Detre K Holubkov R Kelsey S et al Reference

N Engl J Med 1988; 318: 265 Abstract

In August 1985, the Percutaneous Transluminal Coronary Angioplasty Registry of the National Heart, Lung, and Blood Institute reopened at its previous sites to document changes in angioplasty strategy and outcome over time. The new registry entered 1802 consecutive patients who had not had a myocardial infarction in the 10 days before angioplasty. Patient selection, technical outcome, and short-term major complications were compared with those of the 1977 to 1981 registry cohort. The new-registry patients were older and had a significantly higher proportion of multivessel disease (53% versus 25%, p < 0.001), poor left ventricular function (19% versus 8%, p < 0.001), previous myocardial infarction (37% versus 21%, p < 0.001), and previous coronary bypass surgery (13% versus 9%, p < 0.01). The new-registry cohort also had more complex coronary lesions, and angioplasty attempts in these patients involved more multivessel procedures. Despite these differences, the in-hospital outcome in the new cohort was better. Angiographic success rates according to lesion increased from 67% to 88% (p < 0.001), and overall success rates (measured as a reduction of at least 20% in all lesions attempted, without death, myocar-dial infarction, or coronary bypass surgery) increased from 61% to 78% (p < 0.001). In-hospital mortality for the new cohort was 1%, and the nonfatal myocardial infarction rate was 4.3%. Both rates are similar to those for the old registry.

Summary

The National Heart, Lung, and Blood Institute (NHLBI) Registry demonstrated that there were substantial improvements in operator experience and equipment design over the first decade of balloon angioplasty. More complex patients were treated, and procedural success rates increased from 61% to 78%. Despite more complex patients, overall complication rates were unchanged over the study period.

Citation Count 644

Key message

Investigators in the registry have performed angioplasty since before 1980 and thus rank as the most experienced. Certainly, with less experienced operators one would initially expect a less complex angioplasty strategy as well as lower success rates. However, some studies have suggested that improved technique have allowed recent beginners to learn faster.

Why it's important

In the early days of balloon angioplasty, improvements in outcomes were generally documented using single-centre registries and operator anecdotes about their personal experience. The NHBLI Percutaneous Transluminal Coronary Angioplasty (PTCA) Registry was the first to centralize the data collection mechanism, and provide independent and objective assessments of procedural outcome.

Strengths

The standardized data collection forms and definitions used to characterize baseline clinical characteristics and procedural outcomes became the cornerstone for the evaluation of new devices used to treat more complex patient subsets.

Weaknesses

With the rapid evolution of interventional technique and devices, the major limitation of the Registry was that the information was nearly outdated as soon as it is published, and many subtle changes in technique that affect outcome were not captured.

Relevance

In the 25 years following the introduction of balloon angioplasty by Gruentzig and his colleagues, first in Zurich and later in Atlanta [1], the technique of non-surgical coronary artery revascularization has evolved so dramatically that vestiges of "plain 'ole balloon angioplasty" or POBA are barely recognizable. In the early days, a dedicated group of investigators formed the NHLBI PTCA Registry to provide objective analysis of the outcomes associated with balloon angioplasty. A 61% procedural success rate seems unacceptable using contemporary standards, but in the 1977-1981 PTCA Registry, it was viewed as a remarkable success. The subsequent comparisons of the 1985-1986 PTCA Registry results with the early series demonstrated that progress had been made, and more complex patients could be safely treated. This cited Registry also served as the backbone for the objective assessment of outcomes after balloon angioplasty and provided detailed information about early and late (up to 9 years) outcomes after PCI. With the introduction of new devices, the PTCA Registry gave rise to the New Approaches to Coronary Intervention (NACI) Registry that evaluated outcomes with directional, rotation, and extraction atherectomy, excimer laser angioplasty, and stent placement using the Palmaz-Schatz and Gianturco-Roubin stents [4]. Current practice is now captured using a series of time-limited DYNAMIC Registries that document the rapidly changing trends in stent use [5]. These registries series have been invaluable for tracking changes in outcomes in patients with complex lesion subsets [6,15].

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