Summary
It has been shown that statins preloading, before percutaneous coronary intervention (PCI), may reduce the risk of cardiovascular outcomes for acute coronary syndrome patients. Nevertheless, the effect of such pretreatment among patients with stable angina pectoris (SAP) is still debatable. We performed a systematic review and updated meta-analysis of the literature to evaluate the efficacy of short-term statins preloading on periprocedural myocardial infarction (PMI) incidence and mortality after PCI. We included 13 randomized control trials that examined statins preloading in adult patients with SAP undergoing PCI. While the use of preloading statins significantly reduced PMI, the benefit of statins pretreatment on long-term mortality was not statistically significant.
Short summary
High dose statins preloading prior to elective PCI was associated with a significant reduction in PMI in SAP patients. The mortality benefit of such intervention will need to be addressed by further large randomized studies. The routine use of statins in stable patients before PCI should be considered if no contraindications are present.
Highlights
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Statins treatment prior to PCI reduces incidence of periprocedural MI.
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No significant long-term mortality of statins treatment before PCI
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Routine statins use in stable patients before PCI should be considered if no contraindications present.
1
Introduction
Periprocedural myocardial infarction (PMI) is an important and frequent complication for patients undergoing percutaneous coronary intervention (PCI). PMI can lead to higher mortality during the perioperative period [ , ]. It is usually assessed by evaluating electrocardiogram (EKG) changes, angiographic complications, and elevation of cardiac biomarkers.
Different approaches were proposed to reduce the risk of PMI after PCI. Remote ischemic preconditioning showed a potential benefit in reducing the incidence of myocardial infarction (MI) in patients undergoing elective PCI [ ]. Similarly, previous trials have shown that statins preloading before PCI might reduce the risk of cardiovascular outcomes for acute coronary syndrome (ACS) patients [ ]. Recently, this was not confirmed in the SECURE-PCI trial that reported periprocedural-loading doses of atorvastatin did not reduce the rate of major adverse cardiac events in patients with ACS and planned invasive management with PCI at 30 days [ ].
The effect of pretreatment with statins among patients with stable angina pectoris (SAP) is still debatable. Therefore in this study, we performed a systematic review and meta-analysis of the literature to evaluate the efficacy of statins pretreatment on PMI incidence and mortality after PCI.
2
Methods
This meta-analysis was performed in accordance to preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines and criteria [ ].We searched the PubMed/Medline, Embase, and Google Scholar databases in addition to conference abstracts for randomized control trials (RCTs) that examined statins preloading in adult patients with SAP undergoing PCI from January 1, 1994, to February 1, 2018. Two authors independently evaluated the quality of the studies and extracted data. After examining 392 relevant studies, we included 13 RCTs that compared high-dose statins pretreatment with no statins or low-dose statins pretreatment in patients with SAP. Studies were evaluated for the incidence of PMI and mortality.
2.1
Inclusion and exclusion criteria
The focus of our analysis was the incidence of PMI, which was determined by the elevation of cardiac biomarkers and myocardial enzymes. Studies were eligible for inclusion if the following criteria were met: (1) study type was RCT, (2) patients with SAP, (3) cardiac biomarkers (troponin/creatine kinase MB) values were assessed pre-PCI and post-PCI, (4) the trial estimated the effect of statins pretreatment in patients undergoing PCI, and (5) the study reported the incidence of PMI. Exclusion criteria were (1) patients with cardiac biomarker elevation immediately before PCI and (2) patients with ACS. Table 1 summarizes the main characteristics of the 13 RCTs included in this study. Clinical and procedural features in the overall population are summarized in Tables 2 and 3 .
| Study | Year | N | Design | Follow-up (months) | Type of statins and loading dose | End-points | PMI definition |
|---|---|---|---|---|---|---|---|
| CLEAR-PCI (11) | 2015 | 487 | RCT | In hospital | Rosuvastatin 40 mg (2–6 h before PCI) | PMI, MACE and death | CK-MB > 3 ULN |
| ROMA II (15) | 2013 | 450 | RCT | 12 | Atorvastatin 80 mg or Rosuvastatin 40 mg (both 24 h before) | PMI and MACE | CK-MB > 3 ULN |
| Zemánek 2013 (18) | 2013 | 202 | RCT | In hospital | Atorvastatin 80 mg/d (×7 days) | PMI | TnI or CK-MB > 3 ULN |
| Veselka 2011 (17) | 2011 | 200 | RCT | 45 | Atorvastatin 80 mg/d (×2 days) | PMI, Q-wave MI and all-cause death | TnI > 3 ULN |
| ARMYDA (13) | 2004 | 153 | RCT | 1 | Atorvastatin 40 mg/d (×7 days) | PMI and MACE (death, MI, or need for unplanned revascularization) | CK-MB to >2 ULN |
| ROMA (14) | 2013 | 160 | RCT | 12 | Rosuvastatin 40 mg (24 h before) | PMI and MACE | CK-MB > 3 ULN |
| Takano 2013 (16) | 2013 | 210 | RCT | 12 | Rosuvastatin 2.5 mg/d or Rosuvastatin 20 mg/d (both 5–7 days before) | PMI and MACE (cardiac death, MI, and need for unplanned revascularization) | CK-MB > 3 ULN |
| Bozbas 2007 (7) | 2007 | 93 | RCT | In hospital | Pravastatin 10 mg/d or Pravastatin 40 mg/d (both ×7 days) | PMI | CK-MB > 3 ULN |
| Cay 2010 (8) | 2010 | 299 | RCT | In hospital | Rosuvastatin 40 mg (24 h before) | PMI | TnI or CK-MB > 3 ULN |
| Fuji 2011 (9) | 2011 | 80 | RCT | In hospital | Pravastatin 20 mg/d (×30 days) | PMI | TnI > 5 ULN |
| Kinishota 2007 (10) | 2007 | 42 | RCT | 6 | Atorvastatin 5–20 mg/d (>2 wks before, treated to goal LDL of <70 or <100) | PMI and MACE | CK-MB > 3 ULN |
| Nafasi 2014 (12) | 2014 | 190 | RCT | In hospital | Atorvastatin 80 mg (24 h before) | PMI | cTn > 5 URL |
| Veselka 2014 (19) | 2014 | 445 | RCT | In hospital | Rosuvastatin 20 mg (1 dose 12 h before, then 1 dose immediately before PCI) | PMI | TnI > 5 ULN |
| Study | Age (year) | Male % | HTN % | DM % | HLD % | LVEF % | Creatinine (mg/dL) | Current smoker % |
|---|---|---|---|---|---|---|---|---|
| CLEAR-PCI (11) | 61.6 ± 10.3 | 67.9 | 91 | 43 | 88.91 | – | 0.91 | 3.5 |
| ROMA II (15) | 67.6 ± 9.5 | 81.3 | 84.8 | 22.6 | 71.9 | 53.8 | – | 44.7 |
| Zemánek 2013 (18) | 65.6 ± 9.1 | 66.3 | 84.5 | 22.5 | – | – | 1 | 20.5 |
| Veselka 2011 (17) | 65.9 ± 10.5 | 72 | 71 | 2.5 | – | – | – | 19.5 |
| ARMYDA (13) | 64.5 ± 10 | 84.5 | 74 | 23 | 41.5 | 54 | 1.1 | 23.5 |
| ROMA (14) | 67.9 ± 9.6 | 78.1 | 82.5 | 19.3 | 40.6 | 53.3 | – | – |
| Takano 2013 (16) | 68.5 ± 9.5 | 72.6 | 74.3 | 50.9 | – | 58.4 | – | 27.1 |
| Bozbas 2007 (7) | 58.9 ± 10.8 | 77.4 | 54.6 | 21.7 | 61.2 | – | 0.93 | 47.8 |
| Cay 2010 (8) | 61 ± 11.5 | 72.6 | 43.5 | 17.3 | – | 52.2 | 0.94 | 24.1 |
| Fuji 2011 (9) | 68 ± 9.5 | 80 | 62.3 | 44 | – | 61.5 | – | 31.5 |
| Kinishota 2007 (10) | 66.5 ± 10 | 73.5 | 54.5 | – | – | – | – | 64.5 |
| Nafasi 2014 (12) | 57.4 ± 9.8 | 66.3 | 32.1 | 21 | 25.7 | 50.5 | 1.1 | 20.5 |
| Veselka 2014 (19) | 67.5 ± 9.5 | 67 | 86 | 37 | – | – | 0.93 | 18.5 |
| Study | LM % | LAD % | LCX % | RCA % | Stent number (per patient) | Stent diameter (mm) | Stent length (mm) |
|---|---|---|---|---|---|---|---|
| CLEAR-PCI (11) | 12 | 36.5 | 25.1 | 35.1 | 1.3 | 3.02 | 27.7 |
| ROMA II (15) | – | 78 | 46.6 | 58.6 | 1.4 | – | 25.6 |
| Zemánek 2013 (18) | – | 37 | 23.5 | 40.5 | 1.2 | – | 18.6 |
| Veselka 2011 (17) | 0.5 | 53.5 | 25 | 22.5 | 1.1 | – | 17.3 |
| ARMYDA (13) | – | 52 | 20.5 | 25 | 1.4 | 3.15 | 22.3 |
| ROMA (14) | – | 59.5 | 25 | 30.5 | 1.6 | – | 23.6 |
| Takano 2013 (16) | – | – | – | – | – | – | – |
| Bozbas 2007 (7) | – | – | – | – | 1.2 | – | – |
| Cay 2010 (8) | – | 47.4 | 21.2 | 31.3 | 1.4 | 3 | 18.4 |
| Fuji 2011 (9) | – | 55 | 16.5 | 28.5 | 1.2 | 3.1 | 23.8 |
| Kinishota 2007 (10) | – | 33 | 40 | 26.5 | – | – | 37.9 |
| Nafasi 2014 (12) | 0.55 | 43.1 | 32.1 | 46.8 | – | 2.9 | 24.8 |
| Veselka 2014 (19) | 3 | 39.5 | 26 | 31 | 1.1 | – | 20 |
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