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A Nested, Prospective, Case-Control Study

Gualtiero Palareti, MD; Jack Hirsh, MD; Cristina Legnani, PhD; Cesare Manotti, MD; Armando D'Angelo, MD; Vittorio Pengo, MD; Marco Moia, MD; Giuliana Guazzaloca, MD; Serena Musolesi, PhD; Sergio Coccheri, MD

Arch Intern Med. 2000;160:470-478.

Background  Whether elderly patients are at increased risk of complications during oral anticoagulant treatment (OAT) is still a matter of debate.

Method  Bleeding and thrombotic events occurring during OAT in 461 patients, aged 75 years or older when they started OAT, and in 461 patients younger than 70 years, matched for sex, OAT indication, and treating center, were examined in a prospective, multicenter, inception-cohort study.

Results  Bleeding rate was 9.9% and 6.6% patient-years in elderly and young patients, respectively (P = .07), and 2.1% and 1.1% for major bleeding (P = .19); 6 and 1 events, respectively, were fatal (all intracranial, relative risk, 6.4; P = .05). In the elderly, bleeding rate was lower (4.5%) for international normalized ratios (INRs) between 2.0 and 2.9; it was higher during the first 90 treatment days (P = .05) and when arterial vascular disease was the indication for OAT (P = .03). Thrombosis rate was 4.2% and 2.5% patient-years in elderly and young patients, respectively (P = .10); however, 13 and 5 events were fatal (relative risk, 2.8; P = .04). Thrombosis rate was lower (1.5%) for INRs between 2.0 and 2.9; it was higher during the first 90 treatment days (P<.001) and 6 of 7 venous events occurred at lower than 2.0 INRs.

Conclusions  A nonsignificant trend was noted toward a higher rate of both bleeding and thrombotic complications in elderly vs matched younger patients. Intracranial bleeding and fatal thrombotic events were significantly more frequent in the elderly. Our results also indicate that lower than 2.0 INRs do not preclude bleeding in the elderly nor offer adequate protection from thrombotic events. Moderate anticoagulation (2.0-3.0 INRs) in elderly patients seems the safest and most effective.

From the Departments of Angiology and Blood Coagulation, University Hospital S Orsola-Malpighi, Bologna, Italy (Coordinating Center) (Drs Palareti, Guazzaloca, Legnani, and Coccheri); Research Centre, Hamilton Civic Hospitals, McMaster University, Hamilton, Ontario (Dr Hirsh); Centro Emostasi, Ospedale Regionale, Parma (Dr Manotti), Ambulatorio Emostasi Trombosi, IRCCS Ospedale S Raffaele, Milano (Dr D'Angelo), Servizio Prevenzione Trombosi, Cattedra di Cardiologia, Università di Padova, Padova (Dr Pengo), Centro Emofilia e Trombosi A. Bianchi Bonomi, IRCCS Ospedale Maggiore, Università di Milano, Milano (Dr Moia); and Istituto di Statistica, Università di Bologna, Bologna (Dr Musolesi), Italy.

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