[en] BACKGROUND: Diabetes mellitus has worse outcome after percutaneous coronary intervention. AIM: We assessed stent thrombosis (ST), major adverse cardiac events (MACE), and major bleeding rates at 1 year after implantation of sirolimus-eluting stents (SES) in patients with diabetes mellitus in a large multicenter registry. METHODS: From May 2006 to April 2008, 15,147 unselected consecutive patients were enrolled at 320 centers in 56 countries in a prospective, observational registry after implantation of >/= 1 SES. Source data were verified in 20% randomly chosen patients at > 100 sites. Adverse events were adjudicated by an independent Clinical Event Committee. RESULTS: Complete follow-up at 1 year was obtained in 13,693 (92%) patients, 4,577 (30%) of whom were diabetics. Within diabetics, 1,238 (9%) were insulin-treated diabetics (ITD). Diabetics were older (64 vs. 62 years, P < 0.001), with higher incidence of major coronary risk factors, co-morbidities, and triple-vessel coronary artery disease. Coronary lesions had smaller reference vessel diameter (2.88 +/- 0.46 vs. 2.93 +/- 0.45 mm, P < 0.001) and were more often heavily calcified (26.1% vs. 22.6%, P < 0.001). At 1 year, diabetics had higher MACE rate (6.8% vs. 3.9%, P < 0.001) driven by ITD (10.6% vs. 5.5%, P < 0.001). Finally, diabetics had significant increase in ST (1.7% vs. 0.7%, P < 0.001), principally owing to ITD (3.4% vs. 1.1%, P < 0.001). There was an overall low risk of major bleeding during follow-up, without significant difference among subgroups. CONCLUSIONS: In the e-SELECT registry, diabetics represented 30% of patients undergoing SES implantation and had significantly more co-morbidities and complex coronary lesions. Although 1-year follow-up documented good overall outcome in diabetics, higher ST and MACE rates were observed, mainly driven by ITD. (c) 2015 Wiley Periodicals, Inc.
Disciplines :
Cardiovascular & respiratory systems
Author, co-author :
Bartorelli, Antonio L.
Egidy Assenza, Gabriele
Abizaid, Alexandre
Banning, Adrian
Dzavik, Vladimir
Ellis, Stephen
Gao, Runlin
Holmes, David
Ho Jeong, Myung
LEGRAND, Victor ; Centre Hospitalier Universitaire de Liège - CHU > Cardiologie
Moussa I, Leon MB, Baim DS, O'Neill WW, Popma JJ, Buchbinder M, Midwall J, Simonton CA, Keim E, Wang P, Kuntz RE, Moses JW,. Impact of sirolimus-eluting stents on outcome in diabetic patients: A SIRIUS (sirolimus-coated Bx Velocity balloon-expandable stent in the treatment of patients with de novo coronary artery lesions) substudy. Circulation 2004; 109: 2273-2278.
Abizaid A, Kornowski R, Mintz GS, Hong MK, Abizaid AS, Mehran R, Pichard AD, Kent KM, Satler LF, Wu H, Popma JJ, Leon MB,. The influence of diabetes mellitus on acute and late clinical outcomes following coronary stent implantation. J Am Coll Cardiol 1998; 32: 584-589.
Urban P, Abizaid A, Banning A, Bartorelli AL, Baux AC, Dzavik V, Ellis S, Gao R, Holmes D, Jeong MH, Legrand V, Neumann FJ, Nyakern M, Spaulding C, Worthley S,. Stent thrombosis and bleeding complications after implantation of sirolimus-eluting coronary stents in an unselected worldwide population: A report from the e-SELECT (multi-center post-market surveillance) registry. J Am Coll Cardiol 2011; 57: 1445-1454.
Lam MK, Sen H, Tandjung K, van Houwelingen KG, de Vries AG, Danse PW, Schotborgh CE, Scholte M, Lowik MM, Linssen GC, Ijzerman MJ, van der Palen J, Doggen CJ, von Birgelen C,. Comparison of 3 biodegradable polymer and durable polymer-based drug-eluting stents in all-comers (BIO-RESORT): Rationale and study design of the randomized TWENTE III multicenter trial. Am Heart J 2014; 167: 445-451.
Charlson ME, Pompei P, Ales KL, MacKenzie CR,. A new method of classifying prognostic comorbidity in longitudinal studies: Development and validation. J Chronic Dis 1987; 40: 373-383.
Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW,. Clinical end points in coronary stent trials: A case for standardized definitions. Circulation 2007; 115: 2344-2351.
Montalescot G, White HD, Gallo R, Cohen M, Steg PG, Aylward PE, Bode C, Chiariello M, King SB III, Harrington RA, Desmet WJ, Macaya C, Steinhubl SR,. Enoxaparin versus unfractionated heparin in elective percutaneous coronary intervention. N Engl J Med 2006; 355: 1006-1017.
Jain AK, Lotan C, Meredith IT, Feres F, Zambahari R, Sinha N, Rothman MT,. Twelve-month outcomes in patients with diabetes implanted with a zotarolimus-eluting stent: Results from the E-Five registry. Heart 2010; 96: 848-853.
Spertus JA, Kettelkamp R, Vance C, Decker C, Jones PG, Rumsfeld JS, Messenger JC, Khanal S, Peterson ED, Bach RG, Krumholz HM, Cohen DJ,. Prevalence, predictors, and outcomes of premature discontinuation of thienopyridine therapy after drug-eluting stent placement: Results from the Premier registry. Circulation 2006; 113: 2803-2809.
Caixeta A, Leon MB, Lansky AJ, Nikolsky E, Aoki J, Moses JW, Schofer J, Morice MC, Schampaert E, Kirtane AJ, Popma JJ, Parise H, Fahy M, Mehran R,. 5 year clinical outcomes after sirolimus-eluting stent implantation insights from a patient-level pooled analysis of 4 randomized trials comparing sirolimus-eluting stents with bare-metal stents. J Am Coll Cardiol 2009; 54: 894-902.
Daemen J, Wenaweser P, Tsuchida K, Abrecht L, Vaina S, Morger C, Kukreja N, Juni P, Sianos G, Hellige G, van Domburg RT, Hess OM, Boersma E, Meier B, Windecker S, Serruys PW,. Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: Data from a large two-institutional cohort study. Lancet 2007; 369: 667-678.
Spaulding C, Henry P, Teiger E, Beatt K, Bramucci E, Carrie D, Slama MS, Merkely B, Erglis A, Margheri M, Varenne O, Cebrian A, Stoll HP, Snead DB, Bode C,. Sirolimus-eluting versus uncoated stents in acute myocardial infarction. N Engl J Med 2006; 355: 1093-1104.
Kimura T, Morimoto T, Nakagawa Y, Tamura T, Kadota K, Yasumoto H, Nishikawa H, Hiasa Y, Muramatsu T, Meguro T, Inoue N, Honda H, Hayashi Y, Miyazaki S, Oshima S, Honda T, Shiode N, Namura M, Sone T, Nobuyoshi M, Kita T, Mitsudo K,. Antiplatelet therapy and stent thrombosis after sirolimus-eluting stent implantation. Circulation 2009; 119: 987-995.
Akin I, Bufe A, Eckardt L, Reinecke H, Richardt G, Kuck KH, Senges J, Schneider S, Nienaber CA,. Outcomes after differential use of drug-eluting stents in diabetic patients: 1-year results from the DES.DE (drug-eluting stent.deutschland) registry. Catheter Cardiovasc Interv 2010; 76: 50-57.
Akin I, Bufe A, Eckardt L, Reinecke H, Senges J, Richardt G, Kuck KH, Schneider S, Nienaber CA,. Comparison of outcomes in patients with insulin-dependent versus non-insulin dependent diabetes mellitus receiving drug-eluting stents (from the first phase of the prospective multicenter German DES.DE registry). Am J Cardiol 2010; 106: 1201-1207.
Iakovou I, Schmidt T, Bonizzoni E, Ge L, Sangiorgi GM, Stankovic G, Airoldi F, Chieffo A, Montorfano M, Carlino M, Michev I, Corvaja N, Briguori C, Gerckens U, Grube E, Colombo A,. Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA 2005; 293: 2126-2130.
Airoldi F, Colombo A, Morici N, Latib A, Cosgrave J, Buellesfeld L, Bonizzoni E, Carlino M, Gerckens U, Godino C, Melzi G, Michev I, Montorfano M, Sangiorgi GM, Qasim A, Chieffo A, Briguori C, Grube E,. Incidence and predictors of drug-eluting stent thrombosis during and after discontinuation of thienopyridine treatment. Circulation 2007; 116: 745-754.
Wolf WM, Vlachos HA, Marroquin OC, Lee JS, Smith C, Anderson WD, Schindler JT, Holper EM, Abbott JD, Williams DO, Laskey WK, Kip KE, Kelsey SF, Mulukutla SR,. Paclitaxel-eluting versus sirolimus-eluting stents in diabetes mellitus: A report from the national heart, lung, and blood institute dynamic registry. Circ Cardiovasc Interv 2010; 3: 42-49.
Seabra-Gomes R,. Percutaneous coronary interventions with drug eluting stents for diabetic patients. Heart 2006; 92: 410-419.
Nikolsky E, Mehran R, Dangas G, Fahy M, Na Y, Pocock SJ, Lincoff AM, Stone GW,. Development and validation of a prognostic risk score for major bleeding in patients undergoing percutaneous coronary intervention via the femoral approach. Eur Heart J 2007; 28: 1936-1945.
Ko DT, Yun L, Wijeysundera HC, Jackevicius CA, Rao SV, Austin PC, Marquis JF, Tu JV,. Incidence, predictors, and prognostic implications of hospitalization for late bleeding after percutaneous coronary intervention for patients older than 65 years. Circ Cardiovasc Interv 2010; 3: 140-147.
Eikelboom JW, Mehta SR, Anand SS, Xie C, Fox KA, Yusuf S,. Adverse impact of bleeding on prognosis in patients with acute coronary syndromes. Circulation 2006; 114: 774-782.
Mehran R, Lansky AJ, Witzenbichler B, Guagliumi G, Peruga JZ, Brodie BR, Dudek D, Kornowski R, Hartmann F, Gersh BJ, Pocock SJ, Wong SC, Nikolsky E, Gambone L, Vandertie L, Parise H, Dangas GD, Stone GW,. Bivalirudin in patients undergoing primary angioplasty for acute myocardial infarction (HORIZONS-AMI): 1-year results of a randomised controlled trial. Lancet 2009; 374: 1149-1159.
Rao SV, O'Grady K, Pieper KS, Granger CB, Newby LK, Mahaffey KW, Moliterno DJ, Lincoff AM, Armstrong PW, Van de Werf F, Califf RM, Harrington RA,. A comparison of the clinical impact of bleeding measured by two different classifications among patients with acute coronary syndromes. J Am Coll Cardiol 2006; 47: 809-816.
Subherwal S, Bach RG, Chen AY, Gage BF, Rao SV, Newby LK, Wang TY, Gibler WB, Ohman EM, Roe MT, Pollack CV Jr, Peterson ED, Alexander KP,. Baseline risk of major bleeding in non-ST-segment-elevation myocardial infarction: The CRUSADE (can rapid risk stratification of unstable angina patients suppress adverse outcomes with early implementation of the ACC/AHA guidelines) bleeding score. Circulation 2009; 119: 1873-1882.
Kinnaird TD, Stabile E, Mintz GS, Lee CW, Canos DA, Gevorkian N, Pinnow EE, Kent KM, Pichard AD, Satler LF, Weissman NJ, Lindsay J, Fuchs S,. Incidence, predictors, and prognostic implications of bleeding and blood transfusion following percutaneous coronary interventions. Am J Cardiol 2003; 92: 930-935.
Armstrong EJ, Rutledge JC, Rogers JH,. Coronary artery revascularization in patients with diabetes mellitus. Circulation 2013; 128: 1675-1685.
Park SH, Marso SP, Zhou Z, Foroudi F, Topol EJ, Lincoff AM,. Neointimal hyperplasia after arterial injury is increased in a rat model of non-insulin-dependent diabetes mellitus. Circulation 2001; 104: 815-819.
Luscher TF, Creager MA, Beckman JA, Cosentino F,. Diabetes and vascular disease: Pathophysiology, clinical consequences, and medical therapy: Part II. Circulation 2003; 108: 1655-1661.
Tanaka N, Terashima M, Rathore S, Itoh T, Habara M, Nasu K, Kimura M, Kinoshita Y, Ehara M, Tsuchikane E, Asakura K, Asakura Y, Katoh O, Suzuki T,. Different patterns of vascular response between patients with or without diabetes mellitus after drug-eluting stent implantation: Optical coherence tomographic analysis. JACC Cardiovasc Interv 2010; 3: 1074-1079.
Deb S, Wijeysundera HC, Ko DT, Tsubota H, Hill S, Fremes SE,. Coronary artery bypass graft surgery vs. percutaneous interventions in coronary revascularization: A systematic review. JAMA 2013; 310: 2086-2095.
Aronson D, Edelman ER,. Revascularization for coronary artery disease in diabetes mellitus: Angioplasty, stents and coronary artery bypass grafting. Rev Endocr Metab Disord 2010; 11: 75-86.
Daemen J, Kuck KH, Macaya C, LeGrand V, Vrolix M, Carrie D, Sheiban I, Suttorp MJ, Vranckx P, Rademaker T, Goedhart D, Schuijer M, Wittebols K, Macours N, Stoll HP, Serruys PW,. Multivessel coronary revascularization in patients with and without diabetes mellitus: 3-year follow-up of the ARTS-II (Arterial Revascularization Therapies Study-Part II) trial. J Am Coll Cardiol 2008; 52: 1957-1967.
Bangalore S, Kumar S, Fusaro M, Amoroso N, Kirtane AJ, Byrne RA, Williams DO, Slater J, Cutlip DE, Feit F,. Outcomes with various drug eluting or bare metal stents in patients with diabetes mellitus: Mixed treatment comparison analysis of 22,844 patient years of follow-up from randomised trials. BMJ 2012; 345: e5170.
Kapur A, Hall RJ, Malik IS, Qureshi AC, Butts J, de Belder M, Baumbach A, Angelini G, de Belder A, Oldroyd KG, Flather M, Roughton M, Nihoyannopoulos P, Bagger JP, Morgan K, Beatt KJ,. Randomized comparison of percutaneous coronary intervention with coronary artery bypass grafting in diabetic patients. 1-year results of the CARDIA (coronary artery revascularization in diabetes) trial. J Am Coll Cardiol 2010; 55: 432-440.
Kappetein AP, Head SJ, Morice MC, Banning AP, Serruys PW, Mohr FW, Dawkins KD, Mack MJ,. Treatment of complex coronary artery disease in patients with diabetes: 5-year results comparing outcomes of bypass surgery and percutaneous coronary intervention in the syntax trial. Eur J Cardiothorac Surg 2013; 43: 1006-1013.
Farkouh ME, Domanski M, Sleeper LA, Siami FS, Dangas G, Mack M, Yang M, Cohen DJ, Rosenberg Y, Solomon SD, Desai AS, Gersh BJ, Magnuson EA, Lansky A, Boineau R, Weinberger J, Ramanathan K, Sousa JE, Rankin J, Bhargava B, Buse J, Hueb W, Smith CR, Muratov V, Bansilal S, King S III, Bertrand M, Fuster V,. Strategies for multivessel revascularization in patients with diabetes. N Engl J Med 2012; 367: 2375-2384.
Farkouh ME, Dangas G, Leon MB, Smith C, Nesto R, Buse JB, Cohen DJ, Mahoney E, Sleeper L, King S III, Domanski M, McKinlay S, Fuster V,. Design of the future revascularization evaluation in patients with diabetes mellitus: Optimal management of multivessel disease (FREEDOM) trial. Am Heart J 2008; 155: 215-223.
Stefanini GG, Holmes DR Jr,. Drug-eluting coronary-artery stents. N Engl J Med 2013; 368: 254-265.
Maeng M, Jensen LO, Tilsted HH, Kaltoft A, Kelbaek H, Abildgaard U, Villadsen A, Aaroe J, Thayssen P, Krusell LR, Christiansen EH, Botker HE, Kristensen SD, Ravkilde J, Madsen M, Sorensen HT, Rasmussen K, Thuesen L, Lassen JF,. Outcome of sirolimus-eluting versus zotarolimus-eluting coronary stent implantation in patients with and without diabetes mellitus (a SORT OUT III substudy). Am J Cardiol 2011; 108: 1232-1237.
Silber S, Serruys PW, Leon MB, Meredith IT, Windecker S, Neumann FJ, Belardi J, Widimsky P, Massaro J, Novack V, Yeung AC, Saito S, Mauri L,. Clinical outcome of patients with and without diabetes mellitus after percutaneous coronary intervention with the resolute zotarolimus-eluting stent: 2-year results from the prospectively pooled analysis of the International Global Resolute Program. JACC Cardiovasc Interv 2013; 6: 357-368.