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46 Smith et al. 2005 ACC/AHA/SCAI Practice Guidelines ACC - www.acc.org AHA - www.americanheart.org SCAI - www.scai.org Figure 5. Percutaneous coronary intervention vs fibrinolysis for STEMI. The short-term (4 to 6 weeks; top left) and long-term (top right) outcomes for the various end points shown are plotted for STEMI patients randomized to PCI or fibrinolysis for reperfusion in 23 trials (n=7739). Based on the frequency of events for each end point in the 2 treatment groups, the number needed to treat (NNT) or number needed to harm (NNH) is shown for the short-term (bottom left) and long-term (bottom right) outcomes. Modified with permission from Elsevier (Keeley et al. The Lancet, 2003, 361, 13-20). Note: The magnitude of the treatment differences for death, nonfatal reinfarction, and stroke vary depending on whether PCI is compared with streptokinase or a fibrin-specific lytic. For example, when primary PCI is compared with alteplase (tPA) and the SHOCK trial is excluded, the mortality rate is 5.5% vs 6.7% (OR 0.81, 95% CI 0.64 to 1.03, P equals 0.081). Source: Melandri. Circulation 2003;108:e162. CVA indicates cerebrovascular accident; Hem. Stroke, hemorrhagic stroke; MI, myocardial infarction; PCI, percutaneous coronary intervention; PTCA, percutaneous transluminal coronary angioplasty; Rec. Isch, recurrent ischemia; ReMI, recurrent MI; and STEMI, ST-elevation myocardial infarction. Preliminary reports suggest that compared with conventional BMS, DES are not associated with increased risk when used for primary PCI in patients with STEMI. Postprocedure vessel patency, biomarker release, and the incidence of shortterm adverse events were similar in patients receiving SES or BMS. Thirty-day event rates of death, reinfarction, or revascularization were 7.5% versus 10.4%, respectively (P equals 0.4) (441). Furthermore, the impact of IIb/IIIa platelet receptor antagonists in the setting of primary PCI has undergone considerable evaluation. In a randomized trial of stents plus abciximab compared with fibrinolysis plus abciximab in patients with STEMI, myocardial salvage and salvage index measured by technetium-99m sestamibi scintigraphy was significantly greater in the stent group (430). In a similar study comparing primary PCI with stent plus abciximab to fibrinolysis with alteplase, infarct size was smaller and the cumulative incidence of death, reinfarction, or stroke at 6 months significantly lower in the primary PCI group (411). However, results of studies comparing primary PCI with stents with or without IIb/IIIa platelet receptor antagonists have been less consistent. In the CADILLAC trial, a composite of death, reinfarction, disabling stroke, and ischemiadriven target-vessel revascularization was similar in patients treated with stents with or without abciximab (64). Yet, in a similar randomized comparison of stent plus abciximab versus stent alone in patients with STEMI (ADMIRAL trial; Abciximab before Direct angioplasty and stenting in Myocardial Infarction Regarding Acute and Long-term follow-up), a composite of death, reinfarction, or urgent target-
ACC - www.acc.org AHA - www.americanheart.org SCAI - www.scai.org Smith et al. 2005 ACC/AHA/SCAI Practice Guidelines 47 Figure 6. PCI versus fibrinolysis with fibrin-specific agents: is timing (almost) everything? PCI indicates percutaneous coronary intervention. Modified with permission from Nallamothu and Bates. Am J Cardiol 2003;92:824-6 (421). vessel revascularization at 30 days occurred significantly less often in the abciximab group than in the control group (6.0% vs 14.6%, P equals 0.01), a difference that was sustained at 6 months of follow-up (442). The less favorable comparable clinical outcomes in patients treated with abciximab in the CADILLAC trial compared with those in the ADMIRAL trial have been attributed to the earlier administration of abciximab in the latter trial. The results of a pooled analysis of these 2 trials plus 3 similar trials (RAPPORT, ISAR-2, and ACE) (443-445) suggest that early (before coronary angiography) administration of abciximab will be associated with the most favorable clinical outcomes (446). PCI appears to have its greatest mortality benefit in highrisk patients. In patients with cardiogenic shock, an absolute 9% reduction in 30-day mortality with mechanical revascularization instead of immediate medical stabilization was reported in the SHOCK trial (366) (see Section 5.4.6, PCI for Cardiogenic Shock). In NRMI-II, patients with HF had a Figure 7. Relationship between 30-day mortality and time from study enrollment to first balloon inflation. Patients assigned to angioplasty in whom angioplasty was not performed are also shown. n indicates number of patients; and PTCA, percutaneous transluminal coronary angioplasty. Reprinted with permission from Berger et al. Circulation 1999;100:14-20 (418).
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