Angiographic control versus ischaemia-driven management of patients undergoing percutaneous revascularisation of the unprotected left main coronary artery with second-generation drug-eluting stents: rationale and design of the PULSE trial

Ovidio De Filippo, Matteo Bianco, Matteo Tebaldi, Mario Iannaccone, Luca Gaido, Vincenzo Guiducci, Andrea Santarelli, Lorenzo Zaccaro, Alessandro Depaoli, Paolo Vaudano, Giorgio Quadri, Andrea Gagnor, Giacomo Boccuzzi, Federica Solitro, Giancarlo Cortese, Carla Guarnaccia, Davide Tore, Andrea Veltri, Luca Franchin, Filippo Angelini, Roberto Garbo, Massimo Giammaria, Ferdinando Varbella, Filippo Marchisio, Paolo Fonio, Gaetano Maria De Ferrari, Enrico Cerrato, Gianluca Campo, Fabrizio D'Ascenzo, Ovidio De Filippo, Matteo Bianco, Matteo Tebaldi, Mario Iannaccone, Luca Gaido, Vincenzo Guiducci, Andrea Santarelli, Lorenzo Zaccaro, Alessandro Depaoli, Paolo Vaudano, Giorgio Quadri, Andrea Gagnor, Giacomo Boccuzzi, Federica Solitro, Giancarlo Cortese, Carla Guarnaccia, Davide Tore, Andrea Veltri, Luca Franchin, Filippo Angelini, Roberto Garbo, Massimo Giammaria, Ferdinando Varbella, Filippo Marchisio, Paolo Fonio, Gaetano Maria De Ferrari, Enrico Cerrato, Gianluca Campo, Fabrizio D'Ascenzo

Abstract

Background: The role of planned angiographic control (PAC) over a conservative management driven by symptoms and ischaemia following percutaneous coronary intervention (PCI) of the unprotected left main (ULM) with second-generation drug-eluting stents remains controversial. PAC may timely detect intrastent restenosis, but it is still unclear if this translated into improved prognosis.

Methods and analysis: PULSE is a prospective, multicentre, open-label, randomised controlled trial. Consecutive patients treated with PCI on ULM will be included, and after the index revascularisation patients will be randomised to PAC strategy performed with CT coronary after 6 months versus a conservative symptoms and ischaemia-driven follow-up management. Follow-up will be for at least 18 months from randomisation. Major adverse cardiovascular events at 18 months (a composite endpoint including death, cardiovascular death, myocardial infarction (MI) (excluding periprocedural MI), unstable angina, stent thrombosis) will be the primary efficacy outcome. Secondary outcomes will include any unplanned target lesion revascularisation (TLR) and TLR driven by PAC. Safety endpoints embrace worsening of renal failure and bleeding events. A sample size of 550 patients (275 per group) is required to have a 80% chance of detecting, as significant at the 5% level, a 7.5% relative reduction in the primary outcome.

Trial registration number: NCT04144881.

Keywords: CT scanning; coronary angiography; coronary artery disease; coronary intervention (PCI).

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Study flow. *With non-invasive tests (ie, myocardial SPECT; ergometric stress test; dobutamine stress echocardiography) performed according to physicians’ indication. DES-II, second-generation drug-eluting stent; EGFR, estimated glomerular filtration rate; ISR, intrastent restenosis; PCI, percutaneous coronary intervention; SPECT, single photon emission computed tomography.

References

    1. Neumann F-J, Sousa-Uva M, Ahlsson A, et al. . 2018 ESC/EACTS guidelines on myocardial revascularization. Eur Heart J 2019;40:87–165. 10.1093/eurheartj/ehy394
    1. Sheiban I, Moretti C, D'Ascenzo F, et al. . Long-term (≥10 years) safety of percutaneous treatment of unprotected left main stenosis with drug-eluting stents. Am J Cardiol 2016;118:32–9. 10.1016/j.amjcard.2016.04.007
    1. D'Ascenzo F, Iannaccone M, Saint-Hilary G, et al. . Impact of design of coronary stents and length of dual antiplatelet therapies on ischaemic and bleeding events: a network meta-analysis of 64 randomized controlled trials and 102 735 patients. Eur Heart J 2017;38:3160–72. 10.1093/eurheartj/ehx437
    1. Iannaccone M, D'Ascenzo F, Templin C, et al. . Optical coherence tomography evaluation of intermediate-term healing of different stent types: systemic review and meta-analysis. Eur Heart J Cardiovasc Imaging 2017;18:159–66. 10.1093/ehjci/jew070
    1. Cassese S, Byrne RA, Schulz S, et al. . Prognostic role of restenosis in 10 004 patients undergoing routine control angiography after coronary stenting. Eur Heart J 2015;36:94–9. 10.1093/eurheartj/ehu383
    1. Alfonso F, Byrne RA, Rivero F, et al. . Current treatment of in-stent restenosis. J Am Coll Cardiol 2014;63:2659–73. 10.1016/j.jacc.2014.02.545
    1. Stone GW, Parise H, Witzenbichler B, et al. . Selection criteria for drug-eluting versus bare-metal stents and the impact of routine angiographic follow-up: 2-year insights from the HORIZONS-AMI (Harmonizing outcomes with revascularization and stents in acute myocardial infarction) trial. J Am Coll Cardiol 2010;56:1597–604. 10.1016/j.jacc.2010.08.608
    1. Uchida T, Popma J, Stone GW, et al. . The clinical impact of routine angiographic follow-up in randomized trials of drug-eluting stents: a critical assessment of "oculostenotic" reintervention in patients with intermediate lesions. JACC Cardiovasc Interv 2010;3:403–11. 10.1016/j.jcin.2010.01.010
    1. Lee J-Y, Park D-W, Kim Y-H, et al. . Incidence, predictors, treatment, and long-term prognosis of patients with restenosis after drug-eluting stent implantation for unprotected left main coronary artery disease. J Am Coll Cardiol 2011;57:1349–58. 10.1016/j.jacc.2010.10.041
    1. Biondi-Zoccai GGL, Giraudi E, Moretti C, et al. . Impact of routine angiographic follow-up after percutaneous coronary drug-eluting stenting for unprotected left main disease: the Turin registry. Clin Res Cardiol 2010;99:235–42. 10.1007/s00392-009-0112-3
    1. Valgimigli M, Chieffo A, Lefèvre T, et al. . Revisiting the incidence and temporal distribution of cardiac and sudden death in patients undergoing elective intervention for unprotected left main coronary artery stenosis in the drug eluting stent era. EuroIntervention 2007;2:435–43.
    1. Roura G, Gomez-Lara J, Ferreiro JL, et al. . Multislice CT for assessing in-stent dimensions after left main coronary artery stenting: a comparison with three dimensional intravascular ultrasound. Heart 2013;99:1106–12. 10.1136/heartjnl-2013-303679
    1. Mehran R, Dangas G, Abizaid AS, et al. . Angiographic patterns of in-stent restenosis: classification and implications for long-term outcome. Circulation 1999;100:1872–8. 10.1161/01.cir.100.18.1872
    1. Hicks KA, Tcheng JE, Bozkurt B, et al. . 2014 ACC/AHA key data elements and definitions for cardiovascular endpoint events in clinical trials: a report of the American College of Cardiology/American heart association Task force on clinical data standards (writing Committee to develop cardiovascular endpoints data standards). J Am Coll Cardiol 2015;66:403–69. 10.1016/j.jacc.2014.12.018
    1. Mehta RL, Kellum JA, Shah SV, et al. . Acute kidney injury network: report of an initiative to improve outcomes in acute kidney injury. Crit Care 2007;11:R31. 10.1186/cc5713
    1. Mehran R, Rao SV, Bhatt DL, et al. . Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the bleeding academic research Consortium. Circulation 2011;123:2736–47. 10.1161/CIRCULATIONAHA.110.009449
    1. Thygesen K, Alpert JS, Jaffe AS, et al. . ESC scientific document group: fourth universal definition of myocardial infarction. Eur Heart J 2019;40:237–69.
    1. D'Ascenzo F, Iannaccone M, Giordana F, et al. . Provisional vs. two-stent technique for unprotected left main coronary artery disease after ten years follow up: a propensity matched analysis. Int J Cardiol 2016;211:37–42. 10.1016/j.ijcard.2016.02.136
    1. Tonino PAL, De Bruyne B, Pijls NHJ, et al. . Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med 2009;360:213–24. 10.1056/NEJMoa0807611
    1. D'Ascenzo F, Barbero U, Cerrato E, et al. . Accuracy of intravascular ultrasound and optical coherence tomography in identifying functionally significant coronary stenosis according to vessel diameter: a meta-analysis of 2,581 patients and 2,807 lesions. Am Heart J 2015;169:663–73. 10.1016/j.ahj.2015.01.013
    1. Buchanan GL, Chieffo A, Bernelli C, et al. . Two-year outcomes following unprotected left main stenting with first vs. new-generation drug-eluting stents: the fine registry. EuroIntervention 2013;9:809–16. 10.4244/EIJV9I7A134

Source: PubMed

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

3
Subskrybuj