consecutive patients undergoing TAVI either CoreValve (n=1846) or Evolut R (n=302) were prospectively included in the Italian TAVI ClinicalService® project. For the purpose of our analysis 211 patients treated with the Evolut R were matched to 211 patients treated with the CoreValve. An independent core laboratory reviewed all angiographic procedural data and an independent clinical events committee adjudicated all events. RESULTS: Patients treated with Evolut R experienced higher 1-year overall survival (log rank test p=0.045) and a significantly lower incidence of major vascular access complications, bleeding events and acute kidney injury compared to patients treated with the CoreValve. Recapture manoeuvres to optimize valve deployment were performed 44 times, allowing a less implantation depth for the Evolut R. As a consequence, the rate of more than mild paravalvular leak and new permanent pacemaker was lower in patients receiving the Evolut R. CONCLUSION: In this matched comparison of high surgical risk patients undergoing TAVI, the use of Evolut R was associated with a significant survival benefit at 1year compared with the CoreValve. This was driven by lower incidence of periprocedural complications and higher rates of correct anatomic positioning.

Procedural and Long-Term Outcomes of Percutaneous Coronary Intervention for In-Stent Chronic Total Occlusion.

OBJECTIVES: The study sought to investigate the long-term outcomes and predictors of adverse events of percutaneous coronary intervention (PCI) for in-stent chronic total occlusion (IS-CTO). BACKGROUND: IS-CTO PCI has traditionally been associated with suboptimal success rates. METHODS: We performed a multicenter registry of consecutive patients undergoing CTO PCI at 3 specialized centers. Patients were divided in IS-CTO and de novo CTO. The primary endpoint (major adverse cardiac events [MACE]) was a composite of cardiac death, target-vessel myocardial infarction, and ischemia-driven target-vessel revascularization (TVR) on follow-up. Independent predictors of MACE were sought with Cox regression. RESULTS: We included 899 patients (n = 111 IS-CTO, n = 788 de novo CTO). Baseline clinical and angiographic characteristics were balanced between the 2 groups. Overall mean J-CTO (Japanese-Chronic Total Occlusion) score was 1.88 ± 1.24 and mean PROGRESS-CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention-CTO) score was 1.04 ± 0.88. Antegrade wire escalation was used in 59.0% of IS-CTO and 48.1% of de novo CTO patients (p = 0.08). Procedural success was achieved in 86.5% in both groups (p = 0.99). After a median follow-up of 471 (interquartile range: 354 to 872) days, MACE were observed in 20.8% versus 13.9% in IS-CTO versus de novo CTO (p = 0.07), driven by TVR (16.7% vs. 9.4%; p = 0.03). IS-CTO was an independent predictor of MACE (hazard ratio: 2.16; 95% confidence interval: 1.18 to 3.95; p = 0.01), together with prior surgical revascularization and renal function, CTO PCI indicated for acute coronary syndrome, number of diseased vessels, and PROGRESS-CTO score. CONCLUSIONS: Procedural success was high and similar in patients with IS-CTO, as compared with de novo CTO. However, IS-CTO was independently associated with MACE (driven by TVR) on follow-up.

The ratio of contrast volume to glomerular filtration rate predicts acute kidney injury and mortality after transcatheter aortic valve implantation.

OBJECTIVE: The aim of this study was to assess the impact of the ratio of volume of contrast medium to the glomerular filtration rate (V/GFR) on acute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI) and its impact on long-term mortality. METHODS: We retrospectively calculated V/GFR in 397 patients undergoing TAVI. AKI was defined as VARC-modified Risk, Injury, Failure, Loss and End-stage (RIFLE) kidney disease score≥2. RESULTS: The incidence of AKI was 17.9%. The mean V/GFR ratio was 3.0±2.7 in patients without AKI and 7.8±8.8 in patients with AKI (p<0.001). The receiver-operator characteristic curve analysis showed fair discrimination between patients with and without AKI (C-statistic 0.85) at a V/GFR ratio of 3.2. Multivariable regression analysis indicated that V/GFR>3.2 was an independent predictor of both AKI (OR 3.4, 95% CI 1.0-6.1, p<0.001) and long-term mortality (OR 3.3, 95% CI 2.0-5.2, p<0.001). CONCLUSIONS: A V/GFR > 3.2 was found to be correlated with a higher incidence of AKI and mortality after TAVI. Therefore, this ratio could potentially be used to calculate the maximum volume of contrast medium that can be administered without significantly increasing the risk of AKI and mortality. Further larger studies are needed to validate these findings.

Outcomes of the retrograde approach through epicardial versus non-epicardial collaterals in chronic total occlusion percutaneous coronary intervention.

BACKGROUND: The retrograde approach through epicardial collaterals (EC) for chronic total occlusion (CTO) percutaneous coronary intervention (PCI) is a challenging procedure. Our study aim was to evaluate the outcomes of patients undergoing CTO PCI using a retrograde approach through epicardial versus non-epicardial collaterals (NEC). METHODS: We collected data from our single-center registry of consecutive patients undergoing retrograde CTO PCI, performed by an experienced operator through EC and NEC (septals and bypass grafts). Clinical, angiographic and procedural data were recorded. The primary endpoint (major adverse cardiac events, MACE) was a composite of cardiac death, target-vessel myocardial infarction (MI) and target-vessel revascularization (TVR) on follow-up. RESULTS: During the study period, 318 CTO PCIs were performed. Of these, 81 procedures (25%) were performed retrogradely in 75 patients (38 using NEC [31 septals, 7 bypass grafts], 37 through EC [34 contralateral, 3 ipsilateral]). Clinical characteristics were balanced between EC and NEC. J-CTO score was 2.1±1.1 and 2.2±1.2, respectively (p=0.92). Collateral tortuosity was more marked in EC. Technical and procedural success was lower in EC (35% vs. 76%, p<0.001; 30% vs. 76%, p<0.001; respectively). There were two perforations (5%) with need for intervention in EC, and none in NEC (p=0.15). After a median follow-up of 443 (331-744) days, MACE were observed in 12.9% (n=4) of EC vs. 5.4% (n=2) in NEC patients (p=0.28). CONCLUSIONS: In our experience, retrograde CTO PCI through EC was associated with lower success rate, and a numerically higher rate of perforation, as compared with NEC. Clinical outcomes on follow-up were similar.

Impact of crossing strategy on midterm outcomes following percutaneous revascularisation of coronary chronic total occlusions.

AIMS: The aim of the present study was to compare the midterm clinical outcomes of patients undergoing successful chronic total occlusion (CTO) percutaneous coronary intervention (PCI) according to the crossing technique used, in a large multicentre registry. METHODS AND RESULTS: We compiled a multicentre registry of consecutive patients undergoing successful CTO PCI. Patients were divided into three groups: true-to-true (TTT) approach, modern dissection/re-entry (DR) techniques (CrossBoss/Stingray, reverse CART), and old DR techniques (LAST, STAR, CART). Cox regression was used to identify independent predictors of major adverse cardiac events (MACE: cardiac death, myocardial infarction and target vessel revascularisation). We included 924 patients (TTT, n=571; modern DR, n=258; old DR, n=95). Patients in both DR groups had a higher prevalence of comorbidities, angiographic and procedural complexity. The 12-month MACE rate was higher in old DR (22.1%) than in modern DR (8.9%) and TTT (9.1%, p<0.001). Old (hazard ratio [HR] 2.02, 95% confidence interval [CI]: 1.12 to 3.61, p=0.02) but not modern (HR 0.98, 95% CI: 0.54 to 1.79, p=0.96) DR techniques were associated with a higher adjusted risk of MACE compared to TTT. CONCLUSIONS: The use of old but not modern DR techniques was associated with a higher risk of MACE. Therefore, CrossBoss/Stingray and reverse CART might be considered as first-line strategies for antegrade and retrograde DR-based CTO PCI, respectively.

Safety and efficacy of rotational atherectomy for the treatment of undilatable underexpanded stents implanted in calcific lesions.

OBJECTIVES: Coronary stent underexpansion is a known risk factor for in-stent restenosis and stent thrombosis. There are limited options once noncompliant balloons have failed to achieve optimal stent expansion. Excimer Laser Coronary Angioplasty with contrast medium injection is one possibility, but not readily available. Rotational atherectomy is an alternative, and has been described in case reports, but concerns exist regarding safety. METHODS: All consecutive patients undergoing rotational atherectomy for symptomatic in-stent restenosis due to stent underexpansion resistant to noncompliant balloon postdilatation between January 2005 and December 2015 were analysed. RESULTS: A total of 16 patients underwent treatment during the study period and the procedure was successful in 14 cases (87.5%). The mean postprocedural minimal lumen diameter increased by 2.3 ± 0.8 mm and percentage diameter stenosis decreased from 82.17% ± 17.2% to 11.9% ± 9.1%. Intraprocedural complications occurred in two patients (burr entrapment successfully managed percutaneously and periprocedural myocardial infarction). At 1-year follow-up, the incidence of target lesion revascularisation was 13.3% (2 out of 15 patients), and one patient died from noncardiac death. CONCLUSION: In this small series of underexpanded stents, rotational atherectomy was an effective treatment for resistant stent underexpansion with acceptable outcomes. © 2016 Wiley Periodicals, Inc.

Long-term outcomes of rotational atherectomy for the percutaneous treatment of chronic total occlusions.

OBJECTIVES: To study the long-term outcomes of rotational atherectomy (RA) for chronic total occlusion (CTO) percutaneous coronary intervention (PCI). BACKGROUND: There is little evidence on the incidence, procedural results and long-term outcomes of RA for CTO PCI. METHODS: This registry included data from consecutive patients undergoing CTO PCI at four specialized centers. Major adverse cardiac events (MACE: cardiac death, target-vessel myocardial infarction and ischemia-driven target-vessel revascularization) on follow-up were the primary endpoint. RESULTS: A total of 1003 patients were included. Of these, 35 (3.5%) required RA. As compared with Conventional PCI, RA patients were older (68.9 ± 9.5 vs. 64.6 ± 10.7 years, P = 0.02), had higher prevalence of diabetes (58% vs. 37%, P = 0.01) and of a J-CTO score ≥2 (80% vs. 58%, P = 0.009), driven by severe calcification. Antegrade wire escalation was used more frequently in RA (74% vs. 53%, P = 0.08). RA was performed for balloon failure-to-cross in 51% and failure-to-expand in 49%. One burr was utilized in 86%. The 1.25-mm burr was the largest burr used in 43%. Slow flow/no-reflow was observed in 17%. No other serious RA-related complications were observed. Procedural success was 77% vs. 89% (P = 0.04) in RA vs. Conventional PCI. After a mean follow-up of 658 ± 412 days, MACE rates were similar between groups (15% vs. 13%, P = 0.70). CONCLUSIONS: The use of RA in CTO PCI was safe, despite a worse patient risk profile and higher procedural complexity, as compared with conventional techniques. Although procedural success was lower in the RA group, there were no differences in long-term clinical outcomes between groups. © 2016 Wiley Periodicals, Inc.

Procedural and longer-term outcomes of wire- versus device-based antegrade dissection and re-entry techniques for the percutaneous revascularization of coronary chronic total occlusions.

BACKGROUND: There are few data regarding the procedural and follow-up outcomes of different antegrade dissection/re-entry (ADR) techniques for chronic total occlusion (CTO) percutaneous coronary intervention (PCI). METHODS: We compiled a multicenter registry of consecutive patients undergoing ADR-based CTO PCI at four high-volume specialized institutions. Patients were divided according to the specific ADR technique used: subintimal tracking and re-entry (STAR), limited antegrade subintimal tracking (LAST), or device-based with the CrossBoss/Stingray system (Boston Scientific, Marlborough, MA). Major adverse cardiac events (MACE: cardiac death, target-vessel myocardial infarction and target-vessel revascularization) on follow-up were the main outcome of this study. Independent predictors of MACE were sought with Cox regression analysis. RESULTS: A total of 223 patients were included (STAR n=39, LAST n=68, CrossBoss/Stingray n=116). Baseline characteristics were similar across groups. Technical and procedural success was lower with STAR (59% and 59%), as compared with LAST (96% and 96%) and CrossBoss/Stingray (89% and 87%; p<0.001 for both). At 24-month follow-up, MACE rates were higher in STAR (15.4%) and LAST (17.5%), as compared with device-based ADR with CrossBoss/Stingray (4.3%, p=0.02), driven by TVR (7.7% vs. 15.5% vs. 3.1%, respectively; p=0.02). Multivariable Cox regression analysis identified wire-based ADR (STAR and LAST) and total stent length as independent predictors of MACE. CONCLUSIONS: In this multicenter cohort of patients undergoing CTO PCI with ADR techniques, STAR had lower success rates, as compared with the CrossBoss/Stingray system and LAST. The CrossBoss/Stingray system was independently associated with lower risk of MACE on follow-up, as compared with wire-based ADR techniques.