Drug-coated balloon combined with drug-eluting stent for the treatment of coronary bifurcation lesions: insights from the HYPER study.

True coronary bifurcation lesions (CBL) represent a challenging scenario for percutaneous coronary interventions (PCI), and are associated with a higher risk of target lesion failure (TLF), particularly when two stents are implanted. A hybrid strategy combining a drug-eluting stent (DES) in the main branch, and a drug-coated balloon in the side branch may improve outcomes by reducing the total stent length while maintaining an effective anti-prolipherative action. In this sub-study of the HYPER trial, 50 patients with true CBL were treated with a hybrid strategy: procedural success was 96%, one case of peri-procedural myocardial infarction and one case of TLF (in a DES-treated segment) at 1 year were reported. This study suggests that such a hybrid strategy may be a safe and effective option for true CBL PCI, and warrants additional investigations to compare outcomes with standard of care strategies.

Acute myocardial infarction and large coronary thrombosis in a patient with COVID-19.

This is a case report of a 60-year-old male, without any cardiovascular risk factor and no cardiac history admitted to hospital with a diagnosis of interstitial pneumonia caused by coronavirus disease 2019 (COVID-19). After 7 days, the blood tests showed a significant rise of inflammatory and procoagulant markers, along with a relevant elevation of high-sensitivity Troponin I. Electrocardiogram and transthoracic echocardiogram (TTE) were consistent with a diagnosis of infero-posterolateral acute myocardial infarction and the patient was transferred to the isolated Cath Lab for primary percutaneous coronary intervention (PCI). The angiography showed an acute massive thrombosis of a dominant right coronary artery without clear evidence of atherosclerosis. Despite the optimal pharmacological therapies and different PCI techniques, the final TIMI flow was 0/1 and after 3 hr the clinical condition evolved in cardiac arrest for pulseless electric activity. Acute coronary syndrome-ST-elevation myocardial infarction is a relevant complication of COVID-19. Due to high levels of proinflammatory mediators, diffuse coronary thrombosis could occur even in patients without cardiac history or comorbidities. This clinical case suggests that coronary thrombosis in COVID-19 patients may be unresponsive to optimal pharmacological (GP IIb-IIIa infusion) and mechanical treatment (PCI).

Comparison of bioresorbable vs durable polymer drug-eluting stents in unprotected left main (from the RAIN-CARDIOGROUP VII Study).

BACKGROUND: There are limited data regarding the impact of bioresorbable polymer drug eluting stent (BP-DES) compared to durable polymer drug eluting stent (DP-DES) in patients treated with percutaneous coronary intervention using ultrathin stents in left main or bifurcations. METHODS: In the RAIN registry (ClinicalTrials NCT03544294, june 2018 retrospectively registered) patients with a ULM or bifurcation stenosis treated with PCI using ultrathin stents (struts thinner than 81 µm) were enrolled. The primary endpoint was the rate of target lesion revascularization (TLR); major adverse cardiovascular events (MACE, a composite of all-cause death, myocardial infarction, TLR and stent thrombosis) and its components, along with target vessel revascularization (TVR) were the secondary ones. A propensity score with matching analysis to compare patients treated with BP-DES versus DP-DES was also assessed. RESULTS: From 3001 enrolled patients, after propensity score analysis 1400 patients (700 for each group) were selected. Among them, 352 had ULM disease and 1048 had non-LM bifurcations. At 16 months (12-22), rates of TLR (3.7% vs 2.9%, p = 0.22) and MACE were similar (12.3% vs. 11.6%, p = 0.74) as well as for the other endpoints. Sensitivity analysis of outcomes after a two-stents strategy, showed better outcome in term of MACE (20.4% vs 10%, p = 0.03) and TVR (12% vs 4.6%, p = 0.05) and a trend towards lower TLR in patients treated with BP-DES. CONCLUSION: In patients with bifurcations or ULM treated with ultrathin stents BP-DES seems to perform similarly to DP-DES: the trends toward improved clinical outcomes in patients treated with the BP-DES might potentially be of value for speculating the stent choice in selected high-risk subgroups of patients at increased risk of ischemic events. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03544294. Retrospectively registered June 1, 2018.

Procedural and one-year outcomes following drug-eluting stent and drug-coated balloon combination for the treatment of de novo diffuse coronary artery disease: the HYPER Study.

BACKGROUND: De novo diffuse coronary artery disease (CAD) is a challenging scenario in interventional cardiology with limited treatment option, beside stent implantation. In this context, a hybrid approach, combining the use of drug-eluting stent (DES) and drug-coated balloon (DCB) to treat different segments of the same lesion (e.g. long lesion and/or true bifurcation), might be an interesting and alternative strategy to limit the metal amount. The aim of this study was to evaluate the safety and efficacy of a hybrid approach in addressing percutaneous treatment of de novo diffuse CAD. METHODS: This was a prospective, multicenter study including patients affected by de novo diffuse CAD treated with a hybrid approach from April 2019 to December 2020. Angiographic and clinical data were collected. The primary endpoint was the one-year device-oriented composite endpoint (DOCE, cardiac death, target vessel myocardial infarction and ischemia-driven target lesion revascularization [ID-TLR]). Periprocedural myocardial infarctions and periprocedural success were included among secondary endpoints. RESULTS: One hundred six patients were included, mean age was 68.2±10.2 years and 78.3% were male. De novo diffuse CAD consisted of 52.8% long lesions and 47.2% true bifurcation lesions. Significant increase in the final minimal lumen diameters and significant decrease in the final diameter stenosis were observed when compared to the baseline values in both DES- and DCB-target segments. Procedural success was 96.2%. DOCE at one-year was 3.7%, with all the adverse events characterized by ID-TLR. CONCLUSIONS: Combination of DES and DCB could be a safe and effective treatment option for the treatment of de novo diffuse CAD (NCT03939468).

Functional (Re)Development of SYNTAX Score II 2020: Predictive Performance and Risk Assessment.

The present study investigates the prognostic value of the Syntax Score II 2020 corrected for flow-limiting lesions and its ability to better address treatment by benefit prediction among patients with left main or multivessel disease. We analyzed 1274 patients from the HALE-BOPP cohort and integrated the Syntax Score II 2020 with the result of the fractional flow reserve (FFR) evaluation. Absolute risk difference (ARD) between surgical and percutaneous revascularization was calculated for anatomic and functional Syntax Score II 2020 predicted mortality. The ARD allowed to stratify the population into two large categories: "coronary artery bypass graft (CABG) better" with ARD ≥ 4.5% and "CABG-percutaneous coronary intervention (PCI) equipoise" with ARD < 4.5%. The mean global anatomical Syntax Score was 15.5 ± 9.2, whereas the functional one was 9.5 ± 10 (p < 0.01). Using the anatomic Syntax Score II 2020, 881 patients had a CABG-PCI equipoise. This number increased to 1041 after considering only flow-limiting lesions by FFR (p < 0.001); therefore, 40% of CABG better patients were reclassified within the CABG-PCI equipoise category. Kaplan-Maier curves showed similar actual survival rates for patients originally with CABG-PCI equipoise and those reclassified, in both cases higher than those from CABG better patients (p < 0.01). The integration between Syntax Score II 2020 and physiology is feasible, and merging clinical, anatomic and functional data allows for better risk prediction and therapeutic guidance.

A HYbrid APproach Evaluating a DRug-Coated Balloon in Combination With a New-Generation Drug-Eluting Stent in the Treatment of De Novo Diffuse Coronary Artery Disease: The HYPER Pilot Study.

OBJECTIVES: To assess feasibility, safety and efficacy of hybrid approach, consisting in a combination of modern drug-eluting stent (DES) and drug-eluting balloon (DCB), for treatment of de-novo diffuse coronary artery disease (CAD). BACKGROUNDS: Contemporary DES are associated with a persistent risk of major cardiovascular events, due to in-stent thrombosis and restenosis. The hybrid approach, reducing the permanent metallic cage length, is supposed to mitigate the risk of device-related adverse events, especially in diffuse CAD. METHODS: This is a prospective, non-randomized, observational, multicenter study intended to obtain data from 100 consecutive patients affected by de-novo diffuse CAD undergoing percutaneous coronary intervention with a hybrid approach, consisting in the combined use of DES and DCB in contiguous coronary segments. The study is recorded in ClinicalTrials.gov with the identifier: NCT03939468. RESULTS: The primary endpoint is a device oriented composite end-point (DOCE) of cardiac death, target vessel myocardial infarction (TV-MI) and ischemia-driven target lesion revascularization (ID-TLR) in DES- and/or DCB-treated segment. DOCE will be assessed at 12-months follow-up. CONCLUSIONS: This will be the first study investigating the feasibility, safety and efficacy of hybrid DES/DCB approach for the treatment of de-novo diffuse CAD. Here we describe the rationale and the design of the study.

PK Papyrus coronary stent system: the ultrathin struts polyurethane-covered stent.

In the emergency setting of a coronary vessel perforation, the knowledge of materials needed to fix it and the intrinsic quality of the device used is mandatory for the interventional cardiologist. The PK Papyrus covered stent (Biotronik AG) is an ultrathin strut (60 µm) balloon-expandable stent covered on the abluminal surface with an electrospun polyurethane matrix. It is intended to facilitate device delivery and effectively treat coronary artery perforations. In published studies, rates of successful device delivery and perforation sealing were above 90%, respectively, and most events were usually resolved with a single stent. In this review we focused on the main technical characteristics as well on the published evidence that compare its performance with other coronary covered stent.

The incidence and timing of major arrhythmias following successful primary angioplasty for acute myocardial infarction.

BACKGROUND: The potential benefits of direct percutaneous transluminal coronary angioplasty (PTCA) on malignant arrhythmias in the hospital phase of acute myocardial infarction have not yet been established. METHODS: We prospectively investigated the incidence and timing of major arrhythmias occurring during direct PTCA and within 24 hours of mechanical reperfusion in 90 consecutive patients with acute myocardial infarction undergoing successful direct PTCA within 12 hours of symptom onset. RESULTS: Ventricular fibrillation and complete atrioventricular block occurred exclusively during direct PTCA and both resolved in the catheterization laboratory. Holter monitoring showed that ventricular tachyarrhythmias, such as runs of more than 3 extrasystoles, were detectable only during the first 8 hours after direct PTCA. CONCLUSIONS: In our group of patients undergoing successful direct PTCA, no in-hospital life-threatening arrhythmias occurred after this procedure.

Short-term high-dose atorvastatin for periprocedural myocardial infarction prevention in patients with renal dysfunction.

OBJECTIVES: Short-term high-dose atorvastatin administered before percutaneous coronary intervention (PCI) reduces the rate of periprocedural myocardial infarction (pMI) in high-risk patients, such as those with acute coronary syndromes and those with elevated high-sensitivity C-reactive protein. It is unknown whether short-term high-dose administration reduces the rate of pMI in patients with chronic kidney disease. Recently, we observed that in 304 patients with estimated creatinine clearance less than 60 ml/min randomized to receive 80 mg/day of atorvastatin or placebo for 48 h before elective coronary angiography and/or angioplasty, statin administration did not reduce contrast-induced nephropathy (CIN). In this post-hoc analysis, we evaluate the pMI in the subgroup of 161 patients who underwent PCI. METHODS: In all patients, creatine kinase myocardial isoenzyme (CK-MB) [upper reference limit (URL) 5 ng/ml] was assessed before and at 12 and 24 h after PCI. The pMI, defined as CK-MB elevation more than three times the URL, occurred in 27 (17%) patients. RESULTS: The incidence of pMI was 10.4% (of 77 patients) in the atorvastatin and 23% (of 84 patients) in the placebo group (P < 0.05). Multivariate analysis identified the pretreatment with high-dose atorvastatin as an independent predictor of reduced risk of pMI [odds ratio 0.39, 95% confidence interval 0.16-0.96, P < 0.05]. CONCLUSION: This post-hoc analysis shows that short-term high-dose atorvastatin administration reduced pMI in patients with renal dysfunction submitted to elective PCI, but without benefit regarding CIN prevention.

Usefulness of atorvastatin (80 mg) in prevention of contrast-induced nephropathy in patients with chronic renal disease.

We investigated the efficacy of short-term high-dose atorvastatin in decreasing the risk of contrast-induced nephropathy (CIN) in patients with chronic kidney disease (CKD) subjected to coronary angiography and/or angioplasty. CIN occurs in up to 15% of patients with pre-existing CKD and affects clinical outcome. The protective effect of statin therapy against CIN is still controversial. A prospective, single-center study of 304 patients with baseline estimated creatinine clearance <60 ml/min were randomized to receive atorvastatin 80 mg/day or placebo for 48 hours before and 48 hours after contrast medium administration. All patients received intravenous saline hydration and oral N-acetylcysteine 1,200 mg 2 times/day. Iso-osmolar contrast medium was used. CIN was defined as an absolute increase of serum creatinine > or = 0.5 mg/dl within 5 days after the procedure. CIN occurred in 31 patients (10%), 16 (11%) in the placebo group and 15 (10%) in the atorvastatin group (p = 0.86). Mean increase in creatinine was not significantly different in the 2 groups (0.59 + or - 0.17 in placebo group vs 0.72 + or - 0.26 mg/dl in atorvastatin group, p = 0.31). Persistent kidney injury, defined as 1-month increase from baseline creatinine value > or = 25%, was observed in 30% in the placebo group and in 31% in the atorvastatin group (p = 0.58). In conclusion, a short-term administration of high doses of atorvastatin before and after contrast exposure, in addition to standard intravenous hydration and oral N-acetylcysteine, does not decrease CIN occurrence in patients with pre-existing CKD.

Preprocedural score for risk of contrast-induced nephropathy in elective coronary angiography and intervention.

OBJECTIVES: To develop a simplified scoring system based on preprocedure clinical characteristics to predict contrast-induced nephropathy (CIN) before elective coronary angiography and percutaneous coronary intervention (PCI). BACKGROUND: CIN is associated with increased mortality and morbidity following coronary angiography and PCI and accounts for increased hospital costs. METHODS: Several baseline clinical characteristics of 1218 patients were considered as candidate univariate predictors of CIN (increase > or =0.5 mg/dl in serum creatinine within 5 days after contrast exposure). On the basis of the odds ratio at multivariate logistic regression, seven markers (with weighted scores) were identified as independent correlates of CIN: age at least 73 years (1), diabetes mellitus (2), left ventricular ejection fraction 45% or less (2), baseline serum creatinine value at least 1.5 mg/dl (2), baseline creatinine clearance 44 ml/min or less (2), posthydration creatinine > or = prehydration creatinine value (2) and one procedure effected within the past 72 h (3). RESULTS: CIN occurred in 114 (9.4%) patients [range 1.1-52.1% for a low (< or =3) and very high (> or =9) risk score, respectively]; the odds of CIN increased significantly with each class (Cochran-Armitage chi-square, P < 0.0001) and the risk score allowed us to determine patients with low and high risk for postprocedure CIN (c-statistic = 0.86). These results were reproduced in a validation set. CONCLUSION: Preprocedural clinical risk factors have different influences on the likelihood of CIN. Risk classification based on the most significant parameters can be used to predict CIN before contrast exposure. The simple scoring system proposed here provides a good estimate of the risk of CIN, allowing the interventional team to make adequate adjustment to the procedures.

Sodium bicarbonate versus saline for the prevention of contrast-induced nephropathy in patients with renal dysfunction undergoing coronary angiography or intervention.

OBJECTIVES: The purpose of this study was to compare the efficacy of sodium bicarbonate versus isotonic saline in addition to N-acetylcysteine (NAC) to prevent contrast-induced nephropathy (CIN) in a larger population of patients with renal dysfunction undergoing coronary angiography or intervention. BACKGROUND: Contrast-induced nephropathy accounts for more than 10% of hospital-acquired renal failure. Recent studies suggest that hydration with sodium bicarbonate is more protective than isotonic saline in the prevention of CIN. METHODS: The prospective, single center study included 502 patients with estimated creatinine clearance <60 ml/min, randomized to receive infusion of either saline or sodium bicarbonate before and after iso-osmolar contrast medium administration. All patients received oral NAC 600 mg twice a day. Contrast-induced nephropathy was defined as an absolute increase of serum creatinine > or =0.5 mg/dl measured within 5 days. RESULTS: Contrast-induced nephropathy occurred in 54 patients (10.8%); 25 (10%) were treated with sodium bicarbonate and 29 (11.5%) with saline (p = 0.60). In patients with CIN, the mean increase in creatinine was not significantly different in the 2 study groups (0.9 +/- 0.6 mg/dl vs. 0.7 +/- 0.2 mg/dl, respectively; p = 0.15). Only 2 patients needed temporary hemofiltration. CONCLUSIONS: Hydration with sodium bicarbonate plus NAC before contrast medium exposure is not more effective than hydration with isotonic saline plus NAC for prophylaxis of CIN in patients with moderate-to-severe renal dysfunction. (Sodium Bicarbonate Versus Saline for the Prevention of Contrast-Induced Nephropathy; NCT00606827).