Should paclitaxel be considered an old generation DCB? The limus era.

Since their introduction Drug Coated Balloons (DCBs) have slowly gained their spot into everyday cath-lab practice, first for treatment of in-stent restenosis (ISR), more recently for small vessels disease; today a growing body of evidence start supporting their use in more complex lesions, from bifurcations, to large vessels, to acute lesions. Although the new generation of DCBs showed a better performance and safety than the older one, the drug of choice has always been the Paclitaxel; last year some concerns were raised on the safety of Paclitaxel devices, in particular the balloons mining their use. Recently Sirolimus ventured in the DCBs world, making its appearance on cath-lab shelves and becoming a good alternative to Paclitaxel (DCB).

Transradial approach for carotid artery stenting: A position paper from the Italian Society of Interventional Cardiology (SICI-GISE).

Carotid artery stenting (CAS) is a valid and effective alternative to endoatherectomy when performed by experienced operators. The conventional approach used is the transfemoral one, but in the last 10 years a transradial (TR) approach, the standard access for cardiac catheterization, became widely adopted for peripheral vascular interventions, included the extracranial carotids. Preliminary experiences suggest this approach as safe and effective, especially in specific anatomical and clinical settings that have been shown to be associated with high risk of complications from the femoral route. Lacking international guidelines, this document, promoted by the Italian Society of Interventional Cardiology - Gruppo Italiano Studi Emodinamici (SICI-GISE), was drawn-up by a panel of interventional cardiologists with a documented experience on the subject, focusing on the indications, techniques and materials that should be used for this type of intervention and the most recent literature on the subject.

Long-term follow-up after sirolimus-coated balloon use for coronary artery disease. Final results of the Nanolutè study.

OBJECTIVES: To test the long-term efficacy of a sirolimus-coated balloon (SCB). BACKGROUND: Nanoluté was a prospective registry to evaluate the clinical performance of a novel SCB (Concept Medical Research Private Limited, India) for the treatment of de novo coronary lesions and in-stent restenosis (ISR). We here present the 24 months clinical data. METHODS: All patients treated with SCB for any type of coronary indication between July 2012 and September 2015 were enrolled at Indian centers and clinically followed up to 24 months. Primary endpoints were major adverse cardiovascular events (MACE) defined as a composite of cardiac death, target lesion revascularization (TLR), and target vessel-myocardial infarction (MI). RESULTS: A total of 484 SCBs were used in 408 patients to treat 435 lesions. In detail, the SCB was used for 183 patients with ISR, 185 with de novo small vessel disease, and 40 with de novo large vessel disease. Mean balloon length and diameter (average ± SD) were 22.3 ± 7.1 mm and 2.7 ± 0.40 mm, respectively. All patients with 24 months follow-up were included. Overall MACE rate was 4.2% (n = 17) with three cardiac deaths (0.7%), 13 TLR (3.2%), and one MI (0.2%). CONCLUSION: The Nanoluté prospective registry is the first long-term clinical evidence of the safety and feasibility of this type of SCB, both in patients with ISR or de novo lesions.

Coronary sinus perforation during reducer implantation.

Coronary Sinus Reducer (Neovasc, Inc., Richmond B.C., Canada) has shown to be an effective and safe treatment option for the treatment of refractory angina. Until now, a few number of complications related to its implantation have been reported. Coronary sinus perforation is a rare complication, more often related to cardiac surgery procedures. We report the first case of coronary sinus perforation after a sinus Reducer implantation.

Transradial versus transfemoral ancillary approach in complex structural, coronary, and peripheral interventions. Results from the multicenter ancillary registry: A study of the Italian Radial Club.

OBJECTIVES: to understand the role of a transradial (TR) secondary approach during complex percutaneous interventions. BACKGROUND: The value of the TR route for ancillary vascular approach has not been adequately validated in this setting, and there is scant data on its role in reducing bleeding complications. METHODS: In the present study we retrospectively included patients undergoing the following interventions requiring two vascular approaches at nine high-volume centers in Italy: structural cardiac interventions, complex PCI, endovascular aortic repair (EVAR) and complex lower limb angioplasty. We compared procedural outcomes according to the type of ancillary vascular approach selected, namely TR or transfemoral/transbrachial (TF/TB). Primary endpoints of the study were procedural success and in-hospital BARC grade 3-5 bleedings. RESULTS: We included 906 patients, 433 receiving TR and 473 TF/TB ancillary approaches. Baseline characteristics did not differ significantly. Patients underwent the following types of intervention: structural 50%, complex coronary PCI 37%, EVAR 11%, peripheral angioplasty 2%. Procedural success was similar (90% in TR and 92% TF/TB, P = NS). In-hospital BARC 3/5 bleedings were more common in TF/TB group as compared to TR group (19.7% vs. 6.7%,P < 0.001). In TF/TB group we also observed a higher postprocedural hemoglobin drop (1.92 vs 1.13 g/dl, P = 0.008) and longer hospital stay as compared to TR group. Similar results were observed in a propensity score-matched population of 450 patients. CONCLUSIONS: In our study TR ancillary approach was associated with a significant reduction in the risk of major bleedings, without jeopardizing the success of complex structural, coronary, and peripheral percutaneous interventions. The value of the transradial route for ancillary vascular approach during percutaneous interventions has not been adequately validated yet. We retrospectively included 906 patients, 433 receiving TR and 473 TF/TB ancillary approach at nine high-volume centers for the following interventions: structural cardiac interventions, complex PCI, EVAR and complex peripheral angioplasty. Procedural success was similar, whereas in-hospital BARC bleedings were more common in the transfemoral/brachial group. Similar results were observed in a propensity score-matched population. In our study TR ancillary approach was associated with a significant reduction in the risk of major bleedings, without jeopardizing the success of complex interventions. © 2017 Wiley Periodicals, Inc.

Absorb bioresorbable vascular scaffold vs. everolimus-eluting metallic stent in small vessel disease: A propensity matched analysis of COMPARE II, RAI, and MAASSTAD-ABSORB studies.

BACKGROUND: Patients with small vessel disease (SVD) are at higher risk of adverse events after PCI compared to non-SVD patients. In this subset, the use of bioresorbable vascular scaffolds (BVS) has raised particular concern. OBJECTIVE: We aimed to compare outcomes of Absorb BVS versus a 2nd-generation metallic everolimus-eluting stents (EES) in the SVD setting, by pooling patients from three large, prospective studies. METHODS: Patients with SVD (reference vessel diameter ≤2.75 mm by QCA) and treated with Absorb BVS were identified in the Italian RAI and the MAASSTAD-Absorb registries. EES controls were identified in the COMPARE II Trial. We performed a propensity-score matching using several clinical and angiographic variables. Implantation technique was not object of matching, being device-specific. RESULTS: Out of 4635 enrolled subjects, 1147 belonged to the SVD population. After matching, we obtained 337 pairs of patients. High clinical and angiographic complexity was found in both groups. Predilation and postdilation rates were significantly higher in BVS patients. No differences were found in terms of the device-oriented composite end-point at 1-year (HR = 1.08, 95%CI 0.5-2.3, P = .8) and 2-years (HR = 1.28, 95% CI: 0.68-2.43, P = .5). Notwithstanding, higher incidence of definite/probable stent thrombosis was observed in the BVS group at 1 year (HR 4.7, 95%CI 0.8-31.4, P = .08) and 2-years (HR = 8.34 95%CI 1.1-60.2, P = .04). CONCLUSION: In this propensity-matched analysis pooling SVD patients of three large prospective studies, incidence of composite device-related events was comparable between BVS and EES up to 2 years follow-up. However, higher rates of stent thrombosis were found in the BVS group.

Fracture with the newer bioresorbable vascular scaffolds.

Bioresorbable vascular scaffolds (BVS) are being increasingly used in complex, real-world lesions. The possibility of strut fractures is a rare entity with the use of drug eluting stents (DES), but has not yet been adequately described for the BVS technology. In this report, we present a case of scaffold fracture of DEsolve BVS (Elixir Medical Corporation, USA) that was diagnosed both angiographically and by optical coherence tomography(OCT). Scaffold fracture with the newer BVS is a new Achilles' heel in the BVS technology. This gap in knowledge about the etiology such as over-expansion and potential predictors of strut fracture need to be deeply investigated before a widespread use of such technologies is adopted. © 2017 Wiley Periodicals, Inc.

Clinical and angiographic outcome of a single center, real world population treated with a dedicated technique of implantation for bioresorbable vascular scaffolds. The FAtebenefratelli Bioresorbable Vascular Scaffold (FABS) registry.

OBJECTIVES: With this prospective study we aim at investigating the long-term outcome of a consecutive cohort of patients successfully treated with bioresorbable scaffold (BVS) implantation. BACKGROUND: It is not clearly understood if there is a relation between the technique of BVS implantation and the outcome. METHODS: Between December 2012 and December 2014, all consecutive patients treated with BVS were included in this registry and received an angiographic follow-up. After a run-in phase, all BVS were implanted using a specific technique consisting of aggressive predilation, correct scaffold sizing, visually determined, and high-pressure post-dilation with a noncompliance balloon. Primary endpoint was late lumen loss (LLL) at 1-year angiographic follow-up and ischemia-driven target-lesion revascularization (ID-TLR) at 2-year clinical follow-up. Secondary endpoints were the occurrence of binary restenosis, major adverse cardiac events (MACE), and every single component of MACE (cardiac death, myocardial infarction, TLR) at 2 years. RESULTS: A total of 144 lesions in 122 patients treated consecutively with BVS, were enrolled. Diabetics were 29.5% and acute coronary syndrome at presentation occurred in 29.5% of patients. At the angiographic follow-up LLL was 0.38 ± 0.9. At 2-year clinical follow-up, ID-TLR occurred in eight patients (5.6%). We observed two cases of scaffold thrombosis (1.38%, one early and one very late). At multivariate statistical analysis, STEMI presentation remained a significant predictor for TLR. CONCLUSIONS: In a complex, all-comers real world population, BVS implantation with a specific, and standardized technique showed to be feasible, with acceptable mid-term angiographic and long-term clinical outcome.

Inflammation and cardiovascular disease: from pathogenesis to therapeutic target.

Atherosclerosis represents the most common pathological substrate of coronary heart disease (CHD), and the characterization of the disease as a chronic low-grade inflammatory condition is now largely accepted. A number of mediators of inflammation have been widely studied, both as surrogate biomarkers and as causal agents, in the pathophysiological network of atherogenesis and plaque vulnerability. The epidemiological observation that biomarkers of inflammation are associated with clinical cardiovascular risk supports the theory that targeted anti-inflammatory treatment appears to be a promising strategy in reducing residual cardiovascular risk on the background of traditional medical therapy. A large number of randomized controlled trials have shown that drugs commonly used in cardiovascular disease (CVD), such as statins, may be effective in the primary and secondary prevention of cardiovascular events through an anti-inflammatory effect. Moreover, several anti-inflammatory drugs are being tested for their potential to reduce residual cardiovascular risk on the background of validated medical therapy for atherosclerotic disease. In this paper, we review relevant evidence with regard to the relationship between inflammation and CVD, from pathogenesis to therapeutic strategies.

Coronary lithotripsy for the treatment of underexpanded stents: the international & multicentre CRUNCH registry.

BACKGROUND: Stent underexpansion increases the risk of cardiac adverse events. At present, there are limited options to treat refractory stent underexpansion. In this context, the intravascular lithotripsy (IVL) system might be a safe and effective strategy. AIMS: We aimed to evaluate the safety and efficacy of IVL in addressing resistant stent underexpansion due to heavy underlying calcification. METHODS: This was an international multicentre registry including patients receiving IVL therapy to treat stent underexpansion from December 2017 to August 2020. Angiographic and intracoronary imaging data were collected. The efficacy endpoint was device success (technical success with a final percentage diameter stenosis <50%). The safety endpoint was in-hospital major adverse cardiac events (MACE). RESULTS: Seventy patients were included, the mean age was 73±9.2 years and 76% were male. The median time from stent implantation to IVL therapy was 49 days (0-2,537). Adjuvant treatment with non-compliant balloon dilatations pre- and post-IVL was performed in 72.3% and 76.8% of patients, respectively, and additional stenting was performed in 22.4%. Device success was 92.3%. Minimum lumen diameter increased from 1.49±0.73 mm to 2.41±0.67 mm (p<0.001) and stent expansion increased by 124.93±138.19% (p=0.016). No IVL-related procedural complications or MACE were observed. The use of bailout IVL therapy directly after stenting and the presence of ostial underexpanded lesions negatively predicted lumen diameter gain. CONCLUSIONS: Coronary lithotripsy is safe and effective in increasing lumen and stent dimensions in underexpanded stents secondary to heavily calcified lesions.

Intravascular Lithotripsy and Dual Drug-Coated Balloons for the Treatment of Severely Calcific Renal In-Stent Restenosis: All Is Fair in War.

Optimal treatment of renal artery "in-stent restenosis" (ISR) is still debated; drug eluting stents (DES), drug coated balloons (DCB) and scoring balloons have all been used, with mixed long term results. The shockwave lithotripsy for the treatment of heavily calcified atherosclerotic plaques has proven to be an effective tool and preliminary data support its use in case of underexpanded stents. Here we present the case of a 60 year old male with a known significant atherosclerotic renal artery stenosis and refractory hypertension who already underwent bilateral renal angioplasty with bare metal stents (BMS) in 2011 and angioplasty with DCB in 2012 for right renal artery ISR. In May 2020 he presented with worsening hypertension and CT scan showed total occlusion of the right with critical ISR of the left renal artery. Because of the high calcium burden he underwent balloon lithotripsy for plaque modification and subsequent renal angioplasty with sirolimus and paclitaxel DCB, with a good angiographic result. This is the first case of recurrent renal ISR successfully treated with Shockwave IVL and double-drug DCB therapy.

Comparison Between Sirolimus- and Paclitaxel-Coated Balloon for Revascularization of Coronary Arteries: The SIRPAC (SIRolimus-PAClitaxel) Study.

OBJECTIVE: Our study sought to compare the 12-month clinical outcome of patients treated with paclitaxel-coated balloons (PCB) vs. sirolimus-coated balloons (SCB) during coronary angioplasty. BACKGROUND: Drug-coated balloons represent an established therapeutic tool for percutaneous coronary interventions (PCI). A comparison between PCB and SCB is still lacking. METHODS: We performed an indirect comparison between two cohorts of patients previously included into two investigator-driven registries with clinical primary endpoints, 494 treated with the Elutax SV PCB (AR Baltic, Lithuania) from the DCB RISE registry, and 596 treated with the Magic Touch SCB (Concept Medical, India) from the EASTBOURNE registry. The primary endpoint was the rate of major adverse cardiovascular events (MACE) at 12-month clinical follow-up. RESULTS: After propensity score matching, a total of 580 patients were well matched for baseline clinical and procedural characteristics and were analyzed. At 12 months there was no significant difference between the matched DCB RISE and EASTBOURNE cohorts in terms of the primary endpoint MACE (10.3% DCB RISE vs. 10.7% EASTBOURNE, p = 0.892). No significant difference was observed also regarding the rate of TLR (7.9% DCB RISE vs. 8.3% EASTBOURNE; p = 0.879, respectively). By multivariate analysis, insulin-dependent diabetes was the only predictor of MACE. CONCLUSIONS: In the SIRPAC study, the first indirect comparison between paclitaxel-coated and sirolimus coated balloons, no significant difference in clinical endpoints were found at 12-month follow-up. Randomized studies are necessary to confirm these findings.

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.

ImpaCt of an Optimal Implantation Strategy on Absorb Long-Term Outcomes: The CIAO Registry.

AIM: To compare the long-term outcomes of patients implanted with Absorb bioresorbable scaffold (BRS) with optimal versus suboptimal technique. METHODS AND RESULTS: All patients who received an Absorb between March 2012 and January 2016 were selected from 19 Italian centers databases to assess the impact of an optimal implantation technique (CIAO criteria) on long-term device-oriented composite end-point (DOCE) - including cardiac death (CD), target-vessel myocardial infarction (TV-MI) and ischemia-driven target lesion revascularization (ID-TLR) - on its single components and on scaffold thrombosis (ScT). CIAO criteria consist of predilation (balloon/vessel ratio 1:1), correct sizing (BRS/proximal reference vessel diameter -RVD- ratio 0.8-1.2) and high-pressure postdilation with non-compliant (NC) balloon (≥20 atm for balloon/BRS ratio 1:1 or ≥16 atm for a 0.25-0.5 mm oversized balloon). Among the 1.434 patients analyzed, 464 (32.4%) fulfilled all CIAO criteria for every BRS implanted (CIAO 3 group), while 970 (67.6%) did not in at least one of the received BRS (CIAO 0-1-2 group). At 31.0 (interquartile range -IQR- 24.8-38.5) months follow-up, CIAO criteria did not impact on DOCE (8.2% vs. 8.0%, p = 0.92), ID-TLR (6.9% vs. 7.1%, p = 0.72) or ScT (1.9% vs. 1.8%, p = 0.80) in the overall population. At multivariate analysis overall BRS length (p = 0.001), severely calcified lesions (p = 0.03) and absence of CIAO criteria (CIAO 0, p = 0.005) were independent predictors of DOCE in long-term follow-up. CONCLUSION: Our data suggest that strict application of an optimal Absorb implantation technique doesn't improve long-term DOCE or ScT but may mitigate the worse outcome of patients with calcific lesions.

Drug-Coated Balloon Versus Drug-Eluting Stent for Small Coronary Vessel Disease: PICCOLETO II Randomized Clinical Trial.

OBJECTIVES: This study sought to compare the performance of a novel drug-coated balloon (DCB) (Elutax SV, Aachen Resonance, Germany), with an everolimus-eluting stent (EES) (Abbott Vascular, Santa Clara, California) in patients with de novo lesions. BACKGROUND: Small vessel coronary artery disease (SVD) represents one of the most attractive fields of application for DCB. To date, several devices have been compared with drug-eluting stents in this setting, with different outcomes. METHODS: The PICCOLETO II (Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment) trial was an international, investigator-driven, multicenter, open-label, prospective randomized controlled trial where patients with de novo SVD lesions were randomized to DCB or EES. Primary study endpoint was in-lesion late lumen loss (LLL) at 6 months (independent core laboratory), with the noninferiority between the 2 arms hypothesized. Secondary endpoints were minimal lumen diameter, percent diameter stenosis at angiographic follow-up, and the occurrence of major adverse cardiac events at 12 months. RESULTS: Between May 2015 and May 2018, a total of 232 patients were enrolled at 5 centers. After a median of 189 (interquartile range: 160 to 202) days, in-lesion LLL was significantly lower in the DCB group (0.04 vs. 0.17 mm; p = 0.001 for noninferiority; p = 0.03 for superiority). Percent diameter stenosis and minimal lumen diameter were not significantly different. At 12-month clinical follow-up, major adverse cardiac events occurred in 7.5% of the DES group and in 5.6% of the DCB group (p = 0.55). There was a numerically higher incidence of spontaneous myocardial infarction (4.7% vs. 1.9%; p = 0.23) and vessel thrombosis (1.8% vs. 0%; p = 0.15) in the DES arm. CONCLUSIONS: In this multicenter randomized clinical trial in patients with de novo SVD lesions, a new-generation DCB was found superior to EES in terms of LLL as the angiographic pattern and comparable in terms of clinical outcome. (Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment [PICCOLETO II]; NCT03899818).

Safety and effectiveness of the self-aPposing, bAlloon-delivered, siRolimus-eluting stent for the Treatment of the coronary Artery disease: SPARTA, a multicenter experience.

AIMS: To assess the long-term outcomes of patients treated with sirolimus-eluting Stentys stent in a real-life setting. BACKGROUND: Few data regarding the safety and effectiveness of self-apposing sirolimus-eluting Stentys stent are available. METHODS: 278 patients (30% stable coronary artery disease, 70% acute coronary syndromes, and 54% on unprotected left main) treated with sirolimus eluting Stentys stent were retrospectively included in the self-aPposing, bAlloon-delivered, siRolimus-eluting stent for the Treatment of the coronary Artery disease multicenter registry. Major adverse cardiovascular events (MACE, a composite of cardiac death, myocardial infarction, target lesion revascularization, stent thrombosis) were the primary end-point, single components of MACE were the secondary ones. RESULTS: After 13 months (interquartile range 5-32), MACE was 14%. Stent thrombosis occurred in 3.9% of the patients (2.5% definite stent thrombosis and 1.4% probable stent thrombosis), 66% of them presenting with ST-segment elevation myocardial infarction (STEMI) at admission. Cardiovascular death, target lesion revascularization and myocardial infarction was 4.7%, 8.3%, and 7.2%, respectively. At multivariate analysis, risk of MACE was increased by diabetes (hazard ratios 4.76; P = 0.002) but was not affected by the indication leading to sirolimus-eluting Stentys stent implantation (marked vessel tapering vs. coronary ecstasies, hazard ratios 0.74, P = 0.71). CONCLUSION: Sirolimus-eluting Stentys stent may represent a potential solution for specific coronary anatomies such as bifurcation, ectasic, or tapered vessels. Risk of stent thrombosis appears related to clinical presentation with STEMI and to anatomic features, stressing the importance of the use of intracoronary imaging for self-expandable stents implantation.

Radial artery perforation: when a friend turns against you.

BACKGROUND: Radial artery approach is currently the most common access site for coronary angiography and percutaneous coronary intervention. It rarely results in complications, improves patient comfort, and reduces the duration of hospitalization. CASE PRESENTATION: A 91-year-old woman presented to our institution with ST-segment elevation myocardial infarction (STEMI). The right radial access was chosen for the performance of percutaneous coronary intervention. After the introduction of 6 F sheath, there was difficulty in the advancement of 0.035 J wire that was exchanged with a Terumo hydrophilic wire. After the procedure and before sheath removal, radial arteriography was done and revealed perforation. Protamine sulfate was administered and prolonged balloon inflation was attempted but failed to seal the perforation, so a 7-F-long vascular sheath was inserted to internally tamponade the vessel, and the patient was sent to the coronary care unit for monitoring. Over the next 3 days, serial radial angiographies were done revealing the persistence of the perforation, and on the fourth day, angiography revealed multiple thrombi. Thrombus aspiration was done using Pronto V4 extraction catheter (Vascular Solutions, USA) and was followed by the deployment of a covered stent. The stent was dislodged and successfully snared. Finally, the perforation was sealed spontaneously and there were no signs of intra-arterial thrombi. CONCLUSION: Despite the very low complication rate of radial approach, the interventional cardiologist should be aware of any possible complication, and how to avoid or, eventually, manage it.

Angiographic performance of a novel sirolimus-coated balloon in native coronary lesions: the FAtebenefratelli SIrolimus COated NATIVES prospective registry.

AIMS: To evaluate the angiographic performance of a novel sirolimus-coated balloon (SCB) in de novo coronary lesions. METHODS: Out of an all-comer prospective registry of patients treated with the SCB at our center from April 2016 to September 2017, we selected those treated for a de novo stenosis on a native vessel, with a scheduled angiographic control at at least 4 months after the index procedure. We performed a centralized, blinded core-lab adjudicated quantitative coronary angiography analysis. Primary endpoint was late lumen loss. Secondary endpoints were binary restenosis and target-lesion revascularization. RESULTS: A total of 27 patients with native coronary arteries treated with SCB and with angiographic follow-up entered the study; seven patients were excluded because a stent was implanted at the lesion site during the index procedure. The degree of calcification (assessed with coronary angiography) was high in six patients (30%) and the average lesion length was 20.52 ±â€Š6.88 mm. The reference vessel diameter was 2.32 ±â€Š0.44 mm and the percentage diameter stenosis was 67 ±â€Š12. Procedural success was obtained in all patients. After a median of 6.6 ±â€Š2.5 months, late lumen loss was 0.09 ±â€Š0.34 mm and the percentage diameter stenosis was 31 ±â€Š18. We observed two cases (10%) of binary restenosis which underwent subsequent target-lesion revascularization: in one a drug-eluting stent was implanted, whereas the other patient was treated with paclitaxel-coated balloon. No myocardial infarction or death was observed during follow-up. CONCLUSION: The use of a novel SCB in native coronary arteries was associated with good angiographic outcome at 6-month follow-up.

A novel nanocarrier sirolimus-coated balloon for coronary interventions: 12-Month data from the Nanoluté Registry.

BACKGROUND: The aim of the Nanoluté registry was to observe the clinical performance of a novel sirolimus coated balloon (SCB) (Concept Medical Research Private Limited, India) for the treatment of coronary de-novo and restenotic lesions. METHODS: All patients treated with SCB between July 2012 and September 2015 were enrolled at Indian centres and clinically followed for 1, 3, 6 and 12 months post-procedure. Primary endpoints were procedural success and device-oriented adverse cardiac events (DOCE) at 12 months. DOCE were defined as a composite of cardiac death, target lesion revascularization (TLR) and target vessel-myocardial infarction. RESULTS: A total of 394 SCB were used in 332 patients to treat 356 lesions. In-stent restenosis and small coronary vessel disease occurred in 46% and 43% of the patients respectively. Mean balloon length and diameter (average ±â€¯SD) were 21.83 ±â€¯6.70 mm and 2.69 ±â€¯0.45 mm respectively. All patients with 1 year follow-up were included. Overall DOCE rate was 4.2% (n = 14) which included death 0.3% (n = 1), TLR 3.6% (n = 12) and myocardial infarction 0.3% (n = 1). CONCLUSION: The Nanoluté prospective registry, is the first clinical evidence of the safety and feasibility of this type of SCB, both in patients with in-stent restenosis or de novo lesions.