Coronary perforation (CP) is a life-threatening complication that can occur during percutaneous coronary intervention (PCI). Little is known, however, about the incidence and clinical outcome of CP. We sought to investigate the occurrence of CP and its determinants and risk profile in a large-scale, prospective registry. From 2005 to 2008, unselected patients (n = 42,068) from 175 centers in 33 countries who underwent a PCI procedure were prospectively enrolled in the PCI registry of the Euro Heart Survey program. For the present analysis, patients experiencing CP during PCI (n = 124, 0.3%) were compared with those who underwent PCI without CP. Patients with CP were older, more often women, had more severe coronary disease, and underwent more complex types of coronary intervention. Independent factors associated with CP were the use of rotablation, intravascular ultrasound-guided PCI, bypass PCI, a totally occluded vessel, a type C lesion, peripheral arterial disease, and body mass index <25. More than 10% of the patients developed cardiac tamponade. In a small minority (3.3%), emergency bypass surgery had to be performed. The inhospital death rate was markedly elevated in patients with CP (7.3% vs 1.5%, p <0.001). After adjustment for the EuroHeart score, CP remained a strong predictor of hospital mortality (odds ratio 5.21, 95% confidence interval 2.34 to 11.60). In conclusion, in this real world, all-comers registry, the incidence of CP was low, occurred more often in patients who underwent more complex coronary interventions, and was associated with a fivefold higher hospital mortality.
The incidence of coronary perforation (CP), which is a rare but potentially life-threatening complication that can occur during percutaneous coronary intervention (PCI), varies from 0.19% to 0.59%. Mortality associated with CP is as high as 7% to 17%. Several studies have identified clinical, angiographic, and interventional parameters as independent risk factors associated with CP ; however, the data reported in these studies derive from retrospective analyses of single interventional centers. In the present study, we evaluated the incidence, independent predictors, and short-term outcomes in patients experiencing CP during PCI who were enrolled in the large Euro Heart Survey (EHS) PCI Registry, which prospectively enrolled consecutive patients from 175 centers in 33 countries. The EHS program was developed under the auspices of the European Society of Cardiology.
Methods
The PCI Registry was designed as a prospective, multicenter, observational registry of current practice with unselected patients who underwent elective or emergency PCI. Consecutive patients with acute coronary syndrome (ACS) or stable coronary artery disease were recruited within the period from May 2005 to April 2008. The participating hospitals were located throughout Europe (175 centers in 33 countries) and included university hospitals, community hospitals, specialist cardiology centers, and private hospitals, all providing PCI. The mean annual PCI volume of the participating facilities was ∼1,000. Details of the registry have been previously reported. During specified periods, all patients treated with PCI were prospectively registered and followed during their clinical course to document patient characteristics, adjunctive medical treatment, procedural details, and inhospital outcomes.
On admission, all relevant patient characteristics were recorded, including age, gender, cardiovascular risk factors, concomitant diseases, previous myocardial infarction, previous stroke, previous cardiovascular interventions, and chronic medical treatment and data on symptoms and prehospital delay. Data on electrocardiographic findings, biochemical markers, procedural details, and adjunctive therapy were documented. At discharge, major cardiovascular and cerebrovascular adverse advents, puncture site complications, and recommended medical treatment were recorded. Every participating center was committed to include every consecutive patient who underwent PCI during selected time periods. All patients gave written informed consent to the processing of their anonymous data. Electronic case report forms were used for data entry and were transferred through the Web to a central database located in the European Heart House, where they were edited for missing data, inconsistencies, and outliers. Additional editing of the data and the statistical analysis for this publication were performed at the Institut fuer Herzinfarktforschung in Ludwigshafen, Germany. The study was approved by the ethics committees responsible for the participating centers as required by local rules. Chronic renal failure was diagnosed by any of the following: serum creatinine >2 mg/dl in the past, on dialysis, or history of renal transplantation.
Categorical data are presented as absolute numbers and percentages, and metric data are given as mean (SD) or median. The frequencies of categorical variables in 2 populations were compared by the Pearson chi-square test, and the distribution of metrical variables was compared by the Mann-Whitney-Wilcoxon test. Descriptive statistics were calculated from the available cases. The impact of different baseline, angiographic, and procedural variables on the incidence of CP was evaluated in a multiple logistic regression model in which adjusted odds ratios with 95% confidence intervals (CIs) were estimated. In addition to age (as a linear term) and gender, the following variables, that exhibited significant associations in univariate comparison, were included in a forward selection procedure applying a threshold of p <0.2 for entry: rotablation, intravascular ultrasound (IVUS)-guided PCI, bypass graft intervention, chronic total occlusion (Thrombolysis In Myocardial Infarction [TIMI] grade 0 to 1 in elective patients), acute occlusion (TIMI grade 0 to 1 in ACS), type C lesion, peripheral artery disease (PAD), 3-vessel disease, embolic protection device, number of treated segments, and body mass index (BMI) <25. Furthermore, we evaluated the effect of CP on hospital mortality in multiple logistic regression models. Odds ratios with 95% CI were calculated and Wald test performed for the unadjusted comparison and a couple of adjustments: (1) for age as a linear term, (2) for age, gender, ST-segment elevation myocardial infarction, non–ST-segment elevation myocardial infarction, and cardiogenic shock/resuscitation, (3) for the EuroHeart score, and (4) for the EuroHeart score plus TIMI grade 0/1 flow before PCI, type C lesion, and PAD. All p values are results of 2-tailed tests and were considered significant if <0.05. The statistical computations were performed with SAS (release 9.3) on a personal computer (SAS Institute, Inc., Cary, North Carolina).
Results
Of the 47,407 consecutive patients with ACS and stable CAD who were enrolled in the EHS PCI Registry, in 42,068, the data field “CP” was filled out in the case report form. Of these patients, those with CP were compared with those without CP. Patients who experienced CP were older, more often women, and had more frequently a history of PAD ( Table 1 ). Regarding indications for PCI and the initial clinical presentation, there was a trend toward a higher rate of ACS in those with CP ( Table 2 ).
