1

Introduction

Primary percutaneous coronary intervention (PCI) is the treatment of choice in ST-segment elevation myocardial infarction (STEMI) . A significant percentage of patients presenting with STEMI have underlying multivessel coronary artery disease; these patients have worse clinical outcomes as compared to those with single-vessel disease . Various treatment strategies for non-culprit vessels have generated considerable interest and controversy. These include medical therapy, multivessel revascularization at the time of primary PCI, and staged PCI. Current guidelines recommend against performing PCI for the non-culprit vessels at the time of primary PCI unless there is hemodynamic instability . Staging the PCI for non-culprit vessels was associated with better short- and long-term outcomes compared to performing a one-time multivessel primary PCI . It is uncertain if staged PCI soon after the primary PCI is safe. We aimed to compare the safety and feasibility of performing staged PCI in the same hospitalization after primary PCI to performing staged PCI at a separate, later hospitalization.

2

Methods

Clinical, procedural, and follow-up data were retrospectively analyzed from a contemporary PCI registry of patients presenting with STEMI and undergoing primary PCI at a single center. Diagnosis of STEMI was based on the occurrence of chest pain lasting ≥ 30 minutes accompanied by ST-segment elevation ≥ 1 mm in ≥ 2 contiguous leads on a 12-lead electrocardiogram. Consecutive patients who fulfilled the criteria of multivessel disease (the presence of ≥ 1 lesion of angiographic ≥ 70% stenosis in another non-culprit vessel supplying a different territory) on presentation with a further staged elective non-culprit vessel PCI within 8 weeks of the primary PCI at a separate procedure were included ( Fig. 1 ). Patients who had one-time multivessel primary PCI, those with non-culprit vessels managed medically and those with staged PCI performed ≥ 8 weeks from the index PCI were excluded. The study population was divided into two groups: Staged PCI performed in the same hospitalization and staged PCI performed at a separate hospitalization (within 8 weeks of the index PCI).

Flow diagram of patients included in the study.

PCI was performed according to guidelines current at the time of the procedure. All patients received aspirin 325 mg and clopidogrel 300–600 mg prior to the procedure. Anticoagulation regimens were chosen at the operator’s discretion and included unfractionated heparin to achieve targeted activated clotting times, with or without a glycoprotein IIb/IIIa receptor inhibitor, or bivalirudin 0.75 mg/kg followed by an infusion of 1.75 mg/kg/hr for the duration of the procedure. Device utilization, such as aspiration thrombectomy and stent choice, was also at the operator’s discretion. Following the procedure, aspirin was prescribed indefinitely and clopidogrel was prescribed for ≥ 1 month in patients who received bare metal stents, and for 6 months in patients receiving drug-eluting stents. The decision and timing for performing staged non-culprit vessel PCI were also left to the discretion of the operator and/or managing physician.

The institutional review boards of MedStar Washington Hospital Center and the MedStar Health Research Institute (Washington, DC, USA) approved this study. A dedicated data coordinating center performed all data management and analyses. Pre-specified clinical and laboratory data during hospitalization periods were obtained from hospital charts reviewed by independent research personnel blinded to the objectives of the study. Primary source documents for all events were obtained and adjudicated by physicians not involved in the procedures and who were unaware of the study objectives. Procedural and in-hospital complications were analyzed for the index hospitalization for primary PCI and the staged PCI hospitalization. The end points of the study were in-hospital major adverse cardiac events (MACE): A composite of all-cause mortality, Q-wave myocardial infarction, urgent in-hospital coronary artery bypass grafting, and urgent repeat PCI after the staged PCI procedure. Other procedural and in-hospital complications, such as acute renal failure, major bleeding, vascular complications, and in-hospital stroke were also evaluated.

Angiographic success was defined as residual stenosis of < 30% with Thrombolysis in Myocardial Infarction grade III flow. Q-wave myocardial infarction was defined as an elevation of creatine kinase-MB ≥ 3 times the upper normal value with new pathologic Q waves in ≥ 2 contiguous leads of the electrocardiogram. Major bleeding was defined as a decrease in hematocrit ≥ 15% and/or the occurrence of gastrointestinal bleeding. Vascular complications were defined as the presence of a large (> 5 cm) hematoma, fistula or pseudoaneurysm formation, retroperitoneal bleeding, and/or the need for surgical repair. In-hospital renal insufficiency was defined as an increase in baseline creatinine level of ≥ 50% within the hospitalization. Procedure-related acute renal failure was defined as a rise in creatinine post procedure that required medication. Acute renal failure requiring dialysis was defined as the need for hemodialysis or peritoneal dialysis post procedure.

Statistical analysis was performed using SAS version 9.1 (SAS Institute Inc., Cary, NC, USA). Normally distributed continuous variables were presented as mean ± SD. Variables that were not normally distributed were shown as median ± interquartile range. Categorical variables were expressed as frequencies and percentages. Baseline characteristics were compared using Student’s t test for parametric variables, or the Mann-Whitney U test when not normally distributed. Categorical variables were compared using chi-square test or Fisher’s exact test as appropriate. In-hospital outcomes were compared with the Log-rank test and were presented by Kaplan-Meier percentages.

2

Methods

Clinical, procedural, and follow-up data were retrospectively analyzed from a contemporary PCI registry of patients presenting with STEMI and undergoing primary PCI at a single center. Diagnosis of STEMI was based on the occurrence of chest pain lasting ≥ 30 minutes accompanied by ST-segment elevation ≥ 1 mm in ≥ 2 contiguous leads on a 12-lead electrocardiogram. Consecutive patients who fulfilled the criteria of multivessel disease (the presence of ≥ 1 lesion of angiographic ≥ 70% stenosis in another non-culprit vessel supplying a different territory) on presentation with a further staged elective non-culprit vessel PCI within 8 weeks of the primary PCI at a separate procedure were included ( Fig. 1 ). Patients who had one-time multivessel primary PCI, those with non-culprit vessels managed medically and those with staged PCI performed ≥ 8 weeks from the index PCI were excluded. The study population was divided into two groups: Staged PCI performed in the same hospitalization and staged PCI performed at a separate hospitalization (within 8 weeks of the index PCI).

Flow diagram of patients included in the study.

PCI was performed according to guidelines current at the time of the procedure. All patients received aspirin 325 mg and clopidogrel 300–600 mg prior to the procedure. Anticoagulation regimens were chosen at the operator’s discretion and included unfractionated heparin to achieve targeted activated clotting times, with or without a glycoprotein IIb/IIIa receptor inhibitor, or bivalirudin 0.75 mg/kg followed by an infusion of 1.75 mg/kg/hr for the duration of the procedure. Device utilization, such as aspiration thrombectomy and stent choice, was also at the operator’s discretion. Following the procedure, aspirin was prescribed indefinitely and clopidogrel was prescribed for ≥ 1 month in patients who received bare metal stents, and for 6 months in patients receiving drug-eluting stents. The decision and timing for performing staged non-culprit vessel PCI were also left to the discretion of the operator and/or managing physician.

The institutional review boards of MedStar Washington Hospital Center and the MedStar Health Research Institute (Washington, DC, USA) approved this study. A dedicated data coordinating center performed all data management and analyses. Pre-specified clinical and laboratory data during hospitalization periods were obtained from hospital charts reviewed by independent research personnel blinded to the objectives of the study. Primary source documents for all events were obtained and adjudicated by physicians not involved in the procedures and who were unaware of the study objectives. Procedural and in-hospital complications were analyzed for the index hospitalization for primary PCI and the staged PCI hospitalization. The end points of the study were in-hospital major adverse cardiac events (MACE): A composite of all-cause mortality, Q-wave myocardial infarction, urgent in-hospital coronary artery bypass grafting, and urgent repeat PCI after the staged PCI procedure. Other procedural and in-hospital complications, such as acute renal failure, major bleeding, vascular complications, and in-hospital stroke were also evaluated.

Angiographic success was defined as residual stenosis of < 30% with Thrombolysis in Myocardial Infarction grade III flow. Q-wave myocardial infarction was defined as an elevation of creatine kinase-MB ≥ 3 times the upper normal value with new pathologic Q waves in ≥ 2 contiguous leads of the electrocardiogram. Major bleeding was defined as a decrease in hematocrit ≥ 15% and/or the occurrence of gastrointestinal bleeding. Vascular complications were defined as the presence of a large (> 5 cm) hematoma, fistula or pseudoaneurysm formation, retroperitoneal bleeding, and/or the need for surgical repair. In-hospital renal insufficiency was defined as an increase in baseline creatinine level of ≥ 50% within the hospitalization. Procedure-related acute renal failure was defined as a rise in creatinine post procedure that required medication. Acute renal failure requiring dialysis was defined as the need for hemodialysis or peritoneal dialysis post procedure.

Statistical analysis was performed using SAS version 9.1 (SAS Institute Inc., Cary, NC, USA). Normally distributed continuous variables were presented as mean ± SD. Variables that were not normally distributed were shown as median ± interquartile range. Categorical variables were expressed as frequencies and percentages. Baseline characteristics were compared using Student’s t test for parametric variables, or the Mann-Whitney U test when not normally distributed. Categorical variables were compared using chi-square test or Fisher’s exact test as appropriate. In-hospital outcomes were compared with the Log-rank test and were presented by Kaplan-Meier percentages.

3

Results

From 2007 to 2011, we identified 282 consecutive STEMI patients with multivessel disease who underwent primary PCI to the culprit vessel, and subsequently a separate staged PCI to the non-culprit vessel(s) at our institution. Of these patients, 184 underwent staged PCI in the same hospitalization as the primary PCI, and 98 underwent staged PCI at a separate hospitalization within 8 weeks of the primary PCI. The average time between the index primary and staged PCI was 3.1 ± 1.8 days in the same hospitalization, and 29.5 ± 14.4 days in the separate hospitalization.

Table 1 shows the baseline characteristics. Cardiovascular risk factors and significant medical history were similar between the 2 study groups. The average left ventricular ejection fraction was 43 ± 12%. On clinical presentation of STEMI, Killip class III/IV heart failure was present in 10 patients (5.5%) from the same hospitalization group and in 2 (2.2%) from the separate hospitalization group. Cardiogenic shock was present in 19 patients (10.4%) in the same hospitalization group and in 12 patients (12.2%) from the separate hospitalization group.

Stay updated, free articles. Join our Telegram channel

Join