Real-world reasons and outcomes for 1-month versus longer dual antiplatelet therapy strategies with a polymer-free BIOLIMUS A9-coated stent.

BACKGROUND: A large trial established the favorable profile of a new polymer-free biolimus A9-eluting stent (PF-BES) with a 1-month dual antiplatelet therapy (DAPT) in high bleeding risk (HBR) patients. This is the first study comparing outcomes for a 1-month versus longer DAPT strategies following PF-BES-percutaneous coronary intervention (PCI). METHODS: All patients undergoing PF-BES-PCI (January 2016 to July 2018) were included in the multicenter CHANCE registry. Patients were stratified according to DAPT strategy at discharge (planned 1-month vs. planned >1-month). Primary outcomes were the 390-day estimates of a patient-oriented and of a device-oriented composite endpoints (POCE: death, myocardial infarction [MI] or target vessel revascularization; DOCE: cardiac death, target vessel-MI or ischemia-driven target lesion revascularization). Landmark analyses from 1-month post-PCI were carried. RESULTS: Following PF-BES-PCI, 328(40.3%) and 485(59.6%) patients were discharged with 1-month and longer DAPT (12 months [6-12]), respectively. Patients with a previous or index MI were less likely to be discharged on 1-month DAPT. Patients prescribed with 1-month DAPT were more likely to be at HBR than those with longer DAPT (90.2% vs. 69.9%, p = .001). No between-groups differences in the primary outcomes (planned 1-month vs. planned >1-month DAPT: POCE 11.9% vs. 13.2%, p = .747; DOCE: 4.8% vs. 8.1%, p = .500) were observed, also after adjusting for confoundings (POCE: adjusted-hazard ratio [adj-HR] 1.26, 95%CI 0.74-2.13; DOCE: adj-HR 1.00, 95%CI 0.49-1.99). Landmark analyses showed similar results. CONCLUSIONS: In a large all-comers registry of PF-BES PCI, no interaction of planned DAPT strategy (1-month vs. >1-month) with outcomes was found. This observation warrants investigation in adequately powered randomized studies (ClinicalTrials.gov NCT03622203).

Dual antiplatelet therapy strategies and clinical outcomes in patients treated with polymer-free biolimus A9-coated stents.

AIMS: A large trial established the favourable clinical profile of a new polymer-free biolimus A9-eluting stent (PF-BES) with a one-month dual antiplatelet therapy (DAPT) regimen in patients at high bleeding risk (HBR). We aimed to evaluate the real-world patterns of indications, DAPT strategies and outcomes for the PF-BES following this evidence. METHODS AND RESULTS: CHANCE is a multicentre registry including all patients who underwent percutaneous coronary intervention (PCI) with at least one PF-BES. The reasons for the PF-BES PCI and planned antithrombotic regimens were collected. Primary outcomes were the 390-day Kaplan-Meier estimates of patient-oriented and device-oriented composite endpoints (POCE: death, myocardial infarction [MI] or target vessel revascularisation [TVR]; DOCE: cardiac death, target vessel MI or ischaemia-driven target lesion revascularisation [ID-TLR]). Between January 2016 and July 2018, 858 patients (age 74±10 years, 64.6% male, 58.7% acute coronary syndrome presentation) underwent PF-BES PCI. The main reasons for the physicians' choice of PF-BES reflected a perceived HBR in 77.7% of patients. One-month DAPT was planned in 40.3% of patients. At 390-day follow-up (median 340 days, interquartile range: 187-390 days), the estimated incidence of POCE was 13.1% (any MI 3.7%, any TVR 3.4%) and of DOCE was 7.1% (TV-MI 3.6%, ID-TLR 1.4%), while the 390-day estimate of any bleeding event was 11.1% (BARC 3-5 bleeding 3.0%). CONCLUSIONS: In a large all-comers registry, PF-BES was used mostly in HBR patients, frequently followed by a very short DAPT regimen. The reported outcomes suggest a favourable safety and efficacy profile for the PF-BES in a real-world clinical setting. ClinicalTrials.gov identifier: NCT03622203.

Sirolimus-Eluting Magnesium Resorbable Scaffold Implantation in Patients with Acute Myocardial Infarction.

To date, very little is known about the performance of a sirolimus-eluting bioresorbable magnesium scaffold (Mg-BRS) in patients with acute myocardial infarction (AMI). A multicenter cohort analysis was performed on 69 consecutive AMI subjects treated with Mg-BRS. Procedural success was obtained in all cases, and no in-hospital events were reported. At 9-month follow-up, no cardiac death, target-vessel myocardial infarction, ischemia-driven target lesion revascularization, or Mg-BRS thrombosis was reported. Although our analysis showed encouraging results, larger studies and longer-term follow-up are needed to better understand the potential benefits associated with the use of a Mg-BRS in AMI patients.

Bioresorbable vascular scaffold versus everolimus-eluting stents or drug eluting balloon for the treatment of coronary in-stent restenosis: 1-Year follow-up of a propensity score matching comparison (the BIORESOLVE-ISR Study).

OBJECTIVES: to compare the 1-year outcome between bioresorbable vascular scaffold (BVS), everolimus-eluting stent (EES), and drug-eluting balloon (DEB) for in-stent restenosis (ISR) treatment. BACKGROUND: BVS has been proposed as alternative for ISR treatment. To date a direct comparison between BVS and DES or DEB for ISR treatment is lacking. METHODS: We retrospectively analyzed all ISR lesions treated with BVS, DEB, and EES from January 2012 to December 2014. A total of 548 lesions (498 patients) were included. By applying two propensity-score matching, 93 lesions treated with BVS were compared with 93 lesions treated with DEB, and 100 lesions treated with BVS were compared to 100 lesions treated with EES. RESULTS: At 1-year follow-up the incidence of device-oriented cardiovascular events (DOCE) and its components did not significantly differ between BVS and DEB (DOCE: 10.9 vs. 11.8%, HR, 0.91; 95% CI, 0.33-2.52; P = 0.86; Cardiac death: 2.2 vs. 1.2%, HR, 1.74, 95% CI 0.16-18.80, P = 0.65; ID-TLR: 8.9 vs. 10.7%, HR, 0.81, 95% CI 0.27-2.48, P = 0.71; TV-MI: 3.3 vs. 1.2%, HR, 2.39, 95% CI 0.27-21.32, P = 0.43) and BVS vs. EES (DOCE: 10.1 vs. 5.2% HR, 1.81, 95% CI, 0.63-5.25; P = 0.27; Cardiac death: 3.0 vs. 1.1%; HR, 2.83, 95% CI 0.29-27.4, P = 0.37; ID-TLR: 7.2 vs. 4.2%, HR, 1.57, 95% CI 0.47-5.23, P = 0.46; TV-MI: 3.1 vs. 0%). CONCLUSION: At 1-year follow-up the use of BVS as ISR treatment is associated with a higher, even if not significant, DOCE rate compared with EES while a similar rate compared to DEB.

A hybrid strategy with bioresorbable vascular scaffolds and drug eluting stents for treating complex coronary lesions.

BACKGROUND: Due to the inherent limitations of current generation BVSs, complex coronary artery disease often contains BVS unsuitable segments. Our aim was to assess the feasibility of a hybrid approach using bioresorbable vascular scaffolds (BVSs) and drug-eluting stents (DESs) for the treatment of complex coronary artery lesions not suitable for a scaffolding only approach. METHODS: A retrospective multicenter cohort analysis was performed on patients with complex de novo or in-stent restenosis lesions treated with a hybrid BVS (Absorb BVS, Abbott Vascular, Santa Clara, CA) and DES strategy. The primary endpoint was target lesion failure (TLF) defined as a composite of cardiac death, target-vessel myocardial infarction (MI) and target lesion revascularization (TLR). RESULTS: A total of 98 patients (105 lesions) were treated with the hybrid strategy. Isolated long lesions in which either proximal or distal reference vessel diameters were not suitable for BVS were an indication in 36.2% (n=38) of cases. In contrast, 28% (n=29) of lesions treated with the hybrid strategy were bifurcations in which the side branch was predominantly treated with DES (n=28). DES bailout after BVS implantation was an indication in 21.9% (n=23 lesions). The rates of type B2/C and long lesions (>28mm) were 95.2% and 74.3% respectively. The mean total BVS and DES lengths implanted were 37.5±24.1mm and 25.0±14.7mm respectively. The rate of TLF in the overall cohort of patients (median follow-up 405days [interquartile range 189-658]) was 11.4% at 1-year. This was primarily driven by TLR (9.5%), with rates of cardiac death and target vessel MI of 2.1% and 1.4% respectively. No cases of definite or probable BVS/DES thrombosis occurred. CONCLUSION: In conclusion, the use of a hybrid BVS/DES strategy was feasible and associated with acceptable outcomes at 1-year, considering the length and complexity of lesions treated. Further, larger studies with longer follow-up are needed to confirm our findings.

Coronary Sinus Reducer system™: A new therapeutic option in refractory angina patients unsuitable for revascularization.

A challenge of modern cardiovascular medicine is to find new, effective treatments for patients with refractory angina pectoris (RAP), a clinical condition characterized by severe angina despite optimal medical therapy and "no option" for a surgical or percutaneous revascularization. Although the relevant advance of both pharmaceutical and interventional treatments for patients affected by symptomatic coronary artery disease has greatly contributed to prolong survival, the increasing number of patients experimenting persistent and invalidating angina symptoms, highlights that quality of life of these patients has not been equally improved. Clinical limitations of the efficiency of conventional and relatively new approaches justify the search for new therapeutic options. In this review, we will focus on the epidemiology of RAP, and we will provide a brief update on the different options actually available to these patients with particular interest to an innovative device that narrow the coronary sinus: the Reducer system (Neovasc Inc., Richmond B.C., Canada). The efforts of present and future clinical studies will ultimately answer the question of whether this intriguing therapy is a suitable strategy for treatment of patients with RAP.

An unusual case of cardiogenic shock late following surgical aortic valve replacement.

The present case describes a rare but potentially life-threatening complication following surgical aortic valve replacement (AVR): iatrogenic coronary ostial stenosis (ICOS). The incidence of ICOS is estimated to be between 0.3% and 5% of all AVR and it generally occurs within 6 months after the procedure. In most cases, either the left main stem or the ostium of the right coronary artery (RCA) is affected, although stenosis of the ostium of the left anterior descending artery can also occur. However, to the best of our knowledge, the simultaneous involvement of both coronary ostia, presenting with rapid onset cardiogenic shock requiring inotropic support and intra-aortic balloon pump placement, has never been reported. .