Further information: Percutaneous Coronary Intervention for Acute Myocardial Infarction (see p1021) and Drug-Eluting Coronary Stents (see p1031) from Cardiovascular Medicine, 3rd Edn*

The Swedish Coronary Angiography and Angioplasty Registry (SCAAR) is a group of 47,967 patients in Sweden who received a coronary stent between 2003 and 2006, and of those patients, 10,294 received one drug-eluting stent and 18,659 received one bare-metal stent. An earlier paper [1] had reported results from the trial indicating that patients who had received a drug-eluting stent had increased late mortality over those who had received a bare-metal stent, perhaps due to discontinuation of clopidogrel therapy. However, in the more recent report [2], investigators used the same cohort of patients, but extended the study to include all patients in Sweden who received a stent during the 2003–2006 period for whom there was more than 1 year of follow-up available.

The analysis was based on 2380 deaths and 3198 myocardial infarctions (MI), and no overall differences were found between the drug-eluting stent group and the bare-metal stent group in the combined end point of death or MI (relative risk [RR] with drug-eluting stents, 0.96; 95% confidence interval [CI], 0.89–1.03) or the individual end points of death (RR, 0.94;95% CI, 0.85–1.05) and MI (RR, 0.97; 95% CI, 0.88–1.06), and there was no significant difference in outcome among subgroups stratified according to the indication for stent implantation. Patients receiving drug-eluting stents in 2003 had a significantly higher rate of late events than patients who received bare-metal stents in the same year, but there was no observable difference in outcome among patients treated in later years. In regard to restenosis, the average rate during the first year was 3.0 events with drug-eluting stents vs. 4.7 with bare-metal stents (adjusted RR, 0.43; 95% CI, 0.36–0.52); 39 patients would need to be treated with drug-eluting stents to prevent one case of restenosis. For high-risk patients, adjusted risk of restenosis was 74% lower with drug-eluting stents than with bare-metal stents, and only 10 lesions would need to be treated to prevent one case of restenosis.

The results as reported in the present study found no difference in long-term survival or in risk of MI between patients receiving drug-eluting stents and those receiving bare-metal stents, yet a decrease was found in the rate of restenosis in high-risk patients. Therefore, the use of drug-eluting stents is safe, as well as effective in reducing restenosis.

[1] Lagerqvist B, James SK, Stenestrand U et al, Long-term outcomes with drug-eluting stents versus bare-metal stents in Sweden. N Engl J Med 2007;356:1009-19
 
[2] James SK, Stenestrand U, Lindbäck J et al. Long-term safety and efficacy of drug-eluting stents versus bare-metal stents in Sweden. N Engl J Med 2009;360:1933-1945

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* To view the online text from the book, please navigate to SpringerLink or use the DVD to access electronic content. SpringerLink is a subscription service. For further information, click here.

Further information: Percutaneous Coronary Intervention for Acute Myocardial Infarction (see p1021) and Drug-Eluting Coronary Stents (see p1031) from Cardiovascular Medicine, 3rd Edn*

The Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial [1] was a prospective, open-label, multicenter, controlled trial involving patients with ST-segment elevation myocardial infarction (STEMI) at 123 centers in 11 countries who were undergoing primary percutaneous coronary intervention (PCI) as a management strategy.

Of 3006 patients who presented with STEMI, 2257 of them were randomized to receive paclitaxel-eluting stents and 749 were randomized to receive bare-metal stents. The primary end-points were the 12-month rates of target-lesion revascularization for ischemia and a composite safety outcome measure of death, reinfarction, stroke, or stent thrombosis. Major secondary end-point was angiographic evidence of restenosis at 13 months.

The patients receiving paclitaxel-eluting stents had significantly lower 12-month rates of ischemia-driven target-lesion revascularization compared with patients who received bare-metal stents (4.5% vs. 7.5%; hazard ratio [HR], 0.59; 95% confidence interval [CI], 0.43–0.83; P=0.002) and target-vessel revascularization (5.8% vs. 8.7%; HR, 0.65; 95% CI, 0.48–0.89; P=0.006), with noninferior rates of the composite safety end-point (8.1% vs. 8.0%; HR, 1.02; 95% CI, 0.76–1.36; absolute difference, 0.1 percentage point; 95% CI, -2.1–2.4; P=0.01 for noninferiority; P=0.92 for superiority). Both groups of patients, those treated with paclitaxel-eluting stents and those treated with bare-metal stents, had similar 12-month rates of death (3.5% and 3.5%, respectively; P=0.98) and stent thrombosis (3.2% and 3.4%, respectively; P=0.77). However, the 13-month rate of binary restenosis was significantly lower with paclitaxel-eluting stents than with bare-metal stents (10.0% vs. 22.9%; HR, 0.44; 95% CI, 0.33–0.57; P<0.001).

The trial results show a significantly reduced rate of angiographically-assessed restenosis and a significantly decreased rate of recurrent ischemia resulting in repeat revascularization with PCI or coronary artery bypass grafting when paclitaxel-eluting stents were used for patients with evolving STEMI. In addition, no safety concerns were apparent at 1 year.

[1] Stone GW, Lansky AJ, Pocock SJ, et al. Paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction. N Engl J Med 2009;360:1946-1959

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*–view the online text from the book, please navigate–SpringerLink or use the DVD–access electronic content. SpringerLink is a subscription service. For further information, click here.

Further information: Medical Treatment of Unstable Angina, Acute Non-ST-Elevation Myocardial Infarction, and Coronary Artery Spasm (see p937) and Percutaneous Coronary Intervention for Acute Myocardial Infarction (see p1021) from Cardiovascular Medicine, 3rd Edn*

The Timing of Intervention in Acute Coronary Syndromes (TIMACS) trial was a randomized, parallel-group, multicenter trial with blinded adjudication of outcomes [1]. Of the total of 3031 patients with acute coronary syndromes (ACS) without ST-segment elevation, 1593 were randomized to the early intervention group (coronary angiography of 24 hours or less after randomization) and 1438 to the delayed intervention group (coronary angiography 36 hours or more after randomization). The primary outcome was the first occurrence of either death, new myocardial infarction (MI) or stroke at 6 months. Two secondary outcomes were first occurrence of the composite of death, MI, or refractory ischemia and the composite of death, MI, stroke, refractory ischemia, or repeat intervention at 6 months. Baseline characteristics were well-matched for both groups, and the use of evidence-based therapies was similar.

In the early-intervention group, 97.6% of patients had coronary angiography (median time after randomization was 14 hours) and 95.7% had coronary angiography in the delayed-intervention group (median time after randomization was 50 hours). The primary outcome occurred at 6 months in 9.6% of patients in the early-intervention group compared with 11.3% of patients in the delayed-intervention group (hazard ratio [HR] in early-intervention group, 0.85; 95% confidence interval [CI], 0.68–1.06; P=0.15). Relative reduction (RR) was 28% in secondary outcome of death, MI, or refractory ischemia in the early-intervention group (9.5%) compared–the delayed-intervention group (12.9%) (HR, 0.72; 95% CI, 0.58–0.89; P=0.003). Prespecified analyses showed that early intervention improved the primary outcome in the patients (one-third) who were at the highest risk (HR, 0.65; 95% CI, 0.48–0.89), but not in two-thirds at low–intermediate risk (HR, 1.12; 95% CI, 0.81–1.56; P=0.01 for heterogeneity).

The results showed that in patients with ACS without ST-segment elevation, early-intervention did not differ from delayed-intervention in preventing a composite outcome of death, MI, or stroke, but early-intervention significantly reduced risk of refractory ischemia and appeared superior–delayed strategy in high-risk patients.

[1] Mehta SR, Granger CB, Boden WE, et al. Early versus delayed invasive intervention in acute coronary syndromes. N Engl J Med 2009;360:2165-2175

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* To view the online text from the book, please navigate to SpringerLink or use the DVD to access electronic content. SpringerLink is a subscription service. For further information, click here.

Further information: Medical Treatment of Unstable Angina, Acute Non-ST-Elevation Myocardial Infarction, and Coronary Artery Spasm (see p937) from Cardiovascular Medicine, 3rd Edn*

The Early Glycoprotein IIb/IIIa (Gp IIb/IIIa) Inhibition in Non-ST-Segment Elevation Acute Coronary Syndrome (EARLY ACS) trial was conducted to evaluate optimum timing in the use of Gp IIb/IIIa inhibitors for patients with non-ST-segment elevation acute coronary syndromes [1]. A strategy of early, routine administration of the Gp IIb/IIIa inhibitor, eptifibatide, was compared with delayed, provisional administration of the drug in reducing ischemic complications in 9420 high-risk patients who had been assigned to an invasive procedure. Patients were randomly assigned to either early eptifibatide in two boluses (each containing 180 µg/kg body weight) or matching placebo boluses administered 10 minutes apart with provisional use of eptifibatide after angiography (delayed eptifibatide). Primary efficacy end-point was a composite of death from any cause, myocardial infarction (MI), recurrent ischemia requiring urgent revascularization, or the occurrence of a thrombotic complication during percutaneous coronary intervention (PCI) that required bolus therapy opposite to the initial study-group assignment (“thrombotic bailout”) at 96 hours. The secondary end-point was a composite of death from any cause or MI within the first 30 days, while safety end-points included rates of hemorrhage, and the need for transfusion within the first 120 hours after randomization.

The primary end-point occurred in 9.3% of patients in the early-eptifibatide group and in 10.0% in the delayed-eptifibatide group (odds ratio [OR], 0.92; 95% confidence interval [CI], 0.80–1.06; P=0.23). After 30 days, the rate of death or MI was 11.2% in the early-eptifibatide group, but 12.3% in the delayed-eptifibatide group (OR, 0.89; 95% CI, 0.79–1.01; P=0.08). Patients in the early-eptifibatide group had significantly higher rates of bleeding and red-cell transfusion, but there was no significant difference in the two groups for rates of severe bleeding or nonhemorrhagic serious adverse events. In high-risk patients with non-ST-segment elevation ACS, early use of eptifibatide before PCI as compared with early placebo followed by provisional eptifibatide did not reduce the rate of the composite primary efficacy end-point at 96 hours. The authors concluded that it was not superior to the provisional use of eptifibatide after angiography.

[1] Giugliano R P, White J A, Bode C, et al. Early versus delayed, provisional eptifibatide in acute coronary syndromes. N Engl J Med 2009;360:2176-2190

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* To view the online text from the book, please navigate to SpringerLink or use the DVD to access electronic content. SpringerLink is a subscription service. For further information, click here.