Data are limited about the prevalence trends of risk factors, lesion morphology, and clinical outcomes of coronary artery disease in patients, aged ≤45 years, undergoing percutaneous coronary intervention (PCI), between the bare-metal stent (BMS; 1994 to 2002) and drug-eluting stent (DES; 2003 to 2012) eras. From the PCI database at the Cleveland Clinic, we identified 1,640 patients aged ≤45 years and without a history of coronary artery bypass grafting who underwent PCI from 1994 to 2012. There were 883 patients in the BMS era cohort with a mean follow-up period of 13.15 years and 757 in the DES era cohort with a mean follow-up of 5.02 years. The DES era had more obese (51.8% vs 44.7%, p <0.001) and diabetes (23.0% vs 19.5%, p = 0.09) patients. DES era patients had more B2/C lesions (74.0% vs 32.5%, p <0.001), more severe preprocedural stenosis (86.1 ± 12.9 vs 72.2 ± 21.3, p <0.001), and longer lesions (15.5 ± 9.9 vs 9.6 ± 6.8, p <0.001). No difference was observed in the 30-day mortality between the DES and BMS eras. Irrespective of era, diabetics had worse long-term mortality (19.4% vs 9.3%, p <0.001) compared with nondiabetics. Obese patients had similar long-term outcomes compared with nonobese patients. In conclusion, patients aged ≤45 years, who underwent a PCI procedure in the DES era had worse risk factor profiles, including obesity, compared with patients in the BMS era. They also had more complex lesions. Procedural and long-term outcomes of these patients have not changed between the 2 eras. Young diabetic patients have worse long-term outcomes compared with nondiabetics.
Cardiovascular diseases contribute to annually 0.6 million deaths, which translate to 25% of all deaths and more than 50% of deaths among men in the United States, and nearly 109 billion dollars of medical expenses. Coronary artery disease (CAD) in the young population is particularly important as it is considered premature and a more aggressive form of CAD. In 2010, the overall prevalence of CAD in the general population was 6.0% compared with 1.2% in the 18 to 44 year age group (the young adults). Recent evidence suggests that the decrease in cardiovascular mortality from 1979 to 2011 was mainly due to a reduction in mortality in older CAD patients and not in younger patients. With increasing use of novel medications and interventional techniques over the last 20 years, the clinical outcomes of percutaneous coronary intervention (PCI) in young adults are expected to improve. However, current interventional data pertaining to this age group are limited and restricted mainly to the pre–drug-eluting stent (DES) era and smaller populations. Our study aimed to analyze the trends in the prevalence of risk factors, to study the angiographic properties of the lesions, and to correlate the clinical outcomes with the risk factor profiles for CAD among young adults who underwent PCI over the last 2 decades.
Methods
The study population was obtained from the prospective interventional registry at the Cleveland Clinic, Cleveland, Ohio (US). Of a total of 38,222 patients in the database, we identified 1,914 patients (5.01%) aged ≤45 years who had CAD and underwent PCI from January 1, 1994, to December 31, 2012. Among patients having multiple procedures, only the index procedure was counted. About 257 patients with a history of coronary artery bypass grafting (CABG) were excluded. After these exclusions, our study cohort of 1,640 patients was then stratified by availability of stents: a bare-metal stent, “BMS era group” comprising patients from 1994 to 2002, and a “DES era group” comprising patients from 2003 to 2012.
Baseline characteristics, angiographic and procedural data including complications, were studied. We defined obesity as body mass index ≥30 kg/m 2 , myocardial infarction (MI) at admission as any MI within the last 7 days, remote MI as any MI more than 7 days before PCI, multivessel disease as involvement of lesions in ≥2 coronary arteries.
Statistical analysis was done using SPSS 23.0. Continuous data are presented as mean ± SD and categorical data as frequencies with percentage. Between the 2 groups, continuous data were compared using an independent sample t test, whereas categorical data were compared using the Pearson chi-square test. All p values <0.05 were considered statistically significant. The Kaplan–Meier method was used to calculate the survival estimates and to graphically present the trend in mortality between the 2 groups and also between diabetics versus nondiabetics, obese versus nonobese, and other comparisons. Time to any event was calculated from the day of PCI, until the day of event. Furthermore, log-rank (Mantel–Cox) was used to compare the different groups in Kaplan–Meier graphs.
The primary outcome for our study was mortality, both 30-day mortality and long-term mortality. Secondary outcomes were target lesion revascularizations (any repeat intervention of the target lesion within 30 days), MI (increase in creatine kinase-MB >3 times upper limit of normal) and patients requiring CABG. The study was approved by the Cleveland Clinic Institutional Review Board.
Results
Baseline and lesion/angiographic characteristics between the 2 groups (BMS/DES eras) are listed in Tables 1 and 2 , respectively. There was no significant difference in the all-cause 30-day mortality between the BMS era group and the DES era group (0.3% vs 0.8%, p = 0.32). Overall, the mean follow-up period for the BMS era patients was 13.15 years, and for patients in the DES era, it was 5.02 years. Eight-year survival rate in BMS era patients was 92.2% and 90.0% in the DES era, with no statistical difference (Mantel–Cox log-rank, 0.072; Figure 1 ). Furthermore, no significant difference was noted with respect to target lesion revascularization (1.0% vs 1.2%, p = 0.81), MI (1.8% vs 2.4%, p = 0.49), and in-hospital CABG (0.8% vs 1.3%, p = 0.33) between the 2 groups.
Characteristic | Patients in BMS Era 1994 – 2002 (n = 883) | Patients in DES Era 2003 – 2012 (n = 757) | P Value |
---|---|---|---|
Age (years), mean ± SD | 40.76 ± 4.03 | 40.56 ± 5.04 | 0.37 |
Women | 173 (19.6%) | 203 (26.8%) | 0.001 |
Smoker | 0.05 | ||
Current | 472 (53.5%) | 367 (48.5%) | |
Former | 166 (18.8%) | 177 (23.4%) | |
Never | 245 (27.7%) | 113 (28.1%) | |
Body mass index (kg/m 2 ), mean ± SD | 30.03 ± 6.02 | 31.13 ± 7.21 | <0.001 |
Obese patients | 395 (44.7%) | 392 (51.8%) | <0.001 |
Diabetes mellitus | 172 (19.5%) | 174 (23.0%) | 0.09 |
Insulin therapy | 87 (9.9%) | 87 (11.5%) | 0.30 |
Hypertension | 396 (44.8%) | 474 (62.6%) | <0.001 |
Dyslipidemia | 634 (71.8%) | 563 (74.4%) | 0.27 |
Chronic Obstructive Pulmonary disease | 17 (1.9%) | 49 (6.5%) | <0.001 |
Peripheral Arterial disease | 18 (2.0%) | 38 (5.0%) | 0.001 |
Prior history of CVA | 15 (1.7%) | 20 (2.6%) | 0.23 |
Chronic Renal Failure | 25 (2.8%) | 44 (5.8%) | 0.003 |
Serum Creatinine (mg/dl), mean ± SD | 1.09 ± 1.0 | 1.22 ± 1.40 | 0.09 |
Ejection Fraction | 54.76 ± 10.56 | 49.63 ± 11.97 | <0.001 |
Prior history of PCI | 167 (18.9%) | 138 (18.2%) | 0.70 |
Angina Pectoris | <0.001 | ||
None | 79 (8.9%) | 86 (11.4%) | |
Stable | 127 (14.4%) | 141(18.6%) | |
Unstable | 359 (40.7%) | 161 (21.3%) | |
MI at admission | 318 (36.0%) | 369 (48.7%) | < 0.001 |
Remote MI | 318 (36.0%) | 136 (18.0%) | <0.001 |
Cardiogenic shock | 10 ( 1.1%) | 25 (3.3%) | 0.003 |
Left main trunk disease | 13 (1.2%) | 7 (0.9%) | 0.65 |
Number of Coronary arteries narrowed: | <0.001 | ||
1 | 494 (55.9%) | 616 (81.4%) | |
2 | 280 (31.7%) | 120 (15.9%) | |
3 | 108 (12.2%) | 15 (2.0%) | |
Discharge medications | |||
Aspirin | 137/138 (99.2%) | 690/703 (98.2%) | |
Beta blockers | 118/138 (85.5%) | 589/703 (83.8%) | |
Lipid lowering agent | 34/35 (97.1%) | 672/703 (95.6%) | |
Ace inhibitor | 87/138 (63.0%) | 418/703 (59.5%) |
Characteristic | Patient in BMS Era 1994 – 2003 (n = 883) | Patients in DES Era 2004 – 2012 (n = 757) | P Value |
---|---|---|---|
Total lesions analyzed | 2082 | 1179 | |
PCI treatment type | <0.001 | ||
Bare Metal Stent | 569 (64.4%) | 242 (32.0%) | |
Drug Eluting stent | 0 | 435 (57. 5%) | |
Balloon Angioplasty | 314 (35.4%) | 80 (10.5%) | |
Number of stents per patient, mean ± SD | 1.40 ± 0.67 | 1.65 ± 0.96 | <0.001 |
Stent length (mm), mean ± SD | 21.37 ±11.37 | 29.79 ± 19.08 | <0.001 |
Stent diameter (mm), mean ± SD | 3.36 ± 0.45 | 3.22 ± 0.53 | <0.001 |
Location of coronary narrowing: | 0.10 | ||
Left main | 12 (0.6%) | 7 (0.6%) | |
Left Anterior Descending | 809 (38.9%) | 505 (42.8%) | |
Left circumflex | 462 (22.2%) | 262 (22.2%) | |
Right | 799 (38.4%) | 405 (34.4%) | |
ACC score | <0.001 | ||
A | 721 (34.6%) | 70 (5.9%) | |
B1 | 668 (32.1%) | 235 (19.9%) | |
B2 | 362 (17.4%) | 445 (37.8%) | |
C | 315 (15.1%) | 427 (36.2%) | |
Estimated preprocedural stenosis (%), mean ± SD | 72.24 ± 21.30 | 86.04 ± 12.90 | <0.001 |
Reference vessel diameter (mm), mean ± SD | 2.93 ± 0.64 | 3.08 ± 0.68 | <0.001 |
Lesion length (mm), mean ± SD | 9.60 ± 6.82 | 15.56 ± 10.00 | <0.001 |
Coronary artery size (mm) | <0.001 | ||
> 3 mm | 910 (43.7%) | 564 (47.9%) | |
2.5-3 | 742 (35.6%) | 432 (36.6%) | |
1.5-2.4 | 418 (20.1%) | 183 (15.5%) | |
Ostial stenosis | 90 (10.2%) | 84 ( 11.1%) | 0.57 |
Eccentric stenosis | 172 (19.5%) | 251 (33.2%) | <0.001 |
Chronic total occlusion | 28 (3.2%) | 69 (9.1%) | <0.001 |
Severe Calcification | 10 (1.1%) | 21 (2.8%) | 0.01 |
Pre procedural TIMI flow grade <3 | 264 (29.9%) | 326 (43.1%) | <0.001 |
Post procedural TIMI flow grade <3 | 47 (5.3%) | 59 (7.8%) | 0.04 |