Randomized Comparison of Abluminus DES+ Sirolimus-Eluting Stents Versus Everolimus-Eluting Stents in Coronary Artery Disease Patients With Diabetes Mellitus Global

Coronary Artery Disease Clinical Trial

— ABILITY  

Official title:

ABILITY Diabetes Global

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04236609
• Other study ID #: COMED.CT.DES.001
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 15, 2020
• Est. completion date: September 30, 2024

Study information

• Verified date: March 2023
• Source: Concept Medical Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare in diabetic patients eligible for percutaneous coronary intervention (PCI) with minimal exclusion criteria, the efficacy and safety of Abluminus DES+ sirolimus- eluting stents (SES) versus XIENCE Everolimus-Eluting Stents (EES). At least 40% of patients are expected to be affected by multivessel coronary artery disease and 30% with acute coronary syndrome

Description:

This study aims to determine which DES will best treat the diabetic population. Specifically, the research question of this trial is to evaluate the use of a novel sirolimus-eluting stent coated with drug-eluting polymer after crimping on the balloon as compared to the standard-of-care EES in the treatment of de novo coronary artery disease in patients with diabetes mellitus. ABILITY is a prospective, multi-center, multinational, randomized, open label, 2-arm parallel group, post-approval study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3050
• Est. completion date: September 30, 2024
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

Clinical Inclusion Criteria

1. Patient understands the trial requirements and the treatment procedures and provides written informed consent;

2. Age = 18 years of age (> 19 years of age for South Korea and = 21 years of age for Singapore);

3. Diabetic patient: either:

1. Patient with a previous documented diagnosis of diabetes mellitus (Type 1 or Type 2) and currently undergoing pharmacological treatment (oral hypoglycemic agents or insulin)

2. Newly diagnosed diabetes: either:

i. Fasting plasma glucose (FPG) =126 mg/dL (7.0 mmol/L). Fasting is defined as no caloric intake for =8 hours1 or ii. Two-hour plasma glucose =200 mg/dL (11.1 mmol/L) following a 75g oral glucose tolerance test or iii. HbA1c level = 7% (53 mmol/mol) Patients who are newly diagnosed are included even if they are not on pharmacological treatment (oral hypoglycemic agents or insulin)

4. Symptomatic coronary artery disease including chronic stable angina, silent ischemia, and non-ST-segment elevation acute coronary syndrome (NSTE-ACS)

5. Patient is eligible for percutaneous coronary intervention (PCI); Previous PCI (with balloon angioplasty or stenting) is allowed if performed >12 months before index procedure;

6. Patient is willing and able to comply with all protocol-required follow-up evaluations.

Angiographic Inclusion Criteria (visual estimate)

7. Presence of =1 de novo coronary artery stenosis >50% in a native coronary artery which can be treated with a stent ranging in diameter from 2.25 to 4.0 mm and can be covered with 1 or multiple stents; and

8. No limitation to the number of treated lesions, number of vessels, or lesion length if the patient is judged eligible for PCI by the treating physician according to the local standard of care.

Exclusion Criteria:

Clinical Exclusion Criteria

1. Patient lacking capacity (i.e. patient suffering from dementia and others) to provide informed consent

2. Patient in cardiogenic shock;

3. Patient has known allergy to the study stent system or protocol-required concomitant medications (e.g. aspirin, clopidogrel, prasugrel, ticagrelor, heparin, stainless steel, platinum, chromium, sirolimus, everolimus, radiographic contrast material) that cannot be adequately pre-medicated;

4. Planned surgery (cardiac and non-cardiac) within 6 months after the index procedure unless the dual-antiplatelet therapy (DAPT) can be maintained throughout the peri-surgical period;

5. Patient undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction (STEMI)

6. Patient is pregnant, nursing, or is a woman of child-bearing potential who is not surgically sterile, < 2 years postmenopausal, or does not consistently use effective methods of contraception*;

7. Patient has any other serious medical illness (e.g., cancer, end-stage congestive heart failure) that may reduce life expectancy to less than 12 months;

8. Acute or chronic renal dysfunction (creatinine >3.0 mg/dl);

9. Currently participating in another investigational drug or device study.

Angiographic Exclusion Criteria

10. In-stent restenotic lesions;

11. Lesions involving venous or arterial bypass grafts.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Coronary Disease
• Diabetes
• Diabetes Mellitus
• Myocardial Ischemia

Intervention

Device:
• Abluminus DES+ Sirolimus Eluting Stent System (SES)
The Sirolimus-eluting stent manufactured by Envision and distributed by Concept Medical
• XIENCE Everolimus Eluting Coronary Stent System (XIENCE family)
The Everolimus-eluting stent manufactured and distributed by Abbott Vascular Santa Clara, CA

Locations

Country	Name	City	State
Australia	The Prince Charles Hospital	Chermside
Australia	St Vincent Hospital	Melbourne
Australia	The Wollongong Hospital	Wollongong
Austria	University Heart Center Graz	Graz
Austria	Kardinal Schwarzenberg Klinikum	Schwarzach Im Pongau
Bangladesh	National Heart Foundation Hospital & Research Institute	Dhaka
Belgium	Antwerp Cardiovascular Center Middelheim	Antwerpen
Belgium	UZ Leuven	Leuven
Brazil	Instituto Dante Pazzanese de Cardiologia	São Paulo
Brazil	INSTITUTO DO CORAÇÃO - InCor University of São Paulo Medical School	São Paulo
Czechia	University Hospital Brno, Department of Medecine Cardiology	Brno
Czechia	University Hospital Královské Vinohrady, Department of Medecine Cardiology	Praha
France	Clinique Axium	Aix-en-Provence
France	CHRU Brest	Brest
France	Clinique de Fontaine	Fontaine-lès-Dijon
France	Groupe Hospitalier Mutualiste de Grenoble	Grenoble
France	Hôpital La Timone, Service Cardiologie	Marseille
France	Hôpital Privé Jacques Cartier	Massy
France	CHU de Nîmes	Nîmes
France	Hôpital Cochin	Paris
Germany	Klinik für Kardiologie und Angiologie II, Herz-Zentrum Bad Krozingen	Bad Krozingen
Germany	Kerckhoff-Klinik GmbH Abteilung Kardiologie/Herzchirurgie	Bad Nauheim
Germany	Herzzentrum, Segeberger Kliniken GmbH	Bad Segeberg
Germany	Charite Berlin, Department of Cardiology, Campus Benjamin Franklin	Berlin
Germany	Helios Amper-Klinikum Dachau, Dept. of Cardiology & Pneumology	Dachau
Germany	Elisabeth Krankenhaus Essen	Essen
Germany	121/ MVZ Hamburg, DEU	Hamburg
Germany	UKSH, Campus Kiel, Department of Cardiology	Kiel
Germany	Heart Center Leipzig	Leipzig
Germany	Universitaetsklinikum Tubingen, DEU	Tuebingen
Germany	Schwarzwald Baar Klinikum Villingen-Schwenningen GmbH	Villingen-Schwenningen
India	Madras Medical Mission	Chennai
India	Krishna Institute of Medical Sciences	Secunderabad
Ireland	National University of Ireland, Galway Galway University Hospital	Galway
Italy	Fondazione Poliambulanza di Brescia	Brescia
Italy	P.O. G. Rodolico	Catania
Italy	075/ Magna Graecia University	Catanzaro
Italy	GVM - Cotignola	Cotignola	Ravenna
Italy	Casa di Cura Montevergine	Mercogliano
Italy	Istituto Sant'Ambrogio	Milano
Italy	San Carlo Clinic	Milano
Italy	San Raffaele Hospital	Milano
Italy	133/Clinica Mederranea	Napoli
Italy	Division of Cardiology, University of Campania "Luigi Vanvitelli"	Napoli
Italy	156/ Policlinico San Matteo	Pavia
Italy	Ospedale degli infermi	Rivoli
Italy	Azienda Ospedaliera San Camillo Forlanini	Roma
Italy	Policlinico Umberto I, "Sapienza" University of Rome Dept.of Cardiovascular, Respiratory, Nephrologic & Anesthesiologic Sciences	Roma
Italy	IRCCS - Policlinico San Donato	San Donato Milanese	Milano
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Malaysia	Institut Jantung Negara	Kuala Lumpur
Mexico	Instituto nacional de cardiologia ignacio chavez	Mexico City
Mexico	Grupo Intervención San Luis - Hospital de Especialidades de la Salud - San Luis Potosí City	San Luis Potosí
Mexico	IMSS Hospital de Especialidades UMAE 71	Torreon
Netherlands	Amsterdam UMC	Amsterdam
Netherlands	Maasstad Hospital	Rotterdam
Poland	XII Oddzial Kardiologiczny PAKS w Belchatowie	Belchatów
Poland	Polsko-Amerykanskie Kliniki Serca III Oddzial Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii	Bielsko-Biala
Poland	MCSN AHoP Chrzanow	Chrzanów
Poland	Zgierskie Centrum Kardiologii Med-Pro Polsko-Amerykanskie Kliniki Serca	Dabrowa Górnicza
Poland	American Heart of Poland	Kedzierzyn-Kozle
Poland	University Hospital Krakow	Krakow
Poland	Miedziowe Centrum Zdrowia SA	Lubin
Poland	Nyskie Centrum Kardiologiczne Polsko-Amerykanskich Klinik Serca w Nysie	Nysa
Poland	Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii w Pinczowie	Pinczów
Poland	Szpital Kliniczny Przemienienia Panskiego	Poznan
Poland	Oddzial Kardiologii Szpitale Polskie Sztum	Sztum
Poland	X Department of Invasive Cardiology, Tychy American Heart of Poland SA	Tychy
Poland	I Oddzial Kardiologii AHoP	Ustron
Poland	Department of Interventional Cardiology Med-Pro American Heart of Poland	Zgierz
Singapore	Changi General Hospital	Singapore
Sweden	Örebro Univ. Hospital, Dpt. of cardiology	Örebro
Sweden	Uppsala University hosp	Uppsala
Switzerland	Cardiocentro Ticino	Lugano
Switzerland	Hôpital de La Tour	Meyrin
Switzerland	Triemli Hospital	Zürich
Switzerland	University Hospital Zürich	Zürich
Taiwan	National Cheng Kung University Hospital	Tainan City
Taiwan	Mackay Memorial Hospital	Taipei City
United Kingdom	Belfast Health and Social Care Trust	Belfast
United Kingdom	Royal blackburn hospital	Blackburn
United Kingdom	The Royal Bournemouth Hospital	Bournemouth
United Kingdom	Brighton & Sussex University NHS Hospitals Trust	Brighton
United Kingdom	Golden Jubilee National Hospital	Clydebank
United Kingdom	Craigavon Area Hospital	Craigavon
United Kingdom	Ninewells Hospital	Dundee
United Kingdom	King's College Hospital NHS Foundation Trust	London
United Kingdom	Royal Free Hopsital	London
United Kingdom	Freeman Hospital	Newcastle Upon Tyne
United Kingdom	Worcestershire Acute NHS Trust, Worcestershire Royal Hospital	Worcester

Sponsors (1)

Lead Sponsor	Collaborator
Concept Medical Inc.

Countries where clinical trial is conducted

Australia,  Austria,  Bangladesh,  Belgium,  Brazil,  Czechia,  France,  Germany,  India,  Ireland,  Italy,  Korea, Republic of,  Malaysia,  Mexico,  Netherlands,  Poland,  Singapore,  Sweden,  Switzerland,  Taiwan,  United Kingdom, 

References & Publications (26)

Cutlip DE, Chhabra AG, Baim DS, Chauhan MS, Marulkar S, Massaro J, Bakhai A, Cohen DJ, Kuntz RE, Ho KK. Beyond restenosis: five-year clinical outcomes from second-generation coronary stent trials. Circulation. 2004 Sep 7;110(10):1226-30. doi: 10.1161/01.C — View Citation

Dangas GD, Claessen BE, Caixeta A, Sanidas EA, Mintz GS, Mehran R. In-stent restenosis in the drug-eluting stent era. J Am Coll Cardiol. 2010 Nov 30;56(23):1897-907. doi: 10.1016/j.jacc.2010.07.028. — View Citation

Denardo SJ, Carpinone PL, Vock DM, Batich CD, Pepine CJ. Changes to polymer surface of drug-eluting stents during balloon expansion. JAMA. 2012 May 23;307(20):2148-50. doi: 10.1001/jama.2012.4111. No abstract available. — View Citation

Dibra A, Kastrati A, Mehilli J, Pache J, Schuhlen H, von Beckerath N, Ulm K, Wessely R, Dirschinger J, Schomig A; ISAR-DIABETES Study Investigators. Paclitaxel-eluting or sirolimus-eluting stents to prevent restenosis in diabetic patients. N Engl J Med. 2 — View Citation

Garcia-Garcia HM, McFadden EP, Farb A, Mehran R, Stone GW, Spertus J, Onuma Y, Morel MA, van Es GA, Zuckerman B, Fearon WF, Taggart D, Kappetein AP, Krucoff MW, Vranckx P, Windecker S, Cutlip D, Serruys PW; Academic Research Consortium. Standardized End P — View Citation

Grube E, Chevalier B, Guagliumi G, Smits PC, Stuteville M, Dorange C, Papeleu P, Kaul U, Dzavik V. The SPIRIT V diabetic study: a randomized clinical evaluation of the XIENCE V everolimus-eluting stent vs the TAXUS Liberte paclitaxel-eluting stent in diab — View Citation

Hadi HA, Suwaidi JA. Endothelial dysfunction in diabetes mellitus. Vasc Health Risk Manag. 2007;3(6):853-76. — View Citation

International Diabetes Federation 2015. IDF DIABETES ATLAS Seventh Edition. 2015; ISBN: 978-2-930229-81-2

Kereiakes DJ, Cutlip DE, Applegate RJ, Wang J, Yaqub M, Sood P, Su X, Su G, Farhat N, Rizvi A, Simonton CA, Sudhir K, Stone GW. Outcomes in diabetic and nondiabetic patients treated with everolimus- or paclitaxel-eluting stents: results from the SPIRIT IV — View Citation

Kufner S, Byrne RA, Dommasch M, Massberg S, Schoemig A, Kastrati A. Comparison of "limus"-eluting stents with permanent-vs biodegradable polymer in patients with diabetes mellitus with coronary artery disease. Eur Heart J 2012; 33: 558-9

Lansky AJ, Messe SR, Brickman AM, Dwyer M, van der Worp HB, Lazar RM, Pietras CG, Abrams KJ, McFadden E, Petersen NH, Browndyke J, Prendergast B, Ng VG, Cutlip DE, Kapadia S, Krucoff MW, Linke A, Moy CS, Schofer J, van Es GA, Virmani R, Popma J, Parides M — View Citation

Lee TT, Feinberg L, Baim DS, Holmes DR, Aroesty JM, Carrozza JP Jr, Cohen DJ, Ho KK, Cutlip DE. Effect of diabetes mellitus on five-year clinical outcomes after single-vessel coronary stenting (a pooled analysis of coronary stent clinical trials). Am J Ca — View Citation

Lightell DJ Jr, Woods TC. Relative resistance to Mammalian target of rapamycin inhibition in vascular smooth muscle cells of diabetic donors. Ochsner J. 2013 Spring;13(1):56-60. — View Citation

Maeng M, Jensen LO, Galloe AM, Thayssen P, Christiansen EH, Hansen KN, Helqvist S, Botker HE, Lassen JF, Thuesen L. Comparison of the sirolimus-eluting versus paclitaxel-eluting coronary stent in patients with diabetes mellitus: the diabetes and drug-elut — View Citation

Mahmud E, Ormiston JA, Turco MA, Popma JJ, Weissman NJ, O'Shaughnessy CD, Mann T, Hall JJ, McGarry TF, Cannon LA, Webster MW, Mandinov L, Baim DS. TAXUS Liberte attenuates the risk of restenosis in patients with medically treated diabetes mellitus: result — View Citation

Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for ca — View Citation

Morgan KP, Kapur A, Beatt KJ. Anatomy of coronary disease in diabetic patients: an explanation for poorer outcomes after percutaneous coronary intervention and potential target for intervention. Heart. 2004 Jul;90(7):732-8. doi: 10.1136/hrt.2003.021014. — View Citation

Mulukutla SR, Vlachos HA, Marroquin OC, Selzer F, Holper EM, Abbott JD, Laskey WK, Williams DO, Smith C, Anderson WD, Lee JS, Srinivas V, Kelsey SF, Kip KE. Impact of drug-eluting stents among insulin-treated diabetic patients: a report from the National — View Citation

Popma JJ, Leon MB, Moses JW, Holmes DR Jr, Cox N, Fitzpatrick M, Douglas J, Lambert C, Mooney M, Yakubov S, Kuntz RE; SIRIUS Investigators. Quantitative assessment of angiographic restenosis after sirolimus-eluting stent implantation in native coronary ar — View Citation

Schalkwijk CG, Stehouwer CD. Vascular complications in diabetes mellitus: the role of endothelial dysfunction. Clin Sci (Lond). 2005 Aug;109(2):143-59. doi: 10.1042/CS20050025. — View Citation

Serruys PW, Ruygrok P, Neuzner J, Piek JJ, Seth A, Schofer JJ, Richardt G, Wiemer M, Carrie D, Thuesen L, Boone E, Miquel-Herbert K, Daemen J. A randomised comparison of an everolimus-eluting coronary stent with a paclitaxel-eluting coronary stent:the SPI — View Citation

Stenestrand U, James SK, Lindback J, Frobert O, Carlsson J, Schersten F, Nilsson T, Lagerqvist B; SCAAR/SWEDEHEART study group. Safety and efficacy of drug-eluting vs. bare metal stents in patients with diabetes mellitus: long-term follow-up in the Swedis — View Citation

Stone GW, Kedhi E, Kereiakes DJ, Parise H, Fahy M, Serruys PW, Smits PC. Differential clinical responses to everolimus-eluting and Paclitaxel-eluting coronary stents in patients with and without diabetes mellitus. Circulation. 2011 Aug 23;124(8):893-900. — View Citation

Stone GW, Midei M, Newman W, Sanz M, Hermiller JB, Williams J, Farhat N, Mahaffey KW, Cutlip DE, Fitzgerald PJ, Sood P, Su X, Lansky AJ; SPIRIT III Investigators. Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with co — View Citation

Thiele H, Zeymer U. Chapter: Cardiogenic shock in patients with acute coronary syndromes (p. 441), The ESC Textbook of Intensive and Acute Cardiovascular Care (2 ed.) [IACC]. Edited by Marco Tubaro, Pascal Vranckx, Susanna Price, and Christiaan Vrints. Updated on 22 February 2018 DOI: 10.1093/med/9780199687039.003.0049_update_003

Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Composite of cardiovascular death, target vessel MI and ischemia-driven TLR (TLF)	Cardiovascular death is defined as death resulting from cardiovascular causes. Any MI not clearly attributable to a non-target vessel will be considered as target-vessel MI.; Revascularization is clinically driven if the target lesion diameter stenosis is > 50% by quantitative coronary angiography (QCA) and the subject has clinical or functional ischemia which cannot be explained by another native coronary or bypass graft lesion.	2 year FU
Other	Occurrence of cardiovascular death and target-vessel myocardial infarction (MI)	Cardiovascular death is defined as death resulting from cardiovascular causes. The following categories may be collected: Death caused by acute MI; Death caused by sudden cardiac, including unwitnessed, death; Death resulting from heart failure; Death caused by stroke; Death caused by cardiovascular procedures; Death resulting from cardiovascular hemorrhage; Death resulting from other cardiovascular cause. Any MI not clearly attributable to a non-target vessel will be considered as target-vessel MI.; Percutaneous coronary intervention (PCI) related MI is termed type 4a MI.; Coronary artery bypass grafting (CABG) related MI is termed type 5 MI.	2 year
Other	All-cause mortality	all deaths are considered cardiovascular unless an alternate cause is unequivocally established, even among subjects with serious noncardiac comorbidities.	up to 2 years from procedure
Other	Stroke	according to Neuro-ARC stroke/TIA criteria	up to 2 years from procedure
Other	Stent thrombosis	defined for grade and timing according to the Academic Research Consortium2	2 year
Other	Technical success	Technical success is defined as the ability to cross the occluded segment with both a wire and a balloon, and successfully open the artery; the restoration of antegrade TIMI flow 2 or 3 and a <30% residual stenosis. (As applies to chronic total occlusion - CTO - lesions)	2 year
Other	Clinical procedural success	In the case of percutaneous intervention for obstructive lesions, procedural success is defined as the achievement of a final residual diameter stenosis < 30% by angiography at the end of the procedure (and without flow limiting arterial dissection and hemodynamically significant translesional pressure gradient) without any in-hospital major adverse events (death, acute onset of limb ischemia, need for urgent/emergent vascular surgery). The balloon inflation and/or stent placement may be preceded by use of adjunctive devices (e.g., percutaneous mechanical thrombectomy, directional or rotational atherectomy, laser, chronic total occlusion crossing device).; Ideally, the assessment of the residual stenosis at the end of the procedure should be performed by an angiographic core laboratory.	2 year
Other	Occurrence of ischemia-driven TLR	Revascularization is clinically driven if the target lesion diameter stenosis is > 50% by quantitative coronary angiography (QCA) and the subject has clinical or functional ischemia which cannot be explained by another native coronary or bypass graft lesion.	2 year FU
Other	Target vessel revascularization (TVR)	TLR is a repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.	up to 2 years
Primary	Rate of Ischemia-driven TLR	powered for non-inferiority and sequentially superiority	1 year FU
Primary	Rate of Target lesion failure TLF	composite of cardiovascular death, target vessel myocardial infarction [MI], or ischemia driven target lesion revascularization [idTLR])	1 year FU, powered for non-inferiority
Secondary	Safety composite endpoint	Safety composite endpoint of the occurrence of cardiovascular death and target-vessel myocardial infarction (MI)	1 year (non-inferiority)
Secondary	co-primary TLR endpoint	In case the co-primary TLR endpoint (TLR for non-inferiority) will be demonstrated at 1 year, then the occurrence of ischemia-driven TLR at 2-year FU will be evaluated (efficacy endpoint - superiority)	2 Year FU
Secondary	Composite of cardiovascular death, target vessel MI and ischemia-driven TLR (TLF)	Cardiovascular death is defined as death resulting from cardiovascular causes. The following categories may be collected: Death caused by acute MI; Death caused by sudden cardiac, including unwitnessed, death; Death resulting from heart failure; Death caused by stroke; Death caused by cardiovascular procedures; Death resulting from cardiovascular hemorrhage; Death resulting from other cardiovascular cause Any MI not clearly attributable to a non-target vessel will be considered as target-vessel MI.; Percutaneous coronary intervention (PCI) related MI is termed type 4a MI.; Coronary artery bypass grafting (CABG) related MI is termed type 5 MI. Revascularization is clinically driven if the target lesion diameter stenosis is > 50% by quantitative coronary angiography (QCA) and the subject has clinical or functional ischemia which cannot be explained by another native coronary or bypass graft lesion.	1 year FU
Secondary	Bleeding	Bleeding BARC 2 or greater	2 year