Impact of intravascular ultrasound and final kissing balloon dilatation on long-term clinical outcome in percutaneous revascularization with 1-stent strategy for left main coronary artery stenosis in drug-eluting stent era.

BACKGROUND: It remains uncertain whether intravascular ultrasound (IVUS) use and final kissing balloon (FKB) dilatation would be standard care of percutaneous coronary intervention (PCI) with a simple 1-stent technique in unprotected left main coronary artery (LMCA) stenosis. This study sought to investigate the impact of IVUS use and FKB dilatation on long-term major adverse cardiac events (MACEs) in PCI with a simple 1-stent technique for unprotected LMCA stenosis. METHODS: Between June 2006 and December 2012, 255 patients who underwent PCI with 1 drug-eluting stent for LMCA stenosis were analyzed. Mean follow-up duration was 1663 ± 946 days. Long-term MACEs were defined as death, nonfatal myocardial infarction (MI) and repeat revascularizations. RESULTS: During the follow-up, 72 (28.2%) MACEs occurred including 38 (14.9%) deaths, 21 (8.2%) nonfatal MIs and 13 (5.1%) revascularizations. The IVUS examination and FKB dilatation were done in 158 (62.0%) and 119 (46.7%), respectively. IVUS use (20.3 versus 41.2%; log-rank P < 0.001), not FKB dilatation (30.3 versus 26.5%; log-rank P = 0.614), significantly reduced MACEs. In multivariate analysis, IVUS use was a negative predictor of MACEs [hazards ratio 0.51; 95% confidence interval (CI) 0.29-0.88; P = 0.017], whereas FKB dilatation (hazard ratio 1.68; 95% CI, 1.01-2.80; P = 0.047) was a positive predictor of MACEs. In bifurcation LMCA stenosis, IVUS use (18.7 versus 48.0%; log-rank P < 0.001) significantly reduced MACEs. In nonbifurcation LMCA stenosis, FKB dilatation showed a trend of increased MACEs (P = 0.076). CONCLUSION: IVUS examination is helpful in reducing clinical events in PCI for LMCA bifurcation lesions, whereas mandatory FKB dilatation after the 1-stent technique might be harmful in nonbifurcation LMCA stenosis.

Standardizing the Definition and Analysis Methodology for Complete Coronary Artery Revascularization.

Guideline-based medical therapy is the foundation of treatment for individuals with coronary artery disease. However, revascularization with either percutaneous coronary intervention or coronary artery bypass grafting may be beneficial in patients with acute coronary syndromes, refractory symptoms, or in other specific scenarios (eg, left main disease and heart failure). While the goal of percutaneous coronary intervention and coronary artery bypass grafting is to achieve complete revascularization, anatomical and ischemic definitions of complete revascularization and their methodology for assessment remain highly variable. Such lack of consensus invariably contributes to the absence of standardized approaches for invasive treatment of coronary artery disease. Herein, we propose a novel, comprehensive, yet pragmatic algorithm with both anatomical and ischemic parameters that aims to provide a systematic method to assess complete revascularization after percutaneous coronary intervention or coronary artery bypass grafting in both clinical practice and clinical trials.

Long-term efficacy and safety of drug-coated balloons versus drug-eluting stents for small coronary artery disease (BASKET-SMALL 2): 3-year follow-up of a randomised, non-inferiority trial.

BACKGROUND: In the treatment of de-novo coronary small vessel disease, drug-coated balloons (DCBs) are non-inferior to drug-eluting stents (DESs) regarding clinical outcome up to 12 months, but data beyond 1 year is sparse. We aimed to test the long-term efficacy and safety of DCBs regarding clinical endpoints in an all-comer population undergoing percutaneous coronary intervention. METHODS: In this prespecified long-term follow-up of a multicentre, randomised, open-label, non-inferiority trial, patients from 14 clinical sites in Germany, Switzerland, and Austria with de-novo lesions in coronary vessels <3 mm and an indication for percutaneous coronary intervention were randomly assigned 1:1 to DCB or second-generation DES and followed over 3 years for major adverse cardiac events (ie, cardiac death, non-fatal myocardial infarction, and target-vessel revascularisation [TVR]), all-cause death, probable or definite stent thrombosis, and major bleeding (Bleeding Academic Research Consortium bleeding type 3-5). Analyses were performed on the full analysis set according to the modified intention-to-treat principle. Dual antiplatelet therapy was recommended for 1 month after DCB and 6 months after DES with stable symptoms, but 12 months with acute coronary syndromes. The study is registered with ClinicalTrials.gov, NCT01574534 and is ongoing. FINDINGS: Between April 10, 2012, and Feb 1, 2017, of 883 patients assessed, 758 (86%) patients were randomly assigned to the DCB group (n=382) or the DES group (n=376). The Kaplan-Meier estimate of the rate of major adverse cardiac events was 15% in both the DCB and DES groups (hazard ratio [HR] 0·99, 95% CI 0·68-1·45; p=0·95). The two groups were also very similar concerning the single components of adverse cardiac events: cardiac death (Kaplan-Meier estimate 5% vs 4%, HR 1·29, 95% CI 0·63-2·66; p=0·49), non-fatal myocardial infarction (both Kaplan-Meier estimate 6%, HR 0·82, 95% CI 0·45-1·51; p=0·52), and TVR (both Kaplan-Meier estimate 9%, HR 0·95, 95% CI 0·58-1·56; p=0·83). Rates of all-cause death were very similar in DCB versus DES patients (both Kaplan-Meier estimate 8%, HR 1·05, 95% CI 0·62-1·77; p=0·87). Rates of probable or definite stent thrombosis (Kaplan-Meier estimate 1% vs 2%; HR 0·33, 95% CI 0·07-1·64; p=0·18) and major bleeding (Kaplan-Meier estimate 2% vs 4%, HR 0·43, 95% CI 0·17-1·13; p=0·088) were numerically lower in DCB versus DES, however without reaching significance. INTERPRETATION: There is maintained efficacy and safety of DCB versus DES in the treatment of de-novo coronary small vessel disease up to 3 years. FUNDING: Swiss National Science Foundation, Basel Cardiovascular Research Foundation, and B Braun Medical.

The impact of a dedicated coronavirus disease 2019 primary angioplasty protocol on time components related to ST­segment elevation myocardial infarction management in a 24/7 primary percutaneous coronary intervention-capable hospital.

BACKGROUND: Primary percutaneous coronary intervention (PPCI) as the treatment of choice for ST­segment elevation myocardial infarction (STEMI) should be rapidly performed. It is necessary to use preventive strategies during the coronavirus disease 2019 (COVID­19) outbreak, which is an ongoing global concern. However, critical times in STEMI management may be influenced by the implementation of infection control protocols. AIMS: We aimed to investigate the impact of our dedicated COVID­19 PPCI protocol on time components related to STEMI care and catheterization laboratory personnel safety. A subendpoint analysis to compare patient outcomes at a median time of 70 days during the pandemic with those of patients treated in the preceding year was another objective of our study. METHODS: Patients with STEMI who underwent PPCI were included in this study. Chest computed tomography (CT) and real­time reverse transcriptase-polymerase chain reaction (rRT­PCR) tests were performed in patients suspected of having COVID­19. A total of 178 patients admitted between February 29 and April 30, 2020 were compared with 146 patients admitted between March 1 and April 30, 2019. RESULTS: Severe acute respiratory syndrome coronavirus 2 infection was confirmed by rRT­PCR in 7 cases. In 6 out of 7 patients, CT was indicative of COVID­19. There were no differences between the study groups regarding critical time intervals for reperfusion in STEMI. The 70­day mortality rate before and during the pandemic was 2.73% and 4.49%, respectively (P = 0.4). CONCLUSIONS: The implementation of the dedicated COVID­19 PPCI protocol in patients with STEMI allowed us to achieve similar target times for reperfusion, short­term clinical outcomes, and staff safety as in the prepandemic era.

Systematic Scoring Balloon Lesion Preparation for Drug-Coated Balloon Angioplasty in Clinical Routine: Results of the PASSWORD Observational Study.

INTRODUCTION: Scoring balloon angioplasty (SBA) for lumen gain prior to stent implantations or drug-coated balloon angioplasty (DCB) is considered an essential interventional tool for lesion preparation. Recent evidence indicates that SBA may play a pivotal role in enhancing the angiographic and clinical outcomes of DCB angioplasty. METHODS: We studied the systematic use of SBA with a low profile, non-slip element device prior to DCB angioplasty in an unselected, non-randomized patient population. This prospective, all-comers study enrolled patients with de novo lesions as well as in-stent restenotic lesions in bare metal stents (BMS-ISR) and drug-eluting stents (DES-ISR). The primary endpoint was the target lesion failure (TLF) rate at 9 months (ClinicalTrials.gov Identifier NCT02554292). RESULTS: A total of 481 patients (496 lesions) were recruited to treat de novo lesions (78.4%, 377), BMS-ISR (4.0%, 19), and DES-ISR (17.6%, 85). Overall risk factors were acute coronary syndrome (ACS, 20.6%, 99), diabetes mellitus (46.8%, 225), and atrial fibrillation (8.5%, 41). Average lesion lengths were 16.7 ± 10.4 mm in the de novo group, and 20.1 ± 8.9 mm (BMS-ISR) and 16.2 ± 9.8 mm (DES-ISR) in the ISR groups. Scoring balloon diameters were 2.43 ± 0.41 mm (de novo), 2.71 ± 0.31 mm (BMS-ISR), and 2.92 ± 0.42 mm (DES-ISR) whereas DCB diameters were 2.60 ± 0.39 mm (de novo), 3.00 ± 0.35 mm (BMS-ISR), and 3.10 ± 0.43 mm (DES-ISR), respectively. The overall accumulated TLF rate of 3.0% (14/463) was driven by significantly higher target lesion revascularization rates in the BMS-ISR (5.3%, 1/19) and the DES-ISR group (6.0%, 5/84). In de novo lesions, the TLF rate was 1.1% (4/360) without differences between calcified and non-calcified lesions (p = 0.158) and small vs. large reference vessel diameters with a cutoff value of 3.0 mm (p = 0.901). CONCLUSIONS: The routine use of a non-slip element scoring balloon catheter to prepare lesions suitable for drug-coated balloon angioplasty is associated with high procedural success rates and low TLF rates in de novo lesions.

Magnesium 2000 postmarket evaluation: Guideline adherence and intraprocedural performance of a sirolimus-eluting resorbable magnesium scaffold.

BACKGROUND: The Magmaris bioresorbable magnesium scaffold was successfully tested in in-vitro and in clinical premarket studies. Subsequently the Magmaris postmarket program aimed to review intraprocedural data of at least 2000 patients to assess user preferences, guideline adherence and intraprocedural performance in clinical routine. METHODS: This international multicentre survey encompasses data from 356 hospitals across 45 countries. As part of the certification for Magmaris implantation, each hospital had to complete consecutive post-market evaluation forms of their first 10 commercial Magmaris patients. RESULTS: From June 2016 to May 2018, data on 2018 implantations were collected. Main reasons for selecting Magmaris was patients' life expectancy (67%, n = 1359) and low or not calcified lesions, (67%, n = 1357). Magmaris was successfully deployed in 99% of cases (n = 1995), predilatation was performed in 95% (n = 1922) and post-dilatation in 87% (n = 1756). Physicians rated the overall performance and the pushability as good or very good in 96% of cases (n = 1799). Guide wire friction, trackability, and conformability were rated as good or very good in 94% of cases, and crossability in 93%. The majority of patients were scheduled to receive dual antiplatelet therapy for up to 12 months. CONCLUSION: Generally, implantation guidelines were adhered to and theoretical advantages of the metal scaffold observed in in-vitro tests have translated into practice with good intraprocedural performance outcomes, confirming the controlled roll-out of this novel technology into clinical practice. SUMMARY FOR ANNOTATED TABLE OF CONTENT: The Magmaris 2000 program includes the first commercial cases at each hospital. Overall, data on 2018 implantations were collected. The high rate of pre- and post-dilatation as well as other parameters confirm that generally the implantation guidelines are adhered to and the good intraprocedural performance (rated as good or very good in 96%) confirm the theoretical advantages of a metallic scaffold in practice.

Suspected ST segment elevation myocardial infarction referred for primary angioplasty: a masquerader.

A 50-year-old man collapsed at the roadside with retrosternal pain, shortness of breath and generalised weakness. An ECG in the emergency department was reported as demonstrating ST segment elevation of up to 1.5 mm in leads V1 to V3, leading to a diagnosis of an acute ST-elevation myocardial infarction. He was immediately transferred to the cardiac catheterisation laboratory. Introduction of a coronary catheter produced signs that raised suspicion of aortic dissection. An aortogram revealed a grossly dilated aortic root of 7.3 cm with a type A ascending aortic dissection. The patient was urgently transferred to the cardiothoracic surgical centre and underwent emergency aortic root and ascending aorta replacement. Following a 20-day hospital admission, and postoperative atrial fibrillation, the patient made a steady and full recovery.

Coronary angioplasty in spontaneous coronary artery dissection-Strategy and outcomes.

OBJECTIVE: To study the clinical, angiographic and technical characteristics of patients with spontaneous coronary artery dissection (SCAD) undergoing percutaneous coronary intervention (PCI). METHODS: This was a retrospective single center study where patients with angiographically confirmed SCAD undergoing PCI over a period of 4 years (2013-2017) were analyzed. We also sought to identify the clinical and angiographic predictors of procedural failure during PCI. RESULTS: There were a total of 42 patients with angiographically confirmed SCAD during the study period of which 16 patients (38.1%) underwent PCI. 14 out of the 16 patients (87.5%) taken up for PCI had technical success. In all patients the lesion was initially attempted to cross with a floppy wire and if unsuccessful it was escalated to a hydrophilic wire and finally to a stiff wire The SCAD lesion was crossed with a floppy wire in 71.4% of patients, with a hydrophilic wire in 14.2% and a stiff wire in 7.1% of patients. Wire escalation was required in 5 patients (31.3%) and in 60% of cases there was a technical success after wire escalation. Presence of diabetes mellitus, hypertension, dyslipidemia, smoking, coexisting atherosclerosis, diffuse nature of the lesion, and baseline Thrombolysis in Myocardial Infarction (TIMI)≤2 flow did not predict procedural failure during PCI. CONCLUSION: PCI in SCAD is associated with a fair rate of technical success in our population. Choosing an initial floppy wire and then escalating to a hydrophilic wire followed by a stiff wire is an optimal revascularization strategy.

Comparative efficacy of two paclitaxel-coated balloons with different excipient coatings in patients with coronary in-stent restenosis: A pooled analysis of the Intracoronary Stenting and Angiographic Results: Optimizing Treatment of Drug Eluting Stent In-Stent Restenosis 3 and 4 (ISAR-DESIRE 3 and ISAR-DESIRE 4) trials.

BACKGROUND: Angioplasty with paclitaxel-coated balloons (PCB) is recommended for treatment of patients with coronary in-stent restenosis (ISR) according to European clinical practice guidelines. Most clinical trials have investigated iopromide-based PCB and there is a paucity of data comparing efficacy against butyryl-tri-hexyl citrate (BTHC)-based PCB. Our aim was to compare the performance of two widely-used PCB in the treatment of coronary ISR. METHODS: We analysed patients treated with BTHC- or iopromide-PCB for treatment of drug-eluting stent ISR in the setting of 2 consecutive trials with identical inclusion and exclusion criteria. The primary endpoint was diameter stenosis at 6-8month angiographic surveillance. The secondary endpoint of interest was the composite of death, myocardial infarction (MI) or target-lesion revascularisation (TLR) at 1year. Multivariate analysis was performed to adjust for differences in baseline characteristics between groups. RESULTS: In total, 264 patients were treated with BTHC-PCB (n=127) or iopromide-PCB (n=137). Baseline patient characteristics were similar for both groups. Post-procedure stenosis was slightly larger with BTHC-PCB (22.3 [SD 8.2]% vs. 18.4 [SD 9.9]%, P=0.001). At 6-8month angiography, diameter stenosis was 40.4 [SD 21.9]% vs. 37.4 [SD 21.4]% in the BTHC-PCB and iopromide-PCB groups, respectively (P=0.16, Padjusted=0.32). At 1year, death, MI or TLR occurred in 29 (23.2%) vs. 32 (23.4%) patients in the BTHC-PCB and iopromide-PCB groups, respectively (HR 1.03 [95% CI 0.62-1.70], P=0.91, Padjusted=0.96). CONCLUSIONS: In patients undergoing intervention for ISR, angioplasty with BTHC-PCB showed similar angiographic and clinical results at 1year compared with iopromide-PCB.

Timely Reperfusion in Stroke and Myocardial Infarction Is Not Correlated: An Opportunity for Better Coordination of Acute Care.

BACKGROUND: Timely reperfusion is critical in acute ischemic stroke (AIS) and ST-segment-elevation myocardial infarction (STEMI). The degree to which hospital performance is correlated on emergent STEMI and AIS care is unknown. Primary objective of this study was to determine whether there was a positive correlation between hospital performance on door-to-balloon (D2B) time for STEMI and door-to-needle (DTN) time for AIS, with and without controlling for patient and hospital differences. METHODS AND RESULTS: Prospective study of all hospitals in both Get With The Guidelines-Stroke and Get With The Guidelines-Coronary Artery Disease from 2006 to 2009 and treating ≥10 patients. We compared hospital-level DTN time and D2B time using Spearman rank correlation coefficients and hierarchical linear regression modeling. There were 43 hospitals with 1976 AIS and 59 823 STEMI patients. Hospitals' DTN times for AIS did not correlate with D2B times for STEMI (ρ=-0.09; P=0.55). There was no correlation between hospitals' proportion of eligible patients treated within target time windows for AIS and STEMI (median DTN time <60 minutes: 21% [interquartile range, 11-30]; median D2B time <90 minutes: 68% [interquartile range, 62-79]; ρ=-0.14; P=0.36). The lack of correlation between hospitals' DTN and D2B times persisted after risk adjustment. We also correlated hospitals' DTN time and D2B time data from 2013 to 2014 using Get With The Guidelines (DTN time) and Hospital Compare (D2B time). From 2013 to 2014, hospitals' DTN time performance in Get With The Guidelines was not correlated with D2B time performance in Hospital Compare (n=546 hospitals). CONCLUSIONS: We found no correlation between hospitals' observed or risk-adjusted DTN and D2B times. Opportunities exist to improve hospitals' performance of time-critical care processes for AIS and STEMI in a coordinated approach.

Percutaneous revascularization of chronic total occlusions: Rationale, indications, techniques, and the cardiac surgeon's point of view.

Chronic total occlusions (CTO) are frequently found in clinical practice, yet they are still undertreated, despite the frequent presence of clinical indications for revascularization. The presence of a CTO is a frequent cause of incomplete revascularization, which has been associated with worse long-term outcomes (including mortality), compared to complete revascularization. Such low rates of attempted revascularization can be attributed to a common misconception about the lack of benefit of CTO revascularization, combined with historically lower success rates and higher complication rates of CTO percutaneous coronary intervention. However, modern percutaneous techniques, devices and algorithms now allow successful CTO revascularization in approximately 90% of cases. Additionally, state-of-the-art surgical techniques offer complete revascularization and provide excellent long-term patency rates. The present review provides a critical appraisal of the literature supporting the rationale, indications, modalities and state-of-the-art techniques of CTO revascularization by both percutaneous and surgical approaches.

Impact of call-to-balloon time on 30-day mortality in contemporary practice.

OBJECTIVE: Studies reporting an association between treatment delay and outcome for patients with ST segment elevation myocardial infarction (STEMI) have generally not included patients treated by a primary percutaneous coronary intervention (PPCI) service that systematically delivers reperfusion therapy to all eligible patients. We set out to determine the association of call-to-balloon (CTB) time with 30-day mortality after PPCI in a contemporary series of patients treated within a national reperfusion service. METHODS: We analysed data on 16 907 consecutive patients with STEMI treated by PPCI in England and Wales in 2011 with CTB time of ≤6 hours. RESULTS: The median CTB and door-to-balloon times were 111 and 41 min, respectively, with 80.9% of patients treated within 150 min of the call for help. An out-of-hours call time (58.2% of patients) was associated with a 10 min increase in CTB time, whereas inter-hospital transfer for PPCI (18.5% of patients) was associated with a 49 min increase in CTB time. CTB time was independently associated with 30-day mortality (p<0.0001) with a HR of 1.95 (95% CI 1.54 to 2.47) for a CTB time of >180-240 min compared with ≤90 min. The relationship between CTB time and 30-day mortality was influenced by patient risk profile with a greater absolute impact of increasing CTB time on mortality in high-risk patients. CONCLUSION: CTB time is a useful metric to assess the overall performance of a PPCI service. Delays to reperfusion remain important even in the era of organised national PPCI services with rapid treatment times and efforts should continue to minimise treatment delays.

Age-dependent impact of new ESC-Guideline recommended door-to-balloon times on mid-term survival in acute ST-elevation myocardial infarction patients undergoing primary percutaneous coronary intervention.

BACKGROUND: To investigate the age-dependent impact of the superfast door-to-balloon (D2B) times of ≤60min as recommended by the new ESC Guideline for patients with ST elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI) on mid-term survival rates based on a single center registry dataset. PATIENTS AND METHODS: This study enrolled consecutive STEMI patients who underwent PPCI from Jan 1, 2009 through Sep 30, 2013. We compared demographics, clinical characteristics and the D2B-survival relationships between patients aged ≥65 and <65. RESULTS: The younger group comprised 242 patients (68%) aged <65 and the elder group consisted of 115 patients (32%) aged ≥65. In patients aged <65, the mortality rate decreased linearly with D2B time shortening (>90min vs. 61-90min vs. ≤60min=14.9% vs. 13.3% vs. 1.2%, P=0.001). Contrarily, shortening of D2B time was not associated with reduced mortality rate in patients aged ≥65 (>90min vs. 61-90min vs. ≤60min=23.5% vs. 19% vs. 18.9%, P=0.99). In younger patients but not the elderly, a D2B time of <60min has sufficient power to predict mortality with a sensitivity of 0.83, specificity of 0.74, and Youden index of 0.57. CONCLUSIONS: Our results show that the new ESC Guideline recommendation of D2B time ≤60min is associated with better survival rates in younger STEMI patients undergoing PPCI. Our findings stress the importance of guideline adherence to minimize reperfusion delay to improve survival in these patients.

The impact on long term health outcomes for STEMI patients during a period of process change to reduce door to balloon time.

BACKGROUND: Guidelines for the management of ST-segment elevation myocardial infarction (STEMI) recommend a 'door to balloon time' (DTBT) within 90 minutes. It is unclear whether strategies to reduce DTBT translate to improved longer-term health outcomes for STEMI patients. AIMS: This study sought to determine whether implemented strategies to improve timely management of STEMI reduced DTBT and impacted upon health outcomes such as length of stay, unplanned readmission and 12-month mortality. Predictors of timely management for STEMI were also examined. METHODS: A five-year review was undertaken on primary percutaneous coronary intervention for STEMI in one tertiary hospital. Comparisons were made between process change groups and DTBT. Logistic regression identified predictors of timely management. RESULTS: 470 STEMI patients underwent immediate primary percutaneous coronary intervention. Process change improved the median DTBT (109 min vs. 72 min, p<0.001) with no significant effect on length of stay (p=0.83), unplanned cardiac readmissions (p=0.68) or 12-month mortality (9.0% vs. 8.6%, p=0.64). Those receiving timely treatment (i.e. DTBT< 90 min) were younger (p<0.05), male (p<0.03), presented via ambulance (p<0.004), during business hours (p<0.0001) and had a lower Thrombolysis In Myocardial Infarction score (p<0.006). Timely treatment was associated with lower 12-month mortality (3.7% vs. 15.7%, p<0.0001) and increased uptake of inpatient cardiac rehabilitation (p<0.005), with length of stay and unplanned readmission similar between groups (p=NS). CONCLUSIONS: Process changes improved DTBT but had no effect on length of stay, readmission rate or 12-month mortality. Yet, timely management was critical to 12-month outcomes. Further studies are required to explore the barriers to timely treatment.