OCT or Angiography Guidance for PCI in Complex Bifurcation Lesions.

BACKGROUND: Imaging-guided percutaneous coronary intervention (PCI) is associated with better clinical outcomes than angiography-guided PCI. Whether routine optical coherence tomography (OCT) guidance in PCI of lesions involving coronary-artery branch points (bifurcations) improves clinical outcomes as compared with angiographic guidance is uncertain. METHODS: We conducted a multicenter, randomized, open-label trial at 38 centers in Europe. Patients with a clinical indication for PCI and a complex bifurcation lesion identified by means of coronary angiography were randomly assigned in a 1:1 ratio to OCT-guided PCI or angiography-guided PCI. The primary end point was a composite of major adverse cardiac events (MACE), defined as death from a cardiac cause, target-lesion myocardial infarction, or ischemia-driven target-lesion revascularization at a median follow-up of 2 years. RESULTS: We assigned 1201 patients to OCT-guided PCI (600 patients) or angiography-guided PCI (601 patients). A total of 111 patients (18.5%) in the OCT-guided PCI group and 116 (19.3%) in the angiography-guided PCI group had a bifurcation lesion involving the left main coronary artery. At 2 years, a primary end-point event had occurred in 59 patients (10.1%) in the OCT-guided PCI group and in 83 patients (14.1%) in the angiography-guided PCI group (hazard ratio, 0.70; 95% confidence interval, 0.50 to 0.98; P = 0.035). Procedure-related complications occurred in 41 patients (6.8%) in the OCT-guided PCI group and 34 patients (5.7%) in the angiography-guided PCI group. CONCLUSIONS: Among patients with complex coronary-artery bifurcation lesions, OCT-guided PCI was associated with a lower incidence of MACE at 2 years than angiography-guided PCI. (Funded by Abbott Vascular and others; OCTOBER ClinicalTrials.gov number, NCT03171311.).

Immediate versus staged complete revascularisation in patients presenting with acute coronary syndrome and multivessel coronary disease (BIOVASC): a prospective, open-label, non-inferiority, randomised trial.

BACKGROUND: In patients with acute coronary syndrome and multivessel coronary disease, complete revascularisation by percutaneous coronary intervention (PCI) is associated with improved clinical outcomes. We aimed to investigate whether PCI for non-culprit lesions should be attempted during the index procedure or staged. METHODS: This prospective, open-label, non-inferiority, randomised trial was done at 29 hospitals across Belgium, Italy, the Netherlands, and Spain. We included patients aged 18-85 years presenting with ST-segment elevation myocardial infarction or non-ST-segment elevation acute coronary syndrome and multivessel (ie, two or more coronary arteries with a diameter of 2·5 mm or more and ≥70% stenosis based on visual estimation or positive coronary physiology testing) coronary artery disease with a clearly identifiable culprit lesion. A web-based randomisation module was used to randomly assign patients (1:1), with a random block size of four to eight, stratified by study centre, to undergo immediate complete revascularisation (PCI of the culprit lesion first, followed by other non-culprit lesions deemed to be clinically significant by the operator during the index procedure) or staged complete revascularisation (PCI of only the culprit lesion during the index procedure and PCI of all non-culprit lesions deemed to be clinically significant by the operator within 6 weeks after the index procedure). The primary outcome was the composite of all-cause mortality, myocardial infarction, any unplanned ischaemia-driven revascularisation, or cerebrovascular events at 1 year after the index procedure. Secondary outcomes included all-cause mortality, myocardial infarction, and unplanned ischaemia-driven revascularisation at 1 year after the index procedure. Primary and secondary outcomes were assessed in all randomly assigned patients by intention to treat. Non-inferiority of immediate to staged complete revascularisation was considered to be met if the upper boundary of the 95% CI of the hazard ratio (HR) for the primary outcome did not exceed 1·39. This trial is registered with ClinicalTrials.gov, NCT03621501. FINDINGS: Between June 26, 2018, and Oct 21, 2021, 764 patients (median age 65·7 years [IQR 57·2-72·9] and 598 [78·3%] males) were randomly assigned to the immediate complete revascularisation group and 761 patients (median age 65·3 years [58·6-72·9] and 589 [77·4%] males) were randomly assigned to the staged complete revascularisation group, and were included in the intention-to-treat population. The primary outcome at 1 year occurred in 57 (7·6%) of 764 patients in the immediate complete revascularisation group and in 71 (9·4%) of 761 patients in the staged complete revascularisation group (HR 0·78, 95% CI 0·55-1·11, pnon-inferiority=0·0011). There was no difference in all-cause death between the immediate and staged complete revascularisation groups (14 [1·9%] vs nine [1·2%]; HR 1·56, 95% CI 0·68-3·61, p=0·30). Myocardial infarction occurred in 14 (1·9%) patients in the immediate complete revascularisation group and in 34 (4·5%) patients in the staged complete revascularisation group (HR 0·41, 95% CI 0·22-0·76, p=0·0045). More unplanned ischaemia-driven revascularisations were performed in the staged complete revascularisation group than in the immediate complete revascularisation group (50 [6·7%] patients vs 31 [4·2%] patients; HR 0·61, 95% CI 0·39-0·95, p=0·030). INTERPRETATION: In patients presenting with acute coronary syndrome and multivessel disease, immediate complete revascularisation was non-inferior to staged complete revascularisation for the primary composite outcome and was associated with a reduction in myocardial infarction and unplanned ischaemia-driven revascularisation. FUNDING: Erasmus University Medical Center and Biotronik.

The role of intra-vascular imaging in patients undergoing intravascular lithotripsy: Insights from the COIL registry.

BACKGROUND: The role of intra-coronary imaging in patients with stent failure undergoing intravascular lithotripsy (IVL) is unclear. We aimed to assess clinical outcomes in patients undergoing IVL treatment for stent failure stratified according to the use of intra-coronary imaging and lesion complexity. METHODS: This is a pre-specified subgroup analysis of patients who were included in the coronary intravascular lithotripsy in patients with stent failure (COIL) registry (international multi-centre study assessing IVL treatment for stent failure in 6 European centres). A complex lesion was defined if IVL treatment was used in the left main, true bifurcation, long lesion, or coupled with athero-ablative therapy. The primary endpoint was the composite of cardiac death, spontaneous myocardial infarction, or target vessel revascularization (TVR) at 12 months. RESULTS: There were 102 patients analyzed, of whom 27 (26%) patients had complex anatomy. The use of intra-coronary imaging following IVL in stent failure was more frequent in patients with complex versus Noncomplex anatomy (56% vs. 31%, p = 0.022). IVL treatment was effective in both groups, however, patients with complex anatomy had worse clinical outcomes (30% vs. 11%, p = 0.02), driven by a higher rate of TVR (26% vs. 8%, p = 0.017). In the complex group, patients who underwent intracoronary imaging post intervention had lower event rate compared to those without imaging (13% vs. 50%, p = 0.038). CONCLUSIONS: In patients undergoing IVL treatment for stent failure with complex coronary anatomy, the use of intra-coronary imaging was associated with fewer adverse events compared to angiography guided intervention.

Performance of the minimalistic hybrid approach algorithm versus other conventional algorithms in the percutaneous treatment of chronic total occlusions.

BACKGROUND: The "Minimalistic Hybrid Approach" (MHA) has been proposed to reduce the invasiveness of chronic total occlusion (CTO) percutaneous coronary intervention (PCI). AIMS: This study aims to assess whether MHA may also reduce the utilization of PCI resources (devices, radiations, and contrast) by comparing it with other conventional algorithms. METHODS: We aimed to assess the impact of MHA on device, radiation, and contrast usage during CTO-PCI analyzing data from the Belgian Working Group on CTO (BWG-CTO) registry. Patients were divided, depending on the algorithm used, into two groups: Conventional versus Minimalistic. Primary objectives were procedure performance measures such as device usage (microcatheters and guidewires), radiological parameters, and contrast use. At 1-year follow-up, patients were evaluated for target vessel failure (TVF), defined as a composite of cardiac death, new myocardial infarction, and target vessel revascularization. RESULTS: Overall, we analyzed 821 CTO-PCIs (Conventional n = 650, Minimalistic n = 171). The Minimalistic group demonstrated higher complexity of CTO lesions. After adjusting for propensity score, the Minimalistic group had a significantly lower number of microcatheters used (1.49 ± 0.85 vs. 1.24 ± 0.64, p = 0.026), while the number of guidewires was comparable (4.80 ± 3.29 vs. 4.35 ± 2.94, p = 0.30). Both groups had similar rates of success and procedural complications, as well as comparable procedural and fluoroscopic times and contrast volume used. At the 1-year follow-up, both groups showed comparable rates of TVF (hazard ratio: 0.57; 95% confidence interval: 0.24-1.34, p = 0.195). CONCLUSION: The MHA may slightly reduce the number of dedicated devices used during CTO-PCI, without adversely affecting the procedural success or long-term outcome.

Bleeding and thrombotic risk of different antiplatelet regimens posttranscatheter edge-to-edge mitral valve repair in patients with an indication for oral anticoagulation: Results from an all-comers national registry.

BACKGROUND: Evidence-based recommendations for antithrombotic treatment in patients who have an indication for oral anticoagulation (OAC) after transcatheter edge-to-edge mitral valve repair (TEER) are lacking. AIMS: To compare bleeding and thrombotic risk for different antithrombotic regimens post-TEER with MitraClip in an unselected population with the need for OACs. METHODS: Bleeding and thrombotic complications (stroke and myocardial infarction) up to 3 months after TEER with mitraclip were evaluated in 322 consecutive pts with an indication for OACs. These endpoints were defined by the Mitral Valve Academic Research Consortium criteria and were compared between two antithrombotic regimens: single antithrombotic therapy with OAC (single ATT) and double/triple ATT with a combination of OAC and aspirin and/or clopidogrel (combined ATT). RESULTS: Collectively, 108 (34%) patients received single ATT, 203 (63%) received double ATT and 11 (3%) received triple ATT. Bleeding events occurred in 67 patients (20.9%), with access site related events being the most frequent cause (37%). Bleeding complications were observed more frequently in the combined ATT group than in the single ATT group: 24% versus 14% [p = 0.03, adjusted RR: 0.55 (0.3-0.98)]. Within the combined group, the bleeding risk was 23% in the double ATT and 45% in the triple ATT group. Thrombotic complications occurred in only three patients (0.9%), and all belonged to the combined ATT group. CONCLUSIONS: In patients with an indication for OACs, withholding of antiplatelet therapy post-TEER with Mitraclip was associated with a 45% reduction in bleeding and without a signal of increased thrombotic risk.

Unravelling the Fate of Coronary Artery Disease in Patients Undergoing Valve Replacement for Severe Aortic Valve Stenosis.

Severe aortic valve stenosis is the most frequent valve pathology in the western world and approximately 50% of these patients have concomitant coronary artery disease (CAD). Revascularization of proximal obstructive CAD in patients undergoing surgical aortic valve replacement (SAVR) is common practice considered appropriate. However, the management of patients with CAD undergoing transcatheter aortic valve implantation (TAVI) is more controversial. Nevertheless, performing percutaneous coronary intervention (PCI) of significant ( > 70%) proximal coronary lesions is a widely adopted strategy, but robust supporting scientific evidence is missing. Some studies suggest that complex CAD with incomplete revascularization negatively impacts outcomes post-TAVI. As increasingly younger patients are undergoing TAVI, optimizing the long-term outcomes will become more important. Although PCI in TAVI patients is safe, no benefit on outcomes has been demonstrated, possibly due to an inadequate selection of prognostically important lesions for revascularization. A possible solution might be the use of coronary physiological indices, but these have their own limitations and more data is needed to support widespread adoption. In this review we provide an overview of current evidence on the outcomes after aortic valve replacement (AVR) and the evidence regarding revascularization in this population.

Heart Failure-Related Outcomes in Patients with Left Ventricular Dysfunction Undergoing Percutaneous Chronic Total Occlusion Revascularization.

Background: The presence of a chronic total occlusion (CTO) and severe left ventricular (LV) systolic dysfunction are known negative prognostic factors in patients with coronary artery disease. Several studies have examined the effect of CTO revascularization on mortality, symptoms, occurrence of myocardial infarction (MI), and cardiac function in patients with normal or reduced LV function. However, the effect of CTO revascularization on heart failure-related events in patients with LV dysfunction, such as heart failure hospitalization (HFH), the occurrence of atrial fibrillation (AF), and a worsening renal function (WRF), has not yet been evaluated. To assess the success rate and safety of CTO percutaneous coronary interventions (PCIs) in coronary patients with LV ejection fractions of ≤ 40% and evaluate the impact of successful CTO revascularization on HFH, occurrence of AF, and WRF. Methods: Prospectively, data were collected from CTO PCIs performed at three referral centers and analyzed. From a total of 1435 CTO PCIs, 132 (9.2%) patients with a left ventricular ejection fraction (LVEF) of ≤ 40% were included in this analysis. The median follow-up duration was 23.18 months (interquartile range (IQR): 11.02-46.66 months). Results: A successful CTO PCI was achieved in 109 of these patients, while the procedure was unsuccessful in 23 patients (82.5% procedural success rate). Overall, the intervention had an acceptable number of peri-procedural (or in-hospital) complications (9.1%). During the follow-up period, the rates of all-cause death, cardiovascular death, and non-fatal MI were not significantly different between the two groups. The rates of HFH were significantly lower in the successful PCI group, while WRF and AF did not differ between successful and unsuccessful PCI groups. Successful PCI and higher estimated glomerular filtration rate (eGFR) were independent predictors of a lower risk of HFH, while prior stroke and diabetes were independent predictors of a higher risk of HFH. Conclusions: In patients with reduced LV systolic function (ejection fraction, EF ≤ 40%), CTO PCI is a safe and effective procedure and successful CTO PCI is independently associated with a lower risk of HFH during follow-up. Further expansion of this cohort is necessary to confirm these results.

Angiographic predictors of aberrant circumflex artery during cardiac catheterization.

OBJECTIVES: To identify angiographic predictors of aberrant left circumflex artery (LCx) by comparing left main (LM) length and bifurcation angle between patients with aberrant LCx and normal anatomy. BACKGROUND: Failure to recognize aberrant LCx during a cardiac catheterization may hamper correct diagnosis, delay intervention in acute coronary syndromes, and result in increased contrast volume, radiation exposure, and infarct size. METHODS: We retrospectively analyzed angiograms of aberrant LCx patients and normal anatomy matched controls, in three-participating centers. LM-length, bifurcation angle between the left anterior descending (LAD) and the first non-LAD branch of the LM, and procedural data were compared. RESULTS: Between 2003 and 2020, 136 patients with aberrant LCx and 135 controls were identified. More catheters (2.4 ± 0.6 vs. 2.2 ± 0.9, p = 0.009), larger contrast volumes (169 ± 94 ml vs. 129 ± 68 ml, p < 0.0005), and prolonged fluoroscopy time (652.9 ± 623.7 s vs. 393.1 ± 332.1 s, p < 0.0005), were required in the aberrant LCx-group compared with controls. Patients with aberrant LCx had a longer LM-length and a more acute bifurcation angle, both in caudal and cranial views, compared with controls (24.7 ± 8.1 vs. 10.8 ± 4.5 mm, p < 0.0005 and 26.7 ± 7.4 vs. 12 ± 5.5 mm, p < 0.0005, respectively, and 45.2° ± 12° vs. 88.8° ± 23°, p < 0.0005 and 51.9° ± 21° vs. 68.2° ± 28.3°, p < 0.0005, respectively). In ROC analysis, LM-length showed the best diagnostic accuracy for detecting aberrant LCx. In multiple logistic regression analysis, a cranially measured LM-length > 17.7 mm was associated with a 5.3 times greater probability of predicting aberrant LCx [95% CI (3.4-8.1), p < 0.0001]. CONCLUSIONS: Our study suggests that a long LM-length and an acute bifurcation angle can indicate the presence of aberrant LCx. We present a practical algorithm for its rapid identification.

The coronary and microcirculatory measurements in patients with aortic valve stenosis study: rationale and design.

Although concomitant coronary artery disease (CAD) is frequent in patients with severe aortic stenosis (AS), hemodynamic assessment of CAD severity in patients undergoing valve replacement for severe AS is challenging. Myocardial hypertrophic remodeling interferes with coronary blood flow and may influence the values of fractional flow reserve (FFR) and nonhyperemic pressure ratios (NHPRs). The aim of the current study is to investigate the effect of the AS and its treatment on current indices used for evaluation of CAD. We will compare intracoronary hemodynamics before, immediately after, and 6 mo after aortic valve replacement (AVR) when it is expected that microvascular function has improved. Furthermore, we will compare FFR and resting full-cycle ratio (RFR) with myocardial perfusion single-photon emission-computed tomography (SPECT) as indicators of myocardial ischemia in patients with AS and CAD. One-hundred consecutive patients with AS and intermediate CAD will be prospectively included. Patients will undergo pre-AVR SPECT and intracoronary hemodynamic assessment at baseline, immediately after valve replacement [if transcatheter AVR (TAVR) is chosen], and 6 mo after AVR. The primary end point is the change in FFR 6 mo after AVR. Secondary end points include the acute change of FFR after TAVR, the diagnostic accuracy of FFR versus RFR compared with SPECT for the assessment of ischemia, changes in microvascular function as assessed by the index of microcirculatory resistance (IMR), and the effect of these changes on FFR. The present study will evaluate intracoronary hemodynamic parameters before, immediately after, and 6 mo after AVR in patients with AS and intermediate coronary stenosis. The understanding of the impact of AVR on the assessment of FFR, NHPR, and microvascular function may help guide the need for revascularization in patients with AS and CAD planned for AVR.

iFR uncovers profound but mostly reversible ischemia in CTOs and helps to optimize PCI results.

OBJECTIVES: The study aimed to demonstrate through instant wave-free ratio (iFR) measurements that myocardium distal to a chronic total occlusion (CTO) is ischemic, that ischemia is reversible by PCI, and that iFR assessment after PCI can be used to optimize PCI results. BACKGROUND: The greatest benefit of revascularization is found in patients with low fractional flow reserve. In patients with CTOs, iFR measurement may be more appropriate to evaluate ischemia as it does not require maximal microvascular vasodilation, which may be hampered by microvascular dysfunction. METHODS: The iFR was measured in 81 CTO patients, both pre- and post-PCI in 63 patients, and only post-PCI in the following 18 patients. A pressure wire pullback was performed post-PCI if iFR ≤0.89. RESULTS: The first 63 patients all had significant ischemia distal to the CTO with a median iFR of 0.33 [0.22; 0.44], improving significantly post-PCI to a median iFR of 0.93 [0.89;0.96] (p < .001). In the complete cohort, the median iFR post-PCI was 0.93 [0.86;0.96] but still ≤0.89 in 23 patients (30%). 12 of these patients had further PCI optimization because of a residual focal pressure gradient on pullback, after which only two had a final iFR ≤0.89. CONCLUSIONS: In CTO patients with an indication for PCI, iFR consistently demonstrated profound myocardial ischemia. Successful PCI immediately relieved ischemia in 70% of patients. In the remaining 30% of cases, a manual iFR pullback proved helpful in guiding further optimization of the PCI result.

BIOSOLVE-IV-registry: Safety and performance of the Magmaris scaffold: 12-month outcomes of the first cohort of 1,075 patients.

OBJECTIVES: We aimed to assess the safety and performance of the Magmaris sirolimus-eluting bioresorbable magnesium scaffold in a large patient population. BACKGROUND: Magmaris has shown good outcomes in small-sized controlled trials, but further data are needed to confirm its usability, safety, and performance. METHODS: BIOSOLVE-IV is an international, single arm, multicenter registry including patients with a maximum of two single de novo lesions. Follow-up is scheduled up to 5 years; the primary outcome is target lesion failure (TLF) at 12 months. RESULTS: A total of 1,075 patients with 1,121 lesions were enrolled. Mean patient age was 61.3 ± 10.5 years and 19.2% (n = 206) presented with non-ST-elevation myocardial infarction (NSTEMI). Lesions were 3.2 ± 0.3 mm in diameter and 14.9 ± 4.2 mm long; 5.1% (n = 57) were bifurcation lesions. Device success was 97.3% (n = 1,129) and procedure success 98.9% (n = 1,063). The Kaplan-Meier estimate of TLF at 12 months was 4.3% [95% confidence interval, CI: 3.2, 5.7] consisting of 3.9% target lesion revascularizations, 0.2% cardiac death, and 1.1% target-vessel myocardial infarction. Definite/probable scaffold thrombosis occurred in five patients (0.5% [95% CI: 0.2, 1.1]), thereof four after early discontinuation of antiplatelet/anticoagulation therapy. CONCLUSION: BIOSOLVE-IV confirms the safety and performance of the Magmaris scaffold in a large population with excellent device and procedure success and a very good safety profile up to 12 months in a low-risk population.

Efficacy of MAVIG X-Ray Protective Drapes in Reducing CTO Operator Radiation.

BACKGROUND: The MAVIG X-ray protective drape (MXPD) has been shown to reduce operator radiation dose during percutaneous coronary interventions (PCI). Whether MXPDs are also effective in reducing operator radiation during chronic total occlusion (CTO) PCI, often with dual access, is unknown. METHODS: We performed a prospective, randomized-controlled study comparing operator radiation dose during CTO PCI (n = 60) with or without pelvic MXPDs. The primary outcomes were the difference in first operator radiation dose (µSv) and relative dose of the first operator (radiation dose normalized for dose area product) at the level of the chest in the two groups. The effectiveness of MXPD in CTO PCI was compared with non-CTO PCI using a patient-level pooled analysis with a previously published non-CTO PCI randomized study. RESULTS: The use of the MXPD was associated with a 37% reduction in operator dose (weighted median dose 26.0 (IQR 10.00-29.47) µSv in the drape group versus 41.8 (IQR 30.82-60.59) µSv in the no drape group; P < 0.001) and a 60% reduction in relative operator dose (median dose 3.5 (IQR 2.5-5.4) E/DAPx10-3 in the drape group versus 8.6 (IQR 4.2-12.5) E/DAPx10-3 in the no drape group; P=0.001). MXPD was equally effective in reducing operator dose in CTO PCI compared with non-CTO PCI (P value for interaction 0.963). CONCLUSIONS: The pelvic MAVIG X-ray protective drape significantly reduced CTO operator radiation dose. This trial is clinically registered with https://www.clinicaltrials.gov (unique identifier: NCT04285944).

Contemporary Strategies and Outcomes of Dedicated Chronic Total Occlusion Percutaneous Coronary Intervention Programs: A Prospective Multicentre Registry.

BACKGROUND: The field of CTO PCI is expanding, but successful and safe percutaneous coronary intervention (PCI) of coronary chronic total occlusions (CTO) requires a substantial resource and experience investment. We aimed to assess temporal trends in strategies and outcomes of 2 dedicated programs for CTO PCI. METHODS: Between 2011 and 2020, 920 CTO PCI procedures were prospectively included at 2 referral centres in Belgium. Temporal trends were assessed, and logistic regression models were built to identify predictors of outcome. RESULTS: Despite an increase in lesion complexity (the J-CTO score increased from 1.3 in year 1 to 1.7-2.0 in years 8-9, p < 0.001), technical success improved from 70.0% to 85.6% in year 9 (p value for trend <0.001). We observed the most significant improvement starting at years 3-4 (OR 2.3 in year 4 versus year 1, p=0.018). Together with an increase in success rates and lesions complexity, there was an increase in the use of dual injections, retrograde approaches, the number of balloons and stents, and the use of microcatheters. Conversely, there was a decrease in large bore access, an increase in radial approach, and a shift towards contemporary dissection/reentry techniques. This strategy resulted in a stable major complication rate of 4.7% (p value for trend 0.33). The rate of coronary procedure-related myocardial injury was high (71.0%) and was associated with the use of more intracoronary devices. CONCLUSIONS: Three to four years after initiation of a dedicated CTO PCI program with 50 CTO PCIs per year, consistent high technical success and low complication rates are achieved using contemporary strategies.

Percutaneous complete revascularization strategies using sirolimus-eluting biodegradable polymer-coated stents in patients presenting with acute coronary syndrome and multivessel disease: Rationale and design of the BIOVASC trial.

BACKGROUND: Complete revascularization in patients with an acute coronary syndrome and multivessel disease is superior compared to culprit-only treatment. However, it is unknown whether direct complete or staged complete revascularization should be pursued. METHODS: The BIOVASC study is an investigator-initiated, prospective, multicenter, randomized, 2-arm, international, open-label, noninferiority trial. We will randomize 1,525 patients 1:1 to immediate complete revascularization (experimental arm) or culprit-only plus staged complete revascularization (control arm). Patients will be enrolled in approximately 30 sites in Belgium, Italy, the Netherlands, and Spain. The primary end point is a composite of all-cause mortality, nonfatal myocardial infarction, any unplanned ischemia-driven revascularization (excluding staged procedures in the control arm at the predetermined time), and cerebrovascular events (MACCE) at 1 year post index procedure. CONCLUSIONS: The BIOVASC study aims to further refine the treatment algorithm for acute coronary syndrome patients with multivessel disease in terms of optimal timing for complete revascularization (Clinicaltrials.gov NCT03621501).

Double stent fracture and in-stent restenosis due to nodular calcification treated with Shockwave coronary intravascular lithotripsy.

We describe the fracture of a double layer of stents caused by nodular calcification. This resulted in recurrent in-stent restenosis, which was treated with Shockwave coronary intravascular lithotripsy.

Nitric oxide for inhalation in ST-elevation myocardial infarction (NOMI): a multicentre, double-blind, randomized controlled trial.

Aims: Inhalation of nitric oxide (iNO) during myocardial ischaemia and after reperfusion confers cardioprotection in preclinical studies via enhanced cyclic guanosine monophosphate (cGMP) signalling. We tested whether iNO reduces reperfusion injury in patients with ST-elevation myocardial infarction (STEMI; NCT01398384). Methods and results: We randomized in a double-blind, placebo-controlled study 250 STEMI patients to inhale oxygen with (iNO) or without (CON) 80 parts-per-million NO for 4 h following percutaneous revascularization. Primary efficacy endpoint was infarct size as a fraction of left ventricular (LV) size (IS/LVmass), assessed by delayed enhancement contrast magnetic resonance imaging (MRI). Pre-specified subgroup analysis included thrombolysis-in-myocardial-infarction flow in the infarct-related artery, troponin T levels on admission, duration of symptoms, location of culprit lesion, and intra-arterial nitroglycerine (NTG) use. Secondary efficacy endpoints included IS relative to risk area (IS/AAR), myocardial salvage index, LV functional recovery, and clinical events at 4 and 12 months. In the overall population, IS/LVmass at 48-72 h was 18.0 ± 13.4% in iNO (n = 109) and 19.4 ± 15.4% in CON [n = 116, effect size -1.524%, 95% confidence interval (95% CI) -5.28, 2.24; P = 0.427]. Subgroup analysis indicated consistency across clinical confounders of IS but significant treatment interaction with NTG (P = 0.0093) resulting in smaller IS/LVmass after iNO in NTG-naïve patients (n = 140, P < 0.05). The secondary endpoint IS/AAR was 53 ± 26% with iNO vs. 60 ± 26% in CON (effect size -6.8%, 95% CI -14.8, 1.3, P = 0.09) corresponding to a myocardial salvage index of 47 ± 26% vs. 40 ± 26%, respectively, P = 0.09. Cine-MRI showed similar LV volumes at 48-72 h, with a tendency towards smaller increases in end-systolic and end-diastolic volumes at 4 months in iNO (P = 0.048 and P = 0.06, respectively, n = 197). Inhalation of nitric oxide was safe and significantly increased cGMP plasma levels during 4 h reperfusion. The Kaplan-Meier analysis for the composite of death, recurrent ischaemia, stroke, or rehospitalizations showed a tendency toward lower event rates with iNO at 4 months and 1 year (log-rank test P = 0.10 and P = 0.06, respectively). Conclusions: Inhalation of NO at 80 ppm for 4 h in STEMI was safe but did not reduce infarct size relative to absolute LVmass at 48-72h. The observed functional recovery and clinical event rates at follow-up and possible interaction with nitroglycerine warrant further studies of iNO in STEMI.

Major adverse cardiovascular events while awaiting staged non-culprit percutaneous coronary intervention after ST-segment elevation myocardial infarction.

BACKGROUND: The optimal therapeutic strategy for ST-segment elevation myocardial infarction (STEMI) patients found to have multi-vessel disease (MVD) is controversial but recent data support complete revascularisation (CR). Whether CR should be completed during the index admission or during a second staged admission remains unclear. Our main objective was to measure rates of major adverse cardiovascular events (MACEs) during the waiting period in STEMI patients selected for staged revascularisation (SR), in order to determine the safety of delaying CR. For completeness, we also describe 30-day and long-term outcomes in STEMI patients with MVD who underwent in-hospital CR. METHODS: A single-centre retrospective analysis of 931 STEMI patients treated by primary percutaneous coronary intervention (PCI) identified 397 patients with MVD who were haemodynamically stable and presented within 12 hours of chest pain onset. Of these, 191 underwent multi-vessel PCI: 49 during the index admission and 142 patients undergoing a strategy of SR. RESULTS: Our main finding was that waiting period MACE were 2% (three of 142) in patients allocated to SR (at a median of 31 days). In patients allocated to in-hospital CR, 30-day MACE rates were 10% (five of 49). During a median follow up of 39 months, all-cause mortality was 7.0% vs. 28.6%, and cardiac mortality was 2% vs. 8%, in patients allocated to SR or CR, respectively. CONCLUSIONS: Patients with STEMI and MVD who, based on clinical judgement, were allocated to a second admission SR strategy had very few adverse events during the waiting period and excellent long-term outcomes.

Ultrathin, bioresorbable polymer sirolimus-eluting stents versus thin, durable polymer everolimus-eluting stents in patients undergoing coronary revascularisation (BIOFLOW V): a randomised trial.

BACKGROUND: The development of coronary drug-eluting stents has included use of new metal alloys, changes in stent architecture, and use of bioresorbable polymers. Whether these advancements improve clinical safety and efficacy has not been shown in previous randomised trials. We aimed to examine the clinical outcomes of a bioresorbable polymer sirolimus-eluting stent compared with a durable polymer everolimus-eluting stent in a broad patient population undergoing percutaneous coronary intervention. METHODS: BIOFLOW V was an international, randomised trial done in patients undergoing elective and urgent percutaneous coronary intervention in 90 hospitals in 13 countries (Australia, Belgium, Canada, Denmark, Germany, Hungary, Israel, the Netherlands, New Zealand, South Korea, Spain, Switzerland, and the USA). Eligible patients were those aged 18 years or older with ischaemic heart disease undergoing planned stent implantation in de-novo, native coronary lesions. Patients were randomly assigned (2:1) to either an ultrathin strut (60 µm) bioresorbable polymer sirolimus-eluting stent or to a durable polymer everolimus-eluting stent. Randomisation was via a central web-based data capture system (mixed blocks of 3 and 6), and stratified by study site. The primary endpoint was 12-month target lesion failure. The primary non-inferiority comparison combined these data from two additional randomised trials of bioresorbable polymer sirolimus-eluting stent and durable polymer everolimus-eluting stent with Bayesian methods. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT02389946. FINDINGS: Between May 8, 2015, and March 31, 2016, 4772 patients were recruited into the study. 1334 patients met inclusion criteria and were randomly assigned to treatment with bioresorbable polymer sirolimus-eluting stents (n=884) or durable polymer everolimus-eluting stents (n=450). 52 (6%) of 883 patients in the bioresorbable polymer sirolimus-eluting stent group and 41 (10%) of 427 patients in the durable polymer everolimus-eluting stent group met the 12-month primary endpoint of target lesion failure (95% CI -6·84 to -0·29, p=0·0399), with differences in target vessel myocardial infarction (39 [5%] of 831 patients vs 35 [8%] of 424 patients, p=0·0155). The posterior probability that the bioresorbable polymer sirolimus-eluting stent is non-inferior to the durable polymer everolimus-eluting stent was 100% (Bayesian analysis, difference in target lesion failure frequency -2·6% [95% credible interval -5·5 to 0·1], non-inferiority margin 3·85%, n=2208). INTERPRETATION: The outperformance of the ultrathin, bioresorbable polymer sirolimus-eluting stent over the durable polymer everolimus-eluting stent in a complex patient population undergoing percutaneous coronary intervention suggests a new direction in improving next generation drug-eluting stent technology. FUNDING: BIOTRONIK.