Stent and Dual Antiplatelet Therapy Duration Comparisons in the Setting of a Multicenter Randomized Controlled Trial: Can the Operator Experience Affect the Study Results?

Giuseppe Gargiulo, Dik Heg, Fabrizio Ferrari, Gianfranco Percoco, Gianluca Campo, Carlo Tumscitz, Federico Colombo, Andrea Zuffi, Fausto Castriota, Alberto Cremonesi, Stephan Windecker, Marco Valgimigli, Giuseppe Gargiulo, Dik Heg, Fabrizio Ferrari, Gianfranco Percoco, Gianluca Campo, Carlo Tumscitz, Federico Colombo, Andrea Zuffi, Fausto Castriota, Alberto Cremonesi, Stephan Windecker, Marco Valgimigli

Abstract

Background: Operator experience influences outcomes after percutaneous coronary intervention, but this association in the controlled setting of a randomized, clinical trial is unclear.

Methods and results: We investigated operator-related outcomes (30-day and 2-year efficacy and safety end points) among patients undergoing percutaneous coronary intervention and randomized to different dual antiplatelet therapy durations and stent types. A total of 2003 patients were analyzed, and 7 operator groups were compared. The majority of preprocedural and postprocedural characteristics were imbalanced. The primary end point of the study, the composite of death, myocardial infarction, or cerebrovascular accidents, did not differ among operators at 30 days or 2 years. There were no significant differences also for all other individual and composite end points analyzed at 30 days and 2 years, except for 2-year stent thrombosis (P=0.048) and bleeding events (P=0.022 for Bleeding Academic Research Consortium type 2, 3, or 5). Adjusted comparisons for the main end points showed slight differences among operators at 30 days, but not at 2 years. There was no interaction of operator with dual antiplatelet therapy duration (P=0.112) or stent type (P=0.300). Results remained entirely consistent when operators were stratified by their experience.

Conclusions: There was a weak signal of heterogeneity across study operators for the 30-day, but not the 2-year, main study outcomes. No clear effect of operator or operator experience was observed for the comparative efficacy and safety profile of the randomized stent types or dual antiplatelet therapy duration regimens.

Clinical trial registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00611286.

Keywords: clinical outcomes; operator; percutaneous coronary intervention; randomized trial.

© 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

Figures

Figure 1
Figure 1
Operator procedure distribution.
Figure 2
Figure 2
Stratified effect of operators on the primary comparisons of the primary outcome in the PRODIGY trial. Hazard ratios from Weibull time‐to‐event regression on the composite of all‐cause death, MI, or CVA comparing the randomized DAPT durations or randomized stents and testing for effect modification by the Operators n (1–6). *Short DAPT randomized to 6 months of DAPT, Long DAPT randomized to 24 months of DAPT. **ZES‐S (zotarolimus‐eluting Endeavor Sprint stent), PES (paclitaxel‐eluting stent), and EES (everolimus‐eluting stent) combined. ***The Other Operators are shown for completeness, but not used for interaction testing. BMS indicates bare metal stent; CVA, cerebrovascular accidents; DAPT, dual antiplatelet therapy; DES, drug‐eluting stent; MI, myocardial infarction.

References

    1. Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Hollenberg SM, Khot UN, Lange RA, Mauri L, Mehran R, Moussa ID, Mukherjee D, Nallamothu BK, Ting HH. 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. J Am Coll Cardiol. 2011;58:e44–e122.
    1. Harold JG, Bass TA, Bashore TM, Brindis RG, Brush JE Jr, Burke JA, Dehmer GJ, Deychak YA, Jneid H, Jollis JG, Landzberg JS, Levine GN, McClurken JB, Messenger JC, Moussa ID, Muhlestein JB, Pomerantz RM, Sanborn TA, Sivaram CA, White CJ, Williams ES. ACCF/AHA/SCAI 2013 update of the clinical competence statement on coronary artery interventional procedures: a report of the American College of Cardiology Foundation/American Heart Association/American College of Physicians Task Force on Clinical Competence and Training (writing committee to revise the 2007 clinical competence statement on cardiac interventional procedures). J Am Coll Cardiol. 2013;62:357–396.
    1. McGrath PD, Wennberg DE, Dickens JD Jr, Siewers AE, Lucas FL, Malenka DJ, Kellett MA Jr, Ryan TJ Jr. Relation between operator and hospital volume and outcomes following percutaneous coronary interventions in the era of the coronary stent. JAMA. 2000;284:3139–3144.
    1. Badheka AO, Patel NJ, Grover P, Singh V, Patel N, Arora S, Chothani A, Mehta K, Deshmukh A, Savani GT, Patel A, Panaich SS, Shah N, Rathod A, Brown M, Mohamad T, Tamburrino FV, Kar S, Makkar R, O'Neill WW, De Marchena E, Schreiber T, Grines CL, Rihal CS, Cohen MG. Impact of annual operator and institutional volume on percutaneous coronary intervention outcomes: a 5‐year United States experience (2005–2009). Circulation. 2014;130:1392–1406.
    1. Hulme W, Sperrin M, Rushton H, Ludman PF, De Belder M, Curzen N, Kinnaird T, Kwok CS, Buchan I, Nolan J, Mamas MA. Is there a relationship of operator and center volume with access site‐related outcomes? An analysis from the British Cardiovascular Intervention Society. Circ Cardiovasc Interv. 2016;9:e003333.
    1. King SB III, Aversano T, Ballard WL, Beekman RH III, Cowley MJ, Ellis SG, Faxon DP, Hannan EL, Hirshfeld JW Jr, Jacobs AK, Kellett MA Jr, Kimmel SE, Landzberg JS, McKeever LS, Moscucci M, Pomerantz RM, Smith KM, Vetrovec GW, Creager MA, Hirshfeld JW Jr, Holmes DR Jr, Newby LK, Weitz HH, Merli G, Pina I, Rodgers GP, Tracy CM. ACCF/AHA/SCAI 2007 update of the clinical competence statement on cardiac interventional procedures: a report of the American College of Cardiology Foundation/American Heart Association/American College of Physicians Task Force on Clinical Competence and Training (writing committee to update the 1998 clinical competence statement on recommendations for the assessment and maintenance of proficiency in coronary interventional procedures). J Am Coll Cardiol. 2007;50:82–108.
    1. Post PN, Kuijpers M, Ebels T, Zijlstra F. The relation between volume and outcome of coronary interventions: a systematic review and meta‐analysis. Eur Heart J. 2010;31:1985–1992.
    1. Strom JB, Wimmer NJ, Wasfy JH, Kennedy K, Yeh RW. Association between operator procedure volume and patient outcomes in percutaneous coronary intervention: a systematic review and meta‐analysis. Circ Cardiovasc Qual Outcomes. 2014;7:560–566.
    1. Xu B, Redfors B, Yang Y, Qiao S, Wu Y, Chen J, Liu H, Chen J, Xu L, Zhao Y, Guan C, Gao R, Genereux P. Impact of operator experience and volume on outcomes after left main coronary artery percutaneous coronary intervention. JACC Cardiovasc Interv. 2016;9:2086–2093.
    1. Moscucci M, Share D, Smith D, O'Donnell MJ, Riba A, McNamara R, Lalonde T, Defranco AC, Patel K, Kline Rogers E, D'Haem C, Karve M, Eagle KA. Relationship between operator volume and adverse outcome in contemporary percutaneous coronary intervention practice: an analysis of a quality‐controlled multicenter percutaneous coronary intervention clinical database. J Am Coll Cardiol. 2005;46:625–632.
    1. Doll JA, Dai D, Roe MT, Messenger JC, Sherwood MW, Prasad A, Mahmud E, Rumsfeld JS, Wang TY, Peterson ED, Rao SV. Assessment of operator variability in risk‐standardized mortality following percutaneous coronary intervention: a report from the NCDR. JACC Cardiovasc Interv. 2017;10:672–682.
    1. Valgimigli M, Gagnor A, Calabro P, Frigoli E, Leonardi S, Zaro T, Rubartelli P, Briguori C, Ando G, Repetto A, Limbruno U, Cortese B, Sganzerla P, Lupi A, Galli M, Colangelo S, Ierna S, Ausiello A, Presbitero P, Sardella G, Varbella F, Esposito G, Santarelli A, Tresoldi S, Nazzaro M, Zingarelli A, de Cesare N, Rigattieri S, Tosi P, Palmieri C, Brugaletta S, Rao SV, Heg D, Rothenbuhler M, Vranckx P, Juni P. Radial versus femoral access in patients with acute coronary syndromes undergoing invasive management: a randomised multicentre trial. Lancet. 2015;385:2465–2476.
    1. Valgimigli M, Gargiulo G, Juni P. Radial versus femoral access for cardiac catheterisation—Authors' reply. Lancet. 2015;386:2394.
    1. Le May MR, Singh K, Wells GA. Efficacy of radial versus femoral access in the acute coronary syndrome: is it the operator or the operation that matters? JACC Cardiovasc Interv. 2015;8:1405–1409.
    1. Rao SV, Nolan J, Fraser DG, Mamas MA, Bertrand OF, Pancholy SB, Bernat I, Dharma S, Kedev S, Jolly SS, Valgimigli M. Efficacy of radial versus femoral access in the acute coronary syndrome: is it the operator or the operation that matters? JACC Cardiovasc Interv. 2016;9:978–979.
    1. Vlaar PJ, de Smet BJ, van den Heuvel AF, Anthonio RL, Jessurun GA, Tan ES, Hillege HL, Zijlstra F. Operator dependence of outcome after primary percutaneous coronary intervention. EuroIntervention. 2011;6:760–767.
    1. Valgimigli M, Campo G, Percoco G, Monti M, Ferrari F, Tumscitz C, Zuffi A, Colombo F, Kubbajeh M, Cavazza C, Cangiano E, Tebaldi M, Minarelli M, Arcozzi C, Scalone A, Frangione A, Borghesi M, Marchesini J, Parrinello G, Ferrari R. Randomized comparison of 6‐ versus 24‐month clopidogrel therapy after balancing anti‐intimal hyperplasia stent potency in all‐comer patients undergoing percutaneous coronary intervention design and rationale for the prolonging dual‐antiplatelet treatment after grading stent‐induced intimal hyperplasia study (PRODIGY). Am Heart J. 2010;160:804–811.
    1. Valgimigli M, Campo G, Monti M, Vranckx P, Percoco G, Tumscitz C, Castriota F, Colombo F, Tebaldi M, Fuca G, Kubbajeh M, Cangiano E, Minarelli M, Scalone A, Cavazza C, Frangione A, Borghesi M, Marchesini J, Parrinello G, Ferrari R. Short‐ versus long‐term duration of dual‐antiplatelet therapy after coronary stenting: a randomized multicenter trial. Circulation. 2012;125:2015–2026.
    1. Valgimigli M, Borghesi M, Tebaldi M, Vranckx P, Parrinello G, Ferrari R. Should duration of dual antiplatelet therapy depend on the type and/or potency of implanted stent? A pre‐specified analysis from the prolonging dual antiplatelet treatment after grading stent‐induced intimal hyperplasia study (PRODIGY). Eur Heart J. 2013;34:909–919.
    1. Giustino G, Chieffo A, Palmerini T, Valgimigli M, Feres F, Abizaid A, Costa RA, Hong MK, Kim BK, Jang Y, Kim HS, Park KW, Gilard M, Morice MC, Sawaya F, Sardella G, Genereux P, Redfors B, Leon MB, Bhatt DL, Stone GW, Colombo A. Efficacy and safety of dual antiplatelet therapy after complex PCI. J Am Coll Cardiol. 2016;68:1851–1864.
    1. Habara M, Tsuchikane E, Muramatsu T, Kashima Y, Okamura A, Mutoh M, Yamane M, Oida A, Oikawa Y, Hasegawa K. Comparison of percutaneous coronary intervention for chronic total occlusion outcome according to operator experience from the Japanese retrograde summit registry. Catheter Cardiovasc Interv. 2016;87:1027–1035.
    1. Tamburino C, Latib A, van Geuns RJ, Sabate M, Mehilli J, Gori T, Achenbach S, Alvarez MP, Nef H, Lesiak M, Di Mario C, Colombo A, Naber CK, Caramanno G, Capranzano P, Brugaletta S, Geraci S, Araszkiewicz A, Mattesini A, Pyxaras SA, Rzeszutko L, Depukat R, Diletti R, Boone E, Capodanno D, Dudek D. Contemporary practice and technical aspects in coronary intervention with bioresorbable scaffolds: a European perspective. EuroIntervention. 2015;11:45–52.
    1. Tommaso CL, Bolman RM III, Feldman T, Bavaria J, Acker MA, Aldea G, Cameron DE, Dean LS, Fullerton D, Hijazi ZM, Horlick E, Miller DC, Moon MR, Ringel R, Ruiz CE, Trento A, Weiner BH, Zahn EM. Multisociety (AATS, ACCF, SCAI, and STS) expert consensus statement: operator and institutional requirements for transcatheter valve repair and replacement, part 1: transcatheter aortic valve replacement. J Am Coll Cardiol. 2012;59:2028–2042.
    1. Shah R, Gardner JD. Radial versus femoral access for cardiac catheterisation. Lancet. 2015;386:2392–2393.
    1. Shah R, Ahmed AJ. Validity of randomized trials comparing radial versus femoral access in acute coronary syndrome. JACC Cardiovasc Interv. 2016;9:1517–1518.
    1. Dehmer GJ, Holper EM. Does practice make perfect? JACC Cardiovasc Interv. 2017;10:928–930.

Source: PubMed

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

3
S'abonner