Intravascular ultrasound (IVUS) has been in clinical use for more than three decades. Despite evidence that supports the application of the technology from multiple registries, randomised trials and meta-analyses, adoption remains low. Potential barriers to the adoption of IVUS are a lack of understanding as to how to accurately interpret images and how to incorporate it into clinical workflow. To address this, this paper summarises evidence-based protocols for the application of IVUS during percutaneous coronary intervention (PCI) into an easily understood workflow. Standardisation of approaches and wider adoption of IVUS-optimised PCI should improve patient outcomes and PCI durability.

BACKGROUND:In patients with prior coronary artery bypass grafting (CABG) presenting with graft failure, current guidelines recommend percutaneous coronary intervention (PCI) of the bypassed native coronary artery over PCI of the bypass graft. However, this recommendation relies solely on observational data. OBJECTIVES:This study compared clinical outcomes between a strategy of native vessel PCI with saphenous vein graft (SVG) PCI in post-CABG patients presenting with SVG failure. METHODS:The multicenter, randomized PROCTOR (Percutaneous Coronary Intervention of Native Coronary Artery versus Saphenous Vein Graft in Patients with Prior Coronary Artery Bypass Graft Surgery) trial included patients with significant SVG stenosis and a heart team-defined clinical indication for revascularization. Patients were randomly assigned (1:1) to either a strategy of native vessel PCI or SVG PCI using an interactive web-based randomization platform. The trial was conducted across 14 centers in Europe. We report the occurrence of major adverse cardiac events at 1 year following the index PCI, defined as the composite of all-cause mortality, nonfatal target coronary territory myocardial infarction (MI), or clinically driven target coronary territory revascularization, analyzed on an intention-to-treat basis. The trial is registered with ClinicalTrials.gov (NCT03805048), and long-term follow-up is ongoing. RESULTS:Between January 2019 and December 2023, 220 patients (mean age 73 ± 7 years; 84% men [185/220 patients]) were randomized to a strategy of native vessel PCI (n = 108) or SVG PCI (n = 112). At 1 year, major adverse cardiac events occurred in 37 patients (34%) in the native vessel PCI group and 21 patients (19%) in the SVG PCI group (HR: 2.14; 95% CI: 1.25-3.65; P = 0.006). There was no significant difference in all-cause mortality (HR: 1.59; 95% CI: 0.45-5.64; P = 0.472), whereas both nonfatal target coronary territory MI (HR: 2.12; 95% CI: 1.08-4.17; P = 0.029) and clinically driven target coronary territory revascularization (HR: 2.19; 95% CI: 1.02-4.72; P = 0.044) occurred more frequently in patients assigned to native vessel PCI. The incidence of PCI-related MI was 13% in the native vessel PCI group and 1% in the SVG PCI group (HR: 14.85; 95% CI: 1.95-112.96; P = 0.009). CONCLUSIONS:In the randomized PROCTOR trial, SVG PCI was associated with improved 1-year clinical outcomes compared with native vessel PCI, primarily driven by lower rates of PCI-related MI and clinically driven target coronary territory revascularization.

Drug-coated balloon (DCB) angioplasty in chronic total occlusion (CTO) percutaneous coronary intervention (PCI) is an area of increased clinical and scientific interest. In this article, we summarize some of the key principles underpinning DCB CTO PCI. In addition to reviewing the currently available clinical evidence and ongoing clinical trials in this area, we also provide some guidance on how DCB angioplasty can be incorporated into CTO PCI programs. We also demonstrate some examples of DCB CTO PCI procedures from our own program, highlighting the potential clinical utility of this approach in real-world practice.

INTRODUCTION:Moderate-to-severe calcification is present in ~20%-30% of patients undergoing coronary angiography. Coronary lesion modification is often necessary to facilitate optimal stent delivery and expansion, with several dedicated devices now approved for calcium modification before stent implantation. The CYCLOPES study aims to evaluate an intravascular ultrasound (IVUS) based calcium modification algorithm for the treatment of moderate-to-severely calcified coronary lesions. METHODS AND ANALYSIS:CYCLOPES is a prospective, international, multi-center, observational, single-arm study. 500 patients will be enrolled at 25 centers in Europe. Patients with planned percutaneous coronary intervention (PCI) to a native coronary artery lesion with moderate-to-severe calcification will be eligible. All PCI procedures will be IVUS guided, with drug-eluting stents implanted according to the study-specific algorithm. The co-primary endpoints are the minimum stent area (MSA) at the site of maximum calcification at the end of the index procedure (as determined by core lab analysis), and target lesion failure (TLF) at 1-year post-procedure. Prespecified secondary endpoints include: the individual components of TLF at 1 month and 1 year; the MSA measured at the end of the index procedure; strategy success (defined as successful stent delivery with ≥ 80% stent expansion and complete stent apposition with no significant edge dissection and full lesion coverage with < 50% plaque burden at proximal and distal references with TIMI 3 flow); as well as target vessel revascularization; target lesion revascularization; stent thrombosis; cardiovascular death; and acute kidney injury at 1 year. Coronary angiograms and IVUS images will be analyzed by an independent core Lab. Clinical follow-up will be performed at discharge, 30-days, and 1 year post PCI. TRIAL REGISTRATION:ClinicalTrials.gov identifier: NCT06678594.

Coronary artery ectasia (CAE) is frequently encountered in clinical practice, conjointly with atherosclerotic CAD (CAD). Given the overlapping cardiovascular risk factors for patients with concomitant CAE and atherosclerotic CAD, a common underlying pathophysiology is often postulated. However, coronary artery ectasia may arise independently, as isolated (pure) CAE, thereby raising suspicions of an alternative mechanism. Herein, we review the existing evidence for the pathophysiology of CAE in order to help direct management strategies towards enhanced detection and treatment.

Background Patients with prior coronary arter y bypass grafting (CABG) frequently require repeat percutaneous revascularization due to advanced age, progressive coronary artery disease and bypass graft failure. Percutaneous coronary intervention (PCI) of either the bypass graft or the native coronary artery may be performed. Randomized trials comparing native vessel PCI with bypass graft PCI are lacking and long-term outcomes have not been reported. Methods PROCTOR (NCT03805048) is a prospective, multicenter, randomized controlled trial, that will include 584 patients presenting with saphenous vein graft (SVG) failure and a clinical indication for revascularization, as determined by the local Heart Team. The trial is designed to compare the clinical and angiographic outcomes in patients randomly allocated in a 1:1 fashion to either a strategy of native vessel PCI or SVG PCI. The primary study endpoint is a 3-year composite of major adverse cardiac events (MACE: all-cause mortality, non-fatal target coronary territory myocardial infarction [MI], or clinically driven target coronary territory revascularization). At 3-years, after evaluation of the primary endpoint, follow-up invasive coronary angiography will be performed. Secondary endpoints comprise individual components of MACE at 1, 3 and 5 years follow-up, PCI-related MI, MI > 48 hours after index PCI, target vessel failure, target lesion revascularization, renal failure requiring renal-replacement therapy, angiographic outcomes at 3-years and quality of life (delta Seattle Angina Questionnaire, Canadian Cardiovascular Society Grading Scale and Rose Dyspnea Scale). Conclusion PROCTOR is the first randomized trial comparing an invasive strategy of native coronary arter y PCI with SVG PCI in post-CABG patients presenting with SVG failure.

Background: Measurement of fractional flow reserve (FFR) has an established role in guiding percutaneous coronary intervention. We tested the hypothesis that, at the stage of diagnostic invasive coronary angiography, systematic FFR-guided assessment of coronary artery disease would be superior, in terms of resource use and quality of life, to assessment by angiography alone. Methods: We performed an open-label, randomized, controlled trial in 17 UK centers, recruiting 1100 patients undergoing invasive coronary angiography for the investigation of stable angina or non–ST-segment–elevation myocardial infarction. Patients were randomized to either angiography alone (angiography) or angiography with systematic pressure wire assessment of all epicardial vessels >2.25 mm in diameter (angiography+FFR). The coprimary outcomes assessed at 1 year were National Health Service hospital costs and quality of life. Prespecified secondary outcomes included clinical events. Results: In the angiography+FFR arm, the median number of vessels examined was 4 (interquartile range, 3–5). The median hospital costs were similar: angiography, £4136 (interquartile range, £2613–£7015); and angiography+FFR, £4510 (£2721–£7415; P =0.137). There was no difference in median quality of life using the visual analog scale of the EuroQol EQ-5D-5L: angiography, 75 (interquartile range, 60–87); and angiography+FFR, 75 (interquartile range, 60–90; P =0.88). The number of clinical events was as follows: deaths, 5 versus 8; strokes, 3 versus 4; myocardial infarctions, 23 versus 22; and unplanned revascularizations, 26 versus 33, with a composite hierarchical event rate of 8.7% (48 of 552) for angiography versus 9.5% (52 of 548) for angiography+FFR ( P =0.64). Conclusions: A strategy of systematic FFR assessment compared with angiography alone did not result in a significant reduction in cost or improvement in quality of life. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01070771.

PURPOSE:The aim of this study was to provide 2-year clinical outcomes for patients with Medina 1,1,1 bifurcation lesions treated with a culotte technique, comparing Synergy and Xience drug eluting stent (DES) platforms. A sub-group analysis of 9-month Optical Coherence Tomography (OCT) was performed to assess stent healing. METHODS:A total of 170 patients with non-left main stem Medina 1,1,1 lesions, were randomized to treatment with Synergy or Xience DES. The primary outcome was a composite of death, myocardial infarction, stroke, target vessel failure, stent thrombosis and angiographic restenosis. Qualitative and quantitative analyses of 30 bifurcations were carried out on OCT images taken at 9-month follow-up. RESULTS:After 2 years, the primary outcome had occurred in 17.7% of patients in the Synergy group and 18.8% of patients in the Xience group. The non-inferiority test was met (p = 0.0055). MACCE occurred in 7.3% of all patients by 2 years. OCT analysis found smaller stent and lumen areas in patients treated with Synergy stents. There was a higher proportion of malapposed struts in patients treated with Xience stents. CONCLUSIONS:The first report of the CELTIC bifurcation study demonstrated a low MACCE rate after 9 months. There was little accrual of events after this timepoint. There was no difference in clinical outcomes between the platforms tested. OCT analysis demonstrated excellent healing of both platforms.

Background: Improvements in drug-eluting stent design have led to a reduced frequency of repeat revascularisation and new biodegradable polymer coatings may allow a shorter duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI). Aims: The Improved Drug-Eluting stent for All-comers Left Main (IDEAL-LM) study aims to investigate long-term clinical outcomes after implantation of a biodegradable polymer platinum-chromium everolimuseluting stent (BP-PtCr-EES) followed by 4 months DAPT compared to a durable polymer cobalt-chromium everolimus-eluting stent (DP-CoCr-EES) followed by 12 months DAPT in patients undergoing PCI of unprotected left main coronary artery (LMCA) disease. Methods: This is a multicentre randomised clinical trial study in patients with an indication for coronary artery revascularisation who have been accepted for PCI for LMCA disease after Heart Team consultation. Patients were randomly assigned in a 1:1 ratio to receive either the BP-PtCr-EES or the DP-CoCr-EES. The primary endpoint was a non-inferiority comparison of the rate of major adverse cardiovascular events (MACE), defined as all-cause death, myocardial infarction, or ischaemia-driven target vessel revascularisation at 2 years. Results: Between December 2014 and October 2016, 818 patients (410 BP-PtCr-EES and 408 DP-Co-CrEES) were enrolled at 29 centres in Europe. At 2 years, the primary endpoint of MACE occurred in 59 patients (14.6%) in the BP-PtCr-EES group and 45 patients (11.4%) in the DP-CoCr-EES group; 1-sided upper 95% confidence interval (CI) 7.18%; p=0.04 for non-inferiority; p=0.17 for superiority. The secondary endpoint event of BARC 3 or 5 bleeding occurred in 11 patients (2.7%) in the BP-PtCr-EES group and 2 patients (0.5%) in the DP-CoCr-EES group (p=0.02). Conclusions: In patients undergoing PCI of LMCA disease, after two years of follow-up, the use of a BP-PtCr-EES with 4 months of DAPT was non-inferior to a DP-CoCr-EES with 12 months of DAPT with respect to the composite endpoint of all-cause death, myocardial infarction or ischaemia-driven target vessel revascularisation.

OBJECTIVES The authors used the BCIS (British Cardiovascular Intervention Society) database to define the factors associated with percutaneous coronary intervention (PCI) procedural complexity. BACKGROUND Complex high-risk indicated percutaneous coronary intervention (CHIP-PCI) is an emerging concept that is poorly defined. METHODS The BCIS (British Cardiovascular Intervention Society) database was used to study all PCI procedures in the United Kingdom 2006-2016. A multiple logistic regression model was developed to identify variables associated with inhospital major adverse cardiac or cerebrovascular events (MACCE) and to construct a CHIP score. The cumulative effect of this score on patient outcomes was examined. RESULTS A total of 313,054 patients were included. Seven patient factors (age >= 80 years, female sex, previous stroke, previous myocardial infarction, peripheral vascular disease, ejection fraction <30%, and chronic renal disease) and 6 procedural factors (rotational atherectomy, left main PCI, 3-vessel PCI, dual arterial access, left ventricular mechanical support, and total lesion length >60 mm) were associated with increased in-hospital MACCE and defined as CHIP factors. The mean CHIP score/case for all PCIs increased significantly from 1.06 +/- 1.32 in 2006 to 1.49 +/- 1.58 in 2016 (P < 0.001 for trend). A CHIP score of 5 or more was present in 2.5% of procedures in 2006 increasing to 5.3% in 2016 (P < 0.001 for trend). Overall in-hospital MACCE was 0.6% when the CHIP score was 0 compared with 1.2% with any CHIP factor present (P < 0.001). As the CHIP score increased, an exponential increase in-hospital MACCE was observed. The cumulative MACCE for procedures associated with a CHIP score 4+ or above was 3.2%, and for a CHIP score 5+ was 4.4%. All other adverse clinical outcomes were more likely as the CHIP score increased. CONCLUSIONS Seven patient factors and 6 procedural factors were associated with adverse in-hospital MACCE and defined as CHIP factors. Use of a CHIP score might be a future target for risk modification. (C) 2022 by the American College of Cardiology Foundation.

The Lipid Rich Plaque (LRP) Study established the association between high volume of lipidic content (maximum Lipid Core Burden Index [maxLCBI4mm] >400) in the coronary arteries and subsequent non-culprit major adverse cardiac events (NC-MACE). This analysis sought to assess the clinical impact of more than one lipid-rich plaque in the coronary tree.The LRP patient population was divided into four cohorts: 1) patients with all segments with maxLCBI4mm = 0; 2) patients with all coronary segments maxLCBI4mm < 400, but >0; 3) patients with 1 segment maxLCBI4mm > 400; and 4) patients with 2+ coronary segments with maxLCBI4mm > 400. Baseline characteristics, plaque-level characteristics, and follow-up outcomes were described.Among 1550 patients, only 3.2 % had all segments with maxLCBI4mm = 0; 65.1 % had segments with maxLCBI4mm > 0 but <400; 22.5 % had one segment with maxLCBI4mm > 400; and 9.5 % had 2+ coronary segments with maxLCBI4mm > 400. Distribution within the coronary tree (one versus multiple arteries) did not differ. Overall, 1269 patients were allocated to follow-up (per study design). The composite of all-cause death, cardiac death, any revascularization, and NC-MACE was statistically higher in patients with 1 segment maxLCBI4mm > 400 and numerically even higher in patients with 2+ segments with maxLCBI4mm > 400. Patients with maxLCBI4mm = 0 had no events within two years.There is a stepwise increased risk of all-cause death, cardiac death, any revascularization, and NC-MACE according to the number of coronary segments with maxLCBI4mm > 400. In contrast, maxLCBI4mm = 0 results in a low event rate.The Lipid-Rich Plaque Study (LRP), https://clinicaltrials.gov/ct2/show/NCT02033694, NCT02033694.

HomeCirculationVol. 143, No. 11Durable or Biodegradable Polymer Stent Coatings Free AccessEditorialPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessEditorialPDF/EPUBDurable or Biodegradable Polymer Stent CoatingsSame or Different? Robert A. Byrne, MB BCh, PhD and Colm G. Hanratty, MD Robert A. ByrneRobert A. Byrne Robert A. Byrne, MB BCh, PhD, Cardiovascular Research Institute Dublin, Mater Private Hospital, 73 Eccles Street, Dublin 7, D07 KWR1 Ireland. Email E-mail Address: [email protected] https://orcid.org/0000-0001-5224-6393 Cardiovascular Research Institute Dublin, Mater Private Hospital (R.A.B., C.G.H.). School of Pharmacy and Biomolecular Sciences, RCSI University of Medicine and Health Sciences, Dublin, Ireland (R.A.B.). and Colm G. HanrattyColm G. Hanratty Cardiovascular Research Institute Dublin, Mater Private Hospital (R.A.B., C.G.H.). Originally published15 Mar 2021https://doi.org/10.1161/CIRCULATIONAHA.121.052485Circulation. 2021;143:1092–1094This article is a commentary on the followingDurable Polymer Versus Biodegradable Polymer Drug-Eluting Stents After Percutaneous Coronary Intervention in Patients with Acute Coronary SyndromeArticle, see p 1081It is an increasingly widely held belief that a substantial proportion of clinical trials in cardiovascular medicine are not fit for purpose.1 Frequently, patients enrolled do not well represent those encountered in routine practice. Trials that investigate medications or medical devices that have already received regulatory approval often take too long to set up, are too cumbersome to conduct, and are too costly.2 This can lead to unwanted effects on clinical practice, steering clinical management by the results of strictly controlled trials in highly selected patients. It also means that large-scale trials may rely on industry funding, which may affect the choice of clinical question that is asked.3Change is in the air and is gathering pace. Ongoing initiatives such as the sensible clinical trials initiative aim to draw the attention of academic and regulatory authorities to the matter and propose slimmed down requirements for trial design and conduct.4 The key advantages of randomized trials are not only that measured and unmeasured confounding factors tend to be well balanced between treatment groups but also measurement errors and deviations from standard procedures or processes. In addition, increasing availability of large-scale, granular data collection within collaborative networks or national outcome registries facilitates the conduct of pragmatic randomized clinical trials in an efficient manner.5In the current issue of Circulation, Kim and colleagues6 report results from a large-scale, investigator-initiated randomized trial of patients undergoing percutaneous coronary intervention comparing both antithrombotic and stent treatment strategies in 3413 patients with acute coronary syndrome. HOST-REDUCE-POLYTECH-ACS (Harmonizing Optimal Strategy for Treatment of Coronary Artery Diseases Trial: Comparison of Reduction of Prasugrel Dose & Polymer Technology in ACS Patients) makes use of a large network of collaborating investigators enrolling patients at 35 sites in Korea and was funded partly through the contribution of a variety of industry sponsors. The trial had a 2×2 factorial design comparing outcomes of patients randomly allocated to less potent antithrombotic therapy versus standard antithrombotic therapy and implantation of durable polymer (experimental device) versus biodegradable polymer drug-eluting stents (DES; control device).7The results of the antithrombotic treatment comparison have already been published.8 The data showed that a prasugrel-based dose deescalation strategy 1 month after stenting reduced the overall risk of adverse clinical outcomes—as measured by the composite of all-cause death, nonfatal myocardial infarction, stent thrombosis, repeat revascularization, stroke, and bleeding events of grade 2 or higher according to Bleeding Academic Research Consortium criteria—at 1 year, mainly because of a reduction in bleeding events. The article in the current issue of Circulation reports results from the stent comparison.6The use of a factorial design is a valuable method for maximizing scientific impact from the limited resources available to conduct a clinical trial. Indeed, it is a methodology that should probably be used more frequently. In effect, investigators get 2 trials for the price of 1. There is an important caveat: in designing such studies and estimating power, it is necessary to assume that the treatment effect from the first randomized comparison is largely independent of the treatment effect of the second. One could argue that this principle is violated for studies of antithrombotic therapy and stenting and this is a limitation that should be borne in mind when interpreting the results of both articles. This risk would be best assessed by examination of outcomes in each of the 4 treatment groups.9The main results of the present analysis were that in terms of a patient-oriented composite end point—comprising all-cause death, nonfatal myocardial infarction, and any revascularization—the durable polymer DES group was noninferior to the biodegradable polymer DES group with a high degree of statistical probability. At 12 months, the primary end point occurred in 5.2% in the durable polymer group and 6.4% in the biodegradable polymer group (absolute risk difference, −1.2% [upper margin of the 1-sided 97.5% CI, 0.4%], prespecified margin of noninferiority 2.0%, Pnoninferiority<0.001). Importantly, the observed event rates were broadly in line with those assumed in the trial design. There was no evidence of interaction between treatment effect and prespecified subgroups of interest. Among secondary endpoints analyzed, the device-oriented composite of cardiac death, target vessel myocardial infarction, and target lesion revascularization appeared to favor the durable polymer DES treatment arm; this finding must be interpreted against a background of lack of difference in the primary end point analysis and the risks of multiple testing without statistical adjustment.This pragmatic trial has several strengths, including investigator-initiated design and conduct, large sample size, broad inclusion criteria with high external validity, and representation of patients across the spectrum of acute coronary syndrome. However, although the study findings are important, there are limitations that must be considered when interpreting the results. For the clinician in practice, 2 limitations are foremost.First, the experimental and control arms compare groups of stents rather than individual stents. This is not an approach that has been widely used in the past. The reason is that different stents in the same group may have important performance differences between them.10 As a consequence, the results do not really help clinicians in terms of deciding which stent to use in the catheterization laboratory. Some breakdown of results according to individual stent type is provided in the Appendix in the Data Supplement. Variability in outcomes between stent types was observed in the biodegradable polymer stent group with rates of the primary end point ranging from 5.4% to 10.4%. Moreover, whereas some idea of the relative performance of the 2 polymer families may be extrapolated from the data, the absence of difference is difficult to interpret, particularly at 12 months. Differences attributable to polymer coatings may take many years to appear. Data from earlier trials with extended follow-up have failed to detect a signal of meaningful difference between the device classes out to 10 years.11Second, the rationale for using a noninferiority design is unclear. In designing such a trial, an assumption is made that in case noninferiority is demonstrated, some other pragmatic advantage exists that favors adoption of the experimental DES—in this case, the durable polymer DES.12 That rationale is not made clear in the present report. Moreover, it is somewhat unusual to designate the more established technology (durable polymer technology) as the experimental strategy.In terms of trial design, 2 further limitations are noteworthy. First, the choice of primary end point diverges somewhat from recommendations of academic or regulatory authorities for comparisons between coronary stents.13,14 Typically, a device-specific or device-oriented composite is preferred—usually target lesion failure. Using a patient-oriented outcome increases the chance that spurious differences in noncardiac mortality, myocardial infarction unrelated to the target vessel, or repeat revascularization in a different vessel might cloud real differences related to device performance. Second, primary end point testing was planned to be performed first on an intention-to-treat basis. In our opinion, a per-protocol analysis should be preferred for noninferiority testing because it tends to be more conservative.15 This is a minor limitation in the absence of unbalanced crossover and provided that details of both types of analysis are presented.Well-conducted, investigator-initiated trials, conducted in a pragmatic manner with efficient use of resources, will continue to contribute to the expanding literature on comparative efficacy of new generation DES. Within the limitations of its design, data from HOST-REDUCE-POLYTECH-ACS provide further evidence to suggest that when choosing a stent from those widely used and approved for clinical use in 2021, type of polymer coating is unlikely to represent the decisive factor in its own right. If class of polymer coating has an effect on efficacy and safety, it is likely to emerge late, and long-term follow-up of this study cohort will contribute additional insight in this regard.Supplemental MaterialsAppendixDisclosures Dr Byrne reports research funding to his institution of previous employment from Celonova Biosciences and research or educational funding to the institution of his current employment from Abbott Vascular, Biosensors, Biotronik, and Boston Scientific. Dr Hanratty reports no disclosures.FootnotesThe opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.https://www.ahajournals.org/journal/circRobert A. Byrne, MB BCh, PhD, Cardiovascular Research Institute Dublin, Mater Private Hospital, 73 Eccles Street, Dublin 7, D07 KWR1 Ireland. Email [email protected]comReferences1. Pocock SJ, Gersh BJ. Do current clinical trials meet society's needs? A critical review of recent evidence.J Am Coll Cardiol. 2014; 64:1615–1628. doi: 10.1016/j.jacc.2014.08.008CrossrefMedlineGoogle Scholar2. Yusuf S. Damage to important clinical trials by over-regulation.Clin Trials. 2010; 7:622–625. doi: 10.1177/1740774510387850CrossrefMedlineGoogle Scholar3. Vaduganathan M, Samman-Tahhan A, Patel RB, Kelkar A, Papadimitriou L, Georgiopoulou VV, Greene SJ, Kalogeropoulos AP, Peterson E, Fonarow GC, et al.. Association between funding sources and the scope and outcomes of cardiovascular clinical trials: a systematic review.Int J Cardiol. 2017; 230:301–303. doi: 10.1016/j.ijcard.2016.12.119CrossrefMedlineGoogle Scholar4. Reith C, Landray M, Devereaux PJ, Bosch J, Granger CB, Baigent C, Califf RM, Collins R, Yusuf S. Randomized clinical trials: removing unnecessary obstacles.N Engl J Med. 2013; 369:1061–1065. doi: 10.1056/NEJMsb1300760CrossrefMedlineGoogle Scholar5. Nordanstig J, James S, Andersson M, Andersson M, Danielsson P, Gillgren P, Delle M, Engström J, Fransson T, Hamoud M, et al.. Mortality with paclitaxel-coated devices in peripheral artery disease.N Engl J Med. 2020; 383:2538–2546. doi: 10.1056/NEJMoa2005206CrossrefMedlineGoogle Scholar6. Kim HS, Kang J, Hwang D, Han JK, Yang HM, Kang HJ, Koo BK, Kim SY, Park KH, Rha SW, et al.. Durable polymer versus biodegradable polymer drug-eluting stents after percutaneous coronary intervention in patients with acute coronary syndrome: the HOST-REDUCE-POLYTECH-ACS trial.Circulation. 2021; 143:1081–1091. doi: 10.1161/CIRCULATIONAHA.120.051700LinkGoogle Scholar7. Lee JM, Jung JH, Park KW, Shin ES, Oh SK, Bae JW, Rhew JY, Lee N, Kim DB, Kim U, et al.. Harmonizing optimal strategy for treatment of coronary artery diseases: comparison of Reduction of Prasugrel Dose or Polymer Technology in ACS Patients (HOST-REDUCE-POLYTECH-ACS RCT): study protocol for a randomized controlled trial.Trials. 2015; 16:409. doi: 10.1186/s13063-015-0925-5CrossrefMedlineGoogle Scholar8. Kim HS, Kang J, Hwang D, Han JK, Yang HM, Kang HJ, Koo BK, Rhew JY, Chun KJ, Lim YH, et al.; HOST-REDUCE-POLYTECH-ACS investigators. Prasugrel-based de-escalation of dual antiplatelet therapy after percutaneous coronary intervention in patients with acute coronary syndrome (HOST-REDUCE-POLYTECH-ACS): an open-label, multicentre, non-inferiority randomised trial.Lancet. 2020; 396:1079–1089. doi: 10.1016/S0140-6736(20)31791-8CrossrefMedlineGoogle Scholar9. Lubsen J, Pocock SJ. Factorial trials in cardiology: pros and cons.Eur Heart J. 1994; 15:585–588. doi: 10.1093/oxfordjournals.eurheartj.a060552CrossrefMedlineGoogle Scholar10. Taglieri N, Bruno AG, Ghetti G, Marrozzini C, Saia F, Galié N, Palmerini T. Target lesion failure with current drug-eluting stents: evidence from a comprehensive network meta-analysis.JACC Cardiovasc Interv. 2020; 13:2868–2878. doi: 10.1016/j.jcin.2020.09.014CrossrefMedlineGoogle Scholar11. Kufner S, Joner M, Thannheimer A, Hoppmann P, Ibrahim T, Mayer K, Cassese S, Laugwitz KL, Schunkert H, Kastrati A, et al.; ISAR-TEST 4 (Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting Stents) Investigators. Ten-year clinical outcomes from a trial of three limus-eluting stents with different polymer coatings in patients with coronary artery disease.Circulation. 2019; 139:325–333. doi: 10.1161/CIRCULATIONAHA.118.038065LinkGoogle Scholar12. Byrne RA, Kastrati A. Drug-eluting stent trials: too much non-inferiority, too little progress?Lancet. 2014; 383:386–388. doi: 10.1016/S0140-6736(13)62240-0CrossrefMedlineGoogle Scholar13. Byrne RA, Serruys PW, Baumbach A, Escaned J, Fajadet J, James S, Joner M, Oktay S, Jüni P, Kastrati A, et al.. Report of a European Society of Cardiology–European Association of Percutaneous Cardiovascular Interventions task force on the evaluation of coronary stents in Europe: executive summary.Eur Heart J. 2015; 36:2608–2620. doi: 10.1093/eurheartj/ehv203CrossrefMedlineGoogle Scholar14. Garcia-Garcia HM, McFadden EP, Farb A, Mehran R, Stone GW, Spertus J, Onuma Y, Morel MA, van Es GA, Zuckerman B, et al.; Academic Research Consortium. Standardized end point definitions for coronary intervention trials: the Academic Research Consortium-2 consensus document.Circulation. 2018; 137:2635–2650. doi: 10.1161/CIRCULATIONAHA.117.029289LinkGoogle Scholar15. Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJ; CONSORT Group. Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement.JAMA. 2006; 295:1152–1160. doi: 10.1001/jama.295.10.1152CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetailsRelated articlesDurable Polymer Versus Biodegradable Polymer Drug-Eluting Stents After Percutaneous Coronary Intervention in Patients with Acute Coronary SyndromeHyo-Soo Kim, et al. Circulation. 2021;143:1081-1091 March 16, 2021Vol 143, Issue 11 Advertisement Article InformationMetrics © 2021 American Heart Association, Inc.https://doi.org/10.1161/CIRCULATIONAHA.121.052485PMID: 33720774 Originally publishedMarch 15, 2021 KeywordsEditorialsstentsclinical trialpercutaneous coronary interventionPDF download Advertisement SubjectsBlood PressureMyocardial InfarctionStent

Over the past 2 decades, chronic total occlusion (CTO) percutaneous coronary intervention has developed into its own subspecialty of interventional cardiology. Dedicated terminology, techniques, devices, courses, and training programs have enabled progressive advancements. However, only a few randomized trials have been performed to evaluate the safety and efficacy of CTO percutaneous coronary intervention. Moreover, several published observational studies have shown conflicting data. Part of the paucity of clinical data stems from the fact that prior studies have been suboptimally designed and performed. The absence of standardized end points and the discrepancy in definitions also prevent consistency and uniform interpretability of reported results in CTO intervention. To standardize the field, we therefore assembled a broad consortium comprising academicians, practicing physicians, researchers, medical society representatives, and regulators (US Food and Drug Administration) to develop methods, end points, biomarkers, parameters, data, materials, processes, procedures, evaluations, tools, and techniques for CTO interventions. This article summarizes the effort and is organized into 3 sections: key elements and procedural definitions, end point definitions, and clinical trial design principles. The Chronic Total Occlusion Academic Research Consortium is a first step toward improved comparability and interpretability of study results, supplying an increasingly growing body of CTO percutaneous coronary intervention evidence.

To describe the utility and safety of intravascular lithotripsy (IVL) in the setting of primary percutaneous coronary intervention (PCI) for ST elevation myocardial infarction (STEMI).

This study aimed to present a case series of patient treated for stent underexpansion resistant to conventional treatment with intravascular lithotripsy (IVL).

A 46-year-old man with type 1 diabetes underwent percutaneous coronary intervention with bioresorbable scaffold implantation for a long segment of physiologically significant left anterior descending coronary artery disease. The procedure was complicated by longitudinal stent deformation (LSD). The images carry several important educational messages for clinicians. First, as with all stents, LSD is possible in extreme circumstances. Second, as the device is not seen angiographically, it is imperative that optical coherence tomography be performed to confirm LSD. When recognized and treated, the procedural and long-term outcomes are good for this complication.