Abstract
Dual antiplatelet therapy after percutaneous coronary intervention (PCI) reduces ischemia but increases bleeding. To develop a clinical decision tool to identify patients expected to derive benefit vs harm from continuing thienopyridine beyond 1 year after PCI. Among 11,648 randomized DAPT Study patients from 11 countries (August 2009-May 2014), a prediction rule was derived stratifying patients into groups to distinguish ischemic and bleeding risk 12 to 30 months after PCI. Validation was internal via bootstrap resampling and external among 8136 patients from 36 countries randomized in the PROTECT trial (June 2007-July 2014). Twelve months of open-label thienopyridine plus aspirin, then randomized to 18 months of continued thienopyridine plus aspirin vs placebo plus aspirin. Ischemia (myocardial infarction or stent thrombosis) and bleeding (moderate or severe) 12 to 30 months after PCI. Among DAPT Study patients (derivation cohort; mean age, 61.3 years; women, 25.1%), ischemia occurred in 348 patients (3.0%) and bleeding in 215 (1.8%). Derivation cohort models predicting ischemia and bleeding had c statistics of 0.70 and 0.68, respectively. The prediction rule assigned 1 point each for myocardial infarction at presentation, prior myocardial infarction or PCI, diabetes, stent diameter less than 3 mm, smoking, and paclitaxel-eluting stent; 2 points each for history of congestive heart failure/low ejection fraction and vein graft intervention; -1 point for age 65 to younger than 75 years; and -2 points for age 75 years or older. Among the high score group (score ≥2, n = 5917), continued thienopyridine vs placebo was associated with reduced ischemic events (2.7% vs 5.7%; risk difference [RD], -3.0% [95% CI, -4.1% to -2.0%], P < .001) compared with the low score group (score <2, n = 5731; 1.7% vs 2.3%; RD, -0.7% [95% CI, -1.4% to 0.09%], P = .07; interaction P < .001). Conversely, continued thienopyridine was associated with smaller increases in bleeding among the high score group (1.8% vs 1.4%; RD, 0.4% [95% CI, -0.3% to 1.0%], P = .26) compared with the low score group (3.0% vs 1.4%; RD, 1.5% [95% CI, 0.8% to 2.3%], P < .001; interaction P = .02). Among PROTECT patients (validation cohort; mean age, 62 years; women, 23.7%), ischemia occurred in 79 patients (1.0%) and bleeding in 37 (0.5%), with a c statistic of 0.64 for ischemia and 0.64 for bleeding. In this cohort, the high-score patients (n = 2848) had increased ischemic events compared with the low-score patients and no significant difference in bleeding. Among patients not sustaining major bleeding or ischemic events 1 year after PCI, a prediction rule assessing late ischemic and bleeding risks to inform dual antiplatelet therapy duration showed modest accuracy in derivation and validation cohorts. This rule requires further prospective evaluation to assess potential effects on patient care, as well as validation in other cohorts. clinicaltrials.gov Identifier: NCT00977938.
Highlights
DESIGN, SETTING, AND PARTICIPANTS Among 11 648 randomized Dual Antiplatelet Therapy (DAPT) Study patients from countries (August 2009-May 2014), a prediction rule was derived stratifying patients into groups to distinguish ischemic and bleeding risk to 30 months after percutaneous coronary intervention (PCI)
The prediction rule assigned 1 point each for myocardial infarction at presentation, prior myocardial infarction or PCI, diabetes, stent diameter less than 3 mm, smoking, and paclitaxel-eluting stent; 2 points each for history of congestive heart failure/low ejection fraction and vein graft intervention; −1 point for age 65 to younger than 75 years; and −2 points for age 75 years or older
Study Population A total of 11 648 patients undergoing PCI with coronary stents were randomized in the DAPT Study and included in this analysis (Figure 1)
Summary
The Patient-Related Outcomes With Endeavor vs Cypher Stenting (PROTECT) protocol was approved by ethical boards in accordance with local regulations. All patients in both studies provided written informed consent. The DAPT Study, conducted from August 2009 to May 2014 in countries, enrolled patients after PCI with either drug-eluting stents (DES) or bare metal stents (BMS) and treated them with open-label thienopyridine plus aspirin for months; at 12 months, eligible patients who were free from major bleeding and ischemic events and adherent to therapy remained taking aspirin and were randomized to continued thienopyridine vs placebo for 18 months.[8] The full enrollment and randomization criteria are listed in the eAppendix in the Supplement. At 12 months, only those patients who were adherent with thienopyridine therapy and free from myocardial infarction, stroke, repeat coronary revascularization, stent thrombosis, and moderate or severe bleeding by the GUSTO (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries) criteria[9] during the first 12 months after enrollment were randomized
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