Primary Angioplasty Observational Series and Registries

Many series reported the results of primary angioplasty in various settings of clinical practice. Most are small in size (<100 patients) and include patients selected for this procedure because of contraindications to lytics or institutional preference (29-32). In these series, comparison with outcome of patients treated with fibrinolytic agents is not possible because of critical selection biases.

O'Keefe et al. reported from the Mid-America Heart Institute, which pioneered the procedure in the United States, on the outcome of 1000 consecutive patients treated with primary angioplasty (33). The mean time from symptom onset to reperfusion was 5.4 ±. 4.0 h, and 7.9% of the patients were in cardiogenic shock. Infarct artery patency (not specifically categorized as TIMI 2 or 3 flow) was 94% overall, with lower rates observed for venous bypass grafts (86%). The in-hospital mortality was 7.8% overall, and 44% in those presenting with cardiogenic shock. The global ejection fraction increased from 50% before angioplasty to 57% before discharge. Major bleeding and strokes occurred in 2.8 and 0.5%, respectively. Reocclusion was documented in 13% by angiography in selected patients before hospital discharge.

Rothbaum et al. (29) reported on 151 patients who underwent primary angioplasty with a success rate of 87%. In-hospital mortality was 5 and 37% for successful and failed PTCA, respectively. Most of the deaths occurred in patients with cardiogenic shock. Angiographic follow-up, performed in 70% of eligible patients at 6 mo, demonstrated restenosis in 31%. The mortality at an average follow-up of 1.7 yr was 2.2%.

The Primary Angioplasty Registry (PAR) included 271 patients treated within 12 h of symptom onset at six centers with considerable expertise in primary angioplasty (34). Patients with contraindications to lytic therapy, or with cardiogenic shock were excluded from the registry. The procedural success rate (TIMI 3 flow with <50% residual stenosis), assessed by an independent angiographic laboratory, was 92%. The rates of death (4%), reinfarction (3%), and stroke (1%) were very favorable. Only 2% of those discharged from the hospital died during the 6-mo follow-up, and an additional 3% experienced a nonfatal MI (35). Repeat angioplasty was performed in 16% and bypass surgery was necessary in 4%. Systematic protocol-driven repeat angiography was performed in 76% of the patients eligible for it. Almost half the patients (45%) demonstrated angiographic restenosis, including 13% with total occlusion.

The Myocardial Infarction Triage and Intervention (MITI) program in the Seattle area collated a large cohort of consecutive patients with acute MI treated with primary angioplasty (1050) or fibrinolytic therapy (2095) at 19 hospitals, between 1988 and 1994 (36). Despite nonrandomized treatment allocation, the two groups were well matched with respect to age, gender, incidence of anterior infarction, and presence of high-risk characteristics (21) (Table 1). As expected, the time to treatment in the PTCA group exceeded that in the lytic group by almost one full hour. The in-hospital mortality was similar in the two groups, 5.5 and 5.6%, respectively. Before hospital discharge, 74 and 32% of lytic-treated patients underwent angiography and angioplasty, respectively. The initial hospitalization was significantly longer and less costly in the lysis group. The mortality at 1 and 3 yr was similar in the two groups (Fig. 6), while the use of repeat angiography and angioplasty remained higher in the angioplasty group at both intervals. The initial choice between lysis and angioplasty was not independently associated with

Table 1 The MITI Registry

Characteristic

Lytic therapy n = 2095

Primary angioplasty n = 1050

Age (yr)

60 ± 12

60 ± 12

Female gender (%)

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